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The intraoral camera system, Opti, of CamSight Co., Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.

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The provided text is a 510(k) premarket notification letter from the FDA to CamSight Company, Incorporated, regarding their device "Opti," an intraoral camera system.

Based on the content of this document, none of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment can be provided.

This letter is an approval letter stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not contain any details about performance criteria, specific clinical studies, or technical evaluations that would typically be found in a study report or a more detailed submission.

Therefore, I cannot populate the table or answer the specific questions because the document does not contain any of the requested information about device performance or the studies used to demonstrate it.

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The CDMx-H is intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structure by using scanned dental x-ray images sent through the digital x-ray sensor.

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The provided document is a 510(k) clearance letter from the FDA for a device named CDMx-H. It states that the device is "substantially equivalent" to legally marketed predicate devices. Unfortunately, this document does not contain the specific acceptance criteria, performance data, or details about the studies conducted to demonstrate its performance.

The FDA 510(k) clearance process primarily focuses on substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or if the technological characteristics are different, that the differences do not raise new questions of safety and effectiveness and that the device is as safe and effective as the predicate device. It does not typically require the submission of detailed performance studies in the same way a PMA (Premarket Approval) might.

Therefore,Based on the provided text, I cannot extract the information required to populate the table and answer your questions directly. The document is solely an FDA clearance letter and does not include the details of the studies conducted to establish the device's performance against specific acceptance criteria.

To answer your request, I would need access to the actual 510(k) summary or the full submission document, which would detail the testing and performance data.

Ask a specific question about this device

Ask a specific question about this device