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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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