(175 days)
WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The propose device, WEGO-PDO Barbed Suture, is monofilament, absorbable surgical suture. It is intended for soft tissue approximation where use of an absorbable suture is appropriate. The proposed devices are provided sterile and single use. The proposed device is composed of suture with or without the needle. The sutures with no needle attachments are only available with bi-directional barbs of 77 cm, 1010 cm, 2424 cm and 3030 cm, the diameter of which are USP 2-0, USP0, USP1 and USP2. The suture is made of poly(p-dioxanone). The suture is uncoated. The suture is available undyed and dyed. The suture is designed with small unidirectional and bidirectional barbs along the length of the device. Barbs allow for tissue approximation without the need to tie surgical knots. The needle is made of stainless steel. The needles are available in six types: Taper, Reverse Cutting, Cutting, Taper Cutting, Blunt and Diamond. The Arc (Circle) of needle has 5/8 circle, 1/2 circle and Straight. The proposed devices are provided in various combinations of suture length, barb, diameter, color (dyed or undyed), quantity of needle and needle types. The proposed devices are sterilized by EO to achieve a SAL 10t and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
The provided document is a 510(k) Summary for a medical device (WEGO-PDO Barbed Suture), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a clinical or standalone study.
Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning performance metrics for an AI or imaging device.
The document describes pre-market notification for a surgical suture, not an AI or imaging device. The "Non-Clinical Test Conclusion" and "Clinical Test Conclusion" sections clearly state the types of tests performed (primarily material and sterility standards, with no clinical study included). The "SE Comparison" table compares the proposed suture device to predicate suture devices based on physical characteristics, material properties, and regulatory standards, not diagnostic performance.
To answer your prompt, you would need a document related to the clearance or approval of an AI/imaging medical device, which would detail its performance study, acceptance criteria (e.g., sensitivity, specificity, AUC), sample sizes, ground truth establishment, and expert involvement. This document does not provide such information.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.