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Quil™ 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.

This document is a 510(k) Pre-Market Notification from the FDA regarding a Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design (K15112). This device is a nonabsorbable polypropylene surgical suture.

Based on the provided text, a "study" in the traditional sense of evaluating an AI or software device to meet acceptance criteria with various types of ground truth and reader studies was not conducted. The document describes a substantial equivalence determination for a medical device (suture), not an AI/software as a medical device (SaMD). Therefore, many of the requested elements for AI/SaMD performance evaluation are not applicable.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence determination for a physical medical device (suture), the "acceptance criteria" and "reported device performance" are framed around demonstrating equivalence to a predicate device and adherence to recognized standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document refers to "Non-clinical laboratory performance testing." This typically involves in-vitro or bench testing of the physical suture material. No information about sample size, country of origin, or whether the data was retrospective or prospective is provided in this summary. It is laboratory data, not patient data in the context of disease diagnosis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not a study involving expert review for establishing ground truth for diagnostic or prognostic purposes. The "ground truth" for a suture's physical properties would be established through standardized laboratory testing methods and measurements.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/SaMD device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/SaMD device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device would be based on the physical and mechanical properties of the suture as measured by standardized laboratory methods (e.g., tensile strength, dimension conformity, material composition checks) as defined by the USP monograph for surgical sutures.

8. The sample size for the training set:

Not applicable. This is not an AI/SaMD device that requires training data.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/SaMD device that requires training data and corresponding ground truth.

Summary regarding AI/SaMD criteria applicability:

The provided document describes the FDA's 510(k) clearance for a physical medical device (surgical suture) based on substantial equivalence. It does not provide information relevant to the assessment of an AI/Software as a Medical Device (SaMD), as it is not such a device. Therefore, most of the detailed questions regarding AI/SaMD acceptance criteria, study design, ground truth, and reader studies are not applicable to this document. The "performance tests" mentioned are non-clinical laboratory tests to ensure the physical device meets established material and manufacturing standards and is equivalent to the predicate device.

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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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