(67 days)
Smith & Nephew Durabraid™ Suture is indicated for use in approximation and/or ligation of soft tissues.
DuraBraid Suture is a nonabsorbable, sterile, surgical suture comprised of braided polyester. It is supplied in several USP sizes white and green, and is available with and it swaged needles attached.
The provided text describes a 510(k) summary for the DuraBraid™ Suture, which is a medical device. The
document focuses on demonstrating substantial equivalence to a predicate device rather than
presenting a study of the device's performance against specific acceptance criteria in the manner one
might expect for a new diagnostic or AI-driven system. Therefore, much of the requested information,
particularly regarding "AI" and "expert" roles, is not applicable to this type of regulatory submission.
Here's the information that can be extracted and explanations for what isn't applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are compliance with established consensus
standards, and the "reported device performance" is the demonstration that the DuraBraid Suture
conforms to these standards and has technological characteristics equivalent to the predicate device.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| USP 26, Nonabsorbable Surgical Sutures | DuraBraid Suture material conforms to this standard. |
| USP 26, Tensile Strength | DuraBraid Suture material conforms to this standard. |
| USP 26, Sutures - Diameter | DuraBraid Suture material conforms to this standard. |
| USP 26, Sutures - Needle Attachment | DuraBraid Suture material conforms to this standard. |
| AAMI/ANSI/ISO 10993-1: 1997, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing | DuraBraid Suture material conforms to this standard. |
| AAMI/ANSI/ISO 10993-7: (R) 2001, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals | DuraBraid Suture material conforms to this standard. |
| AAMI/ANSI/ISO 11607: 2000, Packaging for Terminally Sterilized Medical Devices | DuraBraid Suture material conforms to this standard. |
| AAMI/ANSI/ISO 11137: 1994, Sterilization of Health Care Products (Radiation Sterilization) | DuraBraid Suture material conforms to this standard. |
| AAMI/ANSI/ISO 11135: 1994 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization | DuraBraid Suture material conforms to this standard. |
| Technological characteristics similar to predicate (Polyviolene) | DuraBraid Suture has the same material, treatment, dyed/undyed options, and similar configuration and packaging as the predicate. Sizes offered are within the marketed range of predicate sizes. |
| Indication for Use | Indicated for use in approximation and/or ligation of soft tissues, which is a subset of the predicate's indications. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document is a 510(k) summary for a surgical suture and does not describe a clinical study in the sense of a "test set" with patient data. The "testing" referred to is laboratory testing against consensus standards and comparison of material properties and design characteristics, not human clinical sample sizes. Therefore, information on "sample size used for the test set" or "data provenance" in the context of clinical data is not applicable/provided.
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 is a 510(k) submission for a surgical suture, not a diagnostic device or AI system requiring expert-established ground truth from clinical data. The "ground truth" here is compliance with recognized engineering and biological standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human adjudication of test results.
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 device is a surgical suture, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical suture and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is established by recognized consensus standards (USP, AAMI/ANSI/ISO) for material properties (tensile strength, diameter), biological evaluation (biocompatibility, sterilization residuals), and packaging. The claim of substantial equivalence is also a form of "ground truth" derived from comparing the device's characteristics to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is a medical device clearance based on substantial equivalence, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI model in this submission. The "ground truth" (compliance with standards and equivalence to predicate) is established through laboratory testing and comparative analysis against defined specifications.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.