(252 days)
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.
| Acceptance Criteria Category | Specific Tests/Standards Met | Reported Device Performance |
|---|---|---|
| Design & Functionality | Design verification and validation studies | "All necessary performance testing was conducted with bench testing and included: Design verification and validation studies." (General statement of completion) |
| Packaging & Shelf-Life | Packaging and shelf-life studies | "Packaging and shelf-life studies" (General statement of completion) |
| Transit | Transit testing | "Transit testing" (General statement of completion) |
| Biocompatibility | ISO 10993 - Part 1 (for short duration indwelling device) | "Testing was conducted on the device to verify that it is compliant with biocompatibility requirements for a short duration indwelling device, as specified in ISO 10993 - Part 1. The device was found to meet the compliance requirements..." |
| Sterilization | Sterilization procedure validation; ISO 11135-1; ISO 11607; AAMI TIR12:2010; AAMI TIR30:2011 | "Due to the cannula being labeled as sterile, the cannula underwent sterilization validation and shelf life testing to confirm the label shelf life complies with the following standards: ISO 11135-1, ISO 11607, AAMI TIR12:2010, and AAMI TIR30:2011." (Implied compliance as part of validation) |
| Software | Software verification and validation | "Software verification and validation" (General statement of completion) |
| Physical Characteristics | Surface and edges evaluation; Cannula dimensions (maximum insertion width, minimum instrument channel width) | "Surface and edges evaluation; Cannula dimensions (maximum insertion width, minimum instrument channel width)" (General statement of completion) |
| Electrical Safety & EMC | ISO 60601-1; ISO 60601-1-2; IEC 60601-2-18 ("Medical electrical equipment -- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment," including thermal safety) | "The device was found to meet the compliance requirements for electrical safety as specified in ISO 60601-1 including provisions for EMC safety in ISO 60601-1-2 and IEC 60601-2-18 Medical electrical equipment -- Part 2-18: 'Particular requirements for the basic safety and essential performance of endoscopic equipment,' including thermal safety." |
| Mechanical | Mechanical characteristics testing | "Mechanical characteristics were also tested, with successful results." |
| Optical | Field of view accuracy; Direction of view accuracy; Optical resolution | "Optical tests: Field of view accuracy, Direction of view accuracy, Optical resolution." (General statement of completion for these tests) |
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.