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Optilene Nonabsorbable Polypropylene Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.

Optilene is a nonabsorbable monofilament surgical suture which is supplied sterile. Optilene is composed of 95% polypropylene and 5% polyethylene. The Optilene suture is offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Optilene suture previously ranged in diameters from USP size 10-0 through 0 in lengths ranging from 8 cm to 150 cm. The Optilene suture is offered with or without needles attached. The Optilene sutures are also offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are available separately packaged six per pouch.

The purpose of this submission is to seek clearance for a line extension to the Optilene Nonabsorbable Surgical Suture (K133890). This submission proposes two additional USP sizes, size 1 and 2 and to extend the length range to 240 cm.

The provided document is a 510(k) premarket notification for a medical device, specifically a surgical suture. Such documents focus on demonstrating "substantial equivalence" to a predicate device rather than presenting a standalone study with acceptance criteria in the traditional sense of a clinical trial for an AI-powered diagnostic or therapeutic device.

Therefore, the information requested in your prompt (acceptance criteria, details of a study with sample sizes, expert ground truth, MRMC, standalone performance, training set details) is not applicable to this type of regulatory submission.

This document describes a line extension for an existing nonabsorbable surgical suture (Aesculap Optilene Nonabsorbable Suture). The purpose of the submission is to introduce additional USP sizes (size 1 and 2) and to extend the length range (up to 240 cm) for an already cleared device.

Instead of a clinical study demonstrating AI performance, the manufacturer performed non-clinical laboratory performance testing to show that the new sizes and lengths of the suture meet the established standards for nonabsorbable surgical sutures.

Here's how the information aligns with your request, despite the different context:

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

The "acceptance criteria" here are the requirements set forth by the USP (United States Pharmacopeia) Monograph for Nonabsorbable Surgical Sutures and the FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.

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

• Sample Size: Not specified in the document. For non-clinical performance testing of physical devices, specific sample sizes for various tests (e.g., tensile strength, diameter measurements) would be defined in testing protocols, but these details are typically not included in the summary provided in the 510(k).
• Data Provenance: Not explicitly stated, but derived from non-clinical laboratory testing performed by the manufacturer (Aesculap, Inc.) to verify compliance with U.S. and international standards.

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 pertains to a physical medical device (suture), not an AI device requiring expert-established ground truth for diagnostic or prognostic purposes. The "ground truth" is defined by the objective physical and chemical standards of the USP monograph.

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

• Not applicable. This refers to adjudication of expert opinions for ground truth in AI studies.

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 non-AI surgical suture.

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

• Not applicable. This is a non-AI physical device.

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

• The "ground truth" for this device's performance is based on objective, quantifiable physical and material specifications defined by established standards:
  • United States Pharmacopeia (USP) Monograph for Nonabsorbable Surgical Sutures.
  • ISO 10993-1 for biocompatibility of materials.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable.

In summary, this 510(k) premarket notification is for a conventional medical device line extension. The "study" mentioned refers to non-clinical laboratory testing demonstrating compliance with established physical standards for surgical sutures. The concepts of AI acceptance criteria, expert ground truth, training sets, and MRMC studies are not relevant to this specific device and its regulatory submission path.

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Optilene Nonabsorbable Polypropylene/Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.

Optilene is a nonabsorbable monofilament surgical suture which is supplied sterile. Optilene is composed of 95% polypropylene and 5% polyethylene. The Optilene suture will be offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Optilene suture will be offered in diameters ranging from USP size 10-0 through 0 and with be available in a variety of cut lengths with or without needles attached. The Optilene sutures will also be offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are also available separately packaged six per pouch.

This 510(k) Premarket Notification is for the Aesculap Optilene Nonabsorbable Surgical Suture. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

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 specific sample sizes for each mechanical or biocompatibility test. It broadly states that "Tests were conducted for diameter, tensile strength, and needle attachment" and that "Biocompatibility testing... includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Hemolysis, Genotoxicity - Mouse Lymphoma, Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation and Muscle Implantation (12-week)."

The data provenance is not explicitly stated in terms of country of origin. Given that it's a 510(k) submission to the FDA, the testing would generally be expected to comply with US regulatory standards, but the physical location of labs or studies isn't provided. The studies are prospective in nature, as they are specifically conducted to support this premarket notification.

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

This information is not applicable in this context. The "ground truth" for suture performance is established by recognized standards, specifically USP 35 (United States Pharmacopeia) for mechanical properties and ISO 10993-1 for biocompatibility. These standards define the acceptable range or nature of results for the device to be considered safe and effective. Expert consensus is not used to establish these fundamental criteria; rather, the tests are performed in accordance with these pre-defined, validated methodologies.

4. Adjudication Method for the Test Set:

Not applicable. The performance is measured against objective, quantitative standards (USP 35) or standardized test outcomes (ISO 10993-1). There is no "adjudication" in the sense of reconciling differing expert opinions, but rather a direct comparison of test results to predetermined acceptance limits.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study investigates human reader performance, typically with medical imaging or diagnostic devices. This device is a surgical suture, and its performance is evaluated through laboratory and preclinical (biocompatibility) testing, not by human readers interpreting data.

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

Not applicable. This is not an algorithmic or AI-based device. Its performance is inherent to the physical and chemical properties of the suture itself, measured through standalone laboratory and biocompatibility tests.

7. The Type of Ground Truth Used:

The ground truth used is primarily based on:

• Established Standards: USP 35 for mechanical properties (diameter, tensile strength, needle attachment).
• International Standards for Biocompatibility: ISO 10993-1 for biological safety.
• Chemical Equivalence: Comparison of chemical characterization results of the raw materials to those of the predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable, as there is no training set for this type of device submission.

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