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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 iTempShield 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. iTempShield is intended for single use and for persons older than 5 years in healthcare facilities and home environments.

The iTempShield is a wearable device that senses body temperature and communicates with an app on a smartphone or tablet. When the iTempShield is connected to the device, it sends all temperature measurements automatically.

The iTempShield can be worn for up to 60 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 IDION account.

The temperature measurements are in degrees Fahrenheit (F).

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 IDION Shield 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 iTempShield is shipped in a shelf mode power condition (4uA) and can be on the shelf for 14 months before the battery is depleted below the 60-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 iTempShield. Each iTempShield 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 NFC read will wake up the iTempShield 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 iTempShield to collect previous data that was not collected from the iTempShield.

The Idion Application communicates with the Idion 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 Idion 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 will allow the user to view the UUID and will allow the user to replace the iTempShield 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 iTempShield (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 iTempShield requires that the user place medical grade silicone tape to hold the iTempShield in place. The iTempShield is provided with a patient user guide. The end user is expected to provide a mobile device (Android 10 or greater or iPhone SE or greater). The iPhone 6 and earlier will not work. The mobile device must have an NFC reader to fully operate.

Here's a summary of the acceptance criteria and the study information for the iTEMPSHIELD device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information:

1. Sample sizes used for the test set and the data provenance:

   • Usability / Summative Study: 45 participants.
     • Provenance: Not specified (e.g., country of origin).
     • Retrospective/Prospective: Not specified, but generally summative usability studies are prospective.
   • For other performance bench tests (Bluetooth Range, Disinfection Resistance, Operational Temperature, Battery Notification, Product Life/Accelerated Aging), specific sample sizes for the devices tested are not detailed in the provided information, but the results indicate testing was performed.
   • Biocompatibility testing involved in-vitro (cytotoxicity) and animal studies (sensitization, irritation) as per ISO standards. Specific animal numbers are not provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • The document does not mention the use of experts to establish "ground truth" in the context of diagnostic accuracy for the temperature measurements. The accuracy is assessed quantitatively against a known standard (laboratory and clinical accuracy per ISO 80601-2-56), not through expert interpretation of data points.
   • For the Summative Usability Study, the participants included "healthcare professionals, adult patient/caregivers, and adolescent patients." The number or specific qualifications of the healthcare professionals acting as experts is not specified.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified for this type of device and testing. The tests conducted are primarily quantitative performance measurements and usability assessments, not diagnostic evaluations requiring adjudication of subjective interpretations.

4. 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:

   • No MRMC comparative effectiveness study was mentioned. This device is a measurement tool (thermometer), not an AI diagnostic assistant for human readers.

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

   • Yes, standalone performance testing was conducted for various aspects of the device, including:
     • Laboratory Accuracy (per ISO 80601-2-56)
     • Electrical Safety (IEC 60601-1)
     • Electromagnetic Compatibility (IEC 60601-1-2)
     • Ingress Protection (IEC 60529)
     • Bluetooth Range Testing
     • Disinfection Resistance Testing
     • Operational Temperature Range Testing
     • Battery Notification Test
     • Product Life / Accelerated Aging Test
     • Software / Firmware Verification & Validation
     • Biocompatibility Testing (ISO 10993 series)
     • Wireless Testing (FCC Part 15 and Part 2)
     • Cybersecurity Testing
     • Coexistence Study

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

   • For accuracy, the ground truth is established against a recognized standard as defined by ISO 80601-2-56 for clinical thermometers, which typically involves comparing the device's readings to reference thermometers in controlled environments (laboratory accuracy) and or clinical settings (clinical accuracy).
   • For biocompatibility, the ground truth is the biological response based on established test methods and criteria defined by ISO 10993 standards.
   • For electrical safety, EMC, ingress protection, wireless, cybersecurity, the ground truth is compliance with the requirements and thresholds set forth by the respective international and national standards (e.g., IEC, FCC).

7. The sample size for the training set:

   • Not applicable. This document describes the performance testing for a hardware medical device (a clinical electronic thermometer) and its associated software, not a machine learning or AI model that requires a "training set" in the conventional sense. The software verification and validation are against specified requirements and functions, not learned from data.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no mention of a machine learning or AI model "training set."

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