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This device is an electronic clinical thermometer) to measure and monitor body temperature from auditory canal for people of all ages in a home set environment.

The Swaive Thermometer SWT1A is a hand-held, battery-powered electronic thermometer which uses an infrared sensor to detect body temperature from the auditory canal. It is an infrared ear thermometer with disposable probe cover. It measures the thermal infrared radiation emitted from the tympanic membrane and the surrounding tissue by the sensor inside the probe. The electronic signal of sensor is amplified, calculated, converted into temperature value, and then displayed on LED board by the electronic circuit inside. It only takes a few seconds for the whole measurement process. Besides the temperature measurement circuit, a Bluetooth circuit is embedded in SWT1A to transmit the temperature value to smart phone via the specified App "Swaive Thermometer". This App only stores the temperature value on the smart phone if needed and has no clinical intention. SWT1A is a stand-alone device. It measures ear temperature and displays on its LED display with or without connecting with smart phone.

The provided text is a 510(k) summary for the Swaive Thermometer, Model SWT1A. It details the device's characteristics, its comparison to a predicate device, and the non-clinical and clinical testing performed to demonstrate substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Swaive Thermometer are primarily based on established industry standards, specifically ASTM E1965-98:2016 for infrared thermometers. The performance is assessed against the requirements of this standard.

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

• Sample Size for Clinical Test Set: 165 subjects.
  • This was divided into three age groups:
    • Infant (newborn to 1 year): More than 30 subjects
    • Children (greater than 1 to 5 years old): More than 30 subjects
    • Greater than 5 years old: More than 30 subjects
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. It implies a single, controlled human clinical study. The document does not specify if it was retrospective or prospective, but clinical studies for device clearance are typically prospective.

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

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the clinical test set. In the context of clinical thermometer testing according to ASTM E1965, the ground truth is typically established by comparative measurements against a highly accurate reference thermometer (e.g., a rectal thermometer) under controlled clinical conditions, rather than expert judgment or interpretation of images. The standard itself outlines the methodology for establishing this ground truth.

4. Adjudication Method (for the test set)

The document does not describe an adjudication method for the test set. For clinical thermometers, the "ground truth" is typically a direct physiological measurement by a highly accurate reference method, not a subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable to the Swaive Thermometer. This device is a standalone clinical thermometer for measuring body temperature, not an AI-assisted diagnostic imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or would be relevant.

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

The device is inherently a standalone measurement device. The clinical testing described evaluates the device's performance in taking temperature measurements against a referent standard, which is effectively its "standalone" performance. The Bluetooth connectivity is for data transmission to a smartphone app, but the app "only stores the temperature value... and has no clinical intention," meaning it does not alter the core measurement performance or involve an algorithm with "human-in-the-loop" interaction in the diagnostic sense. So, yes, the study assessed its standalone performance.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established through comparative physiological measurements against an accepted reference method, as prescribed by ASTM E1965-98:2016. This standard details how to simulate "body temperature" or directly compare the device's readings to established core body temperature measurements in a clinical setting to assess accuracy. It is not expert consensus, pathology, or outcomes data in the typical sense of AI/imaging devices.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This is a medical device (thermometer) that performs direct physical measurement based on infrared sensing, not a machine learning or AI model that typically requires a large training dataset. The device's calibration and internal algorithms are based on fundamental physics and engineering principles, validated through non-clinical and clinical testing, rather than being "trained" on a dataset in the AI sense.

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

Since there is no "training set" in the context of an AI/ML model for this device, this question is not applicable. The device's accuracy is a function of its hardware design, calibration, and firmware, all of which are verified against standards rather than being "trained" on a specific dataset.

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