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Electronic Thermometer is intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home.

The proposed device, Electronic Thermometer, is a handheld device with battery power supply, intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home. There is no specific use of this device other than temperature measurements, including conversion of temperatures. The proposed device is available in two models, which are WT1 and WT2. Similarities between models: a. Both of them incorporate a temperature sensitive sensor b. Both of them can measure and monitor human body temperature under arm; C. Neither the WT1 nor WT2 has display function, the measured or monitored temperature will be transmitted to a mobile application, Temp Sitter, installed under iOS system via the blue tooth to display the measured and monitored temperature; Differences between models: a. WT1 has an automatic power on/off feature; b. WT1 can be used with an adhesive tape, which could be fix the thermometer under arm for measuring and monitoring; c. WT2 can be used with a designated probe cover; d. WT2 can be used for measurement of oral temperature.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Electronic Thermometer (Models WT1 and WT2), formatted as requested.

Electronic Thermometer (Models WT1 and WT2)

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the acceptance criteria are generally established by compliance with recognized standards and the reported performance is directly stated in the comparison table.

Notes on Acceptance Criteria: The document primarily relies on non-clinical testing against recognized national and international standards (ISO, IEC) to demonstrate substantial equivalence. The detailed accuracy claims are a performance specification that needs to be verified by testing.

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no information about:

• Sample size used for the test set.
• Data provenance (e.g., country of origin, retrospective or prospective).

The "test set" in this context refers to non-clinical tests (e.g., biocompatibility testing, electrical safety testing, EMC testing), which are performed on device samples, not human participants or clinical data. The precise number of device units or samples used for each non-clinical test (e.g., for biocompatibility or electrical safety) is not specified in this summary.

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

Not applicable as no clinical studies were performed, and thus no clinical ground truth was established by experts for a test set. Non-clinical tests establish "ground truth" based on standard protocols, calibrated equipment, and laboratory measurements.

4. Adjudication Method for the Test Set

Not applicable as no clinical studies were performed. Adjudication methods are typically employed in clinical trials or studies where human readers/experts independently assess cases, and a process is needed to resolve discrepancies.

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. This device is an electronic thermometer, not an AI-assisted diagnostic tool involving human readers or interpretation of medical images/data. Therefore, an MRMC study is not relevant to this device.

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

The device itself is a standalone electronic thermometer. The performance described (accuracy, precision, response time) is for the device operating independently to measure temperature. There isn't an "algorithm" in the sense of AI or image processing, but the device's measurement functionality itself operates in a standalone manner to generate a temperature reading. The companion mobile application "Temp Sitter" serves for display and potentially trend monitoring, but the temperature measurement occurs directly by the physical device. The compliance with standards like ISO 80601-2-56 reflects this standalone performance.

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

For the non-clinical tests that were performed:

• Accuracy and Response Time: Ground truth would be established using calibrated reference thermometers and temperature sources as per the methodologies outlined in ISO 80601-2-56 or similar standards.
• Biocompatibility: Ground truth is established by laboratory testing results (e.g., cell viability assays for cytotoxicity, skin patch tests for sensitization, observation of tissue reactions for irritation) against specified limits.
• Electrical Safety and EMC: Ground truth is established by laboratory measurements taken by specialized equipment as per the IEC standards.

8. The Sample Size for the Training Set

Not applicable as no AI or machine learning algorithm requiring a "training set" is mentioned or implied for this device.

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

Not applicable, as no training set was used.

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