(30 days)
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.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.