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Artelon® Surgical Suture is intended for use in general soft tissue approximation and/or ligation during surgery.

ARTELON Surgical Sutures are nonabsorbable sterile surgical sutures (i.e. braided threads) prepared from ARTELON (polycaprolactone based poly (urethane urea)) in a multifilament form intended for soft tissue approximation. Due to limited stiffness of the sutures, they appear stretchy during handling. Although ARTELON sutures are nonabsorbable, they degrade slowly over time; the degradation occurs over a prolonged period of time with a gradual reduction of tensile strength of approximately 20% per year. ARTELON Surgical Sutures are uncoated and undyed. The sutures are supplied sterile.

The provided text describes the ARTELON Surgical Suture and its substantial equivalence to a predicate device but does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on regulatory compliance through substantial equivalence, referencing general standards and a predicate device (ARTELON Surgical Suture, K032160) rather than providing specific performance data from new studies. It lists compliance with:

• ISO 10993 standards (Biological evaluation of medical devices)
• ISO 14971 (Medical devices - Application of risk management to medical devices)
• USP 26 (United States Pharmacopoeia standards for nonabsorbable surgical sutures)
• Class II Special Control Guidance, Surgical Suture; Guidance for Industry and FDA, June 3, 2003

These are general standards or guidance documents, not performance results. The claim is that "The product meets all requirements established by the United States Pharmacopoeia (U.S.P) for nonabsorbable surgical sutures," but no specific performance metrics like tensile strength retention over time or knot security are presented in quantifiable terms against acceptance criteria within this summary.

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The Artelon™ Surgical Suture is intended for use in general soft tissue approximation and/or ligation.

Artelon™ Surgical Suture is a nonabsorbable braided surgical suture, which is supplied sterile. It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form. The Artelon™ Surgical Suture will be offered uncoated and undyed and without needle.

The product meets all requirements established by the United States Pharmacopoeia (U.S.P) for nonabsorbable surgical sutures.

This document describes the Artelon™ Surgical Suture and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of AI/ML performance. Therefore, many of the requested fields are not applicable. However, I can extract the relevant information regarding performance testing that was conducted.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable (N/A). This document does not detail a clinical study with a test set of data. The "performance testing" refers to in-vitro and material characteristic tests rather than performance against a clinical dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. Ground truth is not established in the context of clinical data for this type of device submission. Performance is measured against established physical and biological standards.

4. Adjudication method for the test set:

• N/A. No adjudication method for a test set of data is mentioned as this is not a clinical study.

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:

• N/A. No MRMC study was conducted, as this device (surgical suture) is not an AI/ML-powered diagnostic or assistive tool for human readers.

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

• N/A. Not an AI/ML device.

7. The type of ground truth used:

• For biocompatibility: ISO 10993 standards.
• For physical characteristics (diameter, tensile strength, pliability, handling): USP 26 requirements.
• For regulatory compliance: Guidance for surgical suture documents.

8. The sample size for the training set:

• N/A. This device does not involve machine learning; therefore, no training set or sample size for training is relevant.

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

• N/A. No training set for machine learning. The "ground truth" for the device's performance is established by recognized international and national standards (ISO, USP, FDA guidance).

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