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The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to scan dental X-ray latent images contained in the intraoral imaging plate and then generate, browse, process and review the intraoral dental digital X-ray image.

The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to scan and process image data contained in the intraoral imaging plate. Once the intraoral imaging plate is inserted into the entrance of the scanner, the scanning program will be started to progressively scan the imaging plate, and move forward in the meantime to scan the imaging plate completely with the laser beam in a specified time. In the place where the laser is irradiated, blue fluorescence will be excited and the intensity of the fluorescence brightness is linearly related to the image data density at that point. The fluorescence will be collected by a high-efficiency photoconductor, which is positioned along the laser scanning line and then will be introduced into a photomultiplier tube, where it will be converted into a corresponding electrical signal. After the electrical signal is converted by A/D (analog/digital) converter in the electrical circuit, it can be used for digital image processing and then output to the image display, storage, or transmission communication system.

This Dental Image Plate Scanner, Model DFC-4T-SMART mainly consists of image plate scanner, power adapter, intraoral imaging plate and Dental image plate scanner control system software (Version: V1.0).

The image plate scanner is composed of lasers, optical scanners, photomultiplier tubes, amplifiers, A/D converters, image processing unit and output interfaces etc.

Dental image plate scanner control system software (DFC software) is mainly used to acquire and display the image data of the intraoral imaging plate as well as used for patient management, examination management, image storage, image printing etc. Dental image plate scanner control system software (Version: V1.0) is of Moderate level of concern.

The provided text describes a 510(k) premarket notification for a Dental Image Plate Scanner, Model DFC-4T-SMART. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria, particularly for an AI-powered device.

This document is a regulatory submission for a scanner, which converts X-ray latent images on an imaging plate into digital images. It is not an AI-powered device for image analysis or diagnosis. Therefore, the detailed requirements for AI device testing (like MRMC studies, expert consensus for ground truth, or specific performance metrics like sensitivity/specificity for disease detection) are not present or applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (another image plate scanner) based on technological characteristics and non-clinical bench testing to ensure safety and performance of the hardware and scanner functionalities.

Based on the provided text, I cannot fulfill your request as it pertains to acceptance criteria and study proving an AI device meets those criteria.

The document states:

• "No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the subject device to its predicate device." This explicitly states no clinical trials were done.
• The non-clinical testing listed focuses on electrical safety (IEC 60601-1, IEC 60601-1-2), laser safety (IEC 60825-1), photobiological safety (IEC 62471), risk analysis (ISO 14971), and software/cybersecurity guidelines. These are general safety and performance standards for a medical device, not specific performance metrics for an AI-driven diagnostic or analytical tool.
• The "Image Quality" metric is "≥12lp/mm" (line pairs per millimeter) and "Pixel Size" is "35μm". These are characteristics of the scanner's resolution, not performance metrics of an AI algorithm interpreting the image. MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) are also listed as image quality parameters of the scanner itself.

If you can provide a document for an AI-powered medical device, I would be able to answer your request.

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