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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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WiScope® Digital Bronchoscope System is designed for physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree.

WiScope® Digital Bronchoscope System is designed for physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree. This system includes a single-use digital bronchoscope and an image system.

• The image system OTU-A is the currently marketed in the United States by OTU Medical Inc. under 510(k) # K181977.
• The single-use bronchoscope is comprised of a control body with an articulation lever, a suction connector, a suction button, and a working channel port, and a flexible insertion tube with an on-tip camera module and LED lighting source.

The provided document is a 510(k) summary for the WiScope® Digital Bronchoscope System. It details the device's characteristics, comparison to a predicate device, and non-clinical testing performed to demonstrate substantial equivalence. Crucially, it explicitly states "No clinical study is included in this submission" in section 10, "Performance Data-Clinical".

Therefore, based on the provided text, there is no information available regarding acceptance criteria based on clinical performance, nor any study that proves the device meets such criteria through clinical data. The submission relies entirely on non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence.

However, I can extract the acceptance criteria for the non-clinical performance tests that were conducted and the reported non-clinical device performance.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance (Non-Clinical)

Given that "No clinical study is included in this submission," the acceptance criteria and performance data relate entirely to non-clinical testing and established industry standards for medical devices. The device is deemed to meet acceptance criteria if it passes these tests.

1. Table of Acceptance Criteria and Reported Device Performance

Since the submission explicitly states "No clinical study is included in this submission," the following points directly related to clinical studies or AI/human-in-the-loop performance cannot be addressed from the provided text.

2. Sample size used for the test set and the data provenance: Not applicable for clinical data. For non-clinical, the sample sizes would refer to the number of devices or components tested, which is not specified but implied by the "All tests were passed" statements for various categories (e.g., biocompatibility testing of specific materials, sterilization validation on a batch of devices). Data provenance is not described for these non-clinical tests (e.g., where manufacturing/testing was performed).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there are no clinical studies or ground truth established by experts for such studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for clinical studies.

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, as there is no clinical study and no mention of AI assistance. The device is a physical bronchoscope system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is a physical system, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for clinical data. For non-clinical tests, the "ground truth" is adherence to national and international testing standards (e.g., ISO, ASTM, IEC).

8. The sample size for the training set: Not applicable, as there is no AI component requiring a training set.

9. How the ground truth for the training set was established: 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 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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WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.

WiScope® OM Endoscope System is also intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney, and the pancreaticobiliary system including the hepatic ducts and the common bile duct. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

This system includes a single-use digital ureteroscope/choledochoscope and an image system.

WiScope® Single-Use Digital Flexible Ureteroscope/Choledochoscope is a modified version of the currently marketed WiScope Single-Use Digital Flexible Ureteroscope device that widen its application area from urinary system to bile ducts. Other than that, nothing has changed. The image system stays the same.

The provided FDA 510(k) summary for the "WiScope OM Endoscope System" focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and intended use, rather than on performance against specific acceptance criteria derived from clinical study results of an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study details for proving device performance (such as sample size, expert ground truth establishment, MRMC studies, standalone performance, and training set information) is not present in the provided document.

The document states:

• "No clinical study is included in this submission." (Page 7, Section 10. Clinical Test Conclusion)
• The comparison focuses on "intended use, technological characteristics, and performance characteristics" relative to predicate devices, and claims the device is "as safe and effective as the predicate devices." (Page 4, Section 8. Comparison of Technological Characteristics)
• "Non-Clinical Test Conclusion" (Page 7, Section 9) refers to previous 510(k) submission K181977 and explicitly states: "There is no change on product design, materials and packaging. The no-clinical performance test stays the same as K181977." This implies that the current submission relies on previously established non-clinical performance, not new studies proving performance against acceptance criteria for an AI/ML component.

This 510(k) submission is for an endoscope system (a medical device), not an AI/ML algorithm that identifies or performs automated tasks. Hence, the questions related to AI/ML specific performance metrics (like sensitivity, specificity, clinical outcome improvement via AI, ground truth establishment for AI, etc.) are not applicable to the content provided.

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WiScope™ Digital Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

WiScope™ Digital Endoscope System is designed for physicians to access, visualize, and perform procedures in the urinary tract for diagnosis and treatment. This system includes a single-use digital ureteroscope and an image system. The single-use ureteroscope 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 system processes the images from the ureteroscope and outputs video signals to a display.

The WiScope™ Digital Endoscope System is described as substantially equivalent to a predicate device (Zhuhai Pusen Medical Technology Co., Ltd. Medical Video Endoscope System, K171076) based on non-clinical performance testing. No clinical study was performed.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provides a "General Comparison" table (Table 5A) that directly compares the proposed device to the predicate device in terms of various technological characteristics. This table implicitly sets the acceptance criteria as being "substantially equivalent" to the predicate, or demonstrating comparable or improved performance without raising new safety or effectiveness concerns.

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

The document does not explicitly mention a "test set" in the context of an algorithm or AI model, as this is a traditional medical device 510(k) submission not primarily focused on AI. Performance was primarily evaluated through non-clinical testing (bench testing, engineering verification, and compliance with standards).

For "Note 3" regarding the Field of View, a "comparison study between the proposed and the predicate device by physicians" is mentioned.

• Sample size: Not specified.
• Data provenance: Not explicitly stated, but it seems to be a prospective comparison performed for the purpose of this submission using physical devices. There is no mention of country of origin, but the submitting company is based in the US (OTU Medical Inc.) and the submission correspondent in China (Shanghai CV Technology Co., Ltd.).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

For the "Field of View" comparison, it states "a comparison study...by physicians."

• Number of experts: Not specified (plural "physicians" implies more than one).
• Qualifications of those experts: "Physicians" are mentioned, implying medical doctors who would typically use such a device. No specific subspecialty (e.g., urologist) or years of experience are detailed.

For other non-clinical tests, the "ground truth" is defined by established engineering and medical device standards (e.g., IEC 60601-1, ISO 10993 series, ISO 8600 series). Experts in these fields (e.g., test engineers, certified labs) perform the evaluations.

4. Adjudication Method for the Test Set

For the "Field of View" comparison study by physicians, the adjudication method is not explicitly stated. It only mentions "a comparison study...demons[strating] that the optical parameter is similar and it does not affect safety and effectiveness." This suggests a consensus or expert opinion based on their evaluation, but no formal adjudication process (like 2+1 or 3+1) is detailed.

For other non-clinical tests, compliance with standards serves as the adjudication, where the results either meet or do not meet the specified pass/fail criteria of the standard.

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. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed and is not applicable here, as this device is a traditional endoscope system and not an AI-powered diagnostic/interpretive tool requiring human-in-the-loop performance evaluation against a baseline. The submission explicitly states: "No clinical study is included in this submission."

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

No. This is a hardware medical device (digital endoscope system) with an integrated camera and image processing. It is not an algorithm that operates in a standalone capacity without human interaction for diagnosis or interpretation in the way an AI model would. Its function is to provide visualization to a human physician.

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

The ground truth for most of the evaluations is based on:

• Established industry standards and regulatory requirements: For electrical safety, EMC, biocompatibility, sterilization, and physical performance characteristics (e.g., bending radius, depth of field, resolution, temperature). These standards themselves define acceptable parameters.
• Predicate device comparison: The predicate device (K171076) itself serves as a functional "ground truth" or benchmark against which the proposed device's equivalence is assessed.
• Physician comparison/assessment: For the field of view, physician evaluation served as the "ground truth" to determine if the differing FOV affected safety and effectiveness.

8. The sample size for the training set

Not applicable. As this is not an AI/Machine Learning device, there is no "training set."

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

Not applicable. There is no training set for this device.

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