(51 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 cable 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, as provided sterile, contains an insertion portion, handpiece and the cable. The handpiece is made with polymer plastic, Contacted with users. The insertion portion, as the part connected with patients, includes the sheath which is braided tube made of SUS 304 stainless steel and PEBAX, the controllable portion and the distal tip. The controllable tip is made of SUS 304 stainless steel, covered with silicone rubber. The distal tip is made with ABS. There is a working channel that terminates at the distal tip, which is indirect patient-contacting component, made of Fluorinated ethylene propylene.
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.
The provided text describes a 510(k) premarket notification for a "Medical Video Endoscope System," which is a device for endoscopy and endoscopic surgery within the urinary tract and interior of the kidney. The document discusses device characteristics, intended use, and non-clinical performance data to establish substantial equivalence to a predicate device.
However, the document does not contain specific acceptance criteria for a study showing device performance in the context of an AI/ML algorithm or a human-in-the-loop scenario. The performance data presented is related to safety, electrical safety, EMC, biocompatibility, sterilization, and general functional characteristics of the endoscope itself, rather than performance in terms of diagnostic accuracy or treatment efficacy compared to a predefined benchmark.
Therefore, many of the requested information points, particularly those related to AI/ML specific studies, human reader performance, expert consensus, and ground truth establishment for diagnostic performance, are not available in the provided text.
Here's a summary of what can be extracted from the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various tests performed and states that "All evaluation acceptance criteria were met." However, it does not provide the specific quantitative acceptance criteria or detailed results for device performance in a diagnostic or clinical efficacy context. The tests reported are primarily related to safety and functional specifications.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety (IEC 60601-1:2012, AAMI/ANSI ES60601-1:2005, IEC 60601-2-18:2009) | All evaluation acceptance criteria were met. |
| Electromagnetic Compatibility (IEC 60601-1-2:2007) | All evaluation acceptance criteria were met. |
| Biocompatibility (ISO 10993-1, Cytotoxicity, Irritation, Sensitization) | All evaluation acceptance criteria were met. |
| Sterile Barrier Systems (ISO 11607:2006) | Evaluated in accordance with the standard. |
| Sterilization Process (ISO 11135:2014) | Validated in accordance with the standard. |
| Technological Characteristics (ISO 8600-1:2015 - insertion width, channel width, field of view, direction of view, deflection; Image quality, Illumination, Articulation, Leak, Flow rate of water) | Tested for functions as intended; results demonstrate the device is safe and effective for its intended use. |
2. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical performance data (electrical, EMC, biocompatibility, sterilization, and functional testing), not a diagnostic or clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not established as this is not a diagnostic performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 document does not describe a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an endoscope system, not an AI algorithm.
7. The type of ground truth used: For the non-clinical performance evaluations, the "ground truth" or reference was against established engineering standards (e.g., IEC, ISO) and regulatory guidance for safety and performance.
8. The sample size for the training set: Not applicable, as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.
§ 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.