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

The VivaLnk Fever Scout VV-200 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. The product is composed of The Fever Scout VV-200 patch, The Smartphone app (supporting Apple iOS and Android devices), AAA charging system with BLE relay function, Eight disposable adhesives.

The provided text describes the regulatory filing for a medical device, the Fever Scout Continuous Monitoring Thermometer (K181013), and its substantial equivalence to previously marketed predicate devices. The study detailed focuses on expanding the indications for use, particularly to include single-patient use in hospitals, rather than on proving new performance characteristics of the device itself.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

I. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Fever Scout™ Continuous Monitoring Thermometer are primarily based on its equivalence to existing predicate devices, particularly regarding its technical characteristics and compliance with recognized standards. Since the K181013 submission is for expanded indications for use (adding single-patient use in hospitals) for an identical product (VV-200) that was previously cleared (K162137), the performance acceptance criteria are implicitly those that the original predicate device met, and this submission seeks to demonstrate that the expanded use does not introduce new risks or alter its fundamental performance.

The table below summarizes the technical characteristics that serve as de facto "acceptance criteria" through comparison with predicates, along with the reported performance of the proposed device. The "Performance" section within the document refers to compliance with standards, indicating that meeting these standards serves as the primary proof of performance.

Table 1: Acceptance Criteria (Based on Predicate Equivalence) and Reported Device Performance

II. Study Details for Proving Acceptance Criteria

The document does not detail a new clinical study with a test set, expert readers, or ground truth establishment in the traditional sense of an AI model performance study. Instead, the proof of meeting acceptance criteria for this K181013 submission relies on:

1. Demonstrating Substantial Equivalence: The primary method is to show that the proposed device (with expanded indications) is identical to a previously cleared predicate (K162137) for home use and comparable to a secondary predicate (K160306) for institutional use.
2. Compliance with Recognized Consensus Standards: The document explicitly states that the device "Conformed to" or "Complied with" various international and ASTM standards (ISO 10993 series for biocompatibility, IEC 60601-1 for electrical safety and electromagnetic compatibility, and ASTM E1112 for performance of clinical thermometers). Adherence to these standards is considered sufficient evidence of safety and basic performance.
3. Risk Management for Expanded Use: For the expanded "single patient use in the hospital," the submission addresses potential new risks (specifically cross-contamination) through a "Fever Scout Risk Management Report" and proposed procedural controls (labeling and IFU precautions). This is a mitigation strategy rather than a performance study.

Given this context, many of the requested details for a typical AI model study are not applicable or explicitly stated in this regulatory submission document.

• Sample size used for the test set and data provenance: Not explicitly detailed as a separate clinical test set for performance validation in this submission. The validation is through comparison to predicates and compliance with standards. If a test set was used for the original predicate's clearance (K162137) to meet ASTM E1112, those details are not provided here.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical thermometer performance is typically established through a known temperature reference (e.g., black body calibrators for laboratory accuracy tests, or controlled clinical studies comparing to a gold standard thermometer), as part of compliance with standards like ASTM E1112. The document doesn't describe the expert consensus process for a test dataset.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 a thermometer, not an AI diagnostic tool primarily assisting human readers.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is "standalone" in continuously measuring temperature. Its performance is measured against established accuracy standards (ASTM E1112), not comparative human interpretation.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For thermometer performance, the ground truth is typically a highly accurate reference thermometer or a controlled temperature environment, as per standards like ASTM E1112. The document doesn't detail how ground truth was established for a specific "test set" in this submission.
• The sample size for the training set: Not applicable. This is not an AI model that undergoes a "training" phase with a dataset.
• How the ground truth for the training set was established: Not applicable.

In summary, the device's acceptance is based on its demonstrated substantial equivalence to predicate devices and its compliance with relevant performance and safety consensus standards, rather than a new, extensive clinical study detailing specific test sets, expert ground truth, or MRMC analyses. The expansion of indications for hospital use is addressed through a risk management approach for cross-contamination.

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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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