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The Wireless Thermometer, model WTM-B530-I, is a battery-operated elected electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and is intended for armpit temperature monitoring for persons over two years old.

The proposed device is use to measure, monitor and record the body temperature in armpit, and transmits the data recorded to receiver for display by wireless (blue tooth) way in real time.

The provided text describes a 510(k) submission for the Raiing Medical Company Wireless Thermometer, Model WTM-BT30-I. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with detailed acceptance criteria and performance data for the proposed device itself.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly define "acceptance criteria" for clinical performance in the context of a new study for the WTM-BT30-I, but rather implies meeting established standards through conformity to recognized performance standards.

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

The document does not describe a specific clinical test set and therefore does not provide information on its sample size or data provenance. The assessment is based on conformity to existing standards.

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

Not applicable, as no described clinical test set for the proposed device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no described clinical test set for the proposed device.

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

Not applicable. The device is a thermometer, not an AI-assisted diagnostic tool for human readers.

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

This refers to the performance of the device itself (the thermometer) independent of human interpretation. The claim is that the device "Conformed to ASTM E1112" for performance, which is a standard for electronic thermometers. This implies standalone performance testing against recognized accuracy standards, but the specific results are not detailed beyond conformity.

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

For the performance claim (conformity to ASTM E1112), the ground truth would be established by the reference measurement standards and methods defined within the ASTM E1112 standard itself for evaluating thermometer accuracy. This typically involves comparison to highly accurate reference thermometers in controlled environments.

8. The sample size for the training set

Not applicable. This device is a thermometer, not a machine learning model requiring a training set in the typical sense.

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

Not applicable.

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