(245 days)
Aulisa Temperature Module (TM0002) is a battery-operated electronic device with indication for use in continuously measuring and monitoring armpit body temperature of adults, pediatrics, and infants and transmission of the measuring result via wireless signal. Aulisa Temperature Module (TM0002) is a non-invasive and reusable device for single patient use with intended environments of use are hospitals, medical facilities, home care, and subacute environments. The parameters derived by the Aulisa Temperature Module (TM0002) are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.
The Aulisa Temperature Module (TM0002) is indicated for continuous armpit body temperature monitoring of adults, pediatrics, and infants which measures body temperature and sends the physiological data to an Aulisa-developed software application as cleared through previous Premarket Notification 510(k) submissions under Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (K203208) using Bluetooth technology. If the physiological data sent from the subject device to the software application falls outside of pre-set limits or when a technical error is detected, both auditory and visual alarm signals are generated through the software application to alert the caregiver. The sensor module uses Bluetooth technology to interact with a commercial, thirdparty mobile device whether under iOS or Android operating system, such as iPad, iPhone, Google Pixel ... etc. which is not part of this submission. The vital-signs are transmitted to mentioned mobile device that runs Aulisa-developed application for display and review. The software application can be downloaded from an official APP store, such as iOS APP store or Google Play. The Subject Device is reusable, and its intended environments of use are hospitals, medical facilities, home care, and subacute environments.
Here's an analysis of the provided information regarding the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Standard/Requirement) | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1, IEC 60601-1-11) | Pass |
| Temperature and Humidity (IEC 60601-1, IEC 60601-1-11) | Pass |
| Atmospheric Pressure (Altitude) (IEC 60601-1) | Pass |
| Electromagnetic Immunity and Emissions (IEC 60601-1-2) | Pass |
| Performance (Temperature Measurement Accuracy) (ISO 80601-2-56, ASTM E1112) | Pass |
| Under 37°C: ± 0.2°C | |
| 37.1~39.0°C: ± 0.1°C | |
| 39°C and above: ± 0.2°C | |
| Mechanical Durability (IEC 60601-1, IEC 60601-1-11) | Pass |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Pass |
| Wireless Coexistence Testing (ANSI C63.27) | Pass |
| Software V&V (Guidance for the Content of Premarket Submissions for Device Software Functions) | Pass |
| Security Testing (Cybersecurity in Medical Devices, Quality System Considerations and Content of Premarket Submissions) | Pass |
| Usability Testing (Applying Human Factors and Usability Engineering to Medical Devices) | Pass |
| Clinical Electronic Thermometer (Enforcement Policy for Clinical Electronic Thermometers, Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers) | Pass |
| Bench Testing (Durability and Performance testing, Battery Life Testing) | Pass |
Note on Performance (Temperature Measurement Accuracy): The document explicitly states the specific accuracy values for different temperature ranges, which are considered "Pass" when measured against the standards ISO 80601-2-56 and ASTM E1112. These are the acceptance criteria for the accuracy.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set for any of the reported performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the accuracy or other performance tests. It only states that "Clinical accuracy testing was conducted to ISO 80601-2-56."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth. For temperature measurement, the ground truth is typically established by reference thermometers or established methods defined within the testing standards (ISO 80601-2-56 and ASTM E1112), rather than expert consensus in the way it would be for image interpretation.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method like 2+1 or 3+1. For objective performance tests like temperature accuracy, adjudication methods for expert consensus are generally not applicable. The standards themselves define the criteria for "passing" the test.
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 Aulisa Temperature Module (TM0002). This device is a clinical electronic thermometer and not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, an MRMC comparative effectiveness study or analysis of human reader improvement with AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The device is a hardware module that measures temperature and transmits it. Its "performance" as a standalone device is covered by the performance testing (e.g., accuracy, electrical safety, etc.) which are conducted independent of a human interpreting its output. The output is displayed via an application, but the core measurement accuracy is inherent to the device itself. The document states that "The output temperature of the Subject Device is derived directly from input signal without any adjustment," implying its core function is standalone.
7. The Type of Ground Truth Used
For the core performance claims (e.g., temperature accuracy), the ground truth is established through reference standards as defined by ISO 80601-2-56 and ASTM E1112. These standards specify how to establish laboratory-controlled "true" temperatures to compare against the device's readings. This is a form of scientific/methodological ground truth rather than expert consensus or pathology.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is because the Aulisa Temperature Module (TM0002) is a direct measurement device rather than a machine learning or AI-based device that would require a "training set." Its accuracy is based on its sensor technology and calibration, not learned from data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for this device, the question of how its ground truth was established is not applicable.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.