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THESE DENTAL CHAIRS ARE USED SO THAT THE PATIENTS AT THE DENTIST OFFICE MAY SIT ON THEM WHILE THE DENTIST IS PERFORMING ROUTINE DENTAL EXAMS. THESE CHAIRS DO NOT HAVE ANY INSTRUMENTS THAT MAY BE USED ON THE PATIENT.

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I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for dental chairs, and it primarily discusses the regulatory approval process and legal compliance rather than detailed performance study results.

The document mentions:

• Device Name: Optima Plus "E" Dental Chair, "A" Dental Chair, Excel Chair
• Indications For Use: "THESE DENTAL CHAIRS ARE USED SO THAT THE PATIENTS AT THE DENTIST OFFICE MAY SIT ON THEM WHILE THE DENTIST IS PERFORMING ROUTINE DENTAL EXAMS. THESE CHAIRS DO NOT HAVE ANY INSTRUMENTS THAT MAY BE USED ON THE PATIENT."
• Regulatory Class: I
• Product Code: KLC

However, it does not provide any of the specific study details you requested, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

This type of information would typically be found in a detailed premarket submission summary or a separate clinical/performance study report, not in the FDA clearance letter itself.

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