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Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.

The Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic nonabsorbable tissue-closure device that is intended for use in the closure of soft tissue, excluding closure of the epidermis. It is comprised of high molecular weight, isotactic polypropylene, undyed, or dyed blue with Phthalocyaninato (2-) Copper. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 0 in various lengths affixed to various needle types.

The provided text describes a medical device, the Quill™ Polypropylene Knotless Tissue-Closure Device, and its regulatory submission. It does not contain information about a study with acceptance criteria, reported device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document is a 510(k) summary for a substantial equivalence determination by the FDA, primarily relying on performance testing against existing standards and comparison to predicate devices, rather than a clinical study evaluating diagnostic or therapeutic efficacy with defined acceptance criteria for such metrics.

Therefore, I cannot provide the requested information based on the given text. The document focuses on:

• Device Description: A sterile, synthetic nonabsorbable tissue-closure device with barbs and a loop design, made of polypropylene.
• Indications for Use: Soft tissue approximation, excluding epidermis closure.
• Substantial Equivalence Claims: Based on material composition and intended use being identical to a predicate barbed suture, and design being identical to other knotless tissue-closure devices.
• Performance Tests: Non-clinical laboratory testing to confirm compliance with USP monograph for nonabsorbable sutures regarding tensile strength and needle attachment, performed according to FDA's Class II Special Controls Guidance Document: Surgical Sutures.

Since the device is a surgical suture, the "acceptance criteria" discussed are related to physical and mechanical properties (tensile strength, needle attachment) rather than diagnostic performance metrics (e.g., sensitivity, specificity) expected in studies involving AI algorithms or human reader performance.

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