(193 days)
The Olympus Wireless Image Transmitter Unit UWIT-Y0001 is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The Olympus UWIT-Y0001 is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.
The WIRELESS IMAGE TRANSMITTER UNIT UWIT-Y0001 consists of a Wireless Transmitter UWIT-Y0001-TX, a Wireless Receiver UWIT-Y0001-RX and accessories. The UWIT-Y0001-TX transmits endoscopic image over radio frequency signal and the UWIT-Y0001-RX receives it. The endoscopic image signal output by the Video System Center is sent to the UWIT-Y0001-TX. Then, the UWIT-Y0001-TX converts the endoscopic image signal to the radio frequency signal and transmits it to the UWIT-Y0001-RX. The UWIT-Y0001-RX converts the radio frequency signal received from the UWIT-Y0001-TX to endoscopic image signal and sends it to the video monitor
This 510(k) summary (K120278) describes a Wireless Image Transmitter Unit (UWIT-Y0001) that is substantially equivalent to a predicate device. The document focuses on demonstrating safety and performance rather than diagnostic accuracy or comparative effectiveness with human readers. Therefore, several of the requested categories are not applicable or cannot be extracted from the provided text.
Here is an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards | |
| IEC 60601-1: 1988, Amendment 1: 1991, Amendment 2: 1995 | Compliant |
| IEC 60601-1-1: 2000 | Compliant |
| IEC 60601-1-2: 2007 | Compliant |
| Risk Analysis | |
| ISO 14971: 2007 established in-house acceptance criteria | Risk analysis carried out, design verification tests and acceptance criteria identified and performed. |
| Software Validation | |
| FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Validation activities performed; software considered "Minor Level of Concern." |
| Radio Frequency Compliance | |
| FCC 47 CFR Part 15 - Radio Frequency Devices, Subject C - Intentional Radiators | Evaluated to verify compliance. |
| Intended Functionality | |
| Transmit HD video signals in expected use environment without interfering with other devices. | Evaluation testing demonstrated the device can perform as intended. |
| Mechanical and Functional Performance | Verified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical testing and verification activities. These types of tests are typically performed on the device itself (hardware and software) and do not involve a "test set" of patient data in the way an AI diagnostic algorithm would. Therefore, this information is Not Applicable (N/A) in this context. The study did not involve patient data for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is Not Applicable (N/A). The device is a video transmitter, not a diagnostic tool requiring expert interpretation of medical images or data. Ground truth in this context refers to the successful transmission of video signals, meeting safety standards, and functional specifications, which are confirmed through engineering and compliance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is Not Applicable (N/A). Adjudication methods like 2+1 are used for establishing ground truth in diagnostic studies involving multiple human readers disagreeing on findings. This document describes engineering and safety testing.
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
This is Not Applicable (N/A). The device is a wireless image transmitter, not an AI diagnostic tool or an assistance system for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is Not Applicable (N/A) in the context of an AI algorithm. The device itself (the wireless image transmitter unit) was presumably tested in a standalone capacity to ensure its functional performance (transmitting video signals, compliance with standards) without human intervention in the transmission process. However, this is not equivalent to the "standalone performance of an AI algorithm."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established through adherence to recognized safety and performance standards (e.g., IEC 60601 series, ISO 14971, FCC Part 15) and successful functionality testing (e.g., transmission of HD video signals without interference). This is an engineering and compliance ground truth, not a medical "ground truth" derived from patient outcomes or pathology.
8. The sample size for the training set
This is Not Applicable (N/A). The device is hardware with embedded software, not a machine learning model that requires a training set of data.
9. How the ground truth for the training set was established
This is Not Applicable (N/A). As there is no training set for a machine learning model, there is no ground truth to establish for it.
§ 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.