(31 days)
Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The Quill™ Monoderm™ 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 Size 2-0 in various lengths affixed to various needle types.
The provided document is a 510(k) summary for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design. It describes the device, its indication for use, and a general statement about performance testing. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information to fully address all parts of your prompt.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative values or pass/fail thresholds. The document generally refers to conforming to the USP monograph for absorbable sutures and demonstrating substantial equivalence.
- Reported Device Performance: The document states that "The results of this testing demonstrates that the Quill™ Monoderm™ Knotless Tissue-Closure device, Variable Loop Design, is substantially equivalent to the predicate devices." No specific performance metrics (e.g., actual tensile strength values, degradation rates) are provided.
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Conformance to USP monograph for absorbable sutures for tensile strength and needle attachment. | Conforms |
| Substantial equivalence to predicate devices (Quill™ Monoderm™, Quill™ PDO Knotless Tissue-Closure Device, V-Loc™ 90 Absorbable Wound Closure Device) through simulated use tensile testing in porcine tissue and in vitro post-hydrolysis tensile testing. | Demonstrated substantially equivalent to predicate devices |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: The document only mentions "testing" and "simulated use tensile testing in porcine tissue and in vitro post-hydrolysis tensile testing." It does not specify country of origin, retrospective or prospective nature, or where the testing was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a surgical suture, and the performance tests described are mechanical and material characterization studies, not image interpretation or diagnostic studies that would require expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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
- No. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/imaging device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical laboratory performance testing (tensile strength, needle attachment), the "ground truth" would be established by standardized measurement techniques and USP monograph specifications.
- For the simulated use tensile testing in porcine tissue and in vitro post-hydrolysis tensile testing, the "ground truth" would be the measured physical properties of the device and the predicate devices, compared against each other.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device that requires a training set. The performance tests are experimental studies, not algorithm training.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary: The provided 510(k) summary offers a high-level overview of the device and the types of performance testing conducted to support substantial equivalence. It lacks the detailed quantitative data, sample sizes, and specific methodologies that would be required to fully answer most of your detailed questions, particularly those related to clinical studies, AI performance, or expert-adjudicated ground truth, as those concepts do not apply to this type of device and submission.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, 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.