Search Results

Synthofil® Nonabsorbable PET Surgical Sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

The subiect device is a nonabsorbable, flexible, braided multifilament suture thread which is supplied sterile. It is composed of the long-chain, linear polymer Poly(Ethylene terephthalate), and is indicated for general soft tissue approximation and/or ligation. It will be offered undyed, and dyed with the FDA listed colorant D&C Green No. 6 in accordance with Title 21 CFR, §74.3206. It will be offered uncoated, or coated with a proprietary copolymer to enhance handling characteristics. It will be available with and without standard needles attached.

The provided text describes a 510(k) premarket notification for a surgical suture and does not contain information about acceptance criteria, device performance, or a study that utilizes a test set with ground truth established by experts.

The document discusses the substantial equivalence of the Synthofil® Nonabsorbable PET Surgical Suture to predicate devices based on:

• Material: Same Poly(Ethylene terephthalate) (PET).
• Colorant: Same D&C Green No. 6.
• Design: Sterile, flexible, braided multifilament thread conforming to U.S. Pharmacopeia (U.S.P.) XXIII requirements for diameter, needle attachment, and tensile strength.
• Physical Properties: Stated as substantially equivalent to predicate devices, including fiber diameter, knot pull tensile strength, straight pull tensile strength, flexibility, elongation, knot security, and needle attachment strength.
• Manufacturing: Same melt-spin, drawing, and braiding operations.
• Packaging, Sterilization, and Labeling: Same or equivalent.

Summary of Non-Clinical Tests mentioned:

• Chemical assays for identity and purity.
• Physical testing for all parameters identified above and to prove conformance to U.S.P. requirements.
• In vitro and in vivo biosafety studies.
• One (1) year implant studies in animals to demonstrate retention of tensile strength.

However, the document explicitly states "Summary of Clinical Tests: (Not applicable)".

Therefore, I cannot provide the requested information in the table format or answer the questions related to acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, or comparative effectiveness studies, as these details are not present in the provided text. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, not on a study with a test set and ground truth as outlined in the request.

Ask a specific question about this device