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The Single use flexible ureteroscope 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 Image processor is used in conjunction with the video endoscopes produced by BESDATA to process the images collected by the video endoscopes and send it to the display, and provide power for the endoscope.

The Single use flexible ureteroscope system consists of a sterile Single use flexible ureteroscope and an Image processor.

Description of the ureteroscope:
Name: Single use flexible ureteroscope
Model: UR-D1, UR-D2, UR-F1, UR-F2
There are four models of the Single use flexible ureteroscope. Different models are the same except for size and handle appearance. The ' D ' and ' F ' indicate that the appearance of different handles is different, ' 1 ' and ' 2 'represent different Maximum widths of insulation portion.
Single use flexible ureteroscope is a sterile product for single use, and repeated use is prohibited.The Single use flexible ureteroscope is a portable equipment. The Single use flexible ureteroscope mainly consists of the distal, insertion portion, handle,connection cable and LEMO plug:
1)The distal including LED lighting, optical lens, CMOS imaging module.
2) The insertion portion includes the instrument channel and insertion tube.
3) The handle includes instrument channel ports, hand push rods, imaging control button switches and connecting the cable (with LEMO plug ).
Single use flexible ureteroscope is connected to the image processor through the LEMO plug on the connecting cable, and the patient's area is illuminated and imaged by the LED and camera of the insertion tube Distal. The CMOS sensor of the insertion tube Distal collects optical signals in imaging and converts them into electrical signals, which are transmitted to the image processor for display. There is an instrument channel in the insertion tube for operating diagnostic and therapeutic accessories (not configured on this device) through the instrument channel. The instrument channel can also provide water/air supply facilities for water/air supply through the instrument channel. Water supply is used to remove mucus attached to the surface of the camera, while air supply is used to remove residual water droplets on the camera. The handles each have two imaging button, and a push rod. The imaging button can control imaging (One button controls taking photos and one button controls recording), and the push rod can control the curvature of the insertion tube Distal.

Description of the Image processor:
Name: Image processor
Model: MIP1001, MIP1002
The model MIP1001 and MIP1002 were identical except for position of button and different appearance size.
Image processor is a lightweight endoscope video display, This device is composed of image processor, power adapter(power supply), LCD screen(image display) and image processing motherboard(function).
The endoscopic video image processor can process the image collected by the endoscope and display the image in real time through the LCD module. Users can use the LCD module for humanmachine interaction.
The principle of optical imaging: the light source illuminates the inspected site of the patient, which is imaged by the photosensitive surface of endoscope's CMOS camera module. The optical signal received by the CMOS sensor is converted into electrical signal after processing. The electrical signal is then transmitted by the cable to the signal processing chip embedded on the Image processor where it is restored after processing and finally displayed on the screen of Image processor.

The provided text does not contain information about an AI-powered medical device or its performance study. The document is an FDA 510(k) clearance letter for a Single use flexible ureteroscope system (UR-D1/UR-D2/UR-F1/UR-F2) and its associated Image processor (MIP1001/MIP1002).

The entire document focuses on demonstrating the substantial equivalence of this medical device (a physical endoscope and image processor, not an AI algorithm) to a predicate device based on:

• Indications for Use: Comparing what the devices are used for.
• Technological Characteristics: Comparing physical attributes, specifications (e.g., field of view, resolution, channel width, bending angle), materials, and sterilization methods.
• Non-clinical Performance Data: This section details various types of bench testing performed on the physical device to ensure its safety and effectiveness (e.g., biocompatibility, electrical safety, photobiological safety, sterilization validation, shelf life, packaging, optical performance, mechanical performance). There is no mention of AI, algorithms, or software-based performance studies.
• Clinical Evidence: Explicitly states "N/A" (Not Applicable), meaning no human clinical trials were presented for this submission.
• Animal Studies: Explicitly states "N/A", meaning no animal studies were conducted.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device and its supporting study, as the provided text pertains to a traditional, non-AI medical device.

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