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Wright's PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are intended for use with Wright's INBONE® 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. The PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are intended for single use only.

PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides are designed and manufactured from patient imaging data (CT), and are made from biocompatible nylon. The PROPHECY® Guides serve as an alternative to traditional alignment instrumentation used with Wright's INBONE® Total Ankle System, and thereby reduce the overall number of surgical steps required during total ankle arthroplasty. The guides serve to position and align the INBONE® implants in a comparable position to that attainable with traditional INBONE® instrumentation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides:

The provided document does not contain specific numerical acceptance criteria for the device's performance. Instead, it describes general performance tests and states that the data supports the safety and efficacy of the device as substantially equivalent to a predicate device. Therefore, the "Reported Device Performance" column in the table below will reflect the type of validation performed rather than a specific numerical value against a pre-defined threshold.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. A table of acceptance criteria and the reported device performance

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

The document does not specify the sample size for the "cadaver testing" or the "repeatability testing." It also does not define the data provenance (e.g., country of origin, retrospective/prospective). Given that the device is manufactured in the US, it's highly probable the testing was conducted within the US, but this is not explicitly stated.

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

The document refers to "end users" for cadaver testing. However, it does not specify the number of these "end users" or their explicit qualifications (e.g., "radiologist with 10 years of experience"). It can be inferred that "end users" would be surgeons or individuals with relevant surgical experience, but this is not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method used for the performance testing.

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

No MRMC study is mentioned. The device is a patient-specific surgical guide, not an AI or imaging diagnostic tool that would typically involve "human readers" in the sense of image interpretation. Its function is to assist in the physical positioning and alignment of implants.

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

The device itself (the physical guide) is designed from "patient imaging data (CT)" using a "device design algorithm." The "detailed software descriptions and documentation" and "device design algorithm" mentioned point to standalone performance of the algorithm in generating the guide design. The "repeatability testing across design engineers" likely validates the consistent output of this algorithm regardless of the engineer. However, the ultimate "performance" of the guide is human-in-the-loop (surgical use).

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

For the "cadaver testing," the ground truth was "placement location and orientation" as determined by "end users." This implies an expert-based or intra-operative assessment of the guide's accuracy in achieving desired implant positioning. It's an direct measurement of physical alignment outcomes.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of device design beyond the use of "patient imaging data (CT)" to create individual guides. There is no information regarding a distinct training set size for the software/algorithm that generates the guides.

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

As no explicit "training set" with established ground truth is described (beyond the patient's own CT data serving as the basis for design), this information is not available in the provided text. The "ground truth" for each patient's guide design essentially derived from their specific anatomical landmarks identifiable on their CT scans.

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