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The MMS Video option is intended to acquire, view, record, process, print, archive and retrieve video images such as of gastroenterology and urology procedures.

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I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a device called "MMS Video Option," indicating it has been deemed substantially equivalent to a predicate device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone performance.
• Sample sizes for training or test sets.

The letter primarily focuses on the regulatory clearance of the device for marketing based on its substantial equivalence to a predicate, and its stated "Indications For Use" (acquiring, viewing, recording, processing, printing, archiving, and retrieving video images for gastroenterology and urology procedures). It does not delve into the specific performance metrics or studies used to validate new technological claims.

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