(174 days)
Assufil It is advised when an absorbable suture is needed for use in General Soft Tissue Approximation and Ligation
absorbable surgical suture
This document is a 510(k) premarket notification for a medical device, specifically an absorbable surgical suture called Assufil™. It does not present a study with acceptance criteria and device performance data in the way typically seen for AI/ML-based diagnostic devices.
Instead, this is a regulatory submission for a traditional medical device (suture) seeking substantial equivalence to a predicate device. The information provided is for regulatory clearance, not a performance study evaluating metrics like sensitivity, specificity, or accuracy against a ground truth for a diagnostic algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from the provided text, as this type of information is not contained within this particular 510(k) submission for a surgical suture.
The content focuses on:
- Device Identification: Assufil™ absorbable surgical suture.
- Intended Use: General Soft Tissue Approximation and Ligation.
- Regulatory Classification: Class II, Absorbable poly(glycolide/L-lactide) surgical suture.
- Substantial Equivalence: The FDA's determination that the device is substantially equivalent to a legally marketed predicate device.
To answer your questions, I would need a 510(k) summary or a scientific publication detailing a performance study for a diagnostic or AI-driven device, which would include specific metrics, study design, and ground truth methodology.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.