(24 days)
This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).
The optical fiber transmits the light emitting from the LED light built in the handle to the coelom. The complementary metal-oxide-semiconductor CMOS imaging sensor in the distal tip of the insertion shaft receives the reflected light from the surface of mucosa and transforms the light into electric signal. The wire transfers the electric signal to the data processing center of the Eview , where the electric signal is processed. As a result the color imaging of the capillary network and mucosal morphology is displayed on the screen of the Eview.
The Medical Video Endoscope system is a digital flexible ureteroscope system that consists of the Eview( the video system, touch PC with data processing center) and the Uscope. The Uscope is provided sterile( sterilized by EO) and intended to be single-use.
The Uscope contains an insertion portion, handpiece, cable and water tube.
The Eview, the video system contains touch PC with data processing center and provide energy to Uscope. The Eview can be powered by the main line or lithium battery.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
The document (a 510(k) summary) describes a "Medical Video Endoscope System" and its performance testing. However, it does not provide a detailed table of acceptance criteria with specific numerical targets and reported performance values. Instead, it generally states that evaluation acceptance criteria were met. It also does not describe a study focused on proving that humans improve with AI assistance. The device appears to be a standalone system that performs image acquisition and display for endoscopic procedures with a single-use ureteroscope.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not include a specific table with numerical acceptance criteria and corresponding reported performance. It mentions several standards and states that "All evaluation acceptance criteria were met" for specific tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Evaluated in accordance with IEC 60601-1:2012, AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 and IEC 60601-2-18:2009. All evaluation acceptance criteria were met. |
| Electromagnetic Compatibility (EMC) | Evaluated in accordance with IEC 60601-1-2:2007. All evaluation acceptance criteria were met. |
| Biocompatibility | Evaluated in accordance with ISO 10993-1:2009 and the FDA Guidance document "Use of International Standard ISO 10993-1..." June 16, 2016. Biocompatibility of the patient contacting materials were evaluated safe. |
| Sterile Barrier Systems | Evaluated in accordance with ISO 11607:2006. |
| Sterilization Process | Validated in accordance with ISO 11135:2014. |
| Technological Characteristics (Functionality) | Tested for functions as intended, including verification of performance characteristics per ISO8600 (Maximum insertion portion width, Minimum instrument channel width, Field of view, Direction of view, Deflection) and performances characteristics relevant to functions as intended (Image quality, Illumination, Articulation, Leak, Flow rate of water). The results... demonstrate that the Medical Video Endoscope is considered safe and effective for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for any of the performance tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The tests appear to be laboratory/bench testing of the device itself rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The performance tests described (electrical safety, EMC, biocompatibility, sterilization, and basic functional characteristics) do not typically involve human experts establishing a "ground truth" in the way a diagnostic algorithm might. These tests rely on established engineering and biological standards.
4. Adjudication Method for the Test Set
Not applicable. The tests described are primarily objective engineering and biological evaluations, not human-interpreted diagnostic assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done according to this document. The device is a "Medical Video Endoscope System," which is a viewing and surgical tool, not an AI diagnostic aid designed to improve human reader performance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
Yes, in a sense. The described "Non-Clinical Performance Data" are for the device's standalone operation and functionality (e.g., image quality, illumination, safety standards). There is no mention of an algorithm or AI component in the traditional sense; the "processing center" mentioned handles the video signal. The tests verify the device's ability to perform its core function: acquiring and displaying video from an endoscope.
7. Type of Ground Truth Used
The "ground truth" for the tests described is based on:
- Compliance with recognized international standards (IEC 60601 series, ISO 10993, ISO 11607, ISO 11135, ISO 8600).
- Functional specifications of the device (e.g., image quality, illumination, articulation, leak, flow rate).
This is not "expert consensus," "pathology," or "outcomes data" in the context of diagnostic performance studies. It's engineering and safety compliance.
8. Sample Size for the Training Set
Not applicable. This device is an endoscope system, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no AI training set for this device.
§ 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.