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The Schoelly Laparoscope is indicated for examination of body cavities, holow organs, and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures,

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This document is a 510(k) clearance letter from the FDA for Schoelly Laparoscopes, dated September 14, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

This type of document does not contain the detailed study information requested in your prompt. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific acceptance criteria and performance data like premarket approval (PMA) applications might.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and reported device performance
2. Sample sizes or data provenance
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance data
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This document confirms the device's regulatory clearance but does not include the detailed performance study data you're looking for.

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