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The devices models FT-100A FT-100D FT-100E are electronic clinical thermometer intended to measure human body temperature in people of all ages, its operation is based on measuring the natural thermal radiation emanating from the forehead.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for an infra-red forehead thermometer. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the text does not contain any information about:

• Acceptance criteria and reported device performance.
• The study that proves the device meets the acceptance criteria.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

This document is a regulatory approval letter based on equivalence, not a detailed study report. Therefore, I cannot generate the requested information based on the provided text.

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