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Avicenna Roboflex is indicated for endoscopic examination in the urinary tract with transurethral access and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

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This document does not contain the information required to address your request. The provided text is an FDA 510(k) clearance letter for a medical device called "Avicenna Roboflex". It confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

However, it does not include any details about the acceptance criteria or the study that proves the device meets those criteria. Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance (e.g., country of origin, retrospective/prospective), or the number/qualifications of experts.
• Details on adjudication methods, MRMC studies, standalone algorithm performance, or the type of ground truth used.
• Information regarding the training set's sample size or how its ground truth was established.

The letter primarily focuses on the regulatory clearance and administrative requirements for marketing the device. To fulfill your request, you would need access to the actual 510(k) submission document or a separate clinical study report, which would typically contain these performance details.

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