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The AxSOSTM 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 AxSOSTM Locking Plate System which was cleared in K061012. This line extension is to add humeral long plates to the existing size range of the AxSOSTM Locking Plate System. These monoaxial long plates will be known as AxSOSTM Proximal Lateral Humerus TS (Threaded Shaft) Long Plates and will be available in 6 length sizes in left and right configurations.

The provided text describes a 510(k) submission for a medical device, the "AxSOS™ Locking Plate System," specifically focusing on a line extension called "AxSOS™ Proximal Lateral Humerus TS Long Plates." This document primarily addresses the substantial equivalence of the new device to a predicate device based on its design, materials, and intended use, supported by non-clinical mechanical testing.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative sense as might be found in a clinical trial or performance study. Instead, it focuses on demonstrating substantial equivalence to a predicate device through engineering design and mechanical testing. The performance is assessed against the predicate device, not against specific numerical clinical outcomes.

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

The document describes non-clinical testing (static strength and fatigue strength testing) of the device. It does not mention a "test set" in the context of patient data or clinical samples. Therefore, there is no information about the sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The testing would have involved physical samples of the plates.

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

This information is not applicable as the document describes non-clinical mechanical testing, not a clinical study involving experts establishing ground truth for patient outcomes.

4. Adjudication method for the test set

This information is not applicable as the document describes non-clinical mechanical 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this document pertains to a medical device's mechanical properties and equivalence, not an AI-assisted diagnostic tool or an evaluation of human reader performance.

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

This information is not applicable as the document describes a bone plate system, not an algorithm or software device.

7. The type of ground truth used

The "ground truth" in this context is the mechanical performance (static and fatigue strength) of the predicate device, which the subject device aims to be equivalent to. The performance parameters were established through engineering mechanical testing methods.

8. The sample size for the training set

This information is not applicable as the document describes non-clinical mechanical testing of a bone plate, not a machine learning model requiring a training set.

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

This information is not applicable as there is no training set mentioned. The ground truth for comparison was the established mechanical performance of the predicate device, determined through standard engineering test methods.

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