(265 days)
The Foreseeson Custom Display's WIS1000 transmitter and receiver wirelessly transmit (60GHz) high quality audio and video (up to 1080p/60Hz) to displays during endoscopic and surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery. The WIS1000 wireless components are non-sterile reusable devices not intended for use in the sterile field.
The WIS1000 System is a wireless transmitter and receiver pair which allows delivery of High Definition (HD) video from a wide range of video sources common in a hospital environment to a secondary video display.
The provided document describes a 510(k) premarket notification for the WIS1000 System, a wireless transmitter and receiver for high-definition video in surgical settings. While it mentions bench testing and compatibility testing, it does not contain specific acceptance criteria, reported performance metrics for those criteria, or a detailed study report proving the device meets them.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text. Many of the other requested details for an AI/device performance study are also not present as this is a submission for a hardware device, not an AI or software algorithm.
However, I can extract what is available:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The submission indicates compliance with standards, implying that meeting these standards serves as the "acceptance criteria."
- IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests)
- FCC 47 CFR Part 15 (Radio Frequency Devices)
- "expectations of the medical community" (vague, no specific metrics)
- "product labeling" (vague)
- Reported Device Performance: The document only states that the device is "in compliance with" these standards. No specific performance values (e.g., latency, signal-to-noise ratio, resolution accuracy) are reported against quantitative criteria.
2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a "test set" of clinical data for an algorithm. It's bench testing and compatibility testing of hardware.
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 clinical data is not relevant to this hardware submission.
4. Adjudication method 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: No, an MRMC study was not done, as this is not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is a hardware device, not an algorithm.
7. The type of ground truth used: Not applicable in the context of clinical "ground truth." The "ground truth" here would be the successful operation and compliance of the hardware system with engineering specifications and regulatory standards.
8. The sample size for the training set: Not applicable, as no algorithm training is discussed.
9. How the ground truth for the training set was established: Not applicable.
Summary of the Study Mentioned (What is available):
- Study Type: Bench testing and compatibility testing.
- Purpose: To demonstrate compliance with relevant safety, performance, and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, FCC 47 CFR Part 15), as well as "expectations of the medical community and the product labeling."
- Additional Testing: "Additional compatibility testing was performed to verify that wireless capabilities such as functions, coexistence, quality of service, and security met essential performances."
- Conclusion: Foreseeson concludes that the devices are substantially equivalent to the predicate devices and that "the differences in the devices do not raise any unresolved issues of safety or efficacy."
In essence, the document serves as a regulatory submission for a hardware device and not a performance study of an AI or software algorithm. Therefore, many of the requested details, which are pertinent to AI/software studies, are not present in this text.
§ 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.