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The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

EXARO, Xray2GO, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack, The X-ray tube head, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, EXARO, Xray2GO, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The operating principle of EXARO, Xray2GO starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor)

This device contains a high frequency inverter that converts direct to alternating current. X-ray tube head, electrical protective devices, and other elements. The EXARO, Xray2GO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.

The provided document is a 510(k) premarket notification for a Portable X-ray System (Model: EXARO, Xray2GO). This notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Portable X-Ray System, Model: EXARO, K122124).

The document does not contain information about acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.

Instead, the submission relies on demonstrating substantial equivalence through a comparison of technical specifications and adherence to safety and performance standards.

Here's a breakdown of the information that can be extracted based on your request, and what is missing:

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

This information is not explicitly present in the document in the form of diagnostic accuracy or clinical performance acceptance criteria (e.g., sensitivity, specificity, AUC) and reported device performance against those criteria. The acceptance criteria for the submission appear to be centered around meeting established electrical and radiation safety standards, along with demonstrating comparable technical specifications to a predicate device.

The table provided in the document (pages 4-5) lists technical characteristics of the proposed device and compares them to the predicate device. This is used to demonstrate substantial equivalence, not to report on diagnostic performance against pre-defined clinical acceptance metrics.

The "acceptance criteria" here implicitly are that the proposed device's characteristics are comparable to the predicate such that it does not raise new questions of safety or effectiveness, and that it meets the listed IEC standards.

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

This information is not provided. The submission states: "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." (page 5). However, no details about the "clinical evaluation" such as sample size, type of data (retrospective/prospective), or country of origin are given. This suggests the clinical evaluation performed was likely not a formal diagnostic performance study with a test set in the way you're asking.

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)

This information is not provided. Since no detailed clinical performance study with a test set validation is described, there's no mention of experts establishing ground truth.

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

This information is not provided for the same reasons as point 3.

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

An MRMC study was not conducted or described. This device is an X-ray system, not an AI-powered diagnostic tool. The document focuses on the hardware's safety and performance characteristics and its substantial equivalence to a predicate X-ray system. Improvement with AI assistance is not relevant to this device's submission.

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

A standalone algorithm performance study was not applicable and not done. This is a hardware device for generating X-rays, not a standalone algorithm.

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

This information is not provided as no detailed clinical performance study with a test set is described. For a device like an X-ray generator, the "ground truth" for its output is typically assessed through physical measurements (e.g., radiation output, image quality parameters using phantoms) rather than clinical diagnostic ground truth.

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/ML device that requires a training set.

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

This information is not applicable and not provided for the same reasons as point 8.

Summary of what the document indicates for "acceptance criteria" for this type of device:

For this 510(k) submission, the "acceptance criteria" are implicitly met by:

• Demonstrating the device is substantially equivalent to a predicate device (K122124) in terms of intended use, technology, design, functions, and principle of operation.
• Showing that any differences (e.g., anode current, expose time, battery specifications) do not raise new questions of safety and effectiveness.
• Conforming to recognized safety, EMC (Electromagnetic Compatibility), and performance standards, specifically:
  • IEC 60601-1 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests)
  • IEC 60601-2-7 (Medical electrical equipment - Part 2-7: Particular requirements for the safety of medical photographic X-ray equipment)
  • IEC 60601-2-28 (Medical electrical equipment - Part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis)
  • IEC 60601-2-32 (Medical electrical equipment - Part 2-32: Particular requirements for the safety of associated equipment for X-ray equipment)

The study proving the device meets these acceptance criteria is the technical comparison to the predicate device and the implied testing to relevant IEC standards. The document explicitly states: "No additional testing was added for this submission based on the modifications" (page 5), and "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices" (page 5). However, no details of these specific tests or evaluations are provided beyond the table of characteristic comparisons.

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