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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: US27F-12-EU; US27F-12-US) is intended to be used with the Video Processor (cleared via K211169). The Flexible Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. 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, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the Video Processor, and two optical fibers to transmit illumination from the handle to the distal tip. The distal bending section of the insertion section 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, optical fibers for transmitting illumination from the LED inside the Handle, 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 from the distal tip of the 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 LED on the endoscope.

Flexible Ureterorenoscope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera at the distal tip
• LED in the handle and transmitted to the distal tip by optical fibers
• Sterilized by Ethylene Oxide
• For single use

The provided FDA 510(k) clearance letter and summary for the Flexible Ureterorenoscope (K243857) does not contain details about a study evaluating AI performance directly or outlining acceptance criteria for such a study.

This document primarily focuses on the substantial equivalence of a medical device (endoscope) based on its physical properties, performance characteristics (mechanical, optical), electrical safety, biocompatibility, sterilization, and packaging. The "non-clinical tests summary & conclusions" explicitly state "Clinical Testing: Not Applicable."

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI performance, human reader improvement with AI, or standalone AI performance, as this information is not present in the provided text.

The closest relevant information is about the device's optical performance and image quality, which are foundational for any imaging device, and would implicitly establish a baseline for an AI to process.

Here's what I can provide based on the given information, primarily highlighting the device's tested performance attributes, which serve as foundational acceptance criteria for the hardware itself, not an AI component:

Acceptance Criteria and Device Performance (Flexible Ureterorenoscope - K243857)

Since the provided document is for a medical imaging device (uroscope) and not an AI/software as a medical device (SaMD), the "acceptance criteria" discussed are for the physical and functional performance of the endoscope itself, rather than for an AI algorithm built upon imagery from such a device. There is no mention of AI in this clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document lists "applicable parts" of standards and general categories of testing rather than specific numerical acceptance thresholds or quantitative performance metrics. The reported performance is adherence to these standards and the successful execution of these tests.

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for mechanical performance). The testing is primarily bench/lab-based.
• Data Provenance: The tests are non-clinical, hardware-focused performance evaluations. Data is generated during these laboratory tests performed by the manufacturer, Shanghai AnQing Medical Instrument Co., Ltd. (China). This is implied to be prospective testing for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. The document explicitly states "Clinical Testing: Not Applicable." Ground truth, in this context, would relate to clinical outcomes or expert review of images for diagnostic purposes, which are not part of this 510(k) submission for the device itself. Performance is evaluated against engineering standards and specifications.

4. Adjudication Method for Test Set

• Not applicable. No clinical test set or expert review requiring adjudication is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document explicitly states "Clinical Testing: Not Applicable." No MRMC study or AI assistance evaluation is mentioned.

6. Standalone Performance (Algorithm Only)

• Not applicable. This submission is for the endoscope hardware, not a standalone AI algorithm. No algorithm performance is described.

7. Type of Ground Truth Used

• Engineering/Technical Standards: The "ground truth" for this device's performance is adherence to established international and national standards (e.g., IEC, ISO, ASTM, ANSI AAMI) for medical device safety, electrical performance, optical quality, biocompatibility, sterilization, and mechanical integrity. Performance is measured against these technical specifications.

8. Sample Size for Training Set

• Not applicable. There is no mention of an AI component requiring a training set.

9. How Ground Truth for Training Set Was Established

• Not applicable. There is no mention of an AI component or a training set.

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AnQing Medical Single Use Flexible Cystoscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra.

The Flexible Cystoscope is intended for use in a hospital environment or medical office environment. The Flexible Cystoscope is designed for use in adults.

The Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) is a sterile single-use endoscope which is used with the video processor (Model: EOS-H-01, FDA cleared #K211169) produced by AnQing for providing endoscopic imaging of the lower urinary tract, including the bladder and urethra for the purpose of diagnosis and treatment.

The CY50H-20 and CY55H-24 difference is the size of Distal End Outer Diameter and Working Channel Inner Diameter. The US and EU model are identical except the deflection versions, which is opposite from each other (EU version or US version).

The Flexible Cystoscope is a single-use endoscope, which consists of Handle, Insertion Section, Distal Tip, and 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 contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion section 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.

The provided document does not describe the acceptance criteria and study proving device meets acceptance criteria in the format requested. Specifically, it does not include a table of acceptance criteria vs. device performance, or details regarding sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a 510(k) premarket notification for a Flexible Cystoscope, primarily focusing on demonstrating substantial equivalence to a predicate device (Ambu aScope 4 Cysto) through non-clinical testing.

Here's a breakdown of the information that is available in relation to your request, and what is missing:

1. A table of acceptance criteria and the reported device performance

• Not explicitly provided in the requested format. Instead, the document provides a "Comparison with Predicate Device" table (pages 5-6) which compares various physical, optical, and technological characteristics of the subject device to the predicate device. However, this table lists characteristics and indicates "Same" or "Similar" for comparison, rather than specific acceptance criteria and quantitative performance results for each criterion.
• "Summary of Testing" (page 8-9) lists the types of non-clinical tests performed (Electrical Safety, EMC, Photobiological safety, Mechanical and Optical Performance, Biocompatibility, Sterilization, Shelf life, Package Validation) and the standards they comply with, but does not provide specific acceptance criteria or performance values for the subject device against these criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not provided. The document describes non-clinical bench testing, but does not specify sample sizes for these tests or the origin of any data (as it's physical device testing, not data collection from patients).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable/Not provided. This type of information is typically relevant for AI/ML-based devices where expert-labeled datasets are used to establish ground truth. The Flexible Cystoscope is a physical medical device, and its performance is evaluated against engineering specifications and standards, not against expert-established ground truth on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. As above, this is relevant for AI/ML evaluation, not for the direct performance testing of a physical endoscope.

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

• No, not done. The document explicitly states under "Summary of Clinical Tests" (page 9): "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." This means no human-in-the-loop or MRMC studies were conducted.

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

• Not applicable/Not done. The device is a physical cystoscope, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable/Not provided. The "ground truth" for this device's performance relies on established engineering standards (e.g., ISO 8600 for optical measurements, IEC 62471 for photobiological safety, ISO 10993 for biocompatibility) and direct physical measurements and tests of the device's characteristics (e.g., outer diameter, working length, deflection, depth of field).

8. The sample size for the training set

• Not applicable/Not provided. There is no AI/ML component, so no training set.

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

• Not applicable/Not provided. There is no AI/ML component, so no training set or ground truth for it.

In summary, the provided document details the non-clinical testing and comparison of a flexible cystoscope to a predicate device to demonstrate substantial equivalence, rather than providing the specific AI/ML-related performance evaluation details requested.

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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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