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Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The Quill TM Monoderm TM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. 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 Sizes 2-0 to 0 in various lengths affixed to various needle types.

This document describes the 510(k) submission for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design. The device is an absorbable surgical suture. The submission focuses on demonstrating substantial equivalence to predicate devices through performance testing.

Acceptance Criteria and Device Performance Study Information:

This 510(k) summary does not include detailed acceptance criteria or a "performance table" in the typical sense of a diagnostic device's metrics (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by the requirements of the USP monograph for absorbable sutures and FDA's Class II Special Controls Guidance Document for Surgical Sutures. The device's performance is demonstrated by meeting these standards.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document states "Non-clinical laboratory performance testing was conducted." However, it does not specify the sample size used for the various tests (tensile strength, needle attachment, in vitro post-hydrolysis tensile testing).

The data provenance is non-clinical laboratory testing. The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as these concepts are generally not applicable to laboratory performance testing of this nature.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This type of information is not applicable to this device's submission. The "ground truth" for a surgical suture is defined by established engineering and material science standards (e.g., USP monographs, FDA guidance). Expert review, as in clinical or imaging studies, is not part of establishing the performance for these specific non-clinical tests.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically relevant for clinical studies where multiple reviewers assess outcomes or image interpretations. For laboratory performance testing, the results are objectively measured against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess the impact of AI on their performance. The Quill™ Monoderm™ device is a surgical suture, not a diagnostic tool requiring human interpretation in this context.

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

This information is not applicable. The device is a physical surgical suture, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical performance testing is based on established industry standards and regulatory requirements. Specifically:

• USP monograph for absorbable sutures for tensile strength and needle attachment.
• FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.
• The characteristics and performance of the legally marketed predicate devices to which equivalence is claimed.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a surgical suture, not a machine learning model that requires a training set. The performance testing described is for product verification and validation, not for algorithm training.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this type of medical device submission.

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