(69 days)
INTRASKAN DC PLUS is High Frequency extra oral X Ray source to be used for Intra-Oral X-Ray in Dental radiography for diagnostic purpose.
INTRASKAN DC PLUS is High Frequency extra oral X Ray source to be used for Intra-Oral X-Ray in Dental radiography for diagnostic purpose. The system houses two microprocessors, one for control / supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output. The Intra Oral X-ray does not have provision to connect to wireless networks or LAN.
This document is a 510(k) summary for the INTRASKAN DC PLUS, an extraoral X-ray system for dental radiography. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (INTRASKAN DC).
However, this document does not contain information about the acceptance criteria and the study that proves the device meets those acceptance criteria in the way described in the prompt.
The prompt is asking for information typically found in clinical performance studies of diagnostic devices, especially those using AI. The INTRASKAN DC PLUS is a traditional X-ray hardware device, and its approval focuses on electrical, mechanical, environmental safety, and performance as an X-ray source, not on diagnostic accuracy of an AI algorithm.
Therefore, I cannot provide the requested table and details for the following reasons:
- No acceptance criteria for diagnostic performance: The document confirms compliance with safety and performance standards relevant to X-ray hardware (e.g., UL/IEC 60601 series, FDA 21 CFR 1020.30/31). It does not list specific diagnostic performance metrics (like sensitivity, specificity, AUC) that would be relevant for an AI-powered diagnostic device.
- No diagnostic performance study: The document refers to "Performance testing performed according to FDA 21 CFR 1020.30, 21CFR1020.31 standards, Design Requirement specification, verification & validation plans." These are related to the physics and engineering performance of the X-ray tube and system (e.g., radiation output accuracy, reproducibility, image quality characteristics inherent to the X-ray source), not to the diagnostic accuracy of interpreting images or an AI's ability to locate a disease.
- No AI component: The device description clearly states: "The Intra Oral X-ray does not have provision to connect to wireless networks or LAN." This indicates it's a standalone X-ray generator, not an AI-assisted diagnostic tool.
In summary, the provided document does not contain the type of information requested about acceptance criteria and a study proving diagnostic performance, as it pertains to an X-ray hardware device and not an AI-driven diagnostic system.
§ 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.