The Prophecy® Surgical Planning System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Surgical Planning Guides and Reports are intended for use with the Inbone®. Infinity® and Invision® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (e.g. CT scans and X-rays). The Prophecy® Surgical Planning guides are intended for single use only.

Device Description

The Prophecy® Surgical Planning System is composed of three components:

Prophecy® patient-specific guides
Prophecy® 3D Planner
Prophecy® Preoperative report

The Prophecy® Surgical Planning System is compatible with the Inbone®, Infinity®, and Invision® Total Ankle Systems.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Prophecy® Surgical Planning System. The submission focuses on modifications to the Prophecy® 3D Planner software. The information available details non-clinical testing performed to demonstrate substantial equivalence, but it does not provide specific acceptance criteria or an explicit study proving performance against those criteria in a format you requested for a device that involves performance against defined metrics (e.g., accuracy, sensitivity, specificity).

Here's a breakdown of the available information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "All test results met the acceptance criteria, demonstrating the subject device performs as intended and is substantially equivalent to the predicate device." However, the text does not explicitly list the specific acceptance criteria or the reported device performance metrics in a quantitative manner.

2. Sample size used for the test set and the data provenance

The document mentions "Software verification testing," "Software validation," "Usability test," and "Cybersecurity testing." These are general descriptions of testing types. No specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) are provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states, "Clinical testing was not necessary for the determination of substantial equivalence." This implies that the validation did not rely on expert-established ground truth in a clinical context for performance metrics as you typically find for AI diagnostic devices. For the usability testing, the number and qualifications of intended users (surgeons or engineers) involved in establishing ground truth are not specified.

4. Adjudication method for the test set

Since specific acceptance criteria involving expert-reviewed ground truth are not detailed, no adjudication method is mentioned or implied in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document explicitly states, "Clinical testing was not necessary for the determination of substantial equivalence." Therefore, no MRMC comparative effectiveness study was performed or is referenced.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The Prophecy® Surgical Planning System is described as a tool that "assists in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning," and involves "user interface software intended to be used by orthopedic surgeons" and "trained employees/engineers." This suggests a human-in-the-loop process. While software verification and validation would test the algorithm's performance, the context implies it's not a standalone diagnostic AI, but rather a planning and guidance tool. The text does not explicitly detail a standalone algorithm-only performance study in the manner of a diagnostic AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given that clinical testing was not performed for substantial equivalence, the "ground truth" for the software's performance would likely be based on engineering specifications, design requirements, and possibly simulated or phantom data for accuracy of measurements and guide design. For usability, it would relate to user feedback and completion of tasks as per the system's design. The document mentions "software verification testing to ensure all design outputs meet all specified requirements" and "software validation to ensure software specifications conform to user needs and intended uses," which aligns with this interpretation.

8. The sample size for the training set

The document refers to a "Prophecy® 3D Planner" software update. It does not mention any machine learning or AI model training. Therefore, a training set size is not applicable or provided in this context.

9. How the ground truth for the training set was established

As there's no mention of a traditional machine learning training set, this question is not applicable. The "ground truth" for the software's development (not training) would have been established through engineering design processes and requirements.

Summary

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November 1, 2024

Wright Medical Technology, Inc (Stryker) Jonathan Dimotta Staff Specialist, Regulatory Affairs 1023 Cherry Road Memphis, Tennessee 38117

Re: K241999

Trade/Device Name: Prophecy Surgical Planning System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Codes: HSN, OYK, PBF Dated: October 3, 2024 Received: October 3, 2024

Dear Jonathan Dimotta:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,
Peter G.
Allen -S

Digitally signed by Peter G. Allen -S Date: 2024.11.01 14:25:42 -04'00'

For

Lixin Liu Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241999

Device Name

Prophecy Surgical Planning System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PROPHECY® Surgical Planning System.

(a)(1). Submitted By:	Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
Date:	July 8, 2024
Contact Person:	Jonathan DiMottaStaff Regulatory Affairs Specialist
(a)(2). Proprietary Name:	Prophecy® Surgical Planning System(previously known as Prophecy ® PreoperativeNavigation Alignment System)
Common Name:	Alignment guides & 3D planning software
Classification Name and Reference:	21 CFR 888.3110 - Class II - Ankle joint metal/polymer semi-constrained cementedprosthesis21 CFR 888.3030 – Class II – Single/MultipleComponent Metallic Bone Fixation AppliancesAnd Accessories
Device Product Code, Device Panel:	HSN, OYK, PBF
(a)(3). Predicate Device:	K222835 - Prophecy® Preoperative NavigationAlignment System

(a)(4). Device Description

The Prophecy® Surgical Planning System is composed of three components:

Prophecy® patient-specific guides
- The Prophecy® Surgical Planning guides are patient-specific devices that are o designed based on preoperative planning software and assist surgeons in transferring their preoperative plan to surgery by guiding the marking of bone and/or guiding surgical instruments.
Prophecy® 3D Planner
- The Prophecy® 3D Planner software is a web-based application. The user o interface software is intended to be used by orthopedic surgeons, as a preoperative planning and intraoperative viewing software for total ankle replacement surgery.

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Prophecy® Preoperative report ●
- o The Prophecy® Preoperative reports are patient-specific reports created from imaging scans to provide surgeons a template of the patient's distal tibial and proximal talar anatomy and offers relevant information for a successful total ankle replacement surgery.

The Prophecy® Surgical Planning System is compatible with the Inbone®, Infinity®, and Invision® Total Ankle Systems.

(a)(5). Indications for Use

The Prophecy® Surgical Planning System is intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intraoperatively, in guiding the marking of bone before cutting, and in the pre-surgical planning of the ankle and surrounding anatomy to support the total ankle implant. The Prophecy® Surgical Planning Guides and Reports are intended for use with the Inbone®, Infinity® and Invision® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (e.g. CT scans and X-rays). The Prophecy® Surgical Planning guides are intended for single use only.

(a)(6). Technological Characteristics Comparison

The subject device and predicate device have the same key technological characteristics as follows:

. The system processes original patient medical images (i.e., CT scans) and produces patient-specific digital outputs to create a preoperative report and patient specific alignment guides.
Validated commercially off-the-shelf software applications are used for image segmentation, transfer of patient imaging from a DICOM format to an .STL format, and guide design.
Requires trained employees/engineers to manipulate data, using software applications.
Surgeon works with employees/engineers by providing inputs for implant alignment, implant size and implant type modifications.
. Patient-specific alignment guides and bone models are 3D printed via additive manufacturing as the physical output devices.
. Preoperative case reports are produced as an output for planning total ankle replacement surgeries.

The subject device, Prophecy® Surgical Planning System, is substantially equivalent in materials and performance characteristics to the predicate device.

The modifications do not affect the device's intended use. ●
. No changes to the patient-specific alignment guides, preoperative report, or other software components are proposed by this submission.

This submission proposes the following modifications to the subject device:

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Updates to Prophecy® 3D Planner software to include new functionality for new . (i.e., Stryker's internal Prophecy® engineers). Specifically, the software update will be used in place of the current off-the-shelf software used in the production of Prophecy® patient-specific guides (i.e. SolidWorks). The updated 3D Planner 2.0.0 software will be able to assist with landmark placement, implant alignment and sizing, and guide design. The technological differences between the subject and predicate devices are supported with verification and validation evaluations. The differences in design specifications do not raise any different questions of safety and effectiveness over the predicate, which is demonstrated in the performance testing and process validation.

(b)(1). Substantial Equivalence - Non-Clinical Evidence

Performance data and information demonstrating the safety and effectiveness of the Prophecy® Surgical Planning System with the 3D Planner 2.0.0 software is supported by testing that was conducted in-house. This submission includes the following non-clinical testing:

Software verification testing to ensure all design outputs meet all specified ● requirements.
Software validation to ensure software specifications conform to user needs and intended uses.
Usability test to ensure the software is safe and effective for the intended users, uses and use environments.

The software verification and validation were performed in accordance with FDA Guidance Document "Content of Premarket Submissions for Device Software Functions" (June 14, 2023). The usability testing was performed in accordance with FDA guidance document "Applying Human Factors and Usability Engineering to Medical Devices" (issued February 18, 2016). Cybersecurity testing was performed in accordance with "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (issued September 27, 2023).

All test results met the acceptance criteria, demonstrating the subject device performs as intended and is substantially equivalent to the predicate device.

(b)(2). Substantial Equivalence - Clinical Evidence

Clinical testing was not necessary for the determination of substantial equivalence.

(b)(3). Substantial Equivalence - Conclusions

The subject device and predicate device share identical intended use, general design features and basic fundamental scientific technology. The differences between the subject device and predicate device do not raise any different questions of safety or effectiveness. From the evidence submitted in this Traditional 510(k), the subject device can be expected to perform at least as well as the predicate device and are substantially equivalent.

Regulation Number and Section

§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.