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The Portable X-ray System (Model: HAND-RAY) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

The Portable X-ray System (Model: HAND-RAY) is portable dental X-ray system that operates on 24VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray controls and power source are assembled into a single hand-held enclosure. The package includes battery charger. The Portable X-ray System generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that Xray generated by high voltage electricity into X-ray tube, which penetrates tooth and jaw, and makes X-ray images on receptor (chemical film or digital sensor). The Portable X-ray System (Model: HAND-RAY) is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors. Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The portable X-ray system (Model: HAND-RAY).provides with sharp and clear images and keeps patients and dentists away from radiation using small dose of radiation.

The document provided is a 510(k) Summary for a Portable X-Ray System (Model: HAND-RAY). It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets them.

Therefore, many of the requested fields cannot be directly extracted from this document, as it outlines regulatory compliance and a comparison to predicate devices, not the results of a specific performance study against defined acceptance criteria for diagnostic accuracy of an AI device.

However, I can extract information related to the device's technical specifications and safety/performance standards.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not define specific "acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) that an AI/device would need to meet. Instead, it demonstrates compliance with regulatory standards and technical specifications by comparing them to predicate devices.

The "device performance" reported is primarily in terms of technical specifications, safety, and electromagnetic compatibility (EMC) compliance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. This document describes a traditional X-ray system, not an AI device. The "bench and clinical evaluation" mentioned is for the device's safety and effectiveness compared to predicates, not for the diagnostic performance on a specific dataset. There is no information about data provenance or sample size for a "test set" in the context of an AI algorithm.

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 this is not an AI device, there's no mention of a ground truth established by experts for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No test set for diagnostic performance is described.

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 is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a standalone X-ray hardware device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth is established for diagnostic performance of an algorithm. The "ground truth" here would relate to the physical measurements and operational parameters of the X-ray system itself, verified against engineering standards.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

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