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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. This instrument is also used as a suction catheter that establishes a conduit used for irrigation of kidney stones and stone dust during ureteral lithotripsy.

The Pusen Single Use Flexible Video Ureteroscope (Model: PU3033H, PU3033AH) and Pusen Single Use Suction Access Ureteroscope (Model: PU400A, PU411A) have 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. This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy. This product is for use in a hospital or qualified medical institution.

• Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are provided sterile with the following model differences:
  | Product name | Single Use
  Ureteroscope | Suction Access | Single Use
  Ureteroscope | Flexible Video |
  |----------------|----------------------------|----------------|----------------------------|----------------|
  | Model | PU400A | PU411A | PU3033H | PU3033AH |
  | Suction access | Yes | Yes | Yes | Yes |
  | Buttons | Yes | Yes | No | Yes |
• . The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope have two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope need to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are powered by the HD Medical Video Endoscope Image Processor PV300.
• The HD Medical Video Endoscope Image Processor PV300 was cleared under 510(k) number K222602.

The provided text describes a submission to the FDA for a medical device (Single Use Suction Access Ureteroscope and Single Use Flexible Video Ureteroscope) and its comparison to a predicate device. However, it does not contain information related to software AI performance or studies specifically designed to establish AI acceptance criteria.

The document focuses on the safety and effectiveness of the physical ureteroscope devices, including aspects like:

• Biocompatibility
• Electrical safety and electromagnetic compatibility (EMC)
• Software verification and validation (for the device's operational software, not AI)
• Mechanical and optical performance
• Image quality (of the physical device's optics, not AI-enhanced image analysis)
• Photobiological safety
• Luer taper
• Sterilization and shelf life

Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI component, as it is not present in the given text.

The closest relevant section is "Software Verification and Validation Testing," which states:
"Software verification and validation testing were conducted, and relevant software documentations were provided as recommended by FDA's Guidance for Industry and FDA staff, "Guidance for the Content of Premarket Submissions for Device Software Function" (issued on June 14, 2023)."

This refers to the software controlling the device's basic functions, not an AI component for medical diagnosis or image interpretation. Without specific details on AI functionality, performance metrics, or clinical studies involving AI, the requested table and study details cannot be generated from this document.

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