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This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).

The optical fiber transmits the light emitting from the LED light built in the handle to the coelom. The complementary metal-oxide-semiconductor CMOS imaging sensor in the distal tip of the insertion shaft receives the reflected light from the surface of mucosa and transforms the light into electric signal. The wire transfers the electric signal to the data processing center of the Eview , where the electric signal is processed. As a result the color imaging of the capillary network and mucosal morphology is displayed on the screen of the Eview.

The Medical Video Endoscope system is a digital flexible ureteroscope system that consists of the Eview( the video system, touch PC with data processing center) and the Uscope. The Uscope is provided sterile( sterilized by EO) and intended to be single-use.

The Uscope contains an insertion portion, handpiece, cable and water tube.

The Eview, the video system contains touch PC with data processing center and provide energy to Uscope. The Eview can be powered by the main line or lithium battery.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

The document (a 510(k) summary) describes a "Medical Video Endoscope System" and its performance testing. However, it does not provide a detailed table of acceptance criteria with specific numerical targets and reported performance values. Instead, it generally states that evaluation acceptance criteria were met. It also does not describe a study focused on proving that humans improve with AI assistance. The device appears to be a standalone system that performs image acquisition and display for endoscopic procedures with a single-use ureteroscope.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not include a specific table with numerical acceptance criteria and corresponding reported performance. It mentions several standards and states that "All evaluation acceptance criteria were met" for specific tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for any of the performance tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The tests appear to be laboratory/bench testing of the device itself rather than clinical studies with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The performance tests described (electrical safety, EMC, biocompatibility, sterilization, and basic functional characteristics) do not typically involve human experts establishing a "ground truth" in the way a diagnostic algorithm might. These tests rely on established engineering and biological standards.

4. Adjudication Method for the Test Set

Not applicable. The tests described are primarily objective engineering and biological evaluations, not human-interpreted diagnostic assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done according to this document. The device is a "Medical Video Endoscope System," which is a viewing and surgical tool, not an AI diagnostic aid designed to improve human reader performance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Yes, in a sense. The described "Non-Clinical Performance Data" are for the device's standalone operation and functionality (e.g., image quality, illumination, safety standards). There is no mention of an algorithm or AI component in the traditional sense; the "processing center" mentioned handles the video signal. The tests verify the device's ability to perform its core function: acquiring and displaying video from an endoscope.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on:

• Compliance with recognized international standards (IEC 60601 series, ISO 10993, ISO 11607, ISO 11135, ISO 8600).
• Functional specifications of the device (e.g., image quality, illumination, articulation, leak, flow rate).

This is not "expert consensus," "pathology," or "outcomes data" in the context of diagnostic performance studies. It's engineering and safety compliance.

8. Sample Size for the Training Set

Not applicable. This device is an endoscope system, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no AI training set for this device.

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