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The Bosworth Coraco-Clavicular Screw is intended for uses in cases of acromioclavicular reduction and acromioclavicular fixation; acromioclavicular reduction; coracoclavicular ligament repair, and coracoclavicular fixation; a combination of the aforementioned indications; distal clavicle extension; and muscle transfers.

This Special 510(k) submission is intended to address a material modification to the Bosworth Coraco-Clavicular Screw and the associated washer for use with the screw. The material modification involves changing the material from cast cobalt chromium alloy to wrought cobalt chromium alloy. The design, intended use, packaging and sterilization of the subject devices are identical to those of predicate devices.

The provided text pertains to a Special 510(k) submission for a material modification to a medical device, the Bosworth Coraco-Clavicular Screw. This type of submission is for modifications to existing devices and primarily focuses on demonstrating that the modified device remains substantially equivalent to the predicate device.

Therefore, the submission does not contain information typically found in a clinical study for a new device or a device that uses AI/ML. Specifically, it lacks data on acceptance criteria related to statistical performance metrics, sample sizes for test sets, expert ground truth establishment, or any comparative effectiveness studies involving AI/human readers.

The key information from the provided text is:

• Device Modification: The material for the Bosworth Coraco-Clavicular Screw and associated washer was changed from cast cobalt chromium alloy to wrought cobalt chromium alloy.
• Intended Use: The intended use remains unchanged and includes: acromioclavicular reduction and fixation, coracoclavicular ligament repair and fixation, combination of these indications, distal clavicle excision, and muscle transfers.
• Technological Comparison: Analysis demonstrated comparable properties of the modified device to the predicate device.
• Regulatory Outcome: The FDA determined the device to be substantially equivalent to legally marketed predicate devices.

Given this context, I cannot provide the specific details requested in your prompt because they are not present in the provided document. The document describes a material change and a substantial equivalence determination based on technological comparison, not a performance study against specific acceptance criteria using a test set with expert adjudication for a device involving AI or complex performance metrics.

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