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The MANTIS Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

1. Endoscopic marking
2. Hemostasis for:

• Mucosal/sub-mucosal defects < 3 cm
• Bleeding ulcers
• Arteries < 2 mm
• Polyps < 1.5 cm in diameter
• Diverticula in the colon
• Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection

3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus
4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively

The MANTIS Clip is a sterile device consisting of a pre-loaded, radiopaque, singleuse, endoscopic clipping device consisting of two main components: the delivery system and the clip.
The delivery system consists of a handle assembly and delivery catheter. The deliverv system is constructed using stainless steel, and polyester materials. The delivery system will allow for the device to rotate at the distal end. The MANTIS Clip delivery system is offered in a 235cm working length. The clip consists of a stainlesssteel capsule and clip arms, a cobalt chrome yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The MANTIS Clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device. The clip jaw teeth are designed with smaller angle between the teeth and the clip arm body.

The MANTIS Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: endoscopic marking; hemostasis for mucosal/sub-mucosal defects < 3 cm, bleeding ulcers, arteries < 2 mm, polyps < 1.5 cm in diameter, diverticula in the colon, and prophylactic clipping to reduce the risk of delayed bleeding post lesion resection; anchoring to affix jejunal feeding tubes to the wall of the small bowel; and anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus; and as a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not specify a separate "test set" in the context of a clinical study with human patients. The performance data presented refers to bench testing and in-vitro assessments. The sample sizes for each specific bench test item (e.g., number of clips tested for "Repeated Open/Close Function") are not provided in this summary.

Data Provenance: The data provenance is from bench testing conducted by Boston Scientific Corporation. This is not human data, so country of origin and retrospective/prospective distinctions are not applicable.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for this submission is established through pre-defined engineering specifications and bench test results, not through expert consensus on medical images or clinical outcomes.

4. Adjudication Method

Not applicable. As the validation relies on bench testing against engineering specifications, there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted or mentioned in this summary. The device is a medical instrument (clip), not an AI algorithm assisting human readers.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (algorithm only) performance study was not conducted. This device is a physical medical instrument, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for proving the device meets its acceptance criteria is based on pre-defined engineering specifications and performance metrics derived from bench testing. Additionally, the device's biological compatibility and sterility were assessed against relevant ISO standards.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device.

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