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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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