Search Results

The Radiance Ultra series ZeroWire G2 is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The Radiance Ultra series ZeroWire Embedded and ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field

Radiance Ultra series ZeroWire Embedded monitors are designed with an integrated wireless video receiver module (Rx), enabling the reception of a video signal over a radio frequency link instead of a video cable. These monitors are designed for use in non-sterile healthcare environments. The Radiance Ultra series ZeroWire Embedded is a medical grade wireless video streaming device pair. The external transmitter (Tx) unit is designed to be mounted on a primary display, on an endoscopic cart, or any other elevated location in close vicinity to the video source. The Tx unit obtains its video input signal from either the loop through output of the primary display, or directly from the video source. The Tx unit will accept video in either HDMI/DVI or SDI formats up to 1920 x 1080p 60 Hz resolution. The Tx unit is powered by a NDS 12-24V DC-DC power converter while the Rx module shares the same 24V DC input of the display.

The provided text describes a medical device called "Radiance Ultra series ZeroWire Embedded" and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The document is a 510(k) premarket notification letter from the FDA, along with the applicant's 510(k) summary. It primarily focuses on establishing substantial equivalence to a predicate device (K151609 model ZeroWire G2) based on technological characteristics and intended use.

Here's a breakdown of what can be extracted and what is missing:

Information that can be extracted from the provided text:

• Device Name: Radiance Ultra series ZeroWire Embedded (and ZeroWire G2 for the paired transmitter/receiver system).
• Intended Use: Delivery of video signals from a source (e.g., endoscopy camera/processor) over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. It is a non-sterile reusable device not intended for use in the sterile field.
• Predicate Device: K151609 model ZeroWire G2.
• Performance Claim (General): The device "meet and exceed IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 and FCC part 15." It also states, "The displays have successfully passed design validation to further demonstrate their safety and effectiveness."
• Conclusion: The device demonstrates performance, safety, and effectiveness that are equivalent to the predicate device.

Information that is missing from the provided text regarding acceptance criteria and studies:

• A table of acceptance criteria and the reported device performance: While general standards (IEC, FCC) are mentioned, specific measurable acceptance criteria (e.g., latency, signal integrity, resolution maintenance under specific conditions) and the corresponding device performance against these criteria are not provided.
• Sample size used for the test set and the data provenance: No information on any specific test set, its size, or the origin of data is present.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set requiring expert ground truth.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, the effect size: Not applicable, as this device is a video transmission system, not an AI diagnostic tool that would typically involve human readers.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, for the same reason as above.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as this is hardware for video transmission, not an AI algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a video display and transmission system. It focuses on compliance with general safety and electromagnetic compatibility standards and functional equivalence to a predicate device, rather than detailed performance metrics from a specific clinical or technical study against predefined acceptance criteria for a diagnostic or AI-driven device.

Ask a specific question about this device