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The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.

The Single-use Flexible Ureteroscope is intended to be used with Vathin Digital Video Monitor. During diagnosis and treatment, the Single-use Flexible Ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible Ureteroscope converts the received mucosal reflected light signals into electrical signals, transmitted to the Digital Video Monitor through the cable, the Digital Video Monitor receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display.

The Single-use Flexible Ureteroscope is provided sterile (sterilized by EO) and intended to be single-use. It is for use in professional Healthcare Facility Environment.

The provided FDA 510(k) clearance letter and its associated summary for the "Single-use Flexible Ureteroscope" does not contain information regarding a study with specific acceptance criteria and detailed device performance metrics in the way one might expect for an AI-enabled device or a diagnostic accuracy study. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

Therefore, the requested information cannot be fully extracted from the provided text. I will provide the acceptance criteria as implied by the non-clinical tests conducted to prove substantial equivalence, and note where specific information is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each bench test, nor does it provide specific numerical performance results. Instead, it states that the device "complies with" or "met its design specifications" or "has been validated according to" relevant standards.

Missing Information Details:

2. Sample size used for the test set and the data provenance: This information is not provided in the document. The studies were non-clinical bench tests and biocompatibility tests, not clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the studies were non-clinical bench tests and material safety tests, not studies requiring expert interpretation of clinical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical bench tests.
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 document describes a medical instrument, not an AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical tests, the "ground truth" is typically defined by the specified performance limits or standards outlined in the applicable international standards (e.g., ISO, IEC, ASTM). For biocompatibility, it's the lack of adverse biological reactions.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

In summary, the provided FDA document details the non-clinical testing performed to demonstrate the safety and effectiveness of a physical medical device (a single-use flexible ureteroscope) for substantial equivalence to a predicate device. It does not contain information related to diagnostic accuracy studies, AI performance, or clinical trials with human readers or patient data.

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This Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra. bladder, ureter and renal pelvis.

This Single-use Flexible Cystoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder and renal pelvis.

This Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

The subject device, Urology Videoscope System is consisting of a Single-use Flexible Ureteroscope (SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-24-P SUV-2B-B SUB-2B-P SUV-2C-B SUV-2C-P) or Single-use Flexible Cystoscope (SUV-1D-B SUV-1D-P) and an Endoscopic Image Processor (HDVS-S100A, HDVS-S100D) including the foot switch. The subject device has been designed to be used for endoscopic diagnosis and therapies within the urinary system such as urethra, bladder, ureter and renal pelvis.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single use devices. They are intended to be used in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. There are ten models of Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope, with four kinds of insertion portion widths (2.5mm, 2.7mm, 2.8mm and 5.4 mm), four working lengths (380mm, 550mm, 635mm and 680mm), two different treatment section (with or without suction section).

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single-channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the shelf life of three years.

The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.

The provided text is an FDA 510(k) clearance letter and summary for a Urology Videoscope System. It details acceptance criteria based on non-clinical performance data and various tests. However, it does not include information about a study proving device meets acceptance criteria related to human reader performance with or without AI assistance, a multi-reader multi-case (MRMC) comparative effectiveness study, or any AI component for which such an evaluation would be relevant.

The document primarily focuses on bench testing and technical performance of the Ureteroscope, Cystoscope, and Image Processor, rather than the diagnostic interpretive performance of an AI algorithm.

Therefore, many of the requested points in the prompt (2-9) are not applicable or cannot be answered from the provided text, as they pertain to AI/machine learning model evaluation in a diagnostic context.

Here's the information that can be extracted or deduced from the text, with explanations for what cannot be answered:

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

The document lists various performance tests conducted to demonstrate compliance with standards, implying these are the acceptance criteria for the respective tests. However, it does not provide specific numerical acceptance thresholds or detailed "reported device performance" values for each criterion, only that "The test results demonstrated that the subject device complies with the standard requirements" or that testing was "conducted on the subject device" to "demonstrate the subject endoscope can function as intended."

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

This information is not provided in the document as the studies described are non-clinical, bench-top, and engineering performance tests, not studies on image datasets. The device is manufactured in China.

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)

This information is not applicable/not provided. The ground truth for the non-clinical tests would be established by engineering specifications, physical measurements, and adherence to international standards, not by clinical experts reading images.

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

This information is not applicable/not provided. Adjudication methods are relevant for clinical image interpretation studies, not for the technical performance tests described.

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

There is no mention of an AI component or any MRMC study in this document. The device is an endoscope system for visualization and therapy, not an AI-assisted diagnostic tool. The document explicitly states: "The clinical data is not applicable."

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

There is no mention of an AI algorithm in this document, therefore no standalone algorithm performance study was indicated.

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

For the non-clinical tests described, the "ground truth" would be the engineering specifications, physical parameters, and established international standards (e.g., ISO, IEC) against which the device's performance is measured. It is not clinical ground truth.

8. The sample size for the training set

This information is not applicable/not provided, as there is no AI or machine learning model mentioned that would require a training set.

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

This information is not applicable/not provided, as there is no AI or machine learning model mentioned.

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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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The RenaFlex™ Single-use Flexible Ureteroscope is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra. bladder, ureter, calvces and renal papillae) via transurethral or percutaneous access routes. It can also be used with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Video System Center for Single Use Endoscopes is intended to provide illumination and receive, process, and output images from the compatible Olympus endoscope for diagnostics, treatment, and observation.

The RenaFlex Single-use Flexible Ureteroscope System will provide visualization and access for diagnostic and therapeutic applications, including urinary system biopsy and kidney stone treatment and removal. The RenaFlex Single-use Flexible Ureteroscope and compatible Video System Center for Single-use Endoscopes provide a means for direct visualization, diagnosis, and treatment of various diseases in the urinary tract and kidneys. The ureteroscope component of the system is intended as a single-use device that works to access the anatomy and to guide accessory devices for diagnostic and therapeutic applications in the urinary tract and kidneys. The compatible Video System Center for Singleuse Endoscopes is a reusable software-driven device that provides illumination and receives, processes, and outputs images from the endoscope using field upgradable software for diagnosis, treatment, and observation.

The provided text focuses on the 510(k) summary for the RenaFlex Single-use Flexible Ureteroscope System and does not describe acceptance criteria, performance data, or study designs for an AI/software device. The document states that "Clinical studies were not necessary for substantial equivalence determination," indicating that the submission primarily relied on bench testing and comparison to a predicate device.

Therefore, I cannot provide the requested information about acceptance criteria, performance, or study details for an AI-powered device based on the given text. The device described is a physical medical instrument (ureteroscope) and its associated video system, not an AI software.

The document does not contain the information required to answer the prompt.

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The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.

The Single-use Flexible ureteroscope can be connected to the compatible Vathin Display Units and other accessories for the endoscopy and endoscopic surgery within urinary tract and kidney in adults. The Single-use Flexible ureteroscope is provided sterile (sterilized by EO) and intended to be single-use. The compatible Digital Video Monitor: Model: DVM-A1. The Single-use Flexible ureteroscope and Display Unit make up the video ureteroscope system. During diagnosis and treatment with the video ureteroscope system, the Single-use Flexible ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible ureteroscope converts the received mucosal reflected light signals into electrical signals, transmitted to the Display Unit through the cable, the Display Unit receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display. There are 4 models of Single-Use Flexible Ureteroscope, the difference between US-S170 and US-E170,US-S180 and US-E180 lies in the US-SXXX series with self-lock and suction function, US-EXXX series does not come with self-lock and suction functions, the rest is exactly the same. The difference between the 2 models of US-EXXX series lies in work channel ID, head OD and outer diameter of main hose OD, while the rest are exactly the same. The difference between the 2 models of US-SXXX series also lies in work channel ID, head OD and outer diameter of main hose OD, and the rest are the same. The Single-use Flexible Ureteroscope includes insertion part, control part, connection part. The control part is made with ABS, contacted with users. The insertion part, as the part connected with patients, includes the sheath which is braided tube made with PEBAX tube, the bending section and the distal end. The bending section is made of snake bone, covered with snake bend eraser. The distal end is made of sensor and LED.

The provided text describes the regulatory filing for a medical device (Single-use Flexible Ureteroscope) and details the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria related to its performance in a clinical setting or its impact on human readers, especially regarding AI assistance. The document focuses on physical, optical, electrical and biocompatibility performance.

Therefore, I cannot provide the requested information about acceptance criteria for clinical performance or studies involving human readers/AI assistance based on the text.

However, I can extract information regarding the non-clinical performance acceptance criteria and proof as described in the document.

Here's an interpretation based on the provided text, focusing on the available non-clinical performance and acceptance testing:

Device: Single-use Flexible Ureteroscope

Study Type: Non-clinical Performance Testing and Biocompatibility Testing (for 510(k) Substantial Equivalence)

1. Table of Acceptance Criteria (Non-Clinical) and Reported Device Performance:

The document mentions that "All evaluation acceptance criteria were met" for biocompatibility and that the device "complies with" relevant electrical safety and EMC standards. For functional, mechanical, and optical performance, it lists the tests performed, implying that the device passed these tests to demonstrate equivalence. Specific quantitative acceptance values are not explicitly stated for all tests, but compliance with standards and successful completion of tests serve as the "proof."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated for each test. These are non-clinical (bench) tests, so the "sample size" would refer to the number of device units tested. This might range from a few units to a statistically significant number depending on the specific test and standard, but the document does not specify.
• Data Provenance: The tests were conducted internally by the manufacturer (Hunan Vathin Medical Instrument Co., Ltd.) or by accredited labs on their behalf, likely in China given the company's location. This is inherently retrospective data gathered for the purpose of the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This section typically applies to studies where human interpretation of medical images or clinical data is involved. Since this document describes non-clinical, bench testing, no human experts were used to establish a "ground truth" in the clinical sense. The "ground truth" for these tests are the objective measurements against engineering specifications and international standards.

4. Adjudication Method for the Test Set:

• Not Applicable. As no human interpretation and subsequent need for consensus are involved in these non-clinical tests, no adjudication method was used.

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

• No. The document does not describe any MRMC study. There is no mention of human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-loop) Performance:

• No. This device is an endoscope, not an AI algorithm. Therefore, "standalone" AI performance is not applicable. The performance described is the inherent performance of the optical, mechanical, and electrical components of the device itself.

7. Type of Ground Truth Used:

• For Biocompatibility, Electrical Safety, EMC, and Sterility: Adherence to International Standards (e.g., ISO 10993, ISO 11607, ISO 11135, IEC 60601 series) and Regulatory Requirements.
• For Functional, Mechanical, and Optical Performance: Engineering Specifications and Design Requirements agreed upon during device development.

8. Sample Size for the Training Set:

• Not Applicable. This device is a physical instrument, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As above, no training set is involved.

In summary, the provided FDA clearence letter and supporting summary pertains to the substantial equivalence of a physical medical device (endoscope) based on its non-clinical performance and safety characteristics, not on the performance of a diagnostic AI algorithm or its impact on human readers.

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