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The Digital Clinical thermometers, Models ACT 3020's intended use are medical devices, supplied by internal power and intended to precisely measure human boduy temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.

Digital Clinical Thermometers, Models ACT 3020

The provided text is a 510(k) premarket notification letter from the FDA for a Digital Clinical Thermometer, Model ACT 3020. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, study designs, or performance metrics in the way that would typically be found in a clinical study report for AI/machine learning devices.

Therefore, many of the requested sections regarding AI/ML device performance and study specifics cannot be answered from this document.

Here's an attempt to extract relevant information and note what is not available in the provided text:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance meets established standards, but it does not specify those standards or directly report the device's measured performance against them.

2. Sample size used for the test set and the data provenance

This information is not provided. This document is a regulatory approval letter, not a study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided.

4. Adjudication method for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device is a "Digital Clinical Thermometer," which is a measurement device and not typically an AI/machine learning diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. Again, given the device type, this concept may not be applicable. The "standalone" performance here would refer to the thermometer's accuracy in measuring temperature.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a clinical thermometer, the "ground truth" would typically be a reference standard for temperature measurement. This information is not explicitly stated in the document, but it would have been part of the underlying testing to demonstrate accuracy and substantial equivalence.

8. The sample size for the training set

This information is not provided. This device is not an AI/machine learning product that would have a "training set" in the conventional sense.

9. How the ground truth for the training set was established

This information is not provided. As above, this concept is not applicable to this type of device.

Summary of what is available from the document:

• Device Name: Digital Clinical Thermometer, Model ACT 3020
• Manufacturer: Actherm, Incorporated
• Regulation Number: 880.2910
• Regulation Name: Clinical Electronic Thermometer
• Regulatory Class: II
• Product Code: FLL
• K Number: K021614
• Indications for Use: To precisely measure human body temperature. It can be used for oral, axillary, and rectal temperature measurement.
• Basis of Approval: Substantial equivalence to legally marketed predicate devices (specifically mentions K010238 for Actherm Digital Clinical Thermometers).

The document is a regulatory communication confirming that the device is substantially equivalent to existing devices and can be marketed. It does not delve into the specific technical details or study results that would demonstrate performance against detailed acceptance criteria.

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