(63 days)
The Explor X 70 AP TIME X (the Explor X 70 with the AP TIME X timer) is intended for the dental radiologic application examination and diagnosis of deseases related to the single use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment.
Explor-X 70 with AP Time X timer
This appears to be a 510(k) summary for a dental X-ray device, the Explor-X 70 with an AP Time X timer. However, the provided text does NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document only covers:
- Identification of the applicant and contact information.
- Trade name, common name, and classification (Class II for 21 CFR 872.1800).
- A declaration of substantial equivalence to a predicate device (Explor-X 70 with Diamatic AP timer).
- An FDA letter confirming the 510(k) clearance based on substantial equivalence.
- Indications for Use: "for the dental radiology application examination and diagnosis of diseases related to the single use of an extra oral source x-ray system commonly referred to as intraoral x-ray equipment."
To answer your request, information regarding acceptance criteria and performance studies must be present in the document. As it stands, I cannot complete the requested tables and descriptions.
Therefore, I cannot provide the requested information because the provided text does not contain the necessary details about acceptance criteria or performance study results.
§ 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.