(89 days)
The NDSsi ZeroWire Duo Wireless HD Video Transfer System 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 ZeroWire wireless device 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 ZeroWire® wireless device is a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to a video display such as Radiance and EndoVue LCD surgical monitors.
The provided text is a 510(k) summary for the NDSsi ZeroWire Duo Wireless HD Video Transfer System. It states that "Clinical data is not needed for this type of wireless device 510(k) submission." Therefore, it does not include a study proving the device meets specific acceptance criteria based on clinical performance metrics such as sensitivity, specificity, accuracy, or reader performance.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Stryker Vision Elect Wireless High Definition Television / K081995) through non-clinical tests and surgical-setting tests. The "acceptance criteria" can be inferred from the claims of equivalence and the characteristics described for the device, rather than explicit numerical performance targets.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since clinical performance metrics (like sensitivity, specificity, or accuracy) are not provided, the "acceptance criteria" here relate to the functional and safety equivalence to the predicate device, and the "reported device performance" is a statement of that equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Delivery of video signal over radio-frequency link | "paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display" |
| Compatible with video displays (e.g., Radiance and EndoVue LCD) | "allows delivery of a video signal... to a video display such as Radiance and EndoVue LCD surgical monitors." |
| Full high-definition video | "Delivers full high-definition video" |
| Low latency | "less than 1 frame latency" |
| Resistant to interference | "By utilizing the reserved UWB frequency spectrum, ZeroWire provides a wireless video link that is resistant to interference from other devices." |
| Non-clinical test conformity (medical safety, EMC) | "Both systems conform to non-clinical tests including the medical safety and EMC standards defined by EN 60601-1 and EN 60601-1-2." |
| FCC Part 15 standards conformity (for wireless devices) | "As wireless devices, both systems conform to relevant FCC Part 15 standards." |
| Data security (industry-standard encryption) | "Both systems provide video data security by employing industry-standard data encryption techniques." |
| Performance, safety, and effectiveness equivalent to predicate | "Based on non-clinical tests as well as surgical-setting tests, the ZeroWire wireless device provides performance, safety, and effectiveness that is equivalent to the predicate Stryker Vision Elect Wireless High Definition Television (Stryker VE VHDTV) / K081995." (Conclusion derived from "surgical-setting test results") |
| Not intended for sterile field / reusable / non-sterile | "The Zero Wire wireless device is a non-sterile reusable device not intended for use in the sterile field." |
| Used by qualified physicians with knowledge of surgical procedures | "It is intended for use by qualified physicians having complete knowledge of these surgical procedures." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "surgical-setting test results" but does not detail the number of cases, participants, or specific parameters of these tests.
- Data Provenance: Not explicitly stated. The document describes "surgical-setting test results" but does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) summary focused on substantial equivalence through non-clinical and "surgical-setting tests" (likely functional testing in a surgical environment), it's improbable to be large-scale clinical trial data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided as the submission states, "Clinical data is not needed for this type of wireless device 510(k) submission." Therefore, there's no mention of experts establishing ground truth in the context of diagnostic accuracy or similar clinical outcomes. The "ground truth" for the non-clinical and surgical-setting tests would likely be objective measurements of video signal quality, latency, interference resistance, and adherence to technical standards.
4. Adjudication Method for the Test Set
- This information is not provided for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical data is not needed for this type of wireless device 510(k) submission." The comparison is primarily technical and functional equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The device is a hardware system (transmitter and receiver for video transfer), not an algorithm that produces interpretations or diagnoses. Therefore, the concept of "standalone performance" in the context of an algorithm's diagnostic accuracy is not applicable to this device. The "standalone" performance here would refer to its ability to transmit video signals effectively, which is covered by the non-clinical and surgical-setting tests.
7. The Type of Ground Truth Used
- As clinical data for diagnostic purposes was not required, the "ground truth" used would be based on technical specifications, objective measurements, and compliance with established standards (e.g., video resolution, latency measurements, signal strength, interference levels, adherence to EN 60601-1, EN 60601-1-2, and FCC Part 15).
8. The Sample Size for the Training Set
- This device is a hardware system; it does not involve a "training set" in the context of machine learning or AI algorithms. The system's design and engineering are based on established electronics and wireless communication principles.
9. How the Ground Truth for the Training Set Was Established
- As there is no training set for an AI/ML algorithm, this question is 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.