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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.

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.

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.

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