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'cottony'TM II Polyester Suture Tape is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures.

Deknatel Pledgets are indicated as sterile, single use, implantable devices for general suture reinforcement and suture buttressing.

Deknatel Polyester Suture Tapes are nonabsorbable, sterile surgical sutures composed of Poly(ethylene terephthalate). They are prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. Deknatel Polyester suture tapes are provided braided, undyed (white) and dyed

Deknatel Pledgets are precut pieces from a sheet of polytetrafluoroethylene (PTFE) fabric used to spread the load the suture against host tissue.

The document provided is a 510(k) summary for the 'cottony' II Polyester Suture Tape and Pledgets. It states that the device is substantially equivalent to a predicate device (K021019) and preamendment devices. However, it does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size.

Instead, the document primarily focuses on establishing substantial equivalence through:

1. Indications for Use: The 'cottony' II Tape is for general soft tissue approximation and/or ligation (including cardiovascular, ophthalmic, orthopedic, and neurological procedures), and the Pledgets are for suture reinforcement and buttressing. These indications are aligned with the predicate device.
2. Technological Characteristics: A comparison was performed which demonstrated equivalence in performance characteristics.
3. Materials: All patient-contacting materials comply with ISO10993-1.
4. Performance Data (Non-clinical testing): Testing was performed in accordance with ISO11607-1:2006 (packaging) and USP 36-NF 31 (sutures-needle attachment), and (tensile strength) to demonstrate substantial equivalence to the predicate devices.

Therefore, I cannot provide the specific details requested in the acceptance criteria table and the subsequent points (2-9) because this type of information (e.g., sample size, data provenance, number of experts for ground truth, MRMC study results, standalone performance, training set details) is typically found in clinical studies or detailed performance verification reports, which are not part of this 510(k) summary. The 510(k) process relies on demonstrating equivalence to a legally marketed predicate, rather than establishing de novo performance metrics with acceptance criteria like those described for AI/ML devices.

Summary of available information related to performance criteria (though not in the requested format):

The following information cannot be extracted from the provided document as it does not describe a study involving algorithms, AI, or specific clinical performance metrics with detailed acceptance criteria of the type implied by the questions:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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