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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.

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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The ZeroWire Mobile, Radiance Ultra series ZeroWire G2 are a paired video communication transmitter and receiver, intended for delivery of medical video signals from a source such as an endoscopy cameralprocessor, or other video source over a radio-frequency link to a video for review and analysis of medical images during endoscopic and general surgical procedures.

The ZeroWire Mobile, Radiance Ultra series, and ZeroWire G2 wireless video systems are non-sterile reusable devices not intended for use in the sterile field.

ZeroWire Mobile is a medical grade, battery powered pole stand that eliminates the need for a power cord. It will be used as an accessory, secondary monitor display in Endo/GI procedure rooms, surgical operating rooms, or other clinical settings. ZeroWire Mobile is a cordless stand with a wireless monitor solution that provides the procedure or operating room with a mobile second display monitor eliminating the risk of biohazard contamination of cords and cables, and cable/cord trip hazards. The ZeroWire Mobile is the second accessory to ZeroWire Duo Wireless HD Video Transfer System G2/ ZeroWire G2 Duo (K151609). The first accessory to be approved was the Radiance Ultra ZeroWire Embedded (Special K161228).

The ZeroWire Mobile consists of a 5-wheel mechanical stand to hold a display monitor, up to 32" in size and / or

The provided text describes a 510(k) premarket notification for the "ZeroWire Mobile" device, which is an accessory product. Therefore, the device itself doesn't have "acceptance criteria" in the traditional sense of a diagnostic or treatment device having performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" for a 510(k) submission are typically related to demonstrating substantial equivalence to a predicate device, primarily through compliance with recognized performance standards and safety testing.

Here's an analysis of the provided information based on your request, understanding that the context is about an accessory device's compliance rather than a standalone diagnostic algorithm's performance:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (ZeroWire Mobile), the "acceptance criteria" are compliance with various electrical, medical device, and electromagnetic compatibility (EMC) standards. The "reported device performance" is the successful passing of tests against these standards.

The overall study demonstrating safety and effectiveness is referred to as "design verification testing." It concluded that the ZeroWire Mobile accessory stand "demonstrates safety and effectiveness that is equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The testing described is compliance testing against various standards for electrical and safety performance of the hardware components (ZeroWire Mobile stand, power module, charger, and embedded displays with the mobile unit). This type of testing typically involves physical samples of the device and its components, but not a "test set" of clinical data or images like an AI algorithm would use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and therefore not provided in the document. The device is hardware (a mobile stand and power system for a monitor) and does not involve interpretation of medical images or diagnostic decisions that would require human expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods are relevant for studies where there are multiple interpretations or classifications of data, such as in clinical trials or AI performance evaluations. The testing here is against technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not applicable and therefore not provided in the document. An MRMC study is relevant for evaluating the impact of a system (often AI) on human performance in diagnostic tasks. The ZeroWire Mobile is a hardware accessory; it does not involve human readers making diagnostic assessments.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and therefore not provided in the document. This concept applies to AI algorithms. The ZeroWire Mobile is a physical device accessory, not an algorithm. The core functionality of wireless video transfer (K151609) and the embedded monitors (K161228), which this device is an accessory to, would have undergone their own standalone performance and safety testing.

7. The Type of Ground Truth Used

This information is not applicable in the context of clinical ground truth (like pathology or outcomes data). For this device, the "ground truth" or reference for its performance is defined by the technical specifications of the relevant regulatory standards (e.g., IEC 60601-1 for safety, EN 301 489 for EMC). The device's performance is measured against these established technical benchmarks.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. "Training set" refers to data used to train an AI algorithm. This device is hardware and does not involve machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided in the document, as there is no training set mentioned for this hardware device.

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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.

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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."

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.

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