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1. Complex fracture-dislocations of the proximal Interphalangeal joint.
2. Unstable PIP dislocations
3. Post-traumatic contracture of the PIP joint

The BioSymMetRic Proximal Interphalangeal Joint Fixator is an external fixator to assist in the healing of fractures or other bone cutting procedures of the fingers. The device is an external frame to provide stability and distraction for pins inserted through the skin into the bone.

The provided text is a 510(k) premarket notification for a medical device called the BioSymMetRic™ Proximal Interphalangeal Joint Fixator. It details the device's classification, intended use, risks, and substantial equivalence to a predicate device.

However, the document does not contain the information requested regarding:

• Acceptance criteria and reported device performance: There is no table or discussion of specific performance metrics or thresholds the device must meet, nor any data demonstrating it has met them. The document is a regulatory submission for market clearance based on substantial equivalence, not a performance study report.
• Study design details: There is no mention of a formal study, test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, ground truth types, or training set details. This type of information would typically be found in a clinical trial report or a detailed validation study, which is not present in this 510(k) summary.

Therefore, I cannot provide the requested table and study details. The document's purpose is to establish substantial equivalence to a previously cleared device, not to present a de novo performance study.

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