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This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System is an internal fixation device that consists of monoaxial plates and various types of screws to fit different types of fractures in the tibia and femur. The subject components will be available sterile and non-sterile. The plates will be available in sizes ranging from 95-415mm in length and the screws will range from 10-150mm in length.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Static strength	Substantially equivalent to predicate devices
Dynamic Fatigue Testing	Substantially equivalent to predicate devices
Shear-Off Testing	Substantially equivalent to predicate devices
Insertion Testing	Substantially equivalent to predicate devices
Pull-Out Testing	Substantially equivalent to predicate devices

Sample size used for the test set and the data provenance:

The provided text does not include information on specific sample sizes for the non-clinical tests. The tests were performed on "AxSOS 3 Ti Locking Plate System components" but the number of components tested for each criterion is not specified.

The data provenance is from non-clinical laboratory testing conducted for the AxSOS 3 Ti Locking Plate System components. The location of the laboratory or the specific country of origin for the testing data is not explicitly stated, but the sponsor is Stryker Trauma AG, Switzerland. The study type is non-clinical (benchtop) testing, not related to patient data, so "retrospective or prospective" does not apply in the typical sense.
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 study involved non-clinical mechanical testing, not a clinical evaluation requiring expert interpretation of medical images or data. Ground truth was established through standardized engineering tests.
Adjudication method for the test set:

This information is not applicable as the study involved non-clinical mechanical testing, not a clinical evaluation requiring human interpretation or adjudication.
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:

No MRMC comparative effectiveness study was done. This submission explicitly states, "Clinical testing was not required for this submission." The study focused solely on non-clinical mechanical performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No standalone (algorithm only) performance study was done. This device is a physical bone fixation system and does not involve AI algorithms.
The type of ground truth used:

The ground truth used was based on results from standardized biomechanical and mechanical tests. This includes measurements of static strength, dynamic fatigue, shear-off properties, insertion forces, and pull-out resistance, all compared against established performance benchmarks or predicate devices.
The sample size for the training set:

This information is not applicable as this submission is for a physical medical device (bone plates and screws) and does not involve an AI algorithm with a training set.
How the ground truth for the training set was established:

This information is not applicable as this submission is for a physical medical device and does not involve an AI algorithm with a training set or associated ground truth establishment.

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