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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.

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