(54 days)
The device is a diagnostic X-ray system, which is intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.
The device is a diagnostic X-ray system, which is intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors.
I am sorry, but the provided text from the FDA 510(k) clearance letter for the Remex-GR100 does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it describe an AI component.
The document is a standard FDA clearance letter for an extraoral X-ray system, confirming its substantial equivalence to predicate devices and outlining the regulatory requirements for the manufacturer. It specifies the device's indications for use: "intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects."
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.
To answer your questions, I would need a different document, such as a summary of the clinical or performance testing data submitted to the FDA for the device, or a specific study report.
§ 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.