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The TITANEX® Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.

The TITANEX® Screw Systems contain cannulated bone screws and general instrumentation as a reconstruction solution for foot and ankle applications. The screws are provided in various diameters and lengths with headed, headless, partially, and fully threaded configurations. The implants are composed of titanium alloy. The instrumentation are composed of stainless steels. The devices are provided non-sterile and are intended to be steam sterilized prior to use.

I am sorry, but the provided text from the FDA 510(k) Premarket Notification does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria for an AI/ML-based medical device.

The document pertains to the "TITANEX® Screw Systems," which are metallic bone fixation fasteners, and focuses on demonstrating substantial equivalence to already marketed predicate devices. The non-clinical tests performed (e.g., torsional properties, driving torque, axial pullout strength, sterilization, biological evaluation) are typical for mechanical orthopedic implants.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualification of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone AI performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Training set sample size.
9. Ground truth establishment method for the training set.

This information is not present in the provided document because the device in question is a physical orthopedic implant, not an AI/ML-based diagnostic or therapeutic device.

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