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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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Single-Use Digital Flexible Ureteroscope (F-URS)(ZSR-URS-02, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) : This product is used in medical institutions, in conjunction with our electronic endoscope image processor. for imaging in examination, diagnosis or treatment of urinary system diseases.

Endoscope Imaging Processor (ZSR-EOS10) : Applicable to medical institutions, which are connected with electronic endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors.

Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) Single-Use Digital Flexible Ureteroscope (F-URS) is used in medical institutions, in conjunction with our electronic endoscope image processor, for imaging in examination, diagnosis or treatment of urinary system diseases. This device uses ethylene oxide (EO) sterilization process. This product consists of two main parts: an operating handle with directional control and connecting wires, as well as a flexible insertion tube.

Electronic Endoscope Imaging Processor (ZSR-EOS10) Applicable to medical institutions, which are connected with electronic endoscopes during endoscopic diagnosis and/or treatment/surgery, and effectively display images of the field of view areas of human body cavities observed by endoscopes on monitors. The device is composed of aluminum alloy chassis and motherboard and power supply components.

The Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) and Electronic Endoscope Imaging Processor make up the video ureteroscope system.

The provided text is for a 510(k) premarket notification for a Single-Use Digital Flexible Ureteroscope (F-URS) and an Electronic Endoscope Imaging Processor. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies will differ significantly from what would be found in a submission for a new AI/software device that requires proving clinical benefit.

Based on the provided text, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for this device is based on substantial equivalence to existing predicate devices, not on specific performance metrics established as acceptance criteria for clinical efficacy. The "acceptance criteria" here refer to meeting recognized standards for medical devices of this type, ensuring safety, and demonstrating that any differences from the predicate do not raise new questions of safety or effectiveness.

Discussion of Differences (from Comparison Table, if differences existed):
The document states for "Maximum insertion portion width(mm)" and "Field of view (degree)" that these are "Similar" or "Same" after analysis, concluding that "Only differences in specifications and dimensions. All the performance was tested and the results met the standard requirements, this difference will not raise any issues in safety and effectiveness." This indicates that any numerical differences in these parameters were evaluated against the relevant standards and found to be acceptable.

2. Sample size used for the test set and the data provenance

The document explicitly states: "No clinical study is included in this submission."

Therefore, there is no "test set" in the context of clinical data. The testing performed was non-clinical bench testing to demonstrate compliance with recognized industry standards and evaluate engineering performance, biocompatibility, and sterilization effectiveness.

• Sample Size for Bench Testing: The document does not specify the exact number of units or samples used for each non-clinical test (e.g., how many ureteroscopes were tested for bending angle, how many samples for biocompatibility). This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The data provenance is from non-clinical laboratory and bench testing, likely conducted by the manufacturer or accredited testing facilities. There is no mention of country of origin for this testing, but it can be inferred the testing supports a device manufactured by Dongguan ZSR Biomedical technology Company Limited in the PEOPLE'S REPUBLIC OF CHINA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical study was conducted, there was no clinical "test set" requiring expert ground truth establishment. The "ground truth" for the non-clinical tests is defined by the objective metrics and thresholds established in the referenced international standards (e.g., ISO, IEC, ASTM).

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical instrument (ureteroscope and imaging processor), not an AI/software device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical instrument, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for this 510(k) submission is derived from:

• International Standards and Recognized Test Methods: For performance, biocompatibility, and sterility, the ground truth is compliance with the specifications and thresholds defined in the referenced standards (e.g., ISO, IEC, ASTM).
• Predicate Device Characteristics: For determining substantial equivalence, the technological characteristics and performance of the legally marketed predicate device (K230200) serve as a baseline for comparison.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument, and no machine learning algorithm development (which would require a training set) is mentioned or implied.

9. How the ground truth for the training set was established

Not applicable. There was no training set.

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