(74 days)
VISORB Swift™ Absorbable Surgical Sutures are indicated for use in general soft tissue approximations, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue approximation.
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The provided text describes a 510(k) summary for the VISORB Swift™ absorbable surgical suture. The primary claim for acceptance is based on meeting or exceeding performance requirements set forth by USP 25, and substantial equivalence to predicate devices from Ethicon and B/BRAUN.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| USP 25 Performance Requirements | Meets or exceeds USP 25 performance requirements. |
| Equivalency to Predicate Devices (Design, Material Composition, Performance, Intended Use) | Comparison data demonstrates equivalency to Ethicon and B/BRAUN predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for performance testing (e.g., USP 25 testing) or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "comparison data" for equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The evaluation relies on standardized performance metrics (USP 25) and comparative data against predicate devices, rather than an expert consensus ground truth for a specific test set.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of a medical device like a surgical suture, the "ground truth" would be established through physical and chemical testing against established standards (USP 25) and direct comparison with predicate devices, rather than through an adjudication process by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (e.g., imaging AI) where human readers are directly interacting with the device's output. For a surgical suture, the performance is evaluated through material properties and mechanical strength, not human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not directly applicable to a surgical suture. The device itself is not an "algorithm." Its performance is inherent in its physical and chemical properties. The tests performed (implicitly those required by USP 25) would be "standalone" in the sense that they evaluate the device itself without human interaction beyond conducting the test.
7. The Type of Ground Truth Used
The ground truth used for proving device performance appears to be:
- Standardized Performance Metrics: Specifically, the requirements outlined in USP 25 (United States Pharmacopeia).
- Comparative Data: Performance data compared against legally marketed predicate devices (Ethicon and B/BRAUN) to demonstrate substantial equivalence in design, material composition, performance, and intended use.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. Surgical sutures are physical devices, not machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated in point 8.
§ 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.