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This device is used to provide visual information about the interior of the bladder and the urethra for visualization of the interior organ without a surgical procedure.

The AED line of rigid Cystoscopes is indicated to provide illumination and visualization in:

• Diagnostic cystoscopy procedures.

AED Cystoscope

This document is a 510(k) clearance letter from the FDA for a medical device called the "AED Cystoscope." It states that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study details:

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria.

This document is a regulatory clearance letter, not a technical report or a summary of a performance study. It confirms that the device has met the FDA's requirements for substantial equivalence to a predicate device, which allows it to be marketed. However, it does not detail the specific performance metrics (acceptance criteria) that were tested or the methodologies of any studies conducted to demonstrate those metrics.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details from the provided text.

Based on the document, I can infer:

• Device Name: AED Cystoscope
• Intended Use: To provide visual information about the interior of the bladder and the urethra for visualization of the interior organ without a surgical procedure. Specifically, for diagnostic cystoscopy procedures, providing illumination and visualization.
• Regulatory Class: II (21 CFR §876.1500/Procode: 78 FAJ)
• Type of Clearance: 510(k) substantial equivalence. This type of clearance typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and performance data (which are not detailed in this specific clearance letter).

To obtain the information you're asking for, you would need to access the original 510(k) submission document (K993689) itself, which would contain the technical details and study summaries.

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