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GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes.

GOLNIT Non-absorbable PTFE Surgical Suture is a sterile, disposable, non-absorbable suture that meets the requirements of the United States Pharmacopeia (U.S.P.) except for diameter. The suture is manufactured of a 100% polytetrafluoroethylene (PTFE) polymer as monofilament strands that are uncoated, undyed, and of various diameters and lengths that may be crimped or swaged to a standard, medical grade suture needle. The suture sizes range from U.S.P. 2-0 to 6-0.

The surgical suture incorporates a monofilament manufactured from 100% virgin polytetrafluoroethylene (PTFE) resin that is extruded as an expanded porous (ePTFE) monofilament that is soft and supple.

GOLNIT Non-Absorbable PTFE Surgical Suture is sterilized by ethylene oxide. The GOLNIT surgical suture is intended for single use only. The surgically invasive device is indicated to remain in the body for up to 30 days and is biocompatible.

GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes. The device is not intended for invasive procedures related to central nervous system and central circulatory system.

The provided document describes the GOLNIT Non-absorbable PTFE Surgical Suture, a surgical device, and includes information relevant to its acceptance criteria and the study that proves it meets those criteria.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" in a typical quantitative format. Instead, it refers to fulfilling requirements of the United States Pharmacopeia (U.S.P.) and ISO standards. The performance is generally described as meeting these standards.

Based on the text, here's a reconstructed table:

The general conclusion states that all testing demonstrated the GOLNIT PTFE suture is "as safe and effective as the predicate, meets current performance requirements for nonabsorbable surgical sutures unless stated otherwise in labeling, and the sutures are substantially equivalent to the predicate devices."

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 does not specify the sample size used for the test set for performance testing. It mentions "Testing is performed on each lot of product to verify that these USP requirements have been met," suggesting ongoing quality control, but not a specific sample size for a single substantial equivalence study.

Data provenance (country of origin, retrospective/prospective) is not explicitly stated. The context implies it's internal testing conducted by Antarma dba GOLNIT Sutures for regulatory submission.

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)

This question is not applicable to the type of device and study described. Surgical sutures are physical devices, and their performance is evaluated through objective, standardized physical and biological testing (tensile strength, biocompatibility, etc.), not by expert interpretation of images or clinical outcomes that require "ground truth" established by human experts in the traditional sense of AI/diagnostic device studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept (adjudication for ground truth) is relevant for studies involving human interpretation or clinical endpoints, not for the physical and biological testing of a surgical suture.

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 physical medical device (suture), not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, "ground truth" is established by adherence to recognized national and international standards for medical devices and surgical sutures. Specifically:

• Physical performance: United States Pharmacopeia (U.S.P.) standards for non-absorbable surgical sutures (e.g., tensile strength, needle attachment, diameter).
• Biocompatibility: ISO 10993 series (e.g., ISO 10993-1, -5, -10).
• Sterilization: ISO 11135.
• Packaging: ISO 11607 series, EN 868-5.

These standards serve as the "ground truth" or benchmark for acceptable performance.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a physical product, not an AI model requiring a training set.

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