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The AION TempShield™ is a battery powered wearable thermometer intended for continuous measurement of human body temperature on the upper chest via wireless communication to a smart device application. AION TempShield™ is intended for single-use and for persons aged 1 year and older in either healthcare facilities or home environments.

The AION TempShield™ is a wearable device that senses body temperature and communicates with an app on a smartphone or tablet or certified gateway device. When the AION TempShield™ is connected to the device, it sends all temperature measurements automatically. The AION TempShield™ can be worn for up to 90 days to check current temperature and to allow viewing of historical temperature measurements. The device has the ability to share the data with the clinician if the clinician has established an AION account. The temperature measurements are in degrees Fahrenheit (°F), but can also be configured to display in degrees Celsius (°C). Circuit board with Bluetooth and NFC (near field communication chip). A phone with NFC is used to turn on the device. The device communicates with a phone that has the AION TempShield app installed. The circuit card has two digital temperature sensors and a 32 MHz clock. The device is designed to have a minimum operating range of 10 meters and provides a 2 dBm signal to the radio. The AION TempShield™ is shipped in a shelf mode power condition (4uA) and can be on the shelf for 24 months before the battery is depleted below the 90-day threshold. The Bluetooth transmissions are encrypted using the on-board encryption. Each device has a random pairing code that must be typed in before the sensor and the mobile device can communicate. The modulation for the low energy Bluetooth is QFSK and the device has been certified and registered with the FCC for a class II device (at home use). The hospital use is covered under this classification. The smart phone application requires that the user allow for notifications, has access to location services, and enables both NFC and Bluetooth services to fully activate the AION TempShield™ Each AION TempShield™ has a unique serial number (UUID) and a random pin assigned. This information is accessible via a barcode on the outside of the package and from an NFC read (Similar to apple pay or google pay type of contact with the back of the phone. The NFC read will wake up the AION TempShield™ from deep sleep and initiate the pairing. Once the initial Bluetooth contact has been made the mobile application will present the 6-digit pairing number that the user must type in. Once this is done the mobile device will go into operational mode and send out temperature every five minutes. The Mobile app will look for temperature every five minutes with appropriate guard bands. Every 4hours the mobile application will request a full data offload from the AION TempShield™ to collect previous data that was not collected from the AION TempShield™. The AION TempShield Application communicates with the AION Core (Cloud monitoring service). This service will provide NIH recommendations for fever to the shield to provide indications (alerts)in the data for visualization for the User. There is no PHI stored in the AION cloud. The application has a home screen that displays the last read temperature. The application allows the user to put in activities, to view historical temperature history, and to select time windows to display data. For example: the application will allow the user to only view data for the past 12 hours. The total viewable data window is 48 hours. The application in the settings window will allow the user to view the UUID and will allow the user to replace the AION TempShield™ with another one. The Application will provide the user with the percentage of charge left in the device (battery life indication). When the battery life reaches 10% of charge left, the application will provide an alert that the user should get a new AION TempShield 100 (there will be approximately 1 week of continuous life available. At 5% life the notifications are once per two hours to replace the shield. The AION TempShield TM requires that the user place medical grade silicone tape to hold the AION TempShield™ in place. The AION TempShield™ is provided with a patient user guide. The end user is expected to provide a mobile device (Android 10 or greater or iOS 11 or greater). The iPhone 6 and earlier will not work. The mobile device must have an NFC reader to fully operate.

This document pertains to the AION TempShield™, a wearable clinical electronic thermometer.

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document indicates a "Usability" study which involved participants to verify accurate body temperature in different age groups. This might be considered a clinical test set.

• Sample Size (for Usability/Clinical test):
  • Original study: 137 participants (ages 5 years and older)
  • Addendum study: 39 participants (ages 1-4 years)
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the description of "clinical data" supports the expansion of the patient population, suggesting this was prospective clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document mentions "clinical accuracy testing to the IEC 80601-2-56" and "Usability" studies that "verified accurate body temperature," but it does not detail how the ground truth temperature was established (e.g., gold standard thermometer, multiple medical professionals) or the qualifications of evaluators, if any.

4. Adjudication method for the test set

This information is not provided in the document.

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

This is not applicable. The AION TempShield™ is a clinical electronic thermometer measuring body temperature, not an AI-assisted diagnostic imaging or decision support device that would involve "human readers" or "AI assistance" in the typical MRMC study context.

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

Yes, the device's accuracy and performance are evaluated in a standalone manner, independent of human interpretation or intervention for the core temperature measurement task. The clinical accuracy and performance bench testing described (e.g., ISO 80601-2-56) demonstrate the algorithm/device's ability to measure temperature. The device transmits measurements to an app, but the primary measurement is a standalone function.

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

For clinical accuracy testing, typically a gold standard reference thermometer (e.g., a highly accurate rectal thermometer or a calibrated laboratory reference standard) would be used to establish the ground truth for body temperature measurements following ISO 80601-2-56. While the document mentions "verified accurate body temperature" in the usability study, the specific method for establishing this "ground truth" is not detailed beyond conforming to the standard.

8. The sample size for the training set

This information is not provided in the document. The AION TempShield™ is a hardware-based thermometer with associated firmware/software, not an AI/ML model that typically undergoes a separate "training" phase with a large dataset in the sense of predictive algorithms. The software/firmware development involves verification and validation, but not "training data" in the AI/ML context.

9. How the ground truth for the training set was established

This information is not provided for the reasons mentioned above (not an AI/ML model requiring a training set in that context).

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The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.

The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated.

The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:

• · Pulse rate
• · Oxygen saturation
• · Temperature
• · Movement

The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of.

• · Respiration rate
• · Non-invasive blood pressure
• · Lung function & spirometry
• · Weight

The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.

The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.

The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with devices for monitoring of blood pressure, spirometry & lung function, and weight.

The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP), spirometry & lung function, and weight (WEIGHT).

While the wearable device monitors skin temperature, an additional adhesive axillary sensor can be used to monitor axillary temperature.

In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.g. an office or within the hospital or could be with the patient in their own home.

The provided document does not contain detailed acceptance criteria or the specific study details for validating the device's performance against such criteria. Instead, it lists various "Test Names" and "Test Descriptions" which broadly indicate areas of testing (e.g., electrical safety, EMC, pulse rate testing, SpO2 testing, respiration rate testing, temperature measurement accuracy). However, it does not specify quantitative acceptance thresholds for these performance metrics, nor does it provide the reported device performance in those quantitative terms.

For example, for "Pulse Rate Testing," the description mentions "Validation of the accuracy of pulse rate monitoring of the system in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff. 2007." While this indicates the standards followed, it doesn't state what specific accuracy (e.g., within X beats per minute) was achieved or was the acceptance criterion. The "Results" column consistently states "Passed," but without the specific acceptance criteria, it's impossible to determine the benchmark used for passing.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an attempt to answer based on the absence of the requested information:

1. A table of acceptance criteria and the reported device performance:

   Performance Metric	Acceptance Criteria	Reported Device Performance
   Electrical Safety	Unspecified; adherence to IEC 60601-1	"Passed"
   EMC	Unspecified; adherence to IEC 60601-1-2	"Passed"
   Alarm Testing	Unspecified; adherence to IEC 60601-1-8	"Passed"
   Pulse Rate Accuracy	Unspecified; adherence to ISO 80601-2-61 and FDA Guidance 2007	"Passed"
   SpO2 Accuracy	Unspecified; adherence to ISO80601-2-61 and FDA Guidance 2013	"Passed"
   Respiration Rate Accuracy	Unspecified; comparison to end-tidal CO2	"Passed"
   Temperature Measurement Accuracy	Unspecified; adherence to ISO 80601-2-56	"Passed"
   Battery Life	Unspecified	"Passed"
   PDU Buffering Time	Unspecified	"Passed"
   Usability	Unspecified; adherence to IEC 62366 and IEC 60601-1-11	"Passed"
   Device Ship/Transport	Unspecified; adherence to ASTM D4169	"Passed"
   Biocompatibility	Unspecified; adherence to ISO 10993-1	"Passed"
   Wireless Coexistence	Unspecified	"Passed"
   System V&V	Unspecified	"Passed"
   Software V&V	Unspecified	"Passed"

2. Sample size used for the test set and the data provenance: This information is not provided in the document. The document states "No clinical studies were conducted as part of submission to prove substantial equivalence." The non-clinical tests mention "the system was tested," but do not specify sample sizes for these tests (e.g., how many subjects for pulse rate and SpO2 accuracy, or how many devices for other tests).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.

4. Adjudication method for the test set: This information is not provided.

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: This information is not provided. The device is a "Wearable Health Monitoring System" and the testing described is primarily about the accuracy of its vital sign measurements and compliance with various standards, rather than evaluating AI assistance for human readers in a diagnostic capacity.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes various "non-clinical tests" and "software verification and validation testing" which would fall under standalone performance. However, specific performance metrics quantifying the algorithm's output (e.g., sensitivity, specificity, accuracy %) against a ground truth are not provided. The results are merely "Passed" for general compliance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physiological parameters, the ground truth would typically be established by a reference method. The document mentions "in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff" for pulse rate and SpO2, and "comparison to respiration rate measured via end-tidal CO2" for respiration rate. These represent established reference methods for ground truth, but the details of their application in the study (e.g., specific devices used for reference, blinded measurements) are not given. For other tests like electrical safety or EMC, the ground truth is adherence to the specified standard.

8. The sample size for the training set: This information is not provided. The document does not discuss a training set, as it mainly focuses on verification and validation testing rather than the development of AI/ML models that would require training data.

9. How the ground truth for the training set was established: This information is not provided, as a training set is not discussed.

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