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The AxSOS Locked Plating System in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The AxSOS Locked Plating System is indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur.

This Special 510(k) submission is intended to address modifications to the Device Description. This Special 510(k) backing Insert is being modified as part of a line extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 4mm Locking Inserts to which changes are being made to improve manufacturability. The locking inserts are made from stainless steel per ASTM F138 and ASTM F139. The AxSOS® Locked Plating 4.0mm Locking Inserts have similar or identical and material properties to the predicate 4.0mm Locking Inserts determined substantially equivalent via 510(k) K050512.

This document describes a Special 510(k) submission for a line extension of 4mm locking inserts for the AxSOS® Locked Plating System. This type of submission is for modifications to a legally marketed device that do not alter its intended use or fundamental scientific technology. Therefore, the "study" conducted is primarily non-clinical mechanical testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test. The text mentions "non-clinical laboratory testing was performed," implying a sufficient number of samples were tested to generate reliable data for each mechanical test.
• Data Provenance: Not explicitly stated, but assumed to be laboratory-generated per standard non-clinical testing protocols for medical devices. There is no indication of country of origin for the data, but the manufacturer is based in New Jersey, USA. The testing is retrospective in the sense that it's performed on manufactured devices to compare them to an existing predicate.

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

• Not Applicable. This is a non-clinical, mechanical testing study for substantial equivalence, not a clinical study involving human patient data and expert interpretation. The "ground truth" is defined by established engineering and material science standards and the performance of the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical mechanical testing, there is no need for an adjudication method in the context of expert consensus or dispute resolution. Test results are objective measurements against defined performance requirements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study was not done. The submission explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This is a purely non-clinical submission.

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

• Not Applicable. This is a physical medical device (bone plating system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on established engineering performance requirements and material standards (e.g., ASTM F138 and ASTM F139 for stainless steel), and the demonstrated performance of the legally marketed predicate device (K050512). The goal is to show the modified device performs "as safe and effective as their predicates."

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. It is a physical product undergoing mechanical validation.

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

• Not Applicable. As there is no training set, this question is not relevant.

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