(60 days)
Modified Coated VICRYL* suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
Modified Coated VICRYL* (Polyglactin 910) suture is a synthetic absorbable sterile surgical suture composed of a copolymer made from 90% glycolide and 10% L-lactide. Modified Coated VICRYL* suture, which is prepared by coating VICRYL* suture material with a copolymer of 90% caprolactone and 10% glycolide and subsequently with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) with calcium stearate.
The provided text describes a 510(k) premarket notification for a medical device, which generally does not include the detailed study design elements requested for AI/ML performance evaluations. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical and in-vivo testing.
Therefore, many of the requested categories related to AI/ML specific studies (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of submission.
However, I can extract the available information regarding acceptance criteria and the studies performed to meet them.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Conformance to USP Monograph for absorbable surgical sutures (except for diameter). | Device conformed to the USP Monograph for absorbable surgical sutures. |
| Device performs as intended for general soft tissue approximation and/or ligation. | In-vivo testing demonstrated the device performed as intended. |
| Substantial equivalence to the predicate device (Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture). | Concluded to be substantially equivalent based on 510(k) summaries and information provided. |
2. Sample size used for the test set and the data provenance:
- Not Applicable in the context of AI/ML. The provided document does not specify sample sizes for non-clinical or in-vivo testing in terms of a "test set" for algorithm performance. It refers to "non-clinical laboratory testing" and "in-vivo testing."
- Data Provenance: Not specified beyond "non-clinical laboratory testing" and "in-vivo testing." No country of origin is mentioned, nor whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the AI/ML sense, is not mentioned. The evaluation relies on standardized tests (USP Monograph) and in-vivo performance, which would be assessed by trained professionals following established protocols, rather than expert consensus on data annotations.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods are not described as this is not an AI/ML study involving human interpretation consensus.
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:
- No, an MRMC study was not done. This device is a surgical suture, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an AI/ML algorithm.
7. The type of ground truth used:
- For the non-clinical laboratory testing, the "ground truth" would be established by the definitions and specifications outlined in the USP Monograph for absorbable surgical sutures.
- For the in-vivo testing, the "ground truth" would be the observed performance of the suture in live biological systems according to predefined success criteria for tissue approximation and/or ligation.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML model that requires a training set or ground truth for training.
§ 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.