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Like the Predicate device, Storz 26033, the Baho Autoclavable Laparoscope is inicated for use in the visual examination of body cavities, hollow organs and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Baho Autoclavable Laparoscope

The provided text is related to an FDA 510(k) clearance for a medical device called the "BAHO Autoclavable Laparoscope." It states that the device is "substantially equivalent" to a legally marketed predicate device (Storz 26033). However, it does not contain specific information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

Since this is a substantial equivalence determination based on comparison to a predicate device, a detailed separate study to establish new acceptance criteria and prove device performance in the way described in your request (e.g., with specific performance metrics, sample sizes, expert adjudication, or AI components) is typically not required or presented in such a clearance letter.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts.
4. Adjudication method for a test set.
5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of human readers with/without AI.
6. Standalone performance studies (as the device is a laparoscope, not an AI algorithm).
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The 510(k) process for a device like a laparoscope primarily focuses on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness. The included "Indications for Use" section further clarifies this equivalence, stating: "Like the Predicate device, Storz 26033, the Baho Autoclavable Laparoscope is indicated for use in the visual examination of body cavities, hollow organs and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures."

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