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Forma Medical Headless Compression Screws are indicated for fixation of intra-articular and extra articular fractures, avulsions, non-unions, and osteotomies of small bone fragments; as well as arthrodesis of small joints.

Forma Medical Headless Compression Screws are designed to hold bones in relative stability for fracture fixation and arthrodesis. The screws are available in multiple diameters and lengths based on patient anatomy and clinical application. The screws are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1537, and F138. The system includes screws and instruments. The system instrumentation is manufactured from stainless steel, aluminum, and other surgical grade materials.

The provided text is a 510(k) summary for the Forma Medical Headless Compression Screw. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance, specifically regarding AI/ML device performance or human reader improvement.

The document solely focuses on demonstrating substantial equivalence based on technological characteristics and mechanical performance compared to predicate devices. It mentions mechanical testing per ASTM F543 for torsional strength, insertion/removal torque, and pullout strength. However, it does not provide specific acceptance criteria values or detailed results of these tests.

Therefore, it is not possible to answer the user's request based on the provided text. The request asks for details about acceptance criteria and a study proving "the device meets the acceptance criteria," implying a performance study, likely clinical, which is entirely absent from this 510(k) summary for a mechanical orthopedic implant.

To reiterate, the document details:

• Device name and indications for use.
• Comparison of technological characteristics (classification, regulation, product code, indications for use, description, material, lengths, cannulation) between the Forma Medical screw and several predicate devices.
• Mention of mechanical testing (torsional strength, insertion/removal torque, pullout strength per ASTM F543) to support substantial equivalence.

It does not contain information regarding:

• A table of acceptance criteria with reported device performance values.
• Sample sizes for a test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes for human reader improvement with AI.
• Standalone algorithm performance.
• Types of ground truth (expert consensus, pathology, outcomes data).
• Training set sample size.
• How ground truth for the training set was established.

These specific points are relevant to AI/ML software as a medical device (SaMD) clearances, not directly to a mechanical orthopedic implant like a compression screw where the focus is on mechanical and material equivalence.

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