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These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section. The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Single Use Electrosurgical Snare SD-400, structured to address your specific points:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical trial. As such, information on specific clinical performance metrics (like sensitivity, specificity, accuracy), sample sizes for clinical test sets, expert qualifications for ground truth, and multi-reader multi-case studies are generally not included in this type of submission. The studies described are primarily non-clinical (biocompatibility, electrical safety, etc.) and performance testing aimed at showing the device functions as intended and is safe.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a direct table of specific clinical acceptance criteria and reported device performance in the way one might expect for an AI diagnostic device. Instead, it describes various non-clinical performance tests and their compliance with established standards.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size (Test Set): Not specified in the document. The studies were non-clinical performance and safety tests, likely conducted on a representative sample of manufactured devices rather than a patient-based test set.
• Data Provenance: The studies are laboratory and bench testing, not human patient data. Therefore, the concept of "country of origin" or "retrospective/prospective" doesn't directly apply in the usual clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Given the non-clinical nature of the tests (e.g., measuring dimensions, testing durability, chemical residuals), the concept of "ground truth" derived from medical experts for a "test set" in the context of clinical performance is not applicable. The "ground truth" for these tests would be the established scientific and engineering standards and limits.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human reader interpretation.

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

• No, an MRMC comparative effectiveness study was not done. This is a medical device (electrosurgical snare) and its submission is focused on physical and electrical safety and performance, not on diagnostic image interpretation or AI assistance for human readers.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable as no AI component for diagnostic assistance is mentioned or evaluated.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone algorithm-only performance study was not done. The device itself is a physical instrument, not a diagnostic algorithm.

7. Type of Ground Truth Used

The "ground truth" for the various non-clinical tests involved:

• Engineering specifications and design requirements (for dimensions, operation).
• Established international and national standards (ISO, ASTM, AAMI/ANSI, IEC) for sterilization, shelf-life, biocompatibility, and electrical safety.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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