(135 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to USP monograph for nonabsorbable sutures | Testing demonstrated conformance to the USP monograph. |
| Conformance to FDA's Class II Special Controls Guidance Document | Testing performed in accordance with this guidance document. |
| Substantial equivalence to predicate device (K130078) | "The results of this testing demonstrate that the Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is substantially equivalent to the predicate device." The only difference is suture diameter. |
| Specific performance metrics (e.g., tensile strength, knot security) are implied by USP conformance but not explicitly detailed in the summary. |
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.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.