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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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PTFE SURGICAL SUTURE is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in cardiovascular surgery, ophthalmic surgery, and neural tissue.

PTFE SURGICAL SUTURE

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a "PTFE Surgical Suture," which confirms its substantial equivalence to a predicate device.

The letter lists the device's name, regulation number, regulatory class, product code, and indications for use. However, it does not detail any specific performance acceptance criteria or describe a study that was conducted to demonstrate the device meets such criteria. Therefore, I cannot construct the table or answer the specific questions outlined in your request.

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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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PTFE Surgical Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgenes. The device is not in cardiovascular surgery, ophthalmic surgery, microsurgery, and neural tissue.

PTFE Surgical Suture

The provided document is a 510(k) premarket notification letter from the FDA for a PTFE Surgical Suture. It confirms the substantial equivalence of the device to a legally marketed predicate. However, it does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or a more detailed submission.

Therefore, I cannot provide the requested information based on this document. The document primarily focuses on regulatory approval based on substantial equivalence to an existing device, rather than presenting a detailed performance study as would be done for an AI/ML medical device.

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