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This device is an electronic clinical thermometer using a themistor probe sensor to detect oral, rectal or axillary temperatures. It is intended for home use on people of all ages.

The 9 second Digital Thermometer is designed to measure body temperature. The device is measuring oral, rectal or axillary temperatures by change of resistance in a thermistor located in the tip of the device. When the probe, particular the metal tip is in contact with the body, the thermistor in the probe will generate equivalent electrical resistance, which will be processed by a micro computer chip in the circuitry and then displayed.

This document describes a 510(k) submission for the 9 second Digital Thermometer, Model BT-S09 by Media Trade Corporation. The submission declares substantial equivalence to the predicate device, Microlife MT3001 (QTIJA).

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy +/- X degrees, sensitivity, specificity). Instead, the basis for clearance is substantial equivalence to a predicate device.

The document states:

• "The 9 second Digital Thermometer has the same general design and performance characteristics as the predicate device from Microlife."
• "The main difference is the physical size, shape and weight."
• "The 9 second Digital Thermometer has the same intended use, general design and incorporates similar materials and components, hence should therefore raise no new questions of safety and effectiveness."

Therefore, the "acceptance criteria" can be inferred as meeting the performance (accuracy/precision) of the predicate device, although no specific values are given in this document.

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

The provided 510(k) summary does not contain details of any clinical or in-vivo testing to demonstrate performance specifically for the 9 second Digital Thermometer. The entire argument rests on technological characteristics and substantial equivalence to the predicate device. Therefore, there is no mention of a "test set" sample size or data provenance.

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

As no specific clinical or performance study details are provided, there is no information on the number or qualifications of experts used to establish ground truth.

4. Adjudication method for the test set:

Since no specific study with a test set is described, no adjudication method is mentioned.

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 device is a digital thermometer, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed/described.

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

This is a standalone electronic thermometer. The "study" described is a comparison of the device's technical characteristics to a predicate device for the purpose of demonstrating substantial equivalence. The document states:

• "The 9 second Digital Thermometer has the same Technological Characteristics: general design and performance characteristics as the predicate device from Microlife. The main difference is the physical size, shape and weight."
• "This submitter concludes that the 9 second Digital Thermometer is therefore substantially equivalent to the predicate device 'Microlife MT3001 (QT1JA1)'."

This constitutes the "study" or evidence presented for clearance, focusing on direct comparison of design and intended use rather than specific performance data against a ground truth.

7. The type of ground truth used:

Given the nature of the device and the submission (substantial equivalence based on technological characteristics), no specific "ground truth" in the traditional sense (e.g., pathology, outcomes data, expert consensus on disease presence) is mentioned or used. The ground truth, implicitly, is the established, legally marketed performance of the predicate device.

8. The sample size for the training set:

As this is not an AI/machine learning device, the concept of a "training set" is not applicable and no information is provided.

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

Not applicable, as no training set exists for this device.

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