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It is indicated for Endoscopic clip placement within the Gastromtestinal tract in adult patients only via a straight or side viewing flexible endoscope for the purpose of:
(1) Endoscopic marking
(2) Hemostasis for
(a) Mucosal/ sub-mucosal defects < 3cm
(b)Bleeding ulcers.
(c)Polyps<1.5cm in diameter,
(d)Diverticula in the colon
(e)Arteries <2 mm
(f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection;
(3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively

The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the clip. The delivery system include: metal cap, spring sheath, pulling wire component, coating layer, protective tube, core rod, and slider. The clip include: clip components and sleeve, and it is deployed from the delivery system during use. The hemoclip can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. The device is available in four clip opening widths, which are 9mm, 11mm, and the device effective length is available in 1600mm, 1800mm, 2600mm, 2600mm.

The provided text describes a 510(k) submission for a Disposable Endoscopic Hemoclip (K222146) and compares it to a predicate device (K182556). The submission focuses on demonstrating substantial equivalence through non-clinical testing rather than clinical trials or AI/algorithm performance. Therefore, many of the requested details about acceptance criteria, clinical studies, and AI performance cannot be found in the provided document.

Here's a breakdown of the available information:

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

The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it lists the results of various non-clinical (bench) tests and biological evaluations, aiming to show compliance with standards and equivalence to the predicate. The "performance" is generally described as "passed" or "complies with standards."

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

The document explicitly states: "No clinical study is included in this submission." All tests described are non-clinical (bench tests, biocompatibility, sterilization, packaging, MR safety). Therefore, there is no "test set" in the context of clinical data, sample size for clinical evaluation, or data provenance from a retrospective or prospective study.

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, as no clinical studies or human-in-the-loop performance evaluations were conducted or reported.

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

Not applicable, as no clinical studies or human-in-the-loop performance evaluations were conducted or reported.

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

Not applicable. This device is a physical medical device (hemoclip), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical medical device, not an algorithm.

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

For the non-clinical tests conducted, the "ground truth" would be the specific requirements and specifications defined by the relevant ISO and ASTM standards. For example, for a tensile strength test, the "ground truth" is a defined force threshold that the device must withstand. For sterilization, it's achieving a SAL of 10^-6. These are objective measures against predefined engineering and biological standards.

8. The sample size for the training set

Not applicable, as no clinical studies or AI/algorithm development (with a training set) were conducted or reported.

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

Not applicable, as no clinical studies or AI/algorithm development were conducted or reported.

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