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FONA XDC is an intraoral dental X-ray device intended for dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth in both adult and pediatric patients.

The device consists of an X-ray generator, a CPU that manages the exposure time and a mechanical suspension system, for wall mounting or mobile stand.
The image detectors (a necessary component for a fully-functional diagnostic system) are not part of the current submission.
The device, unlike the previous IntraOs 70 with AC power supply of the tube, is powered at constant potential, i.e. direct current, guaranteeing excellent quality of the final image. From an application point of view, FONA XDC radiographic system is similar to the IntraOs 70; it is possible to select nine anatomical zones (two more than in IntraOs 70), two patient body sizes and three types of receptors that can be set at different sensitivities.
The basic radiographic system allows to operate at 20 cm (8") source-skin distance (SSD) with circular radiation beam. The FONA XDC primary collimator, as for the IntraOs 70, consists of a brass cylinder and the limitation of the beam on a circular surface of 6 cm in diameter from the focus for a working distance of 20 cm. It is possible to bring the working distance to 30 cm from the focus by adding a cone extension. It is also possible to reduce the exposed circular area both by working at 20 cm and at 30 cm. with the interposition of rectanqular 3x4 cm or 2x3 cm BLD adaptor, for image receptors of size 2 (adult) or size 0 (child) respectively

The provided text is a 510(k) summary for a dental X-ray device (FONA XDC) seeking substantial equivalence to a predicate device. It details the device's technical specifications and compares them to the predicate, but it does not include any information about studies proving the device meets acceptance criteria related to AI/algorithm performance.

The document explicitly states: "Based on the device nature (an x-ray generator similar to the predicate), clinical testing is not required to demonstrate substantial equivalence. Successful bench testing results should be enough proof that the FONA XDC works as intended."

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance (for an AI/algorithm-based device): Not applicable, as this is an X-ray generator, not an AI device.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence of the FONA XDC to a predicate device (IntraOs 70) and a reference device (Heliodent Plus) based on technical specifications, intended use, and adherence to performance standards for X-ray generators. The table provided in the document (pages 6-7) compares various technical characteristics like power supply, line voltage, focal spot, tube voltage, tube current, and adherence to electrical safety and radiation protection standards, which would serve as "acceptance criteria" for an X-ray generator.

Summary of Non-Clinical Testing and Conclusion:
The document mentions that "FDA consensus standards have been employed for electrical safety, electromagnetic compatibility, performance and usability. Each produced device is checked against the FDA performance standards for Ionizing radiation emitting products. The performance of the predicate device and the subject device have been validated using the same testing models." This implies that the device underwent bench testing to ensure it met these standards, and these standards serve as the acceptance criteria for the X-ray generator.

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