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It is intended to be used with FDA-cleared endoscopic clip placement within the gastrointestinal tract. It is indicated to be used for
(1) Endoscopic marking
(2) Hemostasis for
(a) Mucosal/sub-mucosal defects

The endoscope clip is a metallic mechanical device used in endoscopy in order to close two mucosal surfaces without the need for surgery and suturing. Its function is similar to a suture in gross surgical applications, as it is used to join together two disjointed surfaces, but, can be applied through the channel of an endoscope under direct visualization. The endoscope clip has found use in treating gastrointestinal bleeding (both in the upper and lower GI tract), in preventing bleeding after therapeutic procedures such as polypectomy, and in closing gastrointestinal perforations.

The Handle Slider and the coil are connected, and the clip are connected. When the Handle Slider is moved backward, the coil connected to the Handle Slider is pulled back, and the clip is also pulled back and the clip is closed as the clip enters the Clip Body. After the clip is completely closed, the clip will no longer be pulled back and when the threshold is reached, the Disconnection connector part will eventually break. As a result, the delivery device and the clip are completely separated, and the clip remains alone to maintain hemostasis.

The provided text is a 510(k) summary for a medical device called "CORE-CLIP," a disposable endoscope clip. It aims to demonstrate substantial equivalence to a predicate device. However, the document does NOT contain the specific details required to answer all parts of your request, especially regarding acceptance criteria, performance metrics, and the full scope of a comparative effectiveness study as one might expect for an AI/CADe device. This device is a mechanical one, and the non-clinical and animal testing focus on its mechanical and biological safety and performance rather than AI algorithm performance.

Therefore, for the questions related to AI/CADe systems (e.g., sample sizes for training/test sets, ground truth establishment methods, expert qualifications, MRMC studies, standalone performance), the information is not present as it is not an AI-powered device.

Here's an analysis of the provided text based on your questions, with N/R (Not Reported) or N/A (Not Applicable) where the information is not relevant or present for this type of mechanical device submission:

Acceptance Criteria and Device Performance (Based on available information for a mechanical device)

Given that this is a mechanical device, the "acceptance criteria" discussed are for its mechanical and biological safety and performance, not for an AI algorithm's diagnostic accuracy. The document states that the "results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." This implies that the device "meets the acceptance criteria" by performing comparably to the predicate and adhering to relevant standards.

1. Table of acceptance criteria and the reported device performance:

The document mentions several non-clinical tests performed, and the acceptance criteria are implicitly the successful completion and meeting of standards within these tests. The reported device performance is that it met these standards.

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: For the non-clinical bench tests (e.g., rotation, open/close, tensile strength, clamping retention time), specific numerical sample sizes are N/R. These tests would typically involve a specific number of units, but the report only states "The mechanical properties tests were performed by being based on each product different properties and dimensions."
• Data Provenance:
  • Country of Origin: The submitter is INCORE Co., Ltd., Republic of Korea. The testing was conducted by them or their contracted labs.
  • Retrospective or Prospective: These are non-clinical, benchtop, and animal tests, not human retrospective/prospective clinical studies. They are specifically performed for this submission.

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

• N/A. This information is for AI/CADe systems where human experts establish ground truth for image interpretation. For a mechanical device, performance is typically assessed against engineering specifications, material standards, and functional requirements.

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

• N/A. This applies to human expert adjudication for image interpretation in AI studies.

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. This is a mechanical device, not an AI software.

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

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

7. The type of ground truth used:

• For the non-clinical tests: The "ground truth" is defined by established engineering and biological standards (e.g., ISO, ASTM, AAMI, USP, in-house predicate-based standards).
• For the animal test: The "ground truth" for adhesion safety and hemostatic performance would be direct observation and measurement in the animal model.

8. The sample size for the training set:

• N/A. This is for AI algorithms. This device does not have a "training set."

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

• N/A. This is for AI algorithms.

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