(78 days)
Modified Coated VICRYL* Plus Antibacterial suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.
Modified Coated VICRYL* Plus Antibacterial (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* Plus 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).
The provided text describes a 510(k) summary for a "Modified Coated VICRYL* Plus Antibacterial (Polyglactin 910) Suture." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics as one might find for a novel diagnostic or AI-driven device.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or extractable from this type of regulatory submission for a surgical suture.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Material Composition: Copolymer of 90% glycolide and 10% L-lactide with Polyglactin 370 and calcium stearate coating, and triclosan. | "Modified Coated VICRYL* Plus Antibacterial (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* Plus 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)." |
| Intended Use: General soft tissue approximation and/or ligation, excluding ophthalmic, cardiovascular, and neurological tissues. | "Modified Coated VICRYL* Plus Antibacterial suture is intended for use in general soft tissue approximation and/or ligation, except for use in ophthalmic, cardiovascular and neurological tissues." |
| Indications for Use: General soft tissue approximation and/or ligation, excluding ophthalmic, cardiovascular, and neurological tissues. | "Modified Coated VICRYL* Plus Antibacterial suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues." |
| Technological Characteristics: Sterile, braided synthetic absorbable suture conforming to USP Monograph for absorbable surgical sutures (except for diameter), containing antibacterial agent Irgacare MP. | "The modified device has similar technological characteristics as the predicate devices. Like the currently marketed Coated VICRYL* Plus suture device, it is a sterile, braided synthetic absorbable suture that conforms to the USP Monograph for absorbable surgical sutures, except for diameter. Like the currently marketed Coated VICRYL Plus Antibacterial suture, the modified device , contains Irgacare** MP, an antibacterial agent." |
| Performance: Conformance to USP Monograph for absorbable surgical sutures; in-vivo/in-vitro performance as intended and claimed. | "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures. Additionally, in-vivo/in-vitro testing was provided showing that the device performed as intended and as claimed." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The summary refers to "Non-clinical laboratory testing" and "in-vivo/in-vitro testing" but does not detail sample sizes, study design (retrospective/prospective), or data provenance (e.g., country of origin for clinical or animal studies).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to a submission for a surgical suture of this type. The "ground truth" for a suture would relate to its physical and biological performance, not an expert-based interpretation as in a diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies primarily to diagnostic studies involving human readers or interpretation.
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 not an AI-driven device, nor is it a diagnostic device where reader performance is the primary metric.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (suture), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" would be established through:
- USP Monograph adherence: Objective chemical and physical properties (e.g., tensile strength, knot security, degradation profile).
- In-vivo/in-vitro testing: Performance metrics demonstrating expected biological response (e.g., absorption rate, tissue reactivity, antimicrobial efficacy) and physical integrity in relevant environments. This is a form of direct observation and measurement rather than expert consensus on interpretation.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.