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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

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 <861> for diameter, USP <871> for needle attachment, and USP <881> 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.

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The GOLNIT Non-Absorbable PTFE Surgical Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental, cardiovascular and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.

The 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. The final configuration of the GOLNIT Non-absorbable PTFE Surgical Suture consists of specified length and diameters of PTFE monofilaments with attached standard, medical grade suture needles. The suture is packaged into a labelled two-pouch packaging system consisting of medical grade heat-sealable pouches. The GOLNIT Non-absorbable PTFE Surgical Suture is sterilized by ethylene oxide and is intended for single use only.

The provided document is a 510(k) summary for a medical device (GOLNIT Non-absorbable PTFE Surgical Suture). It describes the device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through quantitative metrics.

Instead, the document states:

• "All testing demonstrated that the GOLNIT Nonabsorbable PTFE Surgical Suture is as safe and effective as the predicate device."
• "Based on the performance data and comparison to the predicate devices. Antarma concludes that the GOLNIT Non-absorbable PTFE Surgical Suture has been shown to be substantially equivalent to the legally marketed predicate devices."

This indicates that the submission relies on demonstrating substantial equivalence to existing predicate devices, rather than establishing new performance acceptance criteria and a study to meet them on a standalone basis against predefined metrics. The "performance data" mentioned refers to biocompatibility testing, which is generally focused on safety rather than detailed functional performance metrics of the suture.

Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of submission (e.g., one requiring de novo classification or a PMA, or a 510(k) where more detailed performance testing against specific acceptance criteria is required and reported).

However, I can provide what is available regarding performance data:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as quantitative metrics the device must achieve (e.g., tensile strength range, knot security value). The underlying criterion is "as safe and effective as the predicate device" based on biocompatibility testing.
• Reported Device Performance:
  • Biocompatibility Testing: Performed according to ISO 10993-1. All testing demonstrated that the device is "as safe and effective as the predicate device." Specific results (e.g., cytotoxicity, sensitization, irritation indices) are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not specified. The document only mentions "additional biocompatibility testing was performed."

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 type of information is relevant for studies involving subjective human assessment, typically in fields like imaging or diagnostics, not for biocompatibility testing of a suture.

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

• Not applicable. (See #3)

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 not an AI/imaging device submission.

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

• Not applicable. (See #5)

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

• For biocompatibility testing, the "ground truth" would be established by standardized laboratory testing methods and interpretation by qualified toxicologists/biologists according to ISO 10993 guidelines, demonstrating no significant biological reaction in comparison to controls or predicate material.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

• Not applicable. (See #8)

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