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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.

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

The document does not specify a "sample size" in terms of number of patient images or subjects. Instead, the testing refers to performance bench testing of the device itself.

• Sample Size: Not applicable in the traditional sense of patient data. The "test set" consists of the device hardware and its operational parameters.
• Data Provenance: The testing appears to be conducted in a laboratory or engineering environment to meet regulatory standards. No information on country of origin of data or retrospective/prospective nature is applicable as it's not a clinical study on patient data.

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

This information is not applicable. For a device like an X-ray system, "ground truth" typically refers to the physical and electrical parameters of the device, measured by calibrated equipment and verified against engineering specifications, rather than human expert interpretation of clinical images.

4. Adjudication Method for the Test Set

Not applicable. The testing described is objective measurement of physical and electrical parameters of the X-ray device itself against predefined performance requirements and standards. There is no human interpretation or adjudication in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This device is an X-ray system, and the submission is for its substantial equivalence, not for an AI/ML algorithm that assists human readers. Therefore, there's no mention of how human readers improve with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This is an X-ray imaging device, not an AI algorithm. Its performance is inherent to its design and function.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by regulatory standards and engineering specifications. This includes:

• Physical measurements (e.g., source to skin distance, focal spot size, X-ray field size).
• Electrical measurements (e.g., tube voltage, tube current, exposure time, accuracy of loading factors).
• Radiological measurements (e.g., Half-Value Layer, Air KERMA).
• Image quality metrics (Low Contrast and Line Pair performance), which are objectively measured using phantoms according to IEC standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable. As noted above, this is an X-ray imaging device, not an AI/ML system requiring a training set with established ground truth from clinical data.

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