(196 days)
The FONA Pan/Ceph device, comprising models FONA XPan DG Plus, FONA ART Plus, and FONA ART Plus C, is an extraoral source dental X-ray system intended to perform panoramic or cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images.
The FONA Pan/Ceph device is an X-ray equipment designed for:
- Dental panoramic radiography
- Cephalometry, when completed with lateral Ceph arm. .
The FONA Pan/Ceph device comprises four models: - FONA XPan DG and FONA XPan DG Plus, with CCD type of image receptor with CsI scintillator
- FONA ART Plus, FONA ART Plus C, with CMOS type of image receptor with Cd(Zn)Te scintillator. ●
All the models allow for panoramic projections and two of them are extended with cephalometric functionality: - . The models FONA XPan DG and FONA ART Plus feature panoramic projections only (type Pan Solo) and are thus equipped with a fixed image receptor mounted on the rotating arm.
- The models FONA XPan DG Plus and FONA ART Plus C feature panoramic and cephalometric projections ● (type Pan Ceph) and are equipped with a detachable image receptor to be placed on the rotating arm, for the panoramic modality, or on the cephalometric arm, for the cephalometric modality.
The control panel on the unit contains keys and signaling lights for 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, in case, temple supports.
The user controls the exposure using a manual hand-switch, implementing the dead man functionality.
An Ethernet connection cable allows the FONA Pan/Ceph device to interface with a computer for image acquisition, processing and storage.
The user may thus view and store the radiographic images using a software installed on a side computer with peripheral components such as a mouse, keyboard, and monitor. The software takes care of acquisition, processing, displaying, and archiving the image data.
A TWAIN interface is also available for interfacing to other existing programs with processing and storage capabilities, according to the user's needs.
The provided text is a 510(k) summary for the FONA Pan/Ceph dental X-ray system. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the specific information required to answer your request about acceptance criteria and a study proving fulfillment of those criteria for an AI device.
Here's why and what information is missing:
- No AI component mentioned: The document describes a traditional X-ray imaging device (panoramic and cephalometric). It does not mention any artificial intelligence (AI) component, algorithm, or software that performs automated diagnostic tasks.
- Focus on device performance, not AI diagnostic performance: The "performance characteristics" and "non-clinical performance testing" refer to physical qualities of the X-ray system (e.g., voltage, current, exposure time, electrical safety, electromagnetic compatibility, image quality in terms of signal-to-noise ratio, DQE, MTF), not the diagnostic accuracy of an AI algorithm interpreting images.
- Predicate device comparison, not AI clinical study: The purpose of this 510(k) is to demonstrate "substantial equivalence" to existing X-ray systems, not to prove the diagnostic performance of an AI application.
Therefore, I cannot provide the requested table or details because the document does not describe an AI medical device or a study assessing its diagnostic performance.
To answer your request, I would need a 510(k) summary or a scientific publication that explicitly details an AI algorithm's diagnostic performance, its acceptance criteria, and the study methodologies used to validate it, including information on:
- Acceptance Criteria for AI Performance: Specific metrics (e.g., sensitivity, specificity, AUC, F1-score) and their target thresholds.
- Reported Device Performance: The actual values achieved by the AI device for those metrics.
- Sample Size and Data Provenance: Details about the test set used for validation.
- Ground Truth Experts: How many experts, their qualifications, and their role in establishing the ground truth.
- Adjudication Method: How disagreements among experts were resolved.
- MRMC Study: If human readers with and without AI assistance were compared, and the effect size.
- Standalone Performance: If the algorithm's performance without human intervention was assessed.
- Type of Ground Truth: Whether pathology, expert consensus, or outcome data was used.
- Training Set Sample Size: The number of cases used to train the AI model.
- Training Set Ground Truth: How the ground truth for the training data was established.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.