(44 days)
Contour Thread™ Synthetic Absorbable PDO Barbed Sutures are indicated for use in soft tissue approximation where use of absorbable suture is appropriate.
The Contour Thread™ Synthetic Absorbable PDO Barbed Suture is made from the polymer, poly (p-dioxanone). It is available in a dyed (violet) and undyed (clear) incorporating a bi-directional barbed configuration. The sutures are available in various lengths and needle configurations. The Contour Thread™ Synthetic Absorbable PDO Barbed Suture degrades or dissolves over time in tissue. The Contour Thread™ Synthetic Absorbable PDO Barbed Suture approximate tissues by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues. Each Contour Thread™ Synthetic Absorbable PDO Barbed Suture pass provides the security of an interrupted suture strand without the added bulk of a knot. As with interrupted sutures, if the Contour Thread™ Synthetic Absorbable PDO Barbed Suture breaks, the remaining suture passes will hold the wound edges in approximation.
This document describes a 510(k) premarket notification for the Contour Thread™ Synthetic Absorbable PDO Barbed Suture. The key aspect of this submission is demonstrating substantial equivalence to a predicate device, the Quill™ Synthetic Absorbable Barbed Suture (K051609), rather than presenting independent performance criteria and an associated study with specific quantitative acceptance metrics.
Therefore, the requested information elements related to specific acceptance criteria and detailed study results (like sample sizes, ground truth establishment, expert qualifications, and MRMC studies) are not present in this document, as the submission relies on the established safety and effectiveness of the predicate device and the material itself.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific quantitative acceptance criteria or a direct comparison of the Contour Thread™ device's performance against such criteria. Instead, it argues for substantial equivalence to a predicate device.
The "performance data" section states:
"By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. There are no differences between the Quill® Synthetic Absorbable Barbed Suture and the Contour Thread™ Synthetic Absorbable PDO Barbed Suture Furthermore, polydioxanone is well-characterized and has been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices."
And:
"Biocompatibility data, simulated use evaluation, results of in vivo barb holding and absorption assessments, results of in vivo animal studies and human clinical trial results are provided to support the safety and performance of the Contour Thread™ Synthetic Absorbable PDO Barbed Suture and the Quill® Synthetic Absorbable Barbed Suture."
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" or its sample size in the context of device performance evaluation. The submission refers to "in vivo barb holding and absorption assessments," "in vivo animal studies," and "human clinical trial results," but does not provide details on their methodologies, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided because the submission focuses on substantial equivalence rather than a new standalone performance evaluation requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This is not applicable as the device is a surgical suture, not an AI-assisted diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a surgical suture, not an algorithm. The "standalone" evaluation here refers to the device itself. The document states that "Biocompatibility data, simulated use evaluation, results of in vivo barb holding and absorption assessments, results of in vivo animal studies and human clinical trial results are provided to support the safety and performance." These would constitute elements of a standalone evaluation of the physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety and performance data mentioned (biocompatibility, in vivo barb holding, absorption assessments, animal studies, human clinical trials), the ground truth would likely be based on:
- Biocompatibility: Standardized material testing and biological response assays.
- Barb Holding and Absorption: Direct measurement and observation in animal models.
- Clinical Trials: Patient outcomes data, clinical assessments by physicians, and potentially histological analysis for absorption.
However, specific details are not elaborated in this document.
8. The sample size for the training set
This concept is not relevant to this device submission, which is for a surgical suture. There is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable, as explained in point 8.
§ 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.