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The AxSOS™ Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.

This Special 510(k) submission is a line extension to address modifications made to the AxSOS™ Locking Plate System which was cleared in K061012. This line extension is to add four femoral long plates to the existing size range of the AxSOS™ Locking Plate System. These monoaxial long plates will be known as AxSOS™ Distal Lateral Femur TS (Threaded Shaft) Long Plates and will be available in two lengths in left and right configurations.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the "AxSOS™ Distal Lateral Femur TS Long Plates are substantially equivalent to the AxSOS™ Distal Lateral Femur TS Plates of the AxSOS™ Locking Plate System cleared under K061012 in regards to intended use, design, materials, and operational principles as a bone fixation device." The specific performance metrics for static and fatigue strength are stated as having "demonstrated the subject plates are substantially equivalent to the predicate devices" but no numerical acceptance ranges or specific values are provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The provided text only mentions "Static strength as well as fatigue strength testing" for the subject device. It does not specify a sample size for these tests, nor does it describe them as a "test set" in the context of clinical or image-based studies. The data provenance is also not mentioned (e.g., country of origin, retrospective/prospective), as these are in vitro mechanical tests, not human data studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the provided document describes a 510(k) submission for a medical device (bone fixation plates) based on mechanical testing and substantial equivalence, not a study involving human readers or image analysis requiring expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not conducted. This document describes a mechanical device substantially equivalent to a predicate, not an AI or imaging diagnostic tool.

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

A standalone performance study of an algorithm was not done. This document pertains to a physical medical device.

7. The Type of Ground Truth Used

For the mechanical testing (static and fatigue strength), the "ground truth" would be established by standardized engineering testing protocols and measurement instruments. There is no mention of expert consensus, pathology, or outcomes data, as these are material science evaluations.

8. The Sample Size for the Training Set

There is no mention of a "training set" in this document. The submission relies on demonstrating substantial equivalence through design comparisons and mechanical testing, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set mentioned.

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