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The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra.

This Special 510(k) discloses the modifications to the steps to carry out surface disinfection of the model 4500 handle that was reviewed and cleared in K232837. The Uro-G HD Flexible Cystoscope is a handheld, battery- operated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor. When fully assembled, the Uro-G HD Flexible Cystoscope- cannula and handle-has an overall length of 630 mm (approximately 25 inches). The disposable cannula's working length is 380.2 mm (approx. 15 inches) and a total length of 406 mm, from tip to connector. The cannula's maximum width is 5.6 mm and it has a connector for attaching and detaching to the handle.

This document describes a Special 510(k) submission for the Uro-G HD Flexible Cystoscope, focusing on a minor modification to its surface disinfection process. There is NO mention of an AI/ML device or algorithm. Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of AI/ML.

The provided text only discusses the equivalence of the modified device to its predicate, based on unchanged intended use, indications for use, and technological characteristics, except for the disinfection process.

Here's what I can extract regarding the device performance and the "study" mentioned, which is not an AI/ML study but rather microbiology testing for disinfection:

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

Since the document focuses on a change in the disinfection process and asserts that other performance characteristics remain unchanged from the predicate, and does not provide specific acceptance criteria values for the disinfection, I cannot create a table with specific numbers. Instead, I can describe the nature of the change and the demonstrated outcome.

Regarding the study that proves the device meets the acceptance criteria:

The study referenced is a microbiology testing study conducted to evaluate the effectiveness of the revised surface disinfection process for the reusable handle of the Uro-G HD Flexible Cystoscope.

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

• Sample size: Not specified in the provided text. The document refers to "testing" that "found" specific results for log reductions.
• Data provenance: Not specified.

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 is not applicable to a microbiology disinfection study. The "ground truth" would be established by the standardized protocols and results of the microbiological tests themselves, rather than expert consensus on interpretation.

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

• Not applicable to a microbiology disinfection study.

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 is not an AI/ML device, and no MRMC study was performed or mentioned.

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

• Not applicable. This is not an AI/ML device.

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

• For the disinfection efficacy, the "ground truth" was established through microbiology testing results demonstrating "log reductions of ≥ 3 and ≥ 6 of tested pathogens." This is a quantitative measure of antimicrobial effectiveness.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device; there is no training set mentioned.

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

• Not applicable. This is not an AI/ML device.

In summary, the provided document describes a regulatory submission for a medical device (a cystoscope) focusing on a change in its disinfection instructions. The "study" mentioned is a microbiology test to validate the effectiveness of the new disinfection protocol. There is no information related to AI/ML or an algorithm in the provided text.

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The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra.

Generally recognized indications for cystoscopy include:
• Symptomatic voiding dysfunction
• Hematuria
• Bladder tumor surveillance
• Recurrent lower urinary tract infections
• Pelvic pain syndromes

The Uro-G HD Flexible Cystoscope System is a handheld, battery-operated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor. The fully assembled Uro-G HD Cystoscope System—cannula and handle—has an overall length of 630 mm (approximately 25 inches). The disposable cannula's working length is 380.2 mm (approx. 15 inches) and a total length of 406 mm, from tip to connector. The cannula's maximum width is 5.6 mm and it has a connector for attaching and detaching to the handle.

This document is a 510(k) Premarket Notification for the Uro-G HD Flexible Cystoscope, seeking to prove substantial equivalence to a predicate device (Uro-G Flexible Cystoscope, K202921). As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the demonstration that the modified device (Uro-G HD) is as safe and effective as the predicate device, not necessarily a performance study against a specific clinical endpoint. The primary method for proving this is through comparative testing and analysis of technological characteristics.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative targets in a table format within the provided text. Instead, the document uses a comparative approach against a predicate device. The "reported device performance" is essentially the Uro-G HD's characteristics, and "meeting acceptance criteria" means demonstrating that these characteristics are equivalent to or improve upon the predicate without introducing new risks.

Here’s a table summarizing the key characteristics and the comparison to the predicate device, highlighting what could be implicitly considered an "acceptance criterion" (i.e., equivalence or improvement):

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The Uro-G flexible cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.

The Uro-G cystoscope is a handheld, battery-operated portable cystoscope consisting of a sterile, disposable steerable endoscopic cannula and a reusable handle with a video monitor. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and one channel for infusion of irrigating fluid. The handle is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the disposable cannula. The handle contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or to start/stop video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.

The provided text describes the 510(k) summary for the Uro-G Cystoscope. This document primarily focuses on establishing substantial equivalence to a predicate device (Uro-V Cystoscope) rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for an AI/ML device.

The "acceptance criteria" for a medical device like a cystoscope typically refer to the performance standards and safety requirements it must meet to be considered safe and effective, often demonstrated through engineering bench testing, biocompatibility, and electrical safety. The "study that proves the device meets the acceptance criteria" in this context refers to these non-clinical tests.

There is no mention of AI/ML components in the Uro-G Cystoscope from the provided text, nor are there any acceptance criteria, sample sizes, or ground truth establishment relevant to AI/ML or comparative effectiveness studies with human readers. The device is a physical endoscope.

Therefore, I will interpret "acceptance criteria" and "study" in the context of a medical device submission focused on equivalence for a non-AI physical device.

Here's the breakdown based on the provided document:

Acceptance Criteria and Study for Uro-G Cystoscope (Non-AI Device)

The Uro-G Cystoscope is a physical medical device. The "acceptance criteria" are based on demonstrating substantial equivalence to a legally marketed predicate device (Uro-V Cystoscope) and compliance with relevant safety and performance standards through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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The Uro-N Cystoscope is intended for direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.

The UroViu Uro-N Cystoscope System consists of (1) a hand-held, battery operated portable endoscope contained within a reusable handle and (2) a disposable cannula with an injection needle. The fully assembled Uro-N system has overall length of 522 mm (~21 inches). The disposable cannula working length is 269 mm (~11 inches) and total length is 388 mm (~15 inches). The injection needle is 23 Ga (OD 0.635mm, ID 0.318mm). The combined handle and cannula weigh less than 1 pound. The reusable handle has a connector and locking mechanism for attaching and detaching the cannula. The catheter is sterilized by electron beam and is intended for single use only.

The provided text is a 510(k) summary for the Uro-N Cystoscope, demonstrating its substantial equivalence to predicate devices rather than proving it meets specific acceptance criteria through a standalone study with performance metrics. Therefore, many of the requested sections regarding acceptance criteria, performance, sample sizes, expert ground truth, and comparative effectiveness against human readers are not directly addressed in this document.

However, I can extract information related to the device's testing and safety/effectiveness claims based on comparison to its predicates.

Here's the summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices, implying that if it functions similarly and passes specified engineering and biocompatibility tests, it meets the necessary safety and effectiveness profiles.

The performance evaluation is primarily comparative and based on the established safety and effectiveness of the predicate devices.

| Aspect | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Summary) |
|:--------------------------------|:---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Meets ISO 10993 requirements for medical devices with less than 24 hours of patient tissue contact. Materials must be biocompatible (e.g., stainless steel for the needle). | The Uro-N Cystoscope and cannula are made from materials reviewed and cleared in K171500. The only new material, stainless steel for the needle, passed cytotoxicity testing. |
| Electrical Safety | Compliance with IEC 60601-1 (medical electrical equipment - general requirements for basic safety and essential performance), specifically Class I, Type CF, defibrillation proof. | The device complies with IEC 60601-1, as reviewed and cleared in K171500 (predicate device). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (medical electrical equipment - electromagnetic disturbances - requirements and tests). | The device complies with IEC 60601-1-2, as reviewed and cleared in K171500 (predicate device). |
| Software Verification and Validation | Software should be verified and validated to ensure proper function and safety. The software level of concern is "Moderate." | No change was made to the software from the predicate device (K171500), which was previously reviewed and cleared. |
| Mechanical Performance | The device should be mechanically sound, withstand simulated use, and maintain structural integrity (e.g., resistance to bending, pulling, torque, and leaks). It should also maintain acceptable temperature at the tip surface, field of view, direction of view, and image quality comparable to the predicate diagnostic cystoscope. | Mechanical testing included: simulated use testing, mechanical testing (bending, pulling, torque, and presence of leaks), temperature at the surface of the tip testing, field of view testing, direction of view testing, and image quality testing. The results of these tests are not provided in detail, but the conclusion states "The information submitted... confirms that the Uro-N Cystoscope raises no new questions of safety and effectiveness and that it is substantially equivalent to the predicate devices." |
| Sterility | Disposable components (cannula, needle) must achieve a Sterility Assurance Level (SAL) of 10^-6. | Disposable cannula and needle are sterile following exposure to ethylene oxide (EO) with an SAL of 10^-6. |
| Cleanability (Reusable Handle) | The reusable handle, not provided sterile, must be cleanable and disinfectable according to company instructions to prevent cross-contamination. | The handle is cleaned and disinfected following company instructions (implies this is met). |
| Duration of Use | Less than 24 hours for patient contact components. | Less than 24 hours. |

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

The document does not specify a "test set" in the context of collected patient data or images for performance evaluation. The substantial equivalence argument relies on engineering and bench testing, as well as the prior clearance of the predicate devices.

• Sample Size: Not applicable as no clinical or image-based test set was used for de novo performance evaluation against acceptance criteria.
• Data Provenance: Not applicable. The testing was laboratory/bench-based.

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

Not applicable. As no clinical test set requiring expert interpretation was used for de novo performance evaluation, no experts were involved in establishing ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was used.

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

No MRMC comparative effectiveness study was reportedly done. The submission is a 510(k) for substantial equivalence, not a clinical efficacy study involving human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Uro-N Cystoscope is a medical device, not an AI algorithm. Its performance is evaluated through physical, electrical, and materials testing, and by demonstrating equivalence in function and safety to predicate devices.

7. Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is based on demonstrating compliance with regulatory standards (e.g., ISO, IEC), confirmed biocompatibility, and functional equivalence to legally marketed predicate devices through various engineering and bench tests. There is no biological or diagnostic "ground truth" (like pathology or outcomes data) established for a test set in this summary.

8. Sample Size for the Training Set

Not applicable. The Uro-N Cystoscope is a physical device, not an AI/machine learning model, so there is no training set in the context of data for algorithm development.

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

Not applicable, as there is no training set.

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The Uro-V cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.

The UroViu Uro-V cystoscope is a handheld, battery-operated portable cystoscope. It includes a sterile, single-use disposable cannula and a reusable handle. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and one channel for infusion of irrigating fluid. The handle is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the disposable cannula. The handle contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or to start/stop a video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.

The provided text describes the Uro-V Cystoscope and its substantial equivalence to a predicate device, focusing on its design, intended use, and performance data from various bench tests. However, it does not contain information typically found in a clinical study report or a detailed validation study, especially regarding human-in-the-loop performance, ground truth establishment with experts, or comparative effectiveness studies with human readers.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table for performance metrics like sensitivity, specificity, or accuracy. It lists various tests conducted to ensure compliance with standards and safety. The "reported device performance" is primarily a statement of compliance with these standards.

2. Sample size used for the test set and the data provenance

The document specifies "bench testing" and "design verification and validation studies." It does not mention a test set in the context of patient data, clinical images, or AI performance evaluation. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective). The testing focused on device specifications and compliance rather than clinical performance with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a hardware cystoscope, and the testing described is engineering and regulatory compliance testing, not a study involving human experts establishing ground truth for diagnostic accuracy (e.g., in an AI context).

4. Adjudication method for the test set

Not applicable for the same reasons as #3.

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, an MRMC comparative effectiveness study was not conducted. This document describes a traditional 510(k) submission for a medical device (cystoscope), which involves demonstrating substantial equivalence primarily through technical specifications, safety, and performance bench testing. It is not an AI-powered device, and therefore, an MRMC study related to AI assistance for human readers is irrelevant and was not performed.

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

No, a standalone algorithm-only performance study was not done. The device itself is a physical endoscope, not an algorithm, and the testing described focuses on its physical and electrical characteristics, sterilization, and biocompatibility.

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

For the various bench tests, the "ground truth" would be established by engineering specifications, validated test methods, and regulatory standards. For example, for biocompatibility, the ground truth is whether the materials meet ISO 10993. For electrical safety, it's whether the device passes the tests outlined in ISO 60601-1. This is not clinical ground truth from patient pathology or expert consensus.

8. The sample size for the training set

Not applicable. This document pertains to a physical medical device (cystoscope), not an AI algorithm. Therefore, there is no concept of a "training set" in this context.

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

Not applicable for the same reasons as #8.

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