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The BIOFASTIN RC Threaded Suture Anchor is indicated for shoulder rotator cuff repair.

The BIOFASTIN RC Threaded Suture Anchor is an absorbable, threaded suture anchor. The BIOFASTIN RC anchor has 2 threads of an auger-type design with an overall nominal diameter of 5.0 mm and nominal length of 11.5 mm. The device has two suture holes (90 degrees apart) in the anchor head for fixation of #2 suture to bone (sutures provided pre-attached with affixed tapered needles). The sutures provided with the BIOFASTIN RC are either the ETHIBOND non-absorbable or PANACRYL absorbable sutures.

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a medical device (BIOFASTIN RC Threaded Suture Anchor), and it primarily focuses on establishing substantial equivalence to predicate devices, not on detailing specific performance acceptance criteria or a study demonstrating the device meets those criteria.

The "Safety and Performance" section states: "Results of performance testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This is a high-level statement and does not provide the specific details required to answer your request, such as a table of acceptance criteria, sample sizes, ground truth establishment, or study types.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided text.

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