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The Pledgeted COR-SUTURE™ QUICK LOAD® is intended for use in the approximation of soft tissue and prosthetic material.

Each LSI SOLUTIONS® Pledgeted COR-SUTURE™ QUICK LOAD® sterile surgical suture is held in a customized tray, with suture release feature designed to enable the rapid, easy and reliable loading of suture into compatible LSI SOLUTIONS® suturing devices. Pledgeted COR-SUTURE™ QUICK LOAD® suture is available as a non-absorbable monofilament polypropylene and PTFE coated, braided, polyester surgical suture with attached PTFE pledget. A short length of modified surgical stainless steel tubing, called a "ferrule", is attached to each end of the suture. The Pledgeted COR-SUTURE™ QUICK LOAD® suture also includes a detachable clear suture tube to keep the suture from tangling. Pledgeted COR-SUTURE™ QUICK LOAD® surgical suture is packaged for single patient use. The polypropylene suture is dyed blue with the FDA approved colorant [phthalocyaninato(2-)] copper. The polyester suture is offered undyed, or dyed green with the FDA approved colorant D&C Green No. 6. For both polypropylene and polyester suture, there is no known significant change in tensile strength retention to occur in vivo. The Pledgeted COR-SUTURE™ QUICK LOAD® surgical suture is MR safe.

The provided document describes a 510(k) premarket notification for a medical device called "Pledgeted COR-SUTURE™ QUICK LOAD®". This document is an FDA submission for a modified surgical suture.

However, the request asks about acceptance criteria and a study that proves a device meets acceptance criteria, specifically focusing on aspects relevant to AI/ML medical devices (e.g., test set, ground truth, expert adjudication, MRMC studies, standalone performance).

The provided document is not for an AI/ML medical device. It is for a traditional surgical suture. Therefore, the majority of the information requested in the prompt (acceptance criteria related to algorithm performance, sample size for AI test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance) is not applicable to this device.

The "studies" mentioned in the document are bench testing (performance testing) and biocompatibility testing, not clinical studies or AI algorithm validation studies.

Here's how to interpret the document in the context of the prompt, highlighting what can be extracted and what is not applicable:

Device: Pledgeted COR-SUTURE™ QUICK LOAD®
Device Type: Nonabsorbable Surgical Suture

1. A table of acceptance criteria and the reported device performance

For this device, the "acceptance criteria" and "performance" are based on physical and biological properties of the suture, as per recognized standards (USP, ISO).

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: The document does not specify the exact number of units/samples tested for each performance or biocompatibility test. It only states that testing was "conducted in accordance with" the listed standards, implying that the sample sizes required by those standards were used.
• Data Provenance: The document doesn't specify data provenance in terms of country of origin or retrospective/prospective for performance testing. It mentions that biocompatibility data was "leveraged from the manufacturer that supplies the surgical suture material to LSI SOLUTIONS®." This is typical for material suppliers.

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 not an AI/ML device, so "ground truth" in the context of expert review for diagnostic accuracy is not relevant. Performance and biocompatibility are established through objective laboratory testing and adherence to published standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. As this is not an AI/ML device relying on human interpretation for test set ground truth, adjudication methods 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:

• No. This is a physical medical device (suture), not an AI-assisted diagnostic tool. MRMC studies are not applicable.

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), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For performance testing, the "ground truth" is adherence to established physical and mechanical specifications outlined in USP monographs (e.g., specific diameter ranges, minimum tensile strengths).
• For biocompatibility, the "ground truth" is the absence of adverse biological reactions as defined by ISO 10993 testing endpoints.
• The document also leverages data from a predicate device and a reference device, indicating that prior regulatory clearances and established safety profiles form part of the justification through substantial equivalence. Specifically, the Bard® PTFE Felt Pledget's biocompatibility was relied upon due to identical material characteristics and "long clinical history of this type of use."

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set. The "design" and "manufacturing process" are developed, not "trained."

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

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