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MONOFIX PGCL, knotless wound closure device is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. MONOFIX PGCL, knotless wound closure device should not be used to approximate tissue under tension and the use of barbed suture has not been shown to be safe in the closure of hernias, laparotomy incisions, bowel anastomosis or suture lines, vascular suture lines, and vaginal cuff closure in controlled clinical or preclinical studies for minimally invasive or open surgery.

MONOFIX PGCL, knotless wound closure device, comprised of Poly(glycolide-co-carprolactone)(PGA-PCL) is a synthetic absorbable monofilament undyed-suture. It is available sterile, developed by Samyang Holdings Corp., Ltd. The MONOFIX PGCL, knotless wound closure device consists of a Barb-type suture and a surgical needle, with a suture at one end and a stopper shaped end for tissue anchoring at the stopper is attached to the end of the suture and has a triangular shape with one side length of 1.8 to 3.3 mm and a thickness of 0.7 to 1.0 mm. The device is designed with small uni-directional barbs in size 0.18-0.55 mm along the length and stopper that eliminate the need to tie knots during approximation. The device is available in lengths of 15 to 60cm and diameter sizes 1 through 3-0 with needles in 1/2 circle, 5/8 circle, 1/2 curved and straight shapes attached to each end.

This appears to be an FDA 510(k) clearance letter and a summary of the predicate device comparison for a surgical suture, not a diagnostic AI/ML device. Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert consensus, MRMC studies, standalone performance), and ground truth establishment, which are typical for AI/ML device submissions, are not applicable in this context.

The document describes the non-clinical tests performed to demonstrate the device's compliance with established standards for surgical sutures. These include:

• Bench tests: To verify design specifications, focusing on:
  • USP Suture Diameter
  • USP Suture-Needle attachment
  • USP Tensile Strength Surgical Suture
  • USP Monographs: Absorbable Surgical Suture
  • EP Monographs: Sutures, Sterile Synthetic Absorbable Monofilament
• Sterilization validation: ISO 11135:2014, ISO 10993-7
• Sterile barrier system testing: ASTM F 88
• Accelerated aging stability testing: ASTM F 1980
• Biocompatibility testing: A comprehensive suite of ISO 10993 standards (e.g., ISO 10993-5, -10, -11, -4, -12, -3, -6) and ASTM F756-17.
• In vivo tensile strength: Performed to evaluate tensile strength retention rate.

The "Acceptance Criteria" in this document would refer to the specific thresholds and performance requirements defined by these standards (e.g., minimum tensile strength, maximum/minimum diameter, acceptable levels of residuals, successful sterilization). The "Reported Device Performance" would be the results from the tests confirming the device met these criteria.

Therefore, it is impossible to provide the table and study details as requested because this document does not pertain to an AI/ML device. The study outlined is a non-clinical, benchtop and biocompatibility assessment, not a clinical performance study with human readers or AI algorithms.

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