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The device for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for for treating gastrointestinal organ wall lesions, and for making of lesions. The Device is indicated for clip placement within the GI tract for the purpose of:
a .Endoscopic Marking
b. Hemostasis for:

• Mucosal/Submucosal defects < 3cm
• Bleeding Ulcers
• Arteries <2 mm
• Polyps < 1.5 cm in diameter
• Diverticula in the Colon
  c. Closure of GI tract luminal perforations < 20mm that can be treated conservatively.

The Disposable Hemostatic Closure Clip Device is a sterile, single-use endoscopic clipping device, intended for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions, and for making of lesions. The device is indicated for clip placement within the GI tract for the purpose of.
a. endoscopic marking
b. hemostasis for:

• mucosal/submucosal defects < 3cm
• bleeding ulcers
• arteries < 2 mm
• polyps < 1.5 cm in diameter
• diverticuli in the colon
  C. Closure of GI tract luminal perforations < 20mm that can be treated conservatively.
  The Disposable Hemostatic Closure Clip Device consists of one pre-loaded clip and delivery device for single patient use only. The clip is made of nickel-titanium alloy with good superelasticity performance. The clip is pre-loaded in the barrel at the end of the delivery system through its deformation.
  The proposed device has twenty-four (24) specifications that vary to the outer diameter of the clip: φ14.5 mm, φ17.0 mm; working length: 1650 mm, 1950 mm, 2350 mm, 2700 mm; and whether the outer tube is coated or not.
  The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided text describes the acceptance criteria and the studies performed to demonstrate the substantial equivalence of the "Disposable Hemostatic Closure Clip Device" (Proposed Device) to the "OTSC™ (Over-The-Scope-Clip) System Set" (Predicate Device).

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a separate section with pass/fail results for each criterion. Instead, it states that various performance tests were conducted, and the results demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device.

The table below summarizes the technical characteristics compared, which implicitly serve as acceptance criteria for similarity to the predicate device. The "Remark" column indicates if the characteristic is "Same" or "Similar" to the predicate, implying acceptance if it falls within these categories or if differences do not affect substantial equivalence.

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

The document does not specify sample sizes for the test sets of the described performance data. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective nature) for any of the tests. The tests conducted are primarily bench tests and material safety tests, not clinical studies involving human patients or a specific geographic origin of data.

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

This information is not applicable and not provided in the document because the submission does not involve an AI/ML-based device that requires expert-established ground truth for a test set. The validation involves engineering, material science, and microbiology testing against international standards and comparison to a predicate device's characteristics.

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

This information is not applicable and not provided as there is no mention of a human expert adjudication process for establishing ground truth, given that this is not an AI/ML device submission.

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 information is not applicable and not provided as this is not an AI/ML device submission. No MRMC study was performed.

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

This information is not applicable and not provided as this is not an AI/ML device submission.

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

The concept of "ground truth" as typically used in AI/ML validation (e.g., expert consensus, pathology) is not directly applicable here. The "ground truth" for the device's performance is established by:

• Adherence to recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 for sterilization, ASTM standards for MRI compatibility, ASTM F1980-16 and ISO 11607 for shelf-life).
• Demonstrating that the device's functional performance (e.g., release performance, closure force, endoscope adaptability, deployment, clip persistence) meets predetermined engineering specifications (acceptance criteria), which are implicitly based on the predicate device's established safety and effectiveness.
• Direct comparison of technical characteristics to a legally marketed predicate device (K101428).

8. The sample size for the training set

This information is not applicable and not provided as this is not an AI/ML device submission that involves a training set.

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

This information is not applicable and not provided as this is not an AI/ML device submission.

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