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The EC Single Use, Polypectomy Snare is indicated to endoscopically resect tissue from within the GI tract.

The EC Single Use, Polypectomy Snare is a disposable sterile device comprised of a snare loop, a snare tube, a mandrel, a slider and a plug. An electrical connection enables the snare loop to be connected to an electrosurgical generator. Tissue is resected by a combination of mechanical handling of the loop and electrosurgical current.

The provided text is a 510(k) summary for a medical device (EC Single Use, Polypectomy Snare) and does not contain the detailed information typically associated with acceptance criteria and a comprehensive study report for a novel AI/ML device.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Missing Information:
The document does not contain specific acceptance criteria or a study designed to "prove the device meets acceptance criteria" in the way one would expect for a new AI/ML product. This is a 510(k) for a relatively low-risk medical device (a polypectomy snare) which relies on substantial equivalence to an existing predicate device rather than novel performance claims from AI/ML. Therefore, many of the requested items related to AI/ML device validation are not applicable or not present in this type of submission.

Analysis based on available information:

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

   • Not Applicable/Not Present. The document states, "Results of the various tests indicate that the EC Single Use, Polypectomy Snare functions as intended." It does not provide a table of quantitative acceptance criteria typical of AI/ML device performance metrics (e.g., sensitivity, specificity, AUC) or the actual numerical results against such criteria. The "performance testing" mentioned is likely related to bench testing to ensure mechanical and electrical functionality, not clinical performance for diagnostic accuracy.

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

   • Not Present. No information about a "test set" in the context of AI/ML validation (e.g., patient data, images) is provided. This is a hardware device.

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/Not Present. Ground truth establishment by experts is not relevant for this type of device submission as there's no diagnostic AI component.

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

   • Not Applicable/Not Present. Adjudication methods are not relevant for this 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:

   • Not Applicable/Not Present. This device is a surgical tool, not an AI-assisted diagnostic system.

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

   • Not Applicable/Not Present. This is a physical device, not an algorithm.

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

   • Not Applicable/Not Present. Ground truth in the context of AI/ML is not relevant here. The "ground truth" for a polypectomy snare's performance would be its ability to safely and effectively resect tissue, verified through engineering tests and potentially animal or cadaver studies, none of which are detailed here in terms of "ground truth" establishment.

8. The sample size for the training set:

   • Not Applicable/Not Present. There is no AI/ML component, so no training set is used.

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

   • Not Applicable/Not Present. There is no AI/ML component, so no training set or its ground truth establishment is mentioned.

Summary of what is present:

• Device Type: EC Single Use, Polypectomy Snare (a flexible snare for endoscopic tissue resection).
• Intended Use: To endoscopically resect tissue from within the GI tract.
• Predicate Device: Olympus SD Series Snares - K955650.
• Technological Characteristics: Stated to be "virtually identical" to the predicate device.
• Performance Testing: Mentioned that "Results of the various tests indicate that the EC Single Use, Polypectomy Snare functions as intended." This implies internal engineering and functional testing were conducted, but the specifics and results are not provided in this summary.
• Conclusion: The device is substantially equivalent to its predicate device without raising new safety and/or effectiveness issues.

In conclusion, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device for a physical medical instrument, rather than providing the detailed AI/ML performance metrics and study design requested. The questions asked are highly relevant for AI/ML-driven medical devices, but the provided document is for a traditional surgical accessory.

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