(72 days)
The "The View MD Office System" is designed to deliver illumination, provide camera use, and display and store medical images obtained during endoscopic surgical or diagnostic procedures
The View MD Office System is a 50 watt light source, 1 CCD camera, and LCD Monitor with image capture combined into a compact unit.
This device application is for the "View MD Office System," a light source, camera, and monitor combination. The provided documentation does not include information about AI/ML algorithm performance, acceptance criteria for such algorithms, or studies related to AI/ML.
Therefore, I cannot provide the detailed information requested in the prompt using the provided text. The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with electrical safety and electromagnetic compatibility standards.
Based on the provided text, here's what can be inferred/stated regarding the performance and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for safety) | "The View MD Office System has been tested to conform to IEC 60601-1" |
| Conformance to IEC 61000-3-2 / -3 (Electromagnetic compatibility (EMC) - Part 3: Limits - Section 2: Harmonics; Section 3: Voltage changes, fluctuations and flicker) | "The View MD Office System has been tested to conform to... IEC 61000-3-2 / -3" |
| Conformance to IEC 61000-4-2 / -3 / -4 / -5 / -6 / -8 / -11 (Electromagnetic compatibility (EMC) - Part 4: Testing and measurement techniques) | "The View MD Office System has been tested to conform to... 61000-4-2 / -3 / -4 / -5 / -6 / -8 / -11" |
2. Sample size used for the test set and the data provenance:
- Not applicable for AI/ML performance. The device is a hardware system. The "test set" here refers to the device itself undergoing electrical and EMC testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for AI/ML performance. Ground truth, in the context of this submission, relates to the established standards (IEC 60601-1, IEC 61000 series) and the test methodologies specified within those standards. Testing would be performed by qualified engineers or test laboratories.
4. Adjudication method for the test set:
- Not applicable for AI/ML performance. Adjudication is not mentioned as the testing refers to standard compliance.
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 such study was performed or mentioned. The device is a hardware tool for image acquisition and display, not an AI-powered diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No such study was performed or mentioned. There is no indication of an AI algorithm in this submission.
7. The type of ground truth used:
- For the performance data mentioned (IEC standards), the "ground truth" is adherence to the technical specifications and safety requirements defined by these international standards.
8. The sample size for the training set:
- Not applicable. There is no mention of a training set for an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable. There is no mention of a training set for an AI/ML algorithm.
§ 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.