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Duramesh™ Mesh Suture is indicated for general soft tissue approximation and/or ligation in clean (CDC Class I) wounds, including tendon repair and midline laparotomy where the bowel is not entered. Duramesh™ is not for use in the skin and other epithelial surfaces, cardiovascular, ophthalmic, and/or neurological procedures.

DURAMESH™ is a polyfilament, synthetic, non-absorbable, sterile surgical suture composed of isotactic polypropylene polymer of high molecular weight. The suture is provided dyed (blue) and is uniform in appearance. The blue dye pigment is Phthalocyaninato (2-) Copper. The product meets all requirements established by the United States Pharmacopeia (USP) for nonabsorbable surgical suture, except for diameter.

DURAMESH™ is passed on either side of tissues using an attached swaged needle as an introducing agent and tied to itself with at least two knots composed of two throws each to maintain tension.

DURAMESH™ is supplied sterile and is available with two needle configurations (small and large) in four USP sizes (2-0 through 2), each with a length of approximately 36 inches (91 cm). Each box contains one DURAMESH™ housed in a Tyvek envelope within which the DURAMESH™ is packaged in a sterile protective medical grade tube fixed to a sterile card.

The provided text does not describe an AI/ML medical device, but rather a surgical suture (DURAMESH™ Mesh Suture). Therefore, the concepts of acceptance criteria for AI/ML performance metrics (like sensitivity, specificity, AUC), sample size for test/training sets in an AI/ML context, number of experts for ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types related to AI/ML are not applicable to this document.

The document focuses on demonstrating substantial equivalence of the DURAMESH™ Mesh Suture to a predicate device based on material, design, performance, and biological safety. The "acceptance criteria" here refer to the product's ability to meet medical device standards and show equivalence to a predicate, not AI/ML model performance metrics.

Specifically, the "Bench Data" section on page 6 mentions some performance criteria for the suture:

• Needle attachment strength: Meets prospectively defined acceptance criteria per USP43-NF38: 2020 Sutures - Needle Attachment.
• Tensile strength: Meets prospectively defined acceptance criteria per USP43-NF38: 2020 Sutures - Tensile Strength. It also meets USP requirements under simulated surgical deployment, cycle loading, and dynamic loading.
• Knot Size and Knot Strength: DURAMESH™ knots were stronger than predicate knots for the same number of throws. Knot security is achieved with 4 throws as per labeling.
• Diameter: Diameter decreases with increasing axial load.
• "Stripped" samples: Maintain adequate tensile strength to satisfy USP requirements.

The document also describes:

• Biocompatibility testing: Per ISO 10993-1, ISO 14971, and 2020 FDA Biocompatibility Guidance, showing biocompatibility based on various tests (cytotoxicity, sensitization, etc.).
• Packaging testing: According to ASTM D4169-16 and ASTM F1929-15.
• Sterilization: Ethylene Oxide sterilization following AAMI TIR28:2016 and ISO 11135:2014, meeting ISO 10993-7: 2008 limits for residuals.
• Shelf-Life: Accelerated and real-time aging stability testing supports a 5-year shelf life with no loss of tensile strength.
• Animal Data: Two large-animal porcine implantation studies (1- and 3-month) assessed adverse tissue reaction and dehiscence. Outcomes showed successful closure, tissue ingrowth, and slight irritation compared to standard polypropylene suture.
• Clinical Data: A single-investigator clinical trial with 53 patients (80 surgical sites).
  • Primary outcome: Surgical site occurrence (SSO). No early or late SSO observed.
  • Secondary outcomes: Device-related rehospitalization, return to OR, and wounds. No such events occurred.
  • Long-term assessment (12-month): 15 subjects compared to 11 patients with standard sutures, showing equivalent or slightly improved outcomes with DURAMESH™.

Given this context, I cannot generate a response that directly addresses the prompt's specific requirements for AI/ML device acceptance criteria and study design, as the provided document is not about an AI/ML device.

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