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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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