(17 days)
Indicated only for use in superficial soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Coated VICRYL Rapide suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Modified Coated VICRYL* Rapide (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* Rapide suture is first coated (inner coating) with a copolymer of 90/10% w/w caprolactone / glycolide and subsequently coated with a mixture composed of equal parts of Polyglactin 370 (copolymer of glycolide and L-lactide) and vegetable-based calcium stearate.
The provided document is a 510(k) premarket notification for a *"Modified Coated VICRYL Rapide (Polyglactin 910) Suture"**. This document describes a medical device (a surgical suture), not a diagnostic algorithm or AI/ML-driven device. Therefore, the questions related to the performance of a device that requires a "test set," "training set," "ground truth," "experts," or "multi-reader multi-case studies" are not applicable to this type of device.
The document discusses substantial equivalence to a predicate device and provides information on the device's description, intended use, indications, and technological characteristics. The section on "Performance Data" is brief, stating only: "Results of verification testing indicates that the product meets the established performance requirements."
Without specific details of the "verification testing" or "established performance requirements," it is impossible to populate a table of acceptance criteria or describe the study in the detail requested for an AI/ML device. For a surgical suture, performance criteria would typically relate to:
- Tensile Strength (initial and retained over time): How strong the suture is and how quickly it loses strength as it absorbs.
- Knot Security: How well knots hold.
- Absorption Profile: The rate at which the suture material is absorbed by the body.
- Biocompatibility: The body's reaction to the material.
- Sterility: Ensuring the suture is free of viable microorganisms.
- Coating Characteristics: Adhesion, slipperiness, and integrity of the coating.
Given the information provided, here's what can be extracted and a clear statement regarding the inapplicability of the AI/ML-specific questions:
Device Name: Modified Coated VICRYL* Rapide (Polyglactin 910) Suture
Device Type: Synthetic absorbable sterile surgical suture
Predicate Device: Coated VICRYL* Rapide (Polyglactin 910) Suture
Intended Use: Indicated only for use in superficial soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred for a Suture Device) | Reported Device Performance |
|---|---|
| Meets established performance requirements (e.g., tensile strength, absorption profile, knot security, biocompatibility, sterility, coating properties). | "Results of verification testing indicates that the product meets the established performance requirements." |
- Note: The document only provides a high-level statement and does not detail the specific performance requirements (acceptance criteria) or the precise results of the "verification testing." For a suture, these would typically be defined metrics related to material properties, strength, and absorption.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a physical medical device (suture), not an AI/ML algorithm that uses distinct test sets of data. Performance is evaluated through physical and biological testing that doesn't involve "test sets" in the AI/ML context.
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)
- Not Applicable. This is a physical medical device (suture). The concept of "ground truth" established by experts for a test set is not relevant to its evaluation. Performance is assessed through standardized laboratory and in-vivo testing by technical personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a physical medical device (suture). Adjudication methods for test sets are not relevant.
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 physical medical device (suture). MRMC studies are used for evaluating diagnostic software or AI tools, not physical devices. No human "readers" are involved in the performance evaluation of a suture in this context.
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). It is not an algorithm, and the concept of "standalone performance" in an AI/ML context does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. This is a physical medical device (suture). Performance is based on objective measurements from laboratory and in-vivo studies (e.g., tensile strength measurements, absorption profiles from animal studies, biocompatibility testing), not a "ground truth" derived from expert consensus or pathology in the diagnostic sense.
8. The sample size for the training set
- Not Applicable. This is a physical medical device (suture), not an AI/ML algorithm. There is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is a physical medical device (suture), not an AI/ML algorithm. There is no concept of a "training set" or "ground truth" for it.
§ 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.