(46 days)
ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is intended for use in general soft tissue approximation and/or ligation as is the predicate device Coated VICRYL* (Polyglactin 910) suture.
ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is indicated for soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, or neurological tissue.
Synthetic ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is a synthetic braided absorbable surgical suture prepared from a copolymer of lactide and glycolide. The suture is coated with a copolymer of caprolactone and glycolide.
The provided text describes a 510(k) summary for a surgical suture, not a device that uses AI or requires a study with acceptance criteria related to diagnostic performance or image analysis. Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and human reader performance is not applicable to this document.
However, I can extract information related to the performance data presented for the suture:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Highly biocompatible |
| Functionality within indicated uses | Functional |
| Breaking Strength Retention (BSR) | Increased BSR compared to predicate devices |
| Absorption Profile | Increased absorption profile compared to predicate devices |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The tests were "Nonclinical laboratory testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a non-clinical laboratory test for a surgical suture.
4. Adjudication method for the test set
- Not applicable. This is a non-clinical laboratory test for a surgical suture.
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 is a non-clinical laboratory test for a surgical suture, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a non-clinical laboratory test for a surgical suture, not an AI algorithm.
7. The type of ground truth used
- Ground Truth: Laboratory measurements and assessments based on material properties (e.g., breaking strength, biological response in biocompatibility tests).
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI study; there is no "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device submission. The "ground truth" for the performance data relied on the results of the specific nonclinical laboratory tests conducted.
§ 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.