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The SuturTek FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures.

The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures.

It is designed to aid in the prevention of suture needle stick injuries.

The FASTCLOSE Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.

The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the tissue to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the tissue. The two ends of the suture are then tied together in the usual manner.

The provided text describes a 510(k) premarket notification for the SuturTek FASTCLOSE™ Suturing Device. The submission focuses on demonstrating substantial equivalence to a previously marketed device (K011105) and highlights an added "Sharps Injury Prevention Feature Claims."

However, the document does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML device. The provided text describes a medical device (suturing device) and its premarket notification, which is a different type of submission than what would typically include AI/ML performance data.

Here's a breakdown of why the requested information cannot be extracted from the given text:

1. AI/ML Device: The SuturTek FASTCLOSE™ Suturing Device is a manual instrument, not an AI/ML powered device. Therefore, the concepts of "test set," "training set," "ground truth," "experts," "adjudication," "MRMC comparative effectiveness study," or "standalone algorithm performance" as they relate to AI/ML devices are not applicable or discussed in this document.

2. Acceptance Criteria and Device Performance: The document states that "Tests applicable to the type of safety device and safety features of the FASTCLOSE Device per the FDA Guidance on the Content of Premarket Notification Submissions for Medical Devices with Sharps Injury Prevention Features' (March 1995) were: Simulated Use Testing." However, it does not provide:

   • Specific quantitative acceptance criteria (e.g., "sharps injury reduction rate of X%").
   • The reported device performance against those criteria (e.g., "achieved Y% reduction").
   • Any details about the methodology, sample size, or results of the "Simulated Use Testing."

3. Ground Truth, Experts, Adjudication: These terms are relevant for evaluating diagnostic or predictive AI/ML models where there's a need to establish a definitive correct answer (ground truth) often through expert consensus. For a mechanical surgical device with a sharps injury prevention feature, the "ground truth" would likely be the actual occurrence or non-occurrence of a sharps injury during simulated use, and typically wouldn't involve expert adjudication in the same way an image interpretation task would. No such details are present.

In summary, the provided document is a 510(k) summary for a mechanical surgical device and does not contain the specific information you've requested regarding acceptance criteria and performance studies in the context of an AI/ML device.

To illustrate, if this were an AI/ML device, the detailed information about acceptance criteria and study results would typically be found in a "Performance Testing" section that provides quantitative metrics (e.g., sensitivity, specificity, AUC) and a thorough description of the study design. This document does not include such a section.

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