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AxSOS 3 Ti is intended for long bone fracture fixation. Indications include: · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures • Non-unions and malunions · Normal and osteopenic bone · Osteotomies · Periprosthetic fractures of the femur and proximal tibia The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of: · Periprosthetic fractures • Diaphyseal and metaphyseal areas of long bones in pediatric patients. The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.

The AxSOS 3 Ti Plating System consists of various monoaxial plates and screws made from Ti-6AI-4V (ASTM F-136 ELI). The system contains previously cleared distal lateral femur plates, proximal lateral tibial plates, distal anterolateral tibia plates, distal medial plates, proximal medial tibia plates and proximal humerus plates provided in various lengths (K123964, K133440, K141121, and K143138). This premarket notification introduces 4.0 mm waisted compression plates and 5.0 mm broad and narrow waisted compression plates in various lengths and number of holes. The system contains previously cleared screws with various lengths and diameters and provided in various configurations (fully or partially threaded) identified in previously cleared premarket notifications (K123964, K133440, K141121, and K143138). This premarket notification introduces blind screws used with the 4.0 mm and 5.0 mm waisted compression plates.

The provided text is a 510(k) summary for the AxSOS 3 Ti device, a bone fixation system. It details the device's indications for use, its description, and its substantial equivalence to predicate devices based on bench testing. However, it explicitly states that clinical testing, and therefore, any studies proving the device meets acceptance criteria, were not required or performed for this submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no such study is described in this document. The submission relies on demonstrating substantial equivalence to previously cleared devices through bench testing and engineering analysis, rather than a clinical trial with specific performance metrics.

Here's a breakdown of why each specific point you requested cannot be fully addressed based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document does not define specific acceptance criteria for a clinical study or report device performance in that context. The "performance" mentioned refers to characteristics demonstrated during bench testing, not clinical outcomes.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No clinical test set was used. The submission relies on bench testing and engineering analysis.

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. No clinical test set with ground truth established by experts was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set was used.

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 physical medical implant (bone fixation system), not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic imaging devices or AI algorithms.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was established for the purpose of this submission. The "ground truth" for the substantial equivalence would implicitly be the established safety and effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable. This is not an AI algorithm, so there is no training set in that context.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence for a physical medical device (bone fixation system), not on presenting clinical study data with specific performance metrics or AI algorithm validation.

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