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The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Flexible Ureterorenoscope (Model: US31D-12-EU, US31D-12-US) is an endoscope which is used with the Video Processor (Model: EOS-H-01) (FDA cleared K211169) produced by AnQing for providing endoscopic imaging of the ureter and the renal pelvis for the purpose of diagnosis and treatment. The 2 proposed models are identical except the deflection versions, which is opposite from each other (EU version or US version).

The Flexible Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion section contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the Video Processor, LEDs for illumination, and the distal opening of the working channel. The endoscope connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope.

Mechanism of action:

The light emitted by the LED cold light source at the distal tip of the disposable Flexible Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LEDs on the endoscope.

Flexible Ureterorenoscope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single use

The provided document is a 510(k) premarket notification for a medical device (Flexible Ureterorenoscope). It does not describe an acceptance criteria or report on a study proving the device meets acceptance criteria in the manner requested.

Instead, the document details the device's technical specifications, indications for use, comparison to a predicate device, and a summary of non-clinical bench testing, electrical safety, EMC, photobiological safety, biocompatibility, sterilization, and packaging validation tests performed to demonstrate substantial equivalence to a legally marketed predicate device.

Specifically:

• No acceptance criteria table or reported device performance for a specific study is provided. The document focuses on demonstrating substantial equivalence through various tests, not on meeting predefined performance criteria for a novel clinical function.
• No sample size for a test set, data provenance, number of experts for ground truth, or adjudication method are mentioned. This information would typically be part of a clinical study, which the document explicitly states was not required.
• No multi-reader multi-case (MRMC) comparative effectiveness study was done.
• No standalone (algorithm only) performance study was done. This device is a medical instrument (endoscope), not an AI algorithm.
• No specific type of ground truth is mentioned for performance evaluation. The evaluation relies on engineering and biological safety standards.
• No sample size for a training set or method for establishing ground truth for a training set are provided. This is not relevant for this device type.

The document explicitly states:

• "Summary of Clinical Tests: The subject of this premarket submission did not require clinical studies to support substantial equivalence."

Instead, the document summarizes non-clinical tests to demonstrate substantial equivalence:

• Electrical Safety and Electromagnetic Compatibility: Compliance with ANSI/AAMI ES: 60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012; IEC 60601-2-18:2009; IEC 60601-1-2:2014.
• Photobiological Safety: Compliance with IEC 62471:2006.
• Mechanical and Optical Performance: Designed to comply with applicable parts of ISO 8600. Optical measurements performed according to applicable parts of ISO 8600. Mechanical tests included leakage tightness, bending, deflection endurance, and tensile strength testing. Comparative testing for image quality (color reproduction, resolution, depth of field, image intensity uniformity, distortion, dynamic range) against the predicate device.
• Biocompatibility: Evaluated according to ISO 10993-1 and FDA Guidance, including tests for Cytotoxicity (ISO 10993-5:2009/(R) 2014), Sensitization/Irritation (ISO 10993-10:2010), Material-mediated pyrogenicity (ISO 10993-11:2017), and Acute systemic toxicity (ISO 10993-11:2017).
• Sterilization and Shelf Life Testing: Validation to ISO 11135:2014, EO/ECH residual test to ISO 10993-7:2008. Shelf life (3 years) determined by stability study including accelerated aging (ASTM F1980-16).
• Package Validation: Conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, including visual inspection (ASTM F1886), seal strength (F88/F88M-15), dye penetration (ASTM F1929-15), bubble emission (ASTM D3078), and transport/shipping (ASTM D4169-16).

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