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The Conmed Linvatec Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is intended for reattaching soft tissue to glenoid bone in the shoulder. The following are the indications for use: Bankart lessons, SLAP lesions, capsular shifts, capsulolabral reconstructions.

The Hi-Fi™ UltraFix® Knotless Minimite® Suture Anchor is a sterile, single-use, metal implant that is preloaded with high strength size 2 non-absorbable braided polyethylene suture.

The implanted anchor is manufactured from 316LS Stainless Steel, per ASTMF-138, ISO 832-1 and is preloaded with a non-absorbable, braided, ultra-high molecular weight, polyethylene suture.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Hi-Fi UltraFix Knotless Minimite Suture Anchor) and primarily discusses its substantial equivalence to a predicate device, its intended use, and device description.

It does not contain details regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of a test set.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Therefore, I cannot fulfill your request with the given information.

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