(202 days)
The Golnit Nylon Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological procedures.
The Golnit Nylon Monofilament Suture is a synthetic monofilament nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6,6. The suture is pigmented black (logwood extract) or blue (FD&C Blue No. 2) to enhance visibility or is also available undyed (clear). The suture has been designed to meet the requirements of the United States Pharmacopeia (USP) related to diameter, needle attachment and tensile strength. The suture is supplied sterile and is provided according to customer specifications. The device is available in pre-cut lengths from 10 cm to 300 cm in 5 cm intervals and in USP sizes 10-0 through 2. It can be attached to a stainless-steel needle or be without a needle. Needles are available with various tip shapes (taper, cutting, reversecutting, taper-cutting, spatula, and diamond), curvatures (1/2, 3/8, 5/8, 1/4 or straight) and lengths (4 mm to 70 mm). Each suture is packaged into a labelled two-pouch packaging system consisting of medical grade heat-sealable pouches. The suture is sterilized by ethylene oxide and is intended for single use only.
Here's a breakdown of the acceptance criteria and the study information for the Golnit Nylon Monofilament Suture device, based on the provided FDA 510(k) summary:
This document is a 510(k) summary for a medical device (Golnit Nylon Monofilament Suture), which seeks substantial equivalence to a legally marketed predicate device. As such, it focuses on demonstrating that the new device performs as safely and effectively as the predicate, rather than establishing absolute efficacy against a disease target. Therefore, many standard clinical study elements like "number of experts," "adjudication method," "MRMC study," and "effect size" are not applicable here.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by USP and FDA Guidance) | Reported Device Performance (Golnit Nylon Monofilament Suture) |
|---|---|
| Suture Diameter per USP requirements | Meets requirements |
| Suture Needle Attachment per USP requirements | Meets requirements |
| Tensile Strength per USP requirements | Meets requirements |
| Sterile | Yes |
| Biocompatible | Yes |
| Shelf life stability | Supported by real-time aging stability testing |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a numerical sample size. The testing referred to "tests in accordance with the USP monographs for non-absorbable sutures, including an evaluation of diameter, tensile strength, and needle attachment strength." This implies an unspecified but sufficient number of samples were tested to meet USP standards for each characteristic.
- Data Provenance: The testing was likely conducted in a laboratory setting by the manufacturer or a contracted testing facility, as is typical for device performance testing for 510(k) submissions. No specific country of origin or retrospective/prospective classification is mentioned, as this is laboratory-based physical and chemical performance data, not patient-level data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. The "ground truth" for this device's performance is established by standardized, objective physical and chemical tests (e.g., measuring diameter, tensile strength) against published specifications from the United States Pharmacopeia (USP) and FDA Special Controls Guidance. It does not involve expert interpretation of clinical images or patient outcomes.
4. Adjudication Method for the Test Set
- Not Applicable. As the "ground truth" is determined by objective physical and chemical measurements against established standards, no human adjudication of results is required.
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 such study was done or is applicable. This device is a surgical 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) study was done
- Not Applicable. This device is a physical surgical implant, not a software algorithm.
7. The Type of Ground Truth Used
- The ground truth is established by objective, quantitative measurements against pre-defined specifications outlined in the United States Pharmacopeia (USP) monographs for non-absorbable sutures (specifically USP for diameter, USP for needle attachment, and USP for tensile strength), and FDA Class II Special Controls Guidance: Surgical Sutures. Biocompatibility is assessed against ISO 10993-1.
8. The Sample Size for the Training Set
- Not Applicable. This device is not an AI algorithm that requires a "training set." Performance is evaluated through physical and chemical testing.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set is involved.
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; 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.