(32 days)
Quill™ PDO Knotless Tissue-Closure Device comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The Quill™ PDO Knotless Tissue-Closure Device, Variable Loop Design (Polydioxanone) is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The instrument 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 through 3-0 in various lengths affixed to various needle types.
The provided document is a 510(k) summary for a medical device, specifically a surgical suture. It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical laboratory performance testing. This type of regulatory submission does not typically include a clinical study with elements like human readers, ground truth consensus, or AI assistance as it's for a physical medical device, not a diagnostic algorithm.
Therefore, many of the requested categories are not applicable to the information contained within this 510(k) submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission refers to the USP monograph for absorbable sutures and FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003 as the acceptance criteria. The specific quantitative acceptance criteria (e.g., minimum tensile strength values) are not provided in this summary.
| Acceptance Criteria (Standards referred to) | Reported Device Performance |
|---|---|
| USP monograph for absorbable sutures: | "The results of this testing demonstrates that the Quill™ PDO Knotless Tissue-Closure device, Variable Loop Design (Polydioxanone), is substantially equivalent to the predicate device." (Specific quantitative performance metrics against USP standards are not provided in this summary.) |
| - Tensile strength (as applicable) | |
| - Needle attachment | |
| FDA's Class II Special Controls Guidance Document: Surgical Sutures (June 3, 2003) | |
| In vitro post-hydrolysis tensile testing |
2. Sample size used for the test set and the data provenance:
This document describes non-clinical laboratory performance testing. It does not mention a "test set" in the context of human or patient data. The testing was likely performed on the suture devices themselves in a laboratory setting. No information on the number of devices tested or data provenance (country of origin, retrospective/prospective) for these laboratory tests is provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-clinical, laboratory-based study of a physical medical device. No expert ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is a non-clinical, laboratory-based study.
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 a non-clinical study for a surgical suture and does not involve human readers, AI, or comparative effectiveness in a diagnostic imaging context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This submission relates to a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical testing of a surgical suture would be defined by the specific measurement standards and methodologies outlined in the USP monograph and FDA guidance documents for tensile strength, needle attachment, and post-hydrolysis performance. These are objective, quantifiable criteria.
8. The sample size for the training set:
Not applicable. There is no training set mentioned, as this is laboratory testing of a physical product, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, there is no ground truth for a training set to be established.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.