(126 days)
Modified Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, 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 is coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate and a small amount of an antimicrobial agent, Irgacare MP (triclosan).
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
Analysis of Acceptance Criteria and Study Data for K022715
Based on the provided document, the K022715 submission pertains to a "Modified Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture." This is a medical device, not an AI/ML algorithm, and therefore the standard questions related to AI/ML device studies (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not directly applicable.
The document describes the device's substantial equivalence to a predicate device based on its material characteristics and performance in non-clinical laboratory and in-vivo/in-vitro testing. It does not involve human readers interpreting data or AI algorithms making predictions.
However, I can extract the information related to the device's performance against established standards, which serve as its "acceptance criteria" in this context.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Reference Standard) | Performance Metric | Reported Device Performance |
|---|---|---|
| USP Monograph for absorbable surgical sutures | Conformance to characteristics (except diameter) | Conformed to USP Monograph (except for diameter) |
| Intended Use Performance | Device operation as intended | Performed as intended and as claimed |
| Stated Claims Performance | Device operation as claimed | Performed as intended and as claimed |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the provided document. The testing mentioned refers to non-clinical laboratory testing and in-vivo/in-vitro testing.
- Data Provenance: Not specified. The testing seems to be internal to the manufacturer (Ethicon, Inc.). It is non-clinical, meaning it does not involve human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the device is a surgical suture, not an AI/ML diagnostic tool. Ground truth would be established by physical measurements and biological responses in laboratory and animal models, not expert interpretation of data.
4. Adjudication method for the test set
- Not applicable for a physical medical device. Performance is objectively measured against established standards.
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 not an AI/ML algorithm and does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable as this is a physical medical device. The "standalone performance" would be its inherent physical and biological characteristics.
7. The type of ground truth used
- For the non-clinical laboratory testing, the ground truth would be physical and chemical specifications (e.g., tensile strength, knot security, degradation profile, antimicrobial efficacy) defined by standards like the USP Monograph.
- For the in-vivo/in-vitro testing, the ground truth would be biological responses and functional performance in an experimental setting (e.g., absorption rate, tissue reaction, wound healing in animal models or cell cultures).
8. The sample size for the training set
- Not applicable. There is no training set for a physical medical device in the context of an algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no training set. The "ground truth" for the device's design and manufacturing would be established through material science, engineering principles, and extensive research and development in biomaterials.
§ 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.