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Reprocessed Suture Passers are intended to pass sutures through soft tissue during endoscopic/laparoscopic surgery.

The Reprocessed Suture Passer is a set of previously used devices that have been cleaned, tested, inspected, marked with an identifier, packaged, labeled, and sterilized by Vanguard. A "Suture Passer" is a set of three (3) devices, consisting of one (1) Carter-Thomason needle-point suture passer and two (2) suture passer guides. The Carter-Thomason needle-point suture passer is a 3mm diameter stainless steel shaft with a polycarbonate ring-grip handle that opens one side of the pointed tip of the steel shaft when activated. The polycarbonate suture passer guides have a cylindrical hub at the proximal end and a tapered shaft at the distal end. The suture passer guides taper from the junction with the cylindrical hub to the tip. Each suture passer guide has two holes in the hub; the two holes open on opposite sides of the pilot guide shaft. A Suture Passer Guide is inserted into the wound site. A Suture Passer is used to push suture through the suture passer guide and then through the tissue of the wound site. The suture is then retrieved and pulled through the opposite side of the guide. This creates a "loop" that encompasses the full depth of the wound and upon removal of the guide allows full closure of the wound. Vanguard receives previously used Suture Passers from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use. The Vanguard Reprocessed Suture Passers are essentially identical to the currently marketed Original Equipment Manufacturer (OEM) devices. Device materials, specifications, and technological characteristics are equivalent.

This document describes the 510(k) summary for the Vanguard Reprocessed Suture Passer. It establishes substantial equivalence to existing predicate devices based on technological characteristics and performance/test data, rather than clinical studies with explicit acceptance criteria related to device performance metrics.

Here's a breakdown of the requested information based on the provided text, and where clinical study-specific details are not applicable:

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

The provided document describes a reprocessed medical device, not a new diagnostic or prognostic algorithm. Therefore, "acceptance criteria" in the traditional sense of a clinical performance study (e.g., sensitivity, specificity, accuracy) are not defined. Instead, the acceptance criteria for substantial equivalence are based on:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the submission is for a reprocessed surgical instrument, not a diagnostic or prognostic device requiring a "test set" in the context of a clinical performance study. The "testing" referred to is laboratory-based performance, cleaning, and sterilization validation for the reprocessed device. The document does not specify sample sizes for these validations or their provenance beyond the fact that Vanguard Medical Concepts, Inc. (Lakeland, FL, USA) performed the reprocessing and submission.

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)

This is not applicable. There is no "ground truth" establishment by experts in the context of a clinical test set for this device. The evaluation is based on engineering and laboratory performance testing against established standards and equivalence to the original device.

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

This is not applicable for the same reasons as points 2 and 3.

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

This is not applicable. This submission is for a reprocessed surgical instrument, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is not an algorithmic device.

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

This is not applicable. The "ground truth" for this submission revolves around the functional equivalence and safety of the reprocessed device compared to the original, as demonstrated through engineering tests (cleaning, sterilization, physical performance) and biocompatibility, not clinical "ground truth" for a diagnostic outcome.

8. The sample size for the training set

This is not applicable. There is no training set as this is not an algorithmic device.

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

This is not applicable. There is no training set or ground truth in the context of a clinical study for this device.

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