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Indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in Cardiovascular, Ophthalmic and Neural tissue. Surgilon (polyamide), Dermalon, Ophthalon are both braided and monofilament sutures available in white or dyed (black or blue) with a Logwood extract. These sutures are available in various lengths, diameters and quantities with or without surgical needles. These sutures are not absorbed, progressive hydrolysis of the nylon in-vivo may result in gradual loss of its tensile strength.

Surgilon (polyamide) Ophthalon and Dermalon Non-Absorbable Surgical Suture are braided and monofilament sutures with a silicone coated dyed white or black with Logwood extract. These surgical sutures are composed of a long-chain aliphatic polymer Nylon 6 or Nylon 6,6. Surgilon, Dermalon and Ophthalan sutures are a class II device per 21 CFR Section 878.5020. Classification Code: 80GAR.

The provided text describes the 510(k) summary for Surgilon®, Ophthalon®, and Dermalon® Non-Absorbable Surgical Sutures, focusing on their substantial equivalence to previously marketed sutures. The core of the submission is to justify that the change from a manual to an automated end stiffening process does not alter the safety or effectiveness of the device.

Here's an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for specific tests. It refers to testing in accordance with ANSI/AAMI ISO 10993 and compliance with USP and EP standards. These standards themselves define sample size requirements for various tests (e.g., cytotoxicity, sensitization, irritation, material characterization, mechanical properties).

• Sample Size: Not explicitly stated. The tests would have used an appropriate number of suture samples as dictated by the referenced biocompatibility and pharmacopeial standards.
• Data Provenance: Not explicitly stated. However, given that it's a 510(k) submission from "Sherwood-Davis & Geck" (a US-based company), it's highly probable that the testing was conducted in the United States or by labs compliant with US regulatory requirements. The data would be retrospective in the sense that the tests were performed on manufactured devices for the purpose of demonstrating equivalence for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable in the context of this 510(k) summary. This document describes the testing of a physical medical device (surgical sutures) against international and pharmacopeial standards and a predicate device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. For physical device testing against established standards, the results are typically quantitative or qualitative (pass/fail) based on objective measurements and established criteria within the standards.

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

This information is not applicable. This 510(k) submission is for a physical medical device (surgical sutures) and does not involve AI, human readers, or diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This submission is for a physical medical device; there are no algorithms or standalone performance studies in this context.

7. The Type of Ground Truth Used

The "ground truth" for this medical device submission is the established regulatory standards and pharmacopeial requirements, coupled with the performance characteristics of the predicate device.

• Biocompatibility: The "ground truth" is defined by the acceptable limits and methodologies specified in ANSI/AAMI ISO 10993-1.
• Physical and Chemical Properties: The "ground truth" is defined by the specifications and test methods in the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) for surgical sutures.
• Substantial Equivalence: The "ground truth" here is that the new device, despite a manufacturing change, performs equivalently to the predicate device (K930586) across all critical parameters (tensile strength, sterility, indications for use, packaging, etc.). This equivalence is assessed through comparative testing and an understanding of the impact of the manufacturing change.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning study; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set, there is no ground truth for it.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets acceptance criteria is a series of laboratory tests and analyses demonstrating substantial equivalence to a previously cleared predicate device (K930586) and compliance with relevant standards.

The key points from the document regarding this study are:

• Comparative Assessment: The main "study" described is a comparison of the proposed sutures manufactured with an automated end stiffening process to predicate sutures manufactured with a manual process. The focus is on demonstrating that the only difference (automated vs. manual end stiffening) does not alter the fundamental characteristics or safety/effectiveness.
• Biocompatibility Testing: The "representative Surgical Sutures, with adhesive, were tested for biocompatibility in accordance to ANSI/AAMI ISO 10993. Biological Evaluation of Medical Devices Part-1: Evaluation and Testing."
• Pharmacopeial Compliance: The sutures were shown to "meet all requirements established by the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) for surgical sutures." These pharmacopeias include specific tests for tensile strength, diameter, sterility, particulate matter, and other physical/chemical attributes.
• Argument for Substantial Equivalence: Sherwood-Davis & Geck concluded that the proposed sutures are "substantially equivalent in design, composition and intended use" to the predicate, implying that the detailed test results confirmed this equivalence. The similarities cited include: composed of long-chain aliphatic polymer, sterile, same indications for use, same lengths, diameters, quantities, colors, sizes, available with and without needles, and identical packaging.

In essence, the "study" is a comprehensive set of tests and comparisons designed to confirm that the manufacturing process change does not negatively impact the biological safety or functional performance of the sutures, ensuring they remain equivalent to existing, legally marketed sutures and meet all relevant regulatory and quality standards.

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