(144 days)
The NDS ZeroWire G2 is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy camera/processor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field.
Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 4; x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire G2 wireless device is designed as a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to video destination such as Radiance and EndoVue devices.
The provided text describes the ZeroWire Duo Wireless HD Video Transfer System G2 (or ZeroWire G2), a device intended for wireless transmission of video signals during endoscopic and general surgical procedures.
Here's an analysis of the acceptance criteria and the study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of quantitative acceptance criteria with corresponding performance results in numerical form (e.g., latency threshold vs. measured latency). Instead, it states that the device "meets and exceeds" certain standards and has undergone "design validation and clinical study to further demonstrate its safety and effectiveness."
| Acceptance Criteria / Standard Met | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Meets and exceeds IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15. |
| Robust Wireless Video Link | Utilizes directional antenna and beam forming in the 60 GHz frequency spectrum to minimize interference. Provides highest quality of service. |
| Clinical Efficiency and Safety | Enhances clinical efficiency and safety in the OR by eliminating the need for a video cable. |
| Installation | Proprietary memory-enabled pairing system makes installation quick and easy. |
| Equivalence to Predicate Device | Demonstrates performance, safety, and effectiveness equivalent to predicate device K112621 model WIS1000, based on validations from both design and clinical findings. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "test results in clinical environment" but does not specify a sample size for this test set.
The data provenance is presented as "clinical environment," implying prospective testing. However, details about the country of origin are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The nature of the device (wireless video transfer) suggests that "ground truth" might relate more to technical performance (e.g., signal quality, latency) rather than image-based diagnostic accuracy requiring expert interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. As noted above, the assessment likely focuses on technical performance metrics rather than interpretative agreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No MRMC comparative effectiveness study is mentioned. The device is a technology for video transfer, not an AI diagnostic tool requiring human-in-the-loop performance evaluation in the typical sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document mentions "design validation and clinical study" and "test results in clinical environment." This implies standalone testing of the device's technical performance characteristics. The device itself (a wireless video transfer system) inherently operates "standalone" in its primary function of transmitting video. The "clinical study" likely evaluated its performance in a clinical setting independent of human interpretation improvements.
7. The Type of Ground Truth Used
The "ground truth" for this device likely refers to objective technical specifications and performance metrics related to video transmission, such as:
- Video quality: Resolution, color accuracy, absence of artifacts.
- Latency: Delay in video transmission.
- Signal integrity and robustness: Ability to maintain a stable connection and quality in varying environments, including the presence of interference.
- Compliance with electrical and electromagnetic compatibility (EMC) standards: As indicated by meeting IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15.
The document implicitly suggests that these technical characteristics were measured and compared to the predicate device and relevant standards.
8. The Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or AI models. Since this device is a wireless video transfer system and not an AI algorithm, a training set in that context is not applicable or mentioned.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" for an AI model is not applicable to this device, this question is also not relevant to the information provided.
§ 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.