Search Results

For intermittent measurement of body temperature in patients of all ages in home environment

Not Found

The provided document is a 510(k) clearance letter from the FDA for a clinical electronic thermometer. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The document states that the device is a "NPAC Multi-Use Ear Thermometer, Models TP 700, TP 702" and its indications for use are "For intermittent measurement of body temperature in patients of all ages in home environment."

To answer the questions about acceptance criteria and a study, one would typically need access to the 510(k) submission document itself, which would detail the performance data and the comparison to a predicate device. This letter only confirms that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, none of the requested information (acceptance criteria table, sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set size, or ground truth establishment for training set) can be extracted from the provided text.

Ask a specific question about this device