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The Disposable Flexible Ureteroscope (U-Scope) is a sterile, single-use, flexible, digital video ureteroscope intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via trans-urethral or percutaneous access routes. It can also be used in conjunction with endoscopic instruments via its working channel to perform various diagnostic and therapeutic procedures in the urinary tract.

Images Systems (Camera-Controlled Unit) is intended to provide power to and receive, process, display, and output recordings of images from compatible visualization devices, the intended medical indication will be defined by the connected visualization devices.

The Flexible Ureteroscope (U-Scope) is a sterile, single-use, flexible, digital video ureteroscope. It contains a miniature CMOS camera, light-emitting diodes (LED) illumination module at the tip and an EEPROM in the handle to store use time. The tip of the U-Scope has a bending portion with 270° ± 15° bidirectional bend angle in the bending section. The U-Scope connects to the I through a separate electrical connector for sending image data and receiving LED power. The U-Scope has an inner working channel no less than 1.20mm for the infusion fluid and instrument passage with two access ports. The insertion tube distal tip OD is available in two size configurations: Flexible Ureteroscope (2.8/1.2) and Flexible Ureteroscope (2.5/1.2). Apart from the size, the endoscopes share a similar design and working length of the ureteroscope is 670 mm. The Luer Port working lumen ID is 1.35mm and irrigation lumen ID is 1.3mm that is used for irrigation connection and accessory device access.

The reusable Images System (Camera-Controlled Unit) contains most electronics, including a power on/off button, touch screen, video processor, LCD, power management electronics and microcontrollers. The system includes the necessary hardware, software, and firmware to drive the endoscope CMOS camera and light-emitting diodes (LED), adjust live view images, capture images, save images to an external source, capture videos, save videos to an external source, manage saved image and files, and manage saved video files. The reusable Images System (Camera-Controlled Unit) has connectors for attaching and detaching the endoscope, external monitor, external memory, and DC power supply. The LCD has a touchscreen function for user interaction with the GUI to control the CCU functions. The display unit has a VESA mount incorporated into the rear of the enclosure for attachment to a cart or any existing customer mounting bracket that adheres to the same standard mounting pattern.

Both the reusable Images System (Camera-Controlled Unit) and the single-use Flexible Ureteroscope together complete the "Ureteroscope System" enabling a Flexible Ureteroscopy procedure to take place.

The provided FDA 510(k) clearance letter and summary describe a new flexible ureteroscope system. However, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets the acceptance criteria for AI/Software performance.

The document primarily focuses on the physical device (Flexible Ureteroscope) and its Camera-Controlled Unit. The "Software Verification Test was performed to verify the software functions against its intended use" is mentioned, but no detailed performance metrics, acceptance criteria, or study results are provided for any AI or algorithmic component.

Given the input, I cannot answer the questions regarding AI/Software acceptance criteria and performance study details. The information provided is for a traditional medical device (endoscope and camera system) and its non-clinical testing for substantial equivalence to a predicate device, which includes:

• Electrical Safety and Electromagnetic Compatibility: Tested according to IEC 60601-1, EN 60601-1-2, IEC 60601-2-18.
• Photobiological Safety: Assessed according to IEC 62471:2006.
• Mechanical and Optical Performance: Includes bending, working channel, flow rate, tensile and torsional strength, field of view, direction of view, resolution, noise, dynamic range, geometric distortion, and image intensity uniformity (with reference to ISO 8600 series standards).
• Software Verification Test: Performed to verify software functions against intended use. (This is the only mention of software, and it's a verification test, not a clinical performance study with AI metrics)
• Biocompatibility: Assessed according to ISO 10993 standards.
• Sterilization and Shelf Life: Validation according to ISO 11135:2014, environmental conditioning, simulated shipping, package integrity, and device performance testing.

Therefore, I cannot populate the table or answer the specific questions about AI acceptance criteria and performance studies because the provided text does not contain that information. The device described here does not appear to be an AI/ML-driven device based on the provided clearance letter.

To provide the requested information, the input document would need to include details about:

• A specific AI algorithm's function (e.g., automated detection of stones, tissue classification).
• Quantitative performance metrics (e.g., sensitivity, specificity, AUC) for that AI algorithm.
• The study design used to evaluate these metrics (e.g., standalone performance study, MRMC study).
• Details about the dataset (size, provenance, ground truth establishment, expert qualifications, adjudication).
• Specific acceptance criteria tied to the AI's performance.

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