(302 days)
The WEGO-PGLA Absorbable Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
The WEGO-PGLA Absorbable Surgical Suture is a multifilament (braided), synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. It is composed of PGLA suture and needle. The PGLA Suture is composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); it is coated with the copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The PGLA suture is available dyed and undyed (natural). The D&C violet No. 2 (Colour Index Number 60725) is the used colorant for dyed suture. The proposed suture is available in 6-0, 5-0, 4-0, 3-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia. The Synthetic Absorbable Suture is provided EO sterilized as a single use device.
The acceptance criteria for the WEGO-PGLA Absorbable Surgical Suture are defined by its compliance with various United States Pharmacopoeia (U.S.P.) monograph requirements and several international standards for medical devices. The study conducted to prove the device meets these criteria involved a series of bench tests.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|
| USP 35 SUTURES - DIAMETER | Complies |
| USP 35 SUTURES – NEEDLE ATTACHMENT | Complies |
| USP 35 TENSILE STRENGTH | Complies |
| USP MONOGRAPH OF ABSORBABLE SURGICAL SUTURE | Complies |
| ASTM F88-09 (Seal Strength) | Met design specifications |
| ASTM F1140-07 (Internal Pressurization Failure Resistance) | Met design specifications |
| ASTM F1929-98(2004) (Seal Leaks) | Met design specifications |
| ISO 11135-1:2007 (Sterilization) | Complies |
| USP Bacterial Endotoxin Limit | Complies |
| ISO 10993-3:2003 (Genotoxicity, Carcinogenicity, Reproductive Toxicity) | Complies |
| ISO 10993-5:1999 (In vitro cytotoxicity) | Complies |
| ISO 10993-6:1994 (Local Effects after Implantation) | Complies |
| ISO 10993-10:2002 (Irritation and delayed-type hypersensitivity) | Complies |
| ISO 10993-11:1993 (Systemic toxicity) | Complies |
| FDA's Class II Special Controls Guidance Document: Surgical Sutures (Residual Strength and Absorption Rate) | Evaluated in accordance with requirements |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test. It generally states that "Bench tests were conducted to verify that the proposed device met all design specifications."
Data Provenance: Not explicitly stated, however, the manufacturer is Foosin Medical Supplies Inc., Ltd in Weihai, Shandong, China. The testing was conducted to U.S. and International standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for surgical sutures is established by compliance with published, objective, and quantitative technical standards (like USP and ISO standards) and not by expert consensus on subjective observations. The performance metrics are physical and biological measurements.
4. Adjudication method for the test set
Not applicable. The tests are based on objective measurements against predefined thresholds within the standards, not on subjective interpretations 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 for human readers. Therefore, an MRMC comparative effectiveness study involving AI is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical product (surgical suture), not an algorithm or software. Its performance is evaluated through physical and biological bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on objective, quantitative measurements and adherence to established technical standards (e.g., USP monographs for diameter, tensile strength, needle attachment, and biological evaluation standards like ISO 10993).
8. The sample size for the training set
Not applicable. This study does not involve machine learning or AI, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.