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The Pusen Single Use Flexible Video Cystem is intended to be used for endoscopic access to and examination of the lower urinary tract. The Pusen Single Video Cystoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.

The Pusen Single Use Flexible Video Cystoscope System includes a Single Use Flexible Video Cystoscope and an HD Medical Video Endoscope Image Processor. The Pusen Single Use Flexible Video Cystoscope is provided sterile and has the following 4 models: PC200-AS, PC200-AR, PC200-S and PC200-R. The Pusen Single Use Flexible Video Cystoscope has two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Cystoscope needs to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Cystoscope is powered by the HD Medical Video Endoscope Image Processor PV300. The HD Medical Video Endoscope Image Processor PV300 is a reusable device, used to process the image signal from the Pusen Single Use Flexible Video Cystoscope and display the real-time video on its LCD screen, which enables visual examination of the lower urinary tract (the urethra and the bladder).

The provided FDA 510(k) summary for the Pusen Single Use Flexible Video Cystoscope System does not describe specific acceptance criteria in quantitative terms nor does it detail a study that proves the device meets such criteria in the format requested. The document outlines general categories of performance data that were used to demonstrate substantial equivalence to a predicate device.

Here's an attempt to extract and present the information based on the provided text, acknowledging where specific details are missing:

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

The document does not explicitly state quantitative acceptance criteria for the performance tests, nor does it provide specific numerical results for the device performance beyond stating that tests were "passed" or "complies with." The table below summarizes the listed performance tests and the general outcome.

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

The document does not specify the sample sizes used for any of the described performance tests (e.g., how many cystoscopes were tested for mechanical performance, how many individuals for biocompatibility, etc.). It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, though the nature of these tests (bench, lab-based) inherently implies prospective testing within a controlled environment.

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)

The document does not mention the involvement of experts for establishing ground truth, as the performance data is primarily technical and bench-test based (e.g., biocompatibility passes, electrical safety compliance). No clinical studies or expert consensus for interpretation were conducted as part of this submission.

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

Not applicable. The reported data relates to bench testing, not clinical interpretation that would require 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

No such study was conducted or reported. The device is a "Single Use Flexible Video Cystoscope System," not an AI-assisted diagnostic tool.

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

Not applicable, as the device is a medical instrument (cystoscope system), not an algorithm or AI.

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

The "ground truth" for the performance tests described would be derived from:

• Compliance with international standards: For biocompatibility, electrical safety, EMC, photobiological safety, Luer taper, and sterilization validation (e.g., ISO 10993-1, IEC 60601 series, IEC 62471, ISO 80369-7, ISO 11135).
• Engineering specifications/measurements: For mechanical and optical performance (e.g., working length, channel diameter, angle of deflection, field of view, depth of field, flow rates, tensile strength, resolution, color reproduction, distortion).
• Accelerated aging and package integrity testing: For shelf life validation.

8. The sample size for the training set

Not applicable, as this is a medical device approval, not an AI/machine learning algorithm submission that requires a "training set."

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

Not applicable, as there is no "training set."

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Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Ambu® aScope™ 4 Cysto is intended to provide visualization via Ambu® displaying unit and can be used with endoscopic accessories.

Ambu® aScope™ 4 Cysto is intended for use in a hospital environment or medical office environment. Ambu® aScope™ 4 Cysto is designed for use in adults.

Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. Visualization will be achieved by Ambu® displaying unit. The Ambu® aScope™ 4 Cysto is intended to be used with a reusable Ambu® displaying unit to visualize the urethra and the bladder. The Ambu® aScope™ 4 Cysto can be operated by either the left or right hand. The optical module in the distal tip consists of a camera housing containing camera and LED light sources.

Ambu® aScope™ 4 Cysto has the following physical and performance characteristics:
Maneuverable tip controlled by the user
Flexible insertion cord
Working channel that can be used for graspers or other instrumentation
Camera and LED light source at the distal tip
Luer lock connector for irrigation and aspiration
Sterilized by Ethylene Oxide sterilization
For single use

The provided text describes the 510(k) summary for the Ambu® aScope™ 4 Cysto, a medical device. It focuses on demonstrating substantial equivalence to predicate devices through various performance tests and compliance with recognized standards.

However, the document specifically states "Performance Data - Clinical: Not applicable." This indicates that a clinical study with human subjects, which would typically involve assessing how human readers (like radiologists) improve with or without AI assistance, or the performance of an AI algorithm in a clinical setting, was not performed or required for this 510(k) submission.

Therefore, many of the requested elements for describing the acceptance criteria and study that proves the device meets the acceptance criteria (specifically in the context of AI performance or human reader improvement) cannot be directly extracted from this document, as the device is a physical endoscope, not an AI/software device.

I will provide the information that can be extracted or reasonably inferred from the provided text regarding the device's performance, focusing on the physical and functional aspects tested.

Acceptance Criteria and Device Performance for Ambu® aScope™ 4 Cysto

The acceptance criteria for the Ambu® aScope™ 4 Cysto are based on compliance with recognized consensus standards and meeting specified physical and performance characteristics, demonstrating substantial equivalence to predicate devices. The study proving these criteria were met involved a series of bench tests and a declaration of conformity to relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI-specific questions (2-7), the supplied document explicitly states "Performance Data - Clinical: Not applicable." This means no clinical study involving human readers, AI assistance, or standalone AI performance was conducted or submitted for this specific 510(k) clearance, as the device is a physical endoscope and not an AI/software product.

Therefore, I cannot provide information for the following points based on the provided text, as they are not relevant to this device's 510(k) submission:

2. Sample sized used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Conclusion stated in the document:
Based on the indication for use, technological characteristics, performance data, and comparison to predicate devices, it was concluded that the functionality and intended use of Ambu® aScope™ 4 Cysto is equivalent to the predicate and reference devices. The device is concluded to be as safe and effective and performs as well as the chosen legally marketed predicate device.

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