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The EzRay Air 2 Wall (Model Name: VEX-S350W) is a dental X-ray system intended for use by a trained and qualified dentist or dental technician for both adult and pediatric subjects for producing diagnostic dental radiographs for the treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.

The EzRay Air 2 Wall (Model: VEX-S350W) is a dental X-ray system intended for intra-oral imaging. It consists of an X-ray generator, X-ray controller, beam limiting device, operation panel, and mechanical arm. The X-ray controller allows for accurate exposure control, and the adjustable mechanical arm allows for easy positioning. The functions of the VEX-S350W intra-oral system are supported by software (firmware). The software is based on the predicate device and is of Moderate level of concern. The system can be used with an imaging system.

The provided text describes a 510(k) premarket notification for the EzRay Air 2 Wall (Model: VEX-S350W) dental X-ray system. The submission focuses on demonstrating substantial equivalence to a predicate device (EzRay Air Wall (Model: VEX-S300W) / K163705) rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, many of the requested details regarding acceptance criteria for AI/ML performance, study design (sample size, ground truth, expert adjudication, MRMC studies), training set specifics, and effect sizes of human reader improvement with AI assistance are not present in this document. The document primarily addresses the safety and performance of an X-ray imaging system itself, not an AI component.

However, based on the information provided regarding the device's performance testing for its X-ray imaging capabilities, here's an attempt to extract and reframe the information to fit the structure of your request where possible, acknowledging the limitations due to the nature of the submitted document:

Device: EzRay Air 2 Wall (Model: VEX-S350W) - Dental X-ray System

The provided document describes the acceptance criteria and performance study for the EzRay Air 2 Wall, a dental X-ray system. It focuses on the device's imaging capabilities, not an integrated AI component. Therefore, the details requested for AI/ML device validation are not applicable or available in this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this X-ray system are based on compliance with Federal Standards and International Standards related to X-ray performance and safety. The performance is demonstrated through various tests.

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