Dave's PCF WIP: Paragraphs

Paragraphs

Actions	Application	Content	Paragraph Number	Notes	Modified
		Content		Paragraph Number	Notes	Any Field
View Edit Delete	PER-17	In certain embodiments, the system 1000 is configured to advance in order from a current step to a subsequent step in the workflow 1050 in response to an instruction from the user 1002. Said another way, the user 1002 is in control of progression through the workflow 1050. In one embodiment, the steps that are completed by the user 1002 may include a control button that enables the user 1002 to indicate when they have completed that particular step. For example, in the illustrated embodiment, steps to be performed by the user (e.g., indicated by the person head icon 1310) may also include a control button 1317 labeled “I’m done” which a user 1002 can activate when they have completed all tasks to the steps they are responsible for.	317	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In certain embodiments, the system 1000 may advance, in order to, a subsequent step in the sequence of steps 1202 of the workflow 1050 in response to the “I’m done” instruction provided by the user 1002. Finally, the system 1000 may terminate the workflow 1050 when a last step of the workflow 1050 is completed.	318	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In certain embodiments, the system 1000 may review and/or check the work performed by the user 1002 after the user 1002 indicates that they have completed the step assigned to them. For example, where a user adds descriptive text, the system 1000 may spell check the text for accuracy. Alternatively, or in addition, the system 1000 may check that changes made by the user 1002 are within a range of acceptable parameters.	319	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Similarly, a user 1002 may review and/or revise tasks performed by the system 1000 when the system 1000 implements one of the steps assigned to the system 1000. For example, in one embodiment, the system 1000 may be tasked with locating a longitudinal axis for a long bone model. After the system 1000 defines a longitudinal axis, a user 1002 may refine or revise the definition for improved accuracy.	320	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In certain embodiments, the workflow 1050 may include steps that require action by both the system 1000 and the user 1002. Such steps may be referred to as “hybrid steps.” Such steps may be indicated by both a robot head icon 1308 and a person head icon 1310 on the same step. In such steps, the system 1000 or the user 1002 may perform a first set of tasks for the step and the remaining tasks of the step are performed by the other one of the system 1000 or the user 1002. For example, the system 1000 may orient a bone model 404 and may measure a structure within the bone model 404, next a user 1002 may use the measurements to define a cut face for a planned resection of the bone model 404. Thus, in such a step a user 1002 may interact with the bone model 404 to complete the step. Alternatively, or in addition, hybrid steps may be divided into new steps, one to be completed exclusively by the system 1000 and a subsequent step to be completed exclusively by the user 1002.	321	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	FIG. 13B illustrates an exemplary user interface 1300 for one step, one stage, of a workflow 1050 for generating a patient-specific device 1090, according to one embodiment. The canvas 1304 illustrates a model 1312 that is also an active model 1316 of the model 1312. In certain embodiments, a model 1312 can be or can include different types of models. An active model 1316 is a model of a three dimensional object in a solid form. The active model 1316 includes accurate modeling of a surface of the object was well as the internal structures and/or parts of the object (e.g., the solid volume of a bone, including any internal structures).	322	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In the illustrated embodiment, the model 1312 of the first metatarsal 208 is an active model 1316 to enable other steps and/or operations to be performed on the bone model as part of the workflow 1050. For example, by modeling a solid bone the active model 1316 enables an accurate representation of how the bone can be cut, resected, drilled, or otherwise modified as part of the workflow 1050. Generally, a bone model 404 having models that are to be manipulated, modified, and/or changed as part of a workflow 1050 may be modeled as active models 1316 such that the manipulation, modifications, and/or changes are as realistic as possible.	323	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In addition, the system 1000 supports context models (see FIGs. 13C, 13D, 13E). A context model 1318 is a model that provides context in relation to other models, such as active models 1316. A context model 1318 is a representation of an object that provides an indication of the size and/or dimensions of the object and may include coloring of the object. Generally, a context model 1318 is not resected or cut or manipulated in a way such that a solid representation of the object is needed. Typically, the size and configuration of the object indicated by a context model 1318 is sufficient for the purposes of the workflow 1050. Accordingly, a context model 1318 can be represented in the system 1000 as a 3D wireframe and/or a 3D surface that defines a corresponding surface of a bone represented by the context model 1318. In certain instances, a context model 1318 may be a two dimensional image of the object. Advantageously, modeling, modifying, and/or working with a context model 1318 requires minimal computing resources to load, display, manipulate, view, print, store, etc.	324	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Examples of active models 1316 may include a bone model of a first metatarsal 208 and/or a medial cuneiform 202 because these are models of bones that may receive an osteotomy as part of a surgical procedure that uses the patient-specific device 1090. Therefore, the bone models 404 of the first metatarsal 208 and medial cuneiform 202 may be active models 1316 while other bone models of other bones of a patient’s foot around the first metatarsal 208 and a medial cuneiform 202 may be represented by context models 1318.	325	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Advantageously, active model 1316 can provide a highly realistic representation of the physical bones of the patient. These representations are helpful to define one or more osteotomies to be performed on bones represented by the active models 1316. However, modeling, presenting, manipulating, and otherwise working with active model 1316 can consume more computing resources than non-active models 1316. In contrast, context models 1318 include sufficient detail and/or information to give an operator, user, and/or surgeon an understanding of the relationship between bones represented by the active models 1316 and bones represented by the context models 1318 and consume fewer computing resources. Advantageously, the bone models 404 of the present disclosure includes a set of active models 1316 and a set of context models 1318. The context models 1318 are configured to use less/fewer computing resources than the active model 1316. In this manner, the embodiments of the present disclosure optimize the use of computing resources and provide an efficient and effective system 1000 for generating patient-specific devices 1090.	326	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Those of skill in the art will appreciate that in addition to a bone model 404 including a combination of active models 1316 and context models 1318, a patient-specific device model 1072 may include a combination of active models 1316 and context models 1318. For example, certain parts or components of a patient-specific device model 1072 may be well known and/or may not be customized and may thus be represented as context models 1318 rather than active models 1316. In this manner, use of computing resources can be optimized by the system 1000.	327	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Referring to FIG. 13B, as indicated in the workflow pane 1306 with the highlight 1314, the workflow 1050 is on step #9. Steps #6-8 have been completed. The canvas 1304 illustrates an active model 1316 of a first metatarsal 208 with the base on the left side and the head on the right side of the canvas 1304. The view through the canvas 1304 is from a medial side of the active model 1316.	328	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In step 6, a user 1002 has selected a vertex 1320 for defining a bone model longitudinal axis 1322 through the active model 1316 of a first metatarsal 208. In the illustrated embodiment, selection of a vertex 1320 is an initial step in defining a bone model longitudinal axis 1322. Next, in step 7, the system 1000 may define a plane 1324 through the selected vertex 1320 and perpendicular to the view through the canvas 1304. Next, the system 1000 may define a bone model longitudinal axis 1322 as a horizontal line from left to right that intersects the plane 1324 perpendicular to the view at the selected vertex 1320. The horizontal line is then designated, for example by the system 1000, as the bone model longitudinal axis 1322. In the illustrated example, the user 1002 has cooperated with the system 1000 to determine the bone model longitudinal axis 1322.	329	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	As illustrated, the bone model longitudinal axis 1322 is centered vertically within the active model 1316 of the first metatarsal 208. Thus, the bone model longitudinal axis 1322 is centered within the sagittal plane 262. In addition, the bone model longitudinal axis 1322 should be centered within the transverse plane 266 and the frontal plane 264. Consequently, selection of the vertex 1320, step 6 by the user 1002, is an important step in defining the bone model longitudinal axis 1322. In fact, in embodiments that rely on the proper and accurate defining of the bone model longitudinal axis 1322, step 6 may be considered a key step. Said another way, the bone model longitudinal axis 1322 may serve as a reference feature. This reference feature may be used by one or more other aspects in the bone model 404 and/or a patient-specific device model 1072. Those of skill in the art will appreciate that if the bone model longitudinal axis 1322 is not accurate other measurements and/or steps in the workflow 1050 may also be inaccurate.	330	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Advantageously, embodiments of the present disclosure enable key steps to be designated to a skilled operator, user 1002. Alternatively, the user 1002 may perform key steps together with the aid of the system 1000. The performance of key steps by a user 1002 can provide valuable safeguards and checks on the use of automation and/or advanced computer analysis system, expert systems, machine learning, and/or automated/artificial intelligence (e.g., ANN, GAN, or the like).	331	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Note that in one embodiment, step 8 is a step performed by the user 1002. The user 1002 is to adjust and/or check the position of the bone model longitudinal axis 1322 to confirm that the bone model longitudinal axis 1322 is centered within the active model 1316 of the first metatarsal 208 in the sagittal plane 262, transverse plane 266, and frontal plane 264. If the user 1002 determines that the bone model longitudinal axis 1322 is not correctly centered, the user 1002 may adjust the position of the bone model longitudinal axis 1322 within an appropriate axis. Alternatively, or in addition, the user 1002 may use tools of the user interface 1300 to adjust the position of the bone model longitudinal axis 1322. Thus, in this example, the workflow 1050 includes one or more steps of determining a longitudinal axis for an active model 1316 of a bone model 404.	332	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	In certain embodiments, steps such as step 6 and/or steps 6-8 may be optimized by way of automation and/or advanced computer analysis system, expert systems, machine learning, and/or automated/artificial intelligence (e.g., ANN, GAN, or the like). For example, the patient-specific device design apparatus 450 may include executable computer code configured to determine a longitudinal axis for an active model 1316 of the bone model 404. In such embodiments, the accuracy of the automation and/or advanced computer analysis system and/or artificial intelligence may be such that further adjustment by a user may not be necessary. Alternatively, or in addition, a check of the work of the system 1000 by a user 1002 may still be included in the workflow 1050 to ensure that mistakes are not made and/or are not missed. Thus, even key steps in certain embodiments may use automation, advanced computer analysis system, expert systems, machine learning, and/or automated/artificial intelligence (e.g., ANN, GAN, or the like).	333	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	FIG. 13B illustrates that in step 9, a user may define and/or adjust an offset, a width measured from a proximal end 1326 of the active model 1316 to the distal end 1328, for an osteotomy of the proximal end 1326. Such a step can be done by the system 1000 with a default offset and then subsequently adjusted by a user 1002. Alternatively, step 9 can be done solely by the user 1002 with reference to a set of work instructions 1040 and/or a prescription 1100 to make the offset match the request of a surgeon. Once step 9 is completed, a cut plane for an osteotomy is defined for the active model 1316 of the first metatarsal 208.	334	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	FIG. 13C illustrates an exemplary user interface 1300 for one step, one stage, of a workflow 1050 for generating a patient-specific device 1090, according to one embodiment. At this stage, the workflow 1050 has progressed to step 19.	335	Added by DJM Jan 2024	1/6/24, 10:05 PM
View Edit Delete	PER-17	Note that in step 17, a user 1002 has positioned the active model 1316 of the first metatarsal 208 relative to an active model 1316 of the medial cuneiform 202. For the illustrated embodiment, the distal end of the active model 1316 of the medial cuneiform 202 will receive an osteotomy and the proximal end 1326 of the active model 1316 of the first metatarsal 208 will receive an osteotomy. The user 1002 has repositioned the active model 1316 of the first metatarsal 208 relative to an active model 1316 of the medial cuneiform 202 to provide a correction, a corrected positioning/orientation. In one embodiment, the user 1002 may use a context model 1318 of the second metatarsal 210 as a reference feature and may reposition the active model 1316 of the first metatarsal 208 until the active model 1316 of the first metatarsal 208 is parallel and/or substantially parallel to the context model 1318 of the second metatarsal 210. Note that the user 1002 may confirm the corrected positioning in the sagittal plane 262, frontal plane 264, and transverse plane 266. Step 17 may also be a key step and a user 1002 may complete this step independently and/or with the assistance of the system 1000.	336	Added by DJM Jan 2024	1/6/24, 10:05 PM

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