(32 days)
PGA (polyglycolic) Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation; including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
The PGA (Polyglycolic) Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and SAMYANG Corporation are braided and monofilament types and coated with polycaprolate and calcium stearate and are un-dyed with D&C Violet No. 2.
The provided text describes the 510(k) summary for the ARC Medical Supplies (Beijing) Co., Ltd. PGA (Polyglycolic) Synthetic Absorbable Suture, U.S.P. The submission aims to demonstrate substantial equivalence to a predicate device, SURGISORB absorbable surgical sutures manufactured by SAMYANG Corporation.
Here's an analysis based on the information provided, fitting it to your requested structure:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on USP XXIII) | Reported Device Performance (ARC Medical Suture) |
|---|---|
| Suture Diameter | Meets or exceeds U.S.P. specifications |
| Suture Length | Meets or exceeds U.S.P. specifications |
| Knot Pull Tensile Strength | Meets or exceeds U.S.P. specifications |
| Needle Attachment Strength | Meets or exceeds U.S.P. specifications |
| Absorption Rate | Meets or exceeds U.S.P. specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the tests. It broadly mentions "Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength and absorption rate." The data provenance is implied to be from ARC Medical Supplies (Beijing) Co., Ltd., based in China, through their internal testing based on U.S.P. XXIII methods. It is a retrospective demonstration of equivalence against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of information is not relevant or provided for this submission. The ground truth for device performance is based on established, standardized testing methods outlined in U.S.P. XXIII, not on expert consensus or interpretation of subjective data.
4. Adjudication Method for the Test Set
Not applicable. The testing involves objective measurements against predefined specifications. There is no subjective assessment requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable. The PGA suture is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is U.S.P. XXIII specifications and methods. These are objective, internationally recognized standards for the physical and performance characteristics of sutures. The comparative "ground truth" for showing equivalence also relies on the performance of the legally marketed predicate device (SURGISORB absorbable surgical sutures by SAMYANG Corporation) as measured against these same U.S.P. standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/algorithm-based device, there is no training set or associated ground truth establishment process in that context.
§ 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.