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510(k) Data Aggregation
(26 days)
The Radiance Ultra 32" 4K ZeroWire Duo 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 radiofrequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The Radiance Ultra 32" 4K ZeroWire Duo is a non-sterile reusable device not intended for use in the sterile field.
Radiance Ultra 32" 4K ZeroWire Duo is a medical LCD display designed to both wirelessly receive or transmit video signal with up to 4K resolution over a radio frequency link to a partner display.
This document describes acceptance criteria and performance data for the Radiance Ultra 32" 4K ZeroWire Duo, a wireless video communication transmitter and receiver intended for displaying images during endoscopic and general surgical procedures.
Important Note: The provided text is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence to predicate devices. As such, it often refers to "design verification" and "design validation" studies without providing detailed methodologies or specific performance metrics from those studies. Therefore, some requested information may not be explicitly available in the given text, and conclusions will be drawn based on the information provided.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" in a quantitative format with corresponding "reported device performance" in the way one might see for an AI algorithm's diagnostic accuracy. Instead, it compares the technical specifications and standards compliance of the proposed device against its predicate devices. The "performance" in this context refers to meeting these specifications and standards.
| Acceptance Criteria (Implied by Predicate Comparison & Standards) | Reported Device Performance (Radiance Ultra 32" 4K ZeroWire Duo) |
|---|---|
| General Characteristics: | |
| Product Class | Class II |
| Product Code | GCJ |
| Regulation Description | Endoscope and accessories |
| Indications for Use | Paired wireless video communication transmitter and receiver for delivery of video signals from a source (e.g., endoscopy camera/processor) to a ZeroWire Receiver for display during endoscopic and general surgical procedures. Non-sterile, reusable device, not for sterile field. |
| Where Used | Medical Facility |
| Compatibility with environment and other devices | Compliant with IEC 60601-1-2 |
| Design Specifications: | |
| Frequency Spectrum | 59.40 to 63.56 GHz |
| Time Frequency Coding | No |
| Antenna beam forming | Yes |
| Number of Channels | 6 |
| RF Power out (Max) | 28 dBmi |
| Tx/Rx range | ≤ 30ft (9.1m) |
| RF Bandwidth | 1.76 GHz per channel (HRP Bandwidth), 92 MHz per channel (LRP Bandwidth) |
| Video Formats | up to 3840x2160 @60 Hz (improvement over predicates) |
| System Latency | less than 1 frame |
| Video Input | 12G-SDI, DVI-D, DisplayPort, DisplayPort Tx, HDMI, USB Mini B, USB Micro AB (more comprehensive than predicates) |
| Tx/Rx pairing | single Tx-Rx pair |
| Tx/Rx pairing memory | Will retain pair information (improvement over predicate's "Pairing is lost when power is removed") |
| Weight, Tx/Rx pair | 14.5 Kg (32.0 lbs.) |
| Operating Temperature | 32 - 104°F (0-40°C) |
| Storage Temperature | -20 to 50°C |
| Relative Humidity (non-condensing) | 10 to 90% (wider range than one predicate, similar to another) |
| Display Size | 32" (larger than predicate) |
| Maximum Luminance1 (cd/m2, typical) | 700 (lower than one predicate, but for 4K display size) |
| Native Resolution | 3840 x 2160 (higher than predicate) |
| Contrast Ratio (nominal) | 1350:1 (higher than predicate) |
| Dot Pitch (mm) | 0.1845 (smaller than predicate) |
| Vertical and Horizontal Viewing Angle | 178° |
| Advance Encryption Standard for data communication security | 256-bit AES Encryption |
| Output Signals | 12G-SDI, DVI-D (more comprehensive than one predicate) |
| Sterility and Safety: | |
| Sterility | Non-sterile |
| Mechanical Safety | Implied by compliance with IEC 60601-1 |
| Chemical Safety | Implied by compliance with IEC 60601-1 |
| Electrical Safety | Compliant with IEC 60601-1 |
| Radiation Safety | Implied by compliance with FCC Part 15 |
| Standards Compliance: | |
| Safety | Compliant with IEC/EN 60601-1, ANSI/AAMI ES60601-1 |
| EMC | Compliant with IEC/EN 60601-1-2; FCC CFR 47 Part 15 |
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 does not describe a "test set" in the context of clinical data or images. This device is a display/wireless transmission system, not a diagnostic AI device that processes patient data. The "design validation" mentioned in section N and O would refer to testing the hardware and software functionality against engineering specifications and relevant medical device standards, rather than a clinical study with patients or patient data. Therefore, information on data provenance or sample size for a test set of clinical cases is not applicable/provided.
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)
Not applicable, as a test set for clinical ground truth is not detailed for this type of device. The "ground truth" for this device would relate to engineering specifications and performance standards (e.g., video resolution accuracy, signal latency, wireless range), which are evaluated through technical testing by qualified engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the reasons stated above.
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
Not applicable. This device is a medical display and wireless video transmission system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers assisting with AI is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is hardware, not an algorithm. The "standalone" performance would be about its technical capabilities (e.g., video transmission quality, latency, resolution) which are assessed through engineering tests. The document states in section N and O: "The display has successfully passed design validation to further demonstrate its safety and effectiveness" and "Based upon results from the design verification, Radiance Ultra 32" 4K ZeroWire Duo display demonstrates performance, safety, and effectiveness that are equivalent to the predicate devices." This implies various engineering and performance tests were conducted to verify its operation according to specifications and standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be established by industrial standards (e.g., IEC 60601 series, FCC Part 15), engineering specifications, and validated test methodologies. For example, video resolution is objectively measured against a known signal, latency is measured using precise timing equipment, and electromagnetic compatibility is tested according to regulatory standards to ensure it doesn't interfere with other devices and operates safely in its intended environment.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
Not applicable for the same reason mentioned above.
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