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The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier has applications in many types of endoscopic procedures to achieve hemostasis following transection of vessels and other tubular structures, and for radiographic markings.

The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier contains 16 titanium clips. The applier is designed for introduction and use through an appropriately sized trocar sleeve, or larger with the use of a converter. The ENDO CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft rotation knob, clip counter window and a 33 cm shaft with jaws at its distal end. Squeezing the handle places a titanium clip in the jaws and closes the jaws to close the clip on the vessel or structure.

The provided document is a 510(k) summary for the "Auto Suture™ ENDO CLIP™ III 5mm Clip Applier," a surgical device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and an AI study. Therefore, most of the requested information regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment cannot be found in this document.

However, I can extract the relevant information that is available:

Table of Acceptance Criteria and Reported Device Performance:

The document states: "In-vitro and in-vivo tests were performed to verify that the ENDO CLIP™ III 5mm Clip Applier was substantially equivalent to the predicate device in occluding vessels and other tubular structures and to validate that the ENDO CLIP™ III 5mm Clip Applier performed as intended."

This implies the acceptance criterion was "substantial equivalence," meaning the new device performed comparably to the predicate device in its intended function (occluding vessels/tubular structures). Specific quantitative performance metrics or thresholds are not provided in this summary.

Here's a breakdown of the other requested information based on the provided text, indicating where information is not available (N/A) for this type of device submission:

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

   • See table above. The acceptance criteria are implicitly tied to demonstrating "substantial equivalence" and "performing as intended" in occluding vessels and tubular structures. Specific quantitative performance figures are not provided in this summary.

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

   • N/A. The document mentions "In-vitro and in-vivo tests" were performed but does not specify sample sizes, country of origin, or whether the tests were retrospective or prospective.

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)

   • N/A. This is a surgical clip applier, not an AI-driven diagnostic device. The concept of "ground truth" established by experts in the context of an AI study does not apply here. Performance would be assessed by engineers/scientists conducting the tests and potentially surgeons using the device.

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

   • N/A. Adjudication methods are relevant for ambiguous cases in diagnostic studies, particularly with AI. This does not apply to the performance testing of a mechanical surgical device.

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

   • N/A. An MRMC study is specific to evaluating diagnostic AI systems and how they impact human reader performance. This device is a surgical instrument, not an AI solution.

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

   • N/A. This is a hardware device, not an algorithm.

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

   • N/A. For a mechanical device like this, "ground truth" would be established by direct observation of successful vessel occlusion and proper clip deployment in controlled in-vitro and in-vivo settings. It's not a diagnostic outcome requiring expert consensus, pathology, or long-term outcomes data in the way an AI diagnostic device would.

8. The sample size for the training set

   • N/A. This is not an AI device, so there is no training set.

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

   • N/A. This is not an AI device, so there is no training set or ground truth in that context.

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