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The PARE Endoscopic Suturing System will allow the surgical physician to suture soft tissue when doing gastroenterological procedures using the operating channel of a flexible endoscope.

The PARÉ Endoscopic Suturing System consists of three concentric tubes and a wire that can fit down the operating channel of a flexible endoscope. Each of the concentric tubes controls a function that is required to do soft tissue suturing at the distal end of the endoscope. These functions include:

• A needle, which is used to puncture through the soft tissue 1.
• 2. A loop, which is used to capture the free end of the suture.
• 3. A holder for the suture that is formed into a pre-tied knot.
• A knot pusher, which also performs the function of cutting the suture once the knot is positioned and formed.
  The device will be loaded only with sutures that have received FDA approval for human use.

The provided text describes the 510(k) summary for the PARE Endoscopic Suturing System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report as one might find in a peer-reviewed publication or a full PMA.

Here's the breakdown of the information requested based only on the provided text:

Acceptance Criteria and Device Performance Study (PARE Endoscopic Suturing System)

This submission focused on demonstrating substantial equivalence, not on fulfilling specific quantitative acceptance criteria in the same way a new, high-risk device might. The "performance data" section is very brief and qualitative.

Notes on Acceptance Criteria and Performance:
The document does not detail specific, quantitative pass/fail criteria (e.g., "tensile strength of suture line > X N," "suture placement accuracy within Y mm"). Instead, it broadly states that materials meet specifications and the device was able to suture.

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

   • Test Set Sample Size: The device was "in-vitro tested six times using the operating channel of an Olympus Colonoscope type CF-1T140 and six times using an Olympus Gastroscope type GIF-PQ20." This implies a total of 12 in-vitro tests. The tissue types used were "fresh swine esophagus, stomach and colon soft tissue." The exact number of each tissue type is not specified.
   • Data Provenance: The data is from in-vitro bench testing using fresh swine tissue. The country of origin for the data is not specified, but the applicant company is based in Colorado, USA. The study is prospective in the sense that the tests were conducted specifically for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not report on the use of experts to establish ground truth for this bench study. The performance evaluation appears to be based on the direct observation of successful suturing and knot dropping by the testers.

3. Adjudication method for the test set:

   • Not applicable / Not reported. There is no mention of an adjudication method, as the study appears to be a direct bench test observation rather than an expert-read case review.

4. 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 device is a mechanical endoscopic suturing system, not an AI or diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.

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

   • Not applicable. This is a mechanical device, not an algorithm. Its operation inherently involves a human physician.

6. The type of ground truth used:

   • The ground truth for this bench test appears to be the direct observation of the mechanical functionality of the device: "In all experiments the device was able suture the soft tissue including the dropping of the pre-tied knot." This is an objective observation of the successful completion of the intended physical action.

7. The sample size for the training set:

   • Not applicable / Not reported. This is a mechanical device, not a machine learning algorithm that requires a "training set."

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

   • Not applicable. As above, no training set was used.

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