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APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies, and arthrodeses.

The subject device plates have anatomic designs and are provided in two designs, each for the left and right radius: Lunate Facet Plate and Distal Radius Rim Plate. The Lunate Facet Plates have a maximum thickness of 1.6 mm, and maximum overall dimensions of approximately 19 mm x 47 mm before bending to conform to the anatomy of the distal radius. The Distal Radius Rim Plates have a maximum thickness of 1.8 mm, and maximum overall dimensions of approximately 22 mm x 53 mm before bending to conform to the anatomy of the distal radius. The screw holes of the subject device plates are designed to accommodate appropriately sized bone screws (locking and non-locking) presently marketed as part of the APTUS System and previously cleared under K142906, K103332, and K051567. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are made of unalloved titanium. Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document is a 510(k) summary for the APTUS® Wrist 2.5 System, a bone fixation device. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting new, unique performance acceptance criteria for an AI-powered diagnostic device. Therefore, the questions related to AI performance, human reader improvement with AI, ground truth establishment, training sets, and adjudication methods are largely not applicable in this context.

The document describes the device's characteristics and performance data related to its mechanical properties compared to a predicate device to establish substantial equivalence.

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

The document does not explicitly state "acceptance criteria" in the sense of specific thresholds for performance metrics that the device must meet to be approved. Instead, it describes comparative performance testing to demonstrate substantial equivalence to a legally marketed predicate device. The implied acceptance criterion is that the subject device's performance is at least equivalent to, or superior to, the predicate device in relevant mechanical tests, and that any differences do not raise new issues of safety or efficacy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "non-clinical testing data," "engineering analysis," "static mechanical testing," and "dynamic mechanical testing." It does not specify sample sizes for these tests (e.g., number of plates tested) nor the country of origin or type (retrospective/prospective) of this engineering data. This is common for mechanical testing, where instead of "samples" in a clinical sense, a sufficient number of test articles are manufactured and tested to ensure statistical validity and representativeness of the production process. Clinical data was explicitly not provided in this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a mechanical device, not a diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. This is a mechanical device, not a diagnostic device requiring adjudication of human readings.

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

Not applicable. This device is a bone fixation system and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This device does not involve an algorithm.

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

The "ground truth" for the mechanical performance of this device would be established through objective, standardized laboratory measurements against known engineering principles and ASTM standards. For biocompatibility, it's based on established material properties and biological response data for Titanium Grade 4. The comparison is made against the performance of a predicate device established through similar testing.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning model.

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

Not applicable. This is a mechanical device, not a machine learning model.

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