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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

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.

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