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The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

Fever Scout Continuous Monitoring thermometer is an ambulatory continuous body temperature monitor designed for armpit location, and uses Bluetooth Low Energy (BLE) for wireless communication with the Smartphone app for temperature display, trending and alert. This product is composed of The Fever Scout VV-200 patch, The Smartphone app (supporting iOS), AAA charging system with BLE relay function, and Eight adhesives. The patch hardware primarily includes the following function modules: 1) temperature sensor, 2) control module, 3) Bluetooth Low Energy (BLE) communication module and 4) battery. All are integrated onto a flexible electronic printed circuit board. A MS Lithium rechargeable battery is attached to the board to supply 3.0V DC internal power. The app includes 1) User account, profile and alert temperature setup and 2) GUI for temperature display, trending and alerts. The charging system provides a cordless charging method to the patch, a storage to the replaceable double-sided adhesives, as well as an alternative BLE communication channel from the patch to the charger and then to the iPhone, in order to extend communication range. This product contains Type B applied part (per IEC 60601-1: 2012). All components, the patch, charger and adhesives are all user accessible parts. However, the user is only expected to change the charger AAA batteries, but not to open or modify any other parts of the product.

Here's a breakdown of the acceptance criteria and the study information for the "Fever Scout™ Continuous Monitoring thermometer," based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Acceptance Criteria and Performance: The document mainly uses the phrase "Equivalent" or "Identical" when comparing to predicates, and then states that the device "meets" or "conforms" to specific standards. The specific numerical acceptance criteria for the predicates (where available) are inferred here to represent the bar the Fever Scout had to meet for substantial equivalence.

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

• The document mentions "product verification, software verification, user/usability validation, biocompatibility test, mechanical hazards test, EMC test and IEC 60601-1 safety compliance test" as the performance data.
• Specific sample sizes for a clinical test set are not explicitly mentioned in this 510(k) summary. It refers to compliance with standards like ASTM E1112, which typically involve specific test methodologies and potentially human subjects for accuracy testing, but the number of subjects or samples is not provided here.
• Data Provenance: Not explicitly stated as retrospective or prospective for a specific clinical study related to accuracy with human subjects. The tests mentioned are performance and safety engineering tests. No country of origin for specific human subject data is provided.

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

• This information is not provided in the document. For a thermometer, "ground truth" for accuracy is typically established by comparing the device's readings to a highly accurate reference thermometer in a controlled environment or in vivo with a controlled reference method. Experts would likely be involved in designing and executing such tests, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set:

• This information is not provided as there is no mention of a traditional expert-adjudicated test set in the context of diagnostic performance (e.g., medical image interpretation). For a thermometer, accuracy is typically determined through direct comparison with a traceable reference, not through adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical cases with and without AI assistance. This device is a thermometer, and the evaluation focuses on its direct measurement accuracy and safety, rather than its impact on human reader performance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• Yes, a standalone performance was done for the thermometer's core function. The accuracy, measurement range, and operating conditions are assessed directly for the device itself, conforming to standards like ASTM E1112. The "algorithm" here is the temperature sensing and processing, and its output (temperature reading) is evaluated against reference standards. The device is intended for continuous monitoring and displays information via a smartphone app. Its performance is inherent to the device's measurement capabilities.

7. Type of Ground Truth Used:

• The ground truth for thermometer performance (e.g., accuracy) is typically established by comparing the device's measurements to that of a traceable reference thermometer or a recognized standard temperature source in a controlled laboratory setting, as defined by standards like ASTM E1112. For biocompatibility and electrical safety, the ground truth is adherence to the specified international standards (e.g., ISO 10993, IEC 60601-1).

8. Sample Size for the Training Set:

• This information is not applicable and not provided. The "Fever Scout™ Continuous Monitoring thermometer" is a sensor-based medical device, not an AI/ML diagnostic algorithm that requires a separate "training set" of data in the conventional sense. Its temperature sensing and processing are based on established physics and sensor technology, verified through engineering tests and adherence to standards.

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

• This information is not applicable and not provided for the same reason as point 8.

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