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Indicated use- Measure of individual temperature
Measurements- Oral, Axillary -under arm, Rectal
Range of measurement- 90.0° - 108.0° F (32.0° - 42.0° C)
Accuracy- +/-0.2° F
Targeted population- Individuals requiring temperature measurements
Environment of use- Hospital and home
Disposable / reusable- Reusable, clean with alcohol

The intended product is an electronic digital thermometer for measuring patient temperature.

The provided document is a 510(k) premarket notification for the Global Treasure Industries GT980201 Electronic Thermometer. It details the device's characteristics and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GT980201 are primarily established by its claim of substantial equivalence to the predicate device (Wiltec Industries Ltd - K961879) and its compliance with the ASTM E1112 standard.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the sample size used for a specific test set or the data provenance (country of origin, retrospective/prospective). The primary evidence for meeting acceptance criteria is through comparison to a predicate device and compliance with ASTM E1112. This implies that the testing to meet these standards would have been performed, but the specifics of that testing (sample size, data origin) are not described in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document does not mention the use of experts to establish ground truth for a test set in the context of device performance. The device is a clinical electronic thermometer, and its performance is typically assessed against established metrology standards (like ASTM E1112) or by comparison to reference thermometers, rather than expert consensus on a test set in the way one might evaluate diagnostic imaging.

4. Adjudication Method for the Test Set

As explained above, the document does not describe a test set with human assessment of ground truth, and therefore, an adjudication method is not applicable or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices where human interpretation is crucial. For a digital thermometer, the performance is objective (e.g., accuracy of temperature reading).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

For the GT980201 Electronic Thermometer, the device itself is a "standalone" system in its function. Its performance, such as temperature range, accuracy, and response time, would have been evaluated without human intervention during the measurement process, aside from operating the device. However, the term "standalone" in this context usually refers to AI algorithms. Since this is not an AI-powered device, this question is not directly applicable in the way it's usually posed for AI. The performance metrics listed (e.g., accuracy, response time) are intrinsic to the device's function.

7. The Type of Ground Truth Used

The ground truth for this device's performance would primarily be established by:

• Reference Standards: Measurements would be compared against highly accurate, calibrated reference thermometers in controlled environments.
• Compliance with Industry Standards: The device's ability to meet the requirements of ASTM E1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) serves as a primary form of ground truth for its performance characteristics, especially accuracy.

8. The Sample Size for the Training Set

This document does not describe a "training set" in the context of machine learning or AI. The GT980201 is a traditional electronic thermometer, not an AI-driven device.

9. How the Ground Truth for the Training Set Was Established

As there is no training set mentioned for an AI/ML algorithm, this question is not applicable.

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