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SutureTape is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft tissue are used for repair.

SutureTape is a braided suture made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester, and may include nylon. The proposed suture is braided flat with round ends and has a width of 1.3 mm. SutureTape is available in precut lengths in straight and loop configurations, and with or without needles. SutureTape is packaged sterile for single use. SutureTape meets USP standards for size 2 suture, except for an oversize in diameter. The SutureTape modifications as compared to the predicate device(s) include smaller tape width (1.3mm vs. 1.5mm), lack of a suture core and different braiding pattern of colored yarns. Additionally, SutureTape is braided flat similar to the cleared LabralTape (K122374) but has round suture tails similar to the cleared FiberTape (K032245).

The provided text is a 510(k) summary for a medical device called "SutureTape." It describes the device, its intended use, and performance data from various tests. However, it does not contain information about a study involving AI or human readers, or any other details related to AI performance criteria.

Therefore, many of your requested points cannot be answered from the provided document.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not mentioned in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI-assisted diagnostic device. The "ground truth" here refers to established standards (USP requirements, EP/USP standards).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.

7. The type of ground truth used: For mechanical properties, the ground truth is United States Pharmacopeia (USP) requirements for surgical sutures. For pyrogen testing, the ground truth is EP 2.6.14/USP <85> standards. Biocompatibility and shelf-life are determined based on similarity to predicate devices.

8. The sample size for the training set: Not applicable, as this is not an AI device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

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