(120 days)
The CS 8100SC and the CS 8100SC Access are intended to produce complete or segmented tomographic digital panoramic and cephalometric digital X-ray images to be used at the direction of healthcare professionals of the dentomaxillofacial region of the human anatomy as diagnostic support for pediatric and adult patients. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.
In addition, the CS 8100SC is provided with the panoramic radiological exam option which allows the display of one determined segment of the dental structures using the capability of the system to explore each slice during an exam.
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This document is a 510(k) summary for the CS 8100SC and CS 8100SC Access dental X-ray systems. It primarily describes the FDA's substantial equivalence determination and the indicated uses of the device.
Unfortunately, the provided document does not contain the requested information about acceptance criteria, specific study details, sample sizes for test or training sets, expert qualifications, or ground truth establishment. This type of detailed performance testing data for novel algorithms or specific diagnostic claims is typically found within the 510(k) submission, not in the FDA's decision letter or "Indications for Use" statement.
The document states that the devices are "intended to produce complete or segmented tomographic digital panoramic and cephalometric digital X-ray images... as diagnostic support... This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment." This indicates the general purpose, but not the quantitative performance metrics or the studies proving those metrics.
To answer your questions, the relevant information would need to be extracted from the full 510(k) submission, specifically the sections detailing performance testing and clinical evaluations, which are not included in this extract.
§ 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.