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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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Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry.

Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.

Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry.

Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.

Stellaris 3D is a dental X-ray system for Panoramic and Cone Beam Computed Tomography (CBCT) which allows to perform all the radiographic projections, both 2D and 3D, of most interest for the dentist, the surgeon and the maxilla-facial radiologist.

In addition to the functions of Panoramic and 3D radiography, Stellaris 3D Ceph also allows to perform One-Shot Cephalometric radiographs.

Stellaris 2D is a dental X-ray system for Panoramic which allows to perform all the radiographic projections of most interest for the dentist, the surgeon and the maxilla-facial radiologist.

In addition to the functions of Panoramic, Stellaris 2D Ceph also allows to perform One-Shot Cephalometric radiographs.

Except for the panoramic acquisition sensor, the remaining mechanical, electrical and software characteristics of Stellaris 2D are exactly identical to those of Stellaris 3D.

The control panel interface on the unit provides a complete control of the operation and for the setting of the desired technique factors.

Class I LASER aiming lights support positioning of patient's head, which is stabilized through the use of bite blocks, chin rest, and, if required, temple supports.

The user controls the exposure using a manual hand-switch, implementing the dead man functionality.

An Ethernet connection cable allows the FONA Stellaris devices to interface with a computer for image acquisition, processing and storage.

The provided document is a 510(k) Premarket Notification from FONA S.r.l. to the FDA for their Stellaris dental X-ray systems. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and adherence to relevant standards.

The document does NOT describe the acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.

The Stellaris devices are dental X-ray systems (2D and 3D, with and without cephalometric capabilities). The document explicitly states:

• "The Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices can be used with the OrisWin DG Suite software for image acquisition and database (not part of this submission)..." (page 8)
• "...the 3D sensor has been replaced with a 2D sensor." (page 10)
• "The principle of operation of the Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D, Stellaris 3D Ceph devices remains the same as the predicates. The difference is the type of sensors used which work on similar principles as the sensors found in the predicate devices." (page 7)

There is no mention of any AI or machine learning components within the device itself for diagnostic or image processing purposes that would require specific performance criteria or a study as outlined in the request. The "reconstruction algorithm" mentioned is standard for CT and panoramic imaging, not an AI/ML algorithm requiring separate clinical performance validation from the device's image acquisition capabilities.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document describes a traditional 510(k) submission for an imaging device, demonstrating substantial equivalence through technical characteristics, safety standards (IEC, EN), software standards (EN 62304), and biocompatibility (ISO 10993-1).

In summary, none of the requested information regarding AI/ML acceptance criteria or a comparative study proving device performance against such criteria can be found in this document.

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Acquisition of intraoral X-Ray image of the human dental arch. In particular:
• The STARX-1/ STARX PRO-1 sensors (active area 20 x 30 mm) allow to acquire the majority of intraoral images both vertically and horizontally.
• The STARX-2/ STARX PRO-2 sensors (active area 26 x 34 mm) allow to acquire horizontal bitewing images.

The StarX-1, StarX-2, StarX PRO-1 and the StarX PRO-2 are digital intraoral sensors based on CMOS technology for intraoral X-Ray image acquisition of the human dental arch. The sensors are available in two sizes; in particular:
• StarX-1 / StarX PRO-1 sensors: active area 20 x 30 mm
• StarX-2 / StarX PRO-2 sensors: active area 26 x 34 mm
The differences between the sensors are the sizes and the different kind of scintillator (Cesium lodide - Csl and Gadolinium Oxysulfide - GOS).
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 are directly connected to the acquisition PC through the USB connection. Up to three sensors can be connected to one PC at time.
The type of X-ray systems that integrate with the sensors are wall-mounted Xray intraoral generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to be selected, which will control the exposure time.
The sensor is supplied with an acquisition (TWAIN) module to acquire images from the sensor via the USB. The user can further process these images via a patient management software to process, filter and modify images using a software such as the Oris Win DG software which is not part of this submission.
The device cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver only.
Before FONA sells this device, the team discuss the hardware and software requirements of the user to make sure that their systems are compatible with the FONA sensors.
FONA provides technical support for this device to ensure proper operation and to answer any questions regarding the functioning of the device. Contact details are provided to all end users and in the user manual.

This document describes the regulatory submission for the StarX-1, StarX-2, StarX PRO-1, and StarX PRO-2 intraoral digital X-ray sensors. The submission aims to establish substantial equivalence to a predicate device (Quick Ray HD, K151926).

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document primarily relies on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implied by the performance characteristics and regulatory compliance of the predicate device. The applicant aims to show that their device performs equivalently or better in relevant aspects.

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

The document mentions "Sample clinical images from the FONA device were evaluated." However, it does not specify the sample size for this clinical evaluation.

The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is FONA S.r.l. from Italy. The study appears to be a retrospective evaluation of images.

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

The document states: "Professional evaluation of imaging samples were found to be of good quality, high resolution, clinically acceptable and substantially equivalent to the predicate device."

• Number of experts: Not specified.
• Qualifications of experts: Only referred to as "Professional." No specific qualifications (e.g., "radiologist with 10 years of experience") are provided.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the evaluation of clinical images.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The evaluation method focused on the quality and acceptability of images from the new device rather than comparing human reader performance with and without AI assistance.

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

The device itself (StarX intraoral digital X-ray sensor) is an image acquisition component, not an AI algorithm for image analysis. Therefore, a "standalone algorithm performance" study as typically understood for AI-driven diagnostic tools would not be applicable in this context. The performance evaluated here relates to the imaging capabilities (resolution, grey levels, DQE, etc.) and clinical adequacy of the acquired images.

7. The Type of Ground Truth Used

The ground truth for the clinical evaluation was based on expert consensus regarding the "good quality, high resolution, clinically acceptable" nature of the images.

8. The Sample Size for the Training Set

The document does not mention any training set or associated sample size. This device is an image acquisition sensor, not an AI or machine learning model that would require a training set.

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

As no training set is mentioned (since this is an image acquisition device, not an AI model), this question is not applicable.

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