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The FootBridge Medical HyperFlex™ Bunion Correction System is intended for use in reconstruction (correction) of the hallux valgus deformity by holding the reduction of the 1st metatarsal intermetatarsal (IM) angle in adults and pediatric patients aged ≥13 years in which growth plates have fused.

The FootBridge Medical HyperFlex™ Bunion Correction System is an implantable device and accompanying instrumentation used to treat a hallux valgus deformity (bunion). It includes components that attach to the 1st and 2nd metatarsals which are joined by a suture. The system reduces the IM angle between the 1st and 2nd metatarsal without restricting range of motion in the sagittal plane. The implant will be offered in several sizes to fit the anatomical needs of the patient population.

I apologize, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the "HyperFlex Bunion Correction System," which indicates the device is substantially equivalent to a predicate device.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance: While it mentions various bench tests conducted (Static and Fatigue Tensile Testing, Screw Torsional Strength Testing, etc.), it does not provide specific acceptance criteria or the numerical results of these tests.
2. Sample size used for the test set and data provenance: No information on a test set, its size, or where the data came from is present. The document focuses on bench testing, not clinical data or human-derived test sets.
3. Number of experts and their qualifications for ground truth: Since no human-based test set or ground truth establishment is described, this information is not available.
4. Adjudication method: Not applicable as there is no human-based test set.
5. MRMC comparative effectiveness study: The document does not mention any multi-reader multi-case studies or the effect size of AI assistance.
6. Standalone (algorithm only) performance: This device is a physical bone fixation system, not a software algorithm, so standalone performance in that context is not relevant or discussed.
7. Type of ground truth used: Not applicable as there's no mention of a human-based test set for ground truth.
8. Training set sample size: No training set is mentioned as this is a physical medical device, not an AI/ML algorithm.
9. How ground truth for the training set was established: Not applicable.

The document primarily focuses on establishing "substantial equivalence" through bench testing and comparison to a predicate device (Arthrex Mini TightRope and Mini TightRope FT), rather than a detailed performance study against specific acceptance criteria with human or clinical data.

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