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The DMD Digital X-ray is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

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I am sorry, but the provided text only contains an FDA clearance letter for a device called "DMD Digital X-Ray System" and its indications for use. It does not include acceptance criteria, study details, or performance data as requested in your prompt. Therefore, I cannot generate the specific information about acceptance criteria and study proving device performance based on the given input.

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The Apollo 95E produces visible light for the polymerization of dental materials and for tooth whitening.

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I apologize, but the provided text from the FDA 510(k) letter for the Apollo 95E device does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document is a clearance letter indicating that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device. It defines the "Indications For Use" for the Apollo 95E as producing visible light for the polymerization of dental materials and for tooth whitening.

However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study to prove the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Information on expert qualifications or adjudication methods.
• Whether MRMC or standalone performance studies were conducted.
• The type of ground truth used.

This type of information would typically be found in the 510(k) submission itself, which is a much more extensive document that includes details of testing and performance data. The letter provided is merely the FDA's decision based on that submission.

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Non diagnostic intraoral camera used by dentists to illuminate and magnify dental surfaces.

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The provided text is a 510(k) clearance letter from the FDA for a device named "Telicam," described as a "Non diagnostic intraoral camera used by dentists to illuminate and magnify dental surfaces." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain any information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, rather than a demonstration of meeting specific performance criteria through a study described within this document.

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