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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
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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
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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
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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
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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
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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
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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
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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
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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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PER-17 In step 18, the system 1000 may display/illustrate an active model 1316 of a first proximal phalange 230 and an active model 1316 of a first distal phalange 240 in the same position as these bones where when the medical imaging 1030 was generated. In certain embodiments, the bone model of the first proximal phalange 230 and the bone model of the first distal phalange 240 may be active models 1316 because a surgeon may want to do other procedures on one or more of these bones, such as an Akin procedure. 337 Added by DJM Jan 2024 1/6/24, 10:05 PM
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PER-17 In the illustrated embodiment, the model 1312 is a bone model 404 that includes a set of active models 1316. The set of active models 1316 includes a first metatarsal model, a medial cuneiform model, a first proximal phalange, and a first distal phalange. Those of skill in the art will appreciate that models of bones to be used in a procedure should be in the set of active models 1316 so that an osteotomy and/or interaction with implants and/or hardware can be presented to an operator and/or a surgeon. 338 Added by DJM Jan 2024 1/6/24, 10:05 PM
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PER-17 In certain embodiments, the number of models that are active models 1316 may be kept to a minimum to preserve computing resources. In the illustrated embodiment, the bone models in the canvas 1304 that are not in the set of active models 1316 may be members of the set of context models 1318. Those of skill in the art will appreciate that models for bones that are not active models 1316 provides needed context for the surgical procedure but these models need not be active model 1316 where they are used for context rather than being actively used in a surgical procedure. With up to 26 bones in a human patient’s foot, those of skill in the art will appreciate the benefits of certain bone models being active models 1316 and others context models 1318. 339 Added by DJM Jan 2024 1/6/24, 10:05 PM
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PER-17 In certain embodiments, the set of active models 1316 may also include any of the bones of a patient’s foot. For example, a bone of the second metatarsal 210 and/or a model of the third metatarsal 212 may also be in the set of active models 1316 depending on the set of work instructions 1040. However, the number of bone models that are active models 1316 may be kept to a minimum to conserve computing resources. 340 Added by DJM Jan 2024 1/6/24, 10:05 PM
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PER-17 In one or more examples, the system 900 includes a processor 904, a memory 906 that is accessible by the processor 904, a communication interface 908, an I/O interface 910, and storage device 914. It may be noted by a person of ordinary skill in the art that the system 900 may include other components for performing various functions consistent with the type of computing device 902 being used (e.g., laptop, desktop, server, tablet, smartphone, and so forth). 249 Added by DJM Jan 2024 1/6/24, 10:05 PM
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PER-17 In some examples, the system 900 utilizes the memory 906 to access program code, executable code, and/or data. The memory 906 may include volatile and/or nonvolatile memory and may include memory that may be coupled or decoupled to the system 900 such as a microSD card solid-state drive, or similar storage device. In various examples, the system 900 may access memory 906 that is virtual memory stored in a storage area network, a remote server, cloud-based data storage, or other discrete or distributed network storage devices. 250 Added by DJM Jan 2024 1/6/24, 10:05 PM
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PER-17 In various examples, the system 900 includes a communication interface 908. The communication interface 908 may include hardware circuits and/or software (e.g., drivers, modem, protocol/network stacks) to support wired or wireless communication between the system 900 and another computing device or network. The wireless connection may include a mobile telephone network. The wireless connection may also employ a Wi-Fi network based on any one of the Institute of Electrical and Electronics Engineers (IEEE) 802.11 standards. Alternatively, the wireless connection may be a Bluetooth® connection. In addition, the wireless connection may employ a Radio Frequency Identification (RFID) communication including RFID standards established by the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the American Society for Testing and Materials® (ASTM®), the DASH7™ Alliance, and EPCGlobal™. 251 Added by DJM Jan 2024 1/6/24, 10:05 PM
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PER-17 The wireless connection may be an infrared connection including connections conforming at least to the Infrared Physical Layer Specification (IrPHY) as defined by the Infrared Data Association® (IrDA®). Alternatively, the wireless connection may be a cellular telephone network communication. All standards and/or connection types include the latest version and revision of the standard and/or connection type as of the filing date of this application. 252 Added by DJM Jan 2024 1/6/24, 10:05 PM
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PER-17 In some examples, the system 900 includes an I/O interface 910 that is configured to communicate with accessories, peripheral devices, input devices, output devices, and so forth. In certain examples, the I/O interface 910 may support various industry standards, such as for example, universal serial bus (USB), USB 2.0, USB 3.0, USB3Vision®, USB 3.1, USB 3.2, FireWire®, HMDI, CameraLink, GigE, and so forth which may be used to communicate with devices, peripherals, accessories, and so forth. The foregoing lists of interfaces with a wired or wireless is not intended to be an exhaustive list of the interfaces that may be used in implementing the system 900 and is intended to show that certain interfaces can be used advantageously to implement the system 900. 253 Added by DJM Jan 2024 1/6/24, 10:05 PM
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PER-17 The I/O interface 910 may include or be in communication with a display device 916 and/or an input device 918. The display device 916 may include any device (e.g., screens, TVs, touch screens, or monitors) configured to present a user interface to a user of the system 900. The input device 918 may include any device (e.g., touch screens, keypads, keyboards, etc.) configured to accept and/or interpret user input. 254 Added by DJM Jan 2024 1/6/24, 10:05 PM
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PER-17 The storage device 914 may include one or more non-volatile storage devices and/or non-volatile storage media that can store data for the system 900. For example, the storage device 914 may store anatomic data 412, data that defines a model, user profile data, user preference data, and the like. "Non-volatile storage media" refers to any hardware, device, component, element, or circuit configured to maintain an alterable physical characteristic (deleted) used to represent a binary value of zero or one after a primary power source is removed. Non-volatile storage media may be used interchangeably herein with the term non-volatile memory media. 255 Added by DJM Jan 2024 1/6/24, 10:05 PM

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