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The Anika Tissue Tack is indicated for the fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures, such as rotator cuff repair.

The Anika Tissue Tack Fixation System consists of dart shaped tacks and a delivery instrument. The tissue tacks are comprised of bioabsorbable 82/18 poly(lactic-co-glycolic acid) [PLGA] and dyed with D&C Violet #2. The tissue tacks are designed to provide stable fixation of a prosthetic material or biologics to soft tissues during the healing process and are used in conjunction with a delivery instrument from Anika. The delivery instruments are comprised of surgical grade stainless steels and high temperature plastics and are designed to deliver the tissue tacks. The tissue tacks and delivery instruments are provided sterile for single use only. The tacks are packaged in a caddy within a dual sterile seal configuration.

I am sorry but this document does not contain the information requested. This document is a 510(k) summary for a medical device which describes the device, its indications for use, and its substantial equivalence to predicate devices based on non-clinical testing. It does not include information about acceptance criteria or specific studies that demonstrate the device meets those criteria in the way you have asked for (e.g., with detailed statistics on performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance).

Specifically, the document states:

• "No clinical testing was submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence for the Anika Tissue Tack Fixation System."
• The performance testing summarized includes "Mechanical retention strength, tensile & shear", "Degradation testing", "Insertion and removal evaluation", "Biocompatibility Testing", and "Bacterial endotoxin limit test". However, no specific acceptance criteria or detailed results are provided.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies for this device.

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