(89 days)
Vilet: Vilet (PGLA) surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues. Vilet suture is provided sterile as a single use device.
Vilet Quick: Vilet Quick (fast absorbing PGLA) surgical suture is indicated for use in superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. Vilet Quick suture is provided sterile as a single use device.
Riverpoint Medical PGLA absorbable surgical sutures (Vilet and Vilet Quick) are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. Vilet and Vilet Quick sutures are multifilament, and are composed of braided strands of Polyglycolic-Lactic Acid (PGLA) coated with Poly(glycolide-co-L-lactide) and Calcium Stearate attached to a standard medical grade suture needle as applicable (sutures can be provided without needles as well) Available Suture sizes will be standard according to USP 32 requirements (8/0 through 3, depending on suture type).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Riverpoint Medical PGLA absorbable surgical sutures (Vilet and Vilet Quick):
This document is a 510(k) summary for a medical device and therefore primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a robust clinical trial demonstrating absolute performance against specific, pre-defined acceptance criteria with statistical power.
Acceptance Criteria and Reported Device Performance
The document states that the Riverpoint Medical PGLA sutures (Vilet and Vilet Quick) meet current performance requirements for synthetic absorbable braided surgical sutures unless otherwise labeled. It also explicitly mentions compliance with the requirements for diameter, tensile strength, and needle attachment strength as specified within USP 32.
Since this is a 510(k) submission, the "acceptance criteria" are generally established by the regulatory guidance for the device type, in this case, "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA." The reported device performance is that it meets these requirements. No specific numerical targets or results are provided in this summary.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Properties | Meet requirements for diameter, tensile strength, and needle attachment strength as specified within USP 32. |
| Biocompatibility | Testing performed in accordance to ISO 10993-1. (Implies meeting established safety standards). |
| Resorption Characteristics | In-vitro and in-vivo resorption testing performed. (Implies meeting expected absorption profile). |
| Technological Characteristics | Substantially equivalent to predicate devices (e.g., braided, coated, synthetic absorbable). |
| Sterility | Provided sterile as a single-use device. |
| Material Composition | Materials selected based on known biocompatibility and established histories of use; identical or substantially equivalent to predicate devices. |
Study Information
The document describes several types of performance testing, but not a single, comprehensive "study" that would typically be described with sample sizes, specific methodologies, and detailed results from a clinical trial in the way a new, novel device might. The focus is on demonstrating equivalence.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document mentions "Testing is performed on each lot of product to verify that requirements have been met prior to release." This implies ongoing quality control testing rather than a single fixed "test set" for a pre-market submission.
- Data Provenance: Not specified, but implied to be from internal testing conducted by Riverpoint Medical.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to the type of testing described (mechanical, biocompatibility, resorption). The 'ground truth' for these tests would be the established scientific and regulatory standards (e.g., USP 32 standards for tensile strength).
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Adjudication method for the test set:
- Not applicable. The testing is objective and relies on scientific measurement against pre-defined specifications rather than expert interpretation requiring adjudication.
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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. This is a surgical suture, not an AI or imaging diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This applies to AI/software devices.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance testing described (mechanical, biocompatibility, resorption) are established scientific/regulatory standards and specifications, primarily those outlined in USP 32 and ISO 10993-1.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
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How the ground truth for the training set was established:
- Not applicable. This is not a machine learning or AI device.
§ 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.