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The single-use cystoscope is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The single-use is intended to provide visualization via image processor and can be used with endoscopic accessories. The cystoscope system is intended for use in a hospital environment or medical office environment. The cystoscope system is designed for use for adult patients requiring cystoscopy.

The Cystoscope System consists of a single-use Cystoscope to provide illumination and intuitive images in endoscopic surgery of the lower urinary tract and serves as a guide to diagnosis and management with accessories and an image processor for clinical image processing. The single-use Cystoscope is a sterile single-use flexible Cystoscope. The image processor is a reusable monitor. The single-use Cystoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the Cystoscope and outputs video signals to a display.

This FDA 510(k) summary (K231118) describes the substantial equivalence of the "Cystoscope System" to a predicate device, the "Ambu aScope 4 Cysto." The submission primarily relies on bench performance testing and compliance with voluntary standards rather than clinical or AI performance studies to establish substantial equivalence.

Therefore, the requested information about acceptance criteria and study data for an AI/device performance assessment is largely not applicable to this specific submission, as it concerns a physical medical device (cystoscope) and its image processing unit, not an AI-driven diagnostic or treatment algorithm.

However, I can extract and present the types of performance data that were provided, framed in a way that attempts to answer your questions where possible, though direct "acceptance criteria" for AI performance or "effect size of human readers with AI" are not present.

Here's a breakdown based on the provided text, indicating "N/A" where the requested information is not relevant to this traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The submission focuses on verification and validation of engineering performance and regulatory compliance, not clinical or image-based diagnostic accuracy. Bench tests would use a sample of manufactured devices.
• Data Provenance: Not applicable for a clinical test set. The data originates from laboratory testing, engineering assessments, and quality control processes conducted by the manufacturer (Shenzhen HugeMed Medical Technical Development Co., Ltd. in China).

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

• Number of Experts: Not applicable. This is not an AI/diagnostic algorithm submission requiring expert-established ground truth on medical images.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This submission does not involve an AI component that would necessitate an MRMC study comparing human readers with and without AI assistance. The device is a direct visualization tool.
• Effect Size of Human Readers with AI: Not applicable.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Standalone Study: No. There is no AI algorithm being submitted for standalone performance evaluation in this context. The "software" mentioned relates to the image processor's operational software, not a diagnostic AI.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical ground truth. The "ground truth" for this device's performance is established by engineering specifications, international consensus standards (ISO, IEC, ASTM), and comparison to the predicate device's characteristics. For example, optical performance is measured against ISO 8600 series standards.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This product is a medical device (cystoscope system), not an AI algorithm requiring a training set.

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

• Ground Truth Establishment for Training Set: Not applicable.

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WiScope® Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

WiScope® Digital Cystoscope System is designed for physicians to access, visualize, and perform procedures in the bladder and lower ureter for diagnosis and treatment. This system includes a single-use digital cystoscope.

WiScope®Digital Cystoscope System has the same intended use to the predicate device. Both devices use the same CMOS image sensor technology, i.e., an CMOS image sensor at the scope tip, a back-end image/video processing system, and a cable connecting the CMOS sensor to the processing system. In addition, they have same mechanical functions, e.g., a handle with a deflection control and a two-way deflectable insertion tube.

WiScope®Single-Use Digital Flexible Cystoscope has the following 4 models:

OTU-C300S: Standard Deflection Model for OTU-C300 series

OTU-C300R: Reverse Deflection Model for OTU-C300 series

OTU-C310S: Standard Deflection Model for OTU-C310 series

OTU-C310R: Reverse Deflection Model for OTU-C310 series

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:

Based on the provided text, the submission is a 510(k) for the WiScope® Digital Cystoscope System. The core of this submission is to demonstrate substantial equivalence to a previously cleared device (K212202) rather than proving novel performance against specific clinical acceptance criteria. Therefore, the information typically found in a clinical study seeking to establish performance against acceptance criteria for a new device is largely absent.

Here's the breakdown of the information requested, based on the provided text:

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

The document does not explicitly present a table of acceptance criteria for clinical performance with reported results in the same way a de novo device might. Instead, it relies on demonstrating that the proposed device is substantially equivalent to a predicate device (K212202). The "acceptance criteria" are implicitly met by showing that the differences between the proposed device and the predicate do not raise new questions of safety or effectiveness, which is supported by non-clinical testing.

The non-clinical testing performed includes evaluations of:

Note: For the Optical and Color Performance, the document lists the parameters tested but does not provide specific numerical acceptance criteria or reported performance values (e.g., "Resolution > X lp/mm" or "Distortion

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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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WiScope® Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

WiScope® Digital Cystoscope System is designed for physicians to access, visualize, and perform procedures in the bladder and lower ureter for diagnosis and treatment. This system includes a single-use digital cystoscope and an image system OTU-A. The single-use cystoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source.

The provided text describes the WiScope® Digital Cystoscope System, which is a medical device. The document is a 510(k) premarket notification summary submitted to the FDA.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists numerous tests conducted, and for all of them, the result is "All tests were passed" or "All evaluation acceptance criteria were met." Specific numerical acceptance criteria are not detailed in the provided text, but the claim of passing suggests they were defined and met.

2. Sample size 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 non-clinical tests. It states that "These tests only used to evaluate non-clinical testing of the subject device." There is no mention of country of origin for the data or whether the studies were retrospective or prospective.

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 to the provided document. The studies described are non-clinical performance and safety tests, not studies requiring expert interpretation of medical images or diagnostic outcomes. Therefore, there is no mention of experts establishing ground truth in this context.

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

This information is not applicable. As mentioned above, the studies are non-clinical performance and safety tests, not studies involving human interpretation or adjudication of medical results.

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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission." The submission focuses on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device. The device itself (a cystoscope) is an imaging tool, not an AI-powered diagnostic system that would typically be evaluated for reader improvement.

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

This information is not applicable. The WiScope® Digital Cystoscope System is described as a physical medical device (an endoscope) for visualization and procedures, not an algorithm or AI system for standalone performance evaluation.

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

The concept of "ground truth" as it relates to expert consensus or pathology is not applicable to the non-clinical tests described. The ground truth for these tests would be the established scientific standards, specifications, and physical properties specified in the referenced ISO and ASTM standards. For example, for "Working length of the shaft," the ground truth would be the defined manufacturing specification for the length, and the test verifies if the actual device meets that specification.

8. The sample size for the training set:

This information is not applicable as there is no mention of an algorithm or AI model requiring a training set in the document.

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

This information is not applicable for the reason stated in point 8.

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The Karl Storz Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.

The KARL STORZ Flexible Video-Urethro-Cystoscope System is use of the Video-Urethro-Cystoscope with Karl Storz CCU and Karl Storz Light source. The body contact portions of the Video-Urethro-Cystoscope are composed of materials used in other Karl Storz devices which have a long history of biocompatibility for human use and are commonly used in medical devices for a wide range of applications.

The provided text is a 510(k) summary and FDA clearance letter for a medical device called the "Karl Storz Flexible Video-Urethro-Cystoscope System." This document aims to establish substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria in the way an AI/ML device would. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable or available in this type of submission.

Here's a breakdown based on the provided text, indicating where information is not present:

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

   • Not applicable / Not provided. This document is a 510(k) summary for substantial equivalence, not a performance study report with specific acceptance criteria and performance metrics. The submission asserts that "The minor differences between the Karl Storz Video-Urethro-Cystoscope System and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This statement implies that performance is considered equivalent to the predicate, but no specific performance criteria or data are presented.

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

   • Not applicable / Not provided. No test set or associated data are mentioned for this type of submission.

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. No ground truth establishment is described as this is not a study assessing diagnostic performance against a gold standard.

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

   • Not applicable / Not provided. No test set or adjudication process is 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

   • Not applicable / Not provided. This is a hardware device (an endoscope system), not an AI/ML diagnostic aid, so an MRMC study related to AI assistance is not relevant.

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

   • Not applicable / Not provided. This is a hardware device, not an algorithm.

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

   • Not applicable / Not provided. No ground truth is established for this type of submission. The device's "ground truth" is its functional equivalence to a predicate device for visual examination and therapeutic access in urological procedures.

8. The sample size for the training set

   • Not applicable / Not provided. No training set is relevant as this is a hardware device, not an AI/ML model.

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

   • Not applicable / Not provided. No training set or associated ground truth establishment is mentioned.

Summary based on the provided text:

The submission confirms the device's intended use and describes its components, noting that body contact portions are made of materials with a "long history of biocompatibility for human use." The core of the submission is the claim of "Substantial Equivalence" to predicate devices, meaning it is considered equally safe and effective without raising new questions of safety or effectiveness. There is no performance study described with acceptance criteria in the traditional sense for an AI/ML or diagnostic performance claim. The FDA's clearance is based on this claim of substantial equivalence.

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