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The Handheld Dental X-ray System, model XVbeam2000, is indicated for use only by a trained and qualified dentist or dental technician as an extraoral X-ray source to produce diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

The subject device Handheld Dental X-ray System, model XVbeam2000, is a battery-operated, portable extraoral X-ray source system that is designed to generate X-rays to produce diagnostic quality intraoral X-ray images utilizing intraoral image receptors. The device can be used with three receptor types: film, digital intraoral X-ray sensors, and phosphor plates. The subject device is designed for use in a dental office or similar environments (hospital ward etc.) where appropriate safeguards are implemented. The subject device XVbeam2000 is an X-ray device with a DC generator. The handheld device features a main body (X-ray tube head), rechargeable battery (handset), charger, and charger AC/DC power supply. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient. The power is supplied by a rechargeable Lithium-Ion battery core pack built into a handset. This facilitates portability of the device.

The provided text is a 510(k) summary for a medical device (XVbeam2000 Handheld Dental X-ray System). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria through clinical trials or performance studies that would typically generate the requested information.

Therefore, the requested information about acceptance criteria for device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly available in the provided document. The document focuses on demonstrating substantial equivalence through non-clinical performance testing and compliance with recognized standards.

However, I can extract the information that is present and note where the requested information is not provided.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Compliance with Standards)

The document states that "The test results show that all of the performance specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence."

While specific numerical acceptance criteria and reported device performance for individual metrics are not tabulated, the document generally indicates that the device met the requirements of several FDA-recognized consensus standards for medical electrical equipment and X-ray systems.

Here's a table summarizing the general approach taken, as specific performance criteria and reported values are not detailed in the provided text:

Additional Requested Information (Based on Provided Text):

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

   • Not provided. The document mentions "non-clinical testing, (integration and functional) including phantom tests," but does not specify the sample size of these tests or the provenance of the data. It explicitly states, "Clinical data is NOT required for a finding of substantial equivalence."

2. 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 provided. The testing described is non-clinical and focused on device performance according to engineering specifications and regulatory standards, rather than diagnostic accuracy against a ground truth established by medical experts.

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

   • Not provided. This is typically relevant for diagnostic accuracy studies with human readers, which were not conducted for this 510(k) submission.

4. 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:

   • No MRMC study was done. The device is an X-ray source, not an AI-powered diagnostic tool. The submission states, "Clinical data is NOT required for a finding of substantial equivalence."

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

   • Not applicable for this device. This device is an X-ray generator, not an algorithm. Its performance is evaluated based on its physical properties and adherence to safety and performance standards.

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

   • For the non-clinical and phantom tests, the "ground truth" would be the engineering specifications and the expected output as defined by the relevant performance standards (e.g., measured radiation output within specified tolerance, electrical safety parameters met, software function as programmed). It is not medical ground truth established by experts.

7. The sample size for the training set:

   • Not applicable/Not provided. This device is a hardware X-ray system with embedded control software. While software undergoes verification and validation, it is not an AI/machine learning algorithm that requires a separate "training set" for learning purposes in the way diagnostic AI models do.

8. How the ground truth for the training set was established:

   • Not applicable/Not provided. As there is no AI/machine learning training set, this question is not relevant. The "ground truth" for the embedded software would be its correctly implemented functional requirements and specifications.

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