(511 days)
The THERMOCLICK is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home. The device can be used in connection with a smart phone running the THERMOCLICK Mobile Application. The memory data can be transferred to the smart phone via Bluetooth.
THERMOCLICK is a battery powered non-contact infrared thermometer that is intended to be used for the monitoring of body temperature of people of all ages. The reference body site of the output temperature is the axilla. With a sensor built into the product, it measures the infrared energy emitted from the skin surface of the forehead within 2cm so there is no need for contact with the skin. It can be used in the home or by a doctor in a clinic. It is indicated for use by people of all ages. After measurement, the temperature is directly displayed on the LED screen. The functions of the THERMOCLICK are controlled by software (firmware), and the user can also receive temperature data from a smartphone application via Bluetooth.
Based on the provided text, the device in question is the THERMOCLICK, Model MT-3000, a non-contact infrared thermometer. The key study proving it meets acceptance criteria is a clinical accuracy validation study.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that the device's accuracy performance "complies with the established standards of ASTM E1965-98" and that "The clinical validation results demonstrated that the clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol."
While specific numerical acceptance criteria for clinical bias and repeatability are not provided in this document, the Measurement Accuracy section from the comparison table acts as a key performance metric.
| Metric | Acceptance Criteria (from ASTM E1965-98 via stated compliance) / Reported Performance |
|---|---|
| Measurement Accuracy | For THERMOCLICK: |
| 22.0°C ~ 36.0°C | ± 0.3°C (± 0.6°F) |
| 36.0°C ~ 39.0°C | ± 0.2°C (± 0.4°F) |
| 39.0°C ~ 42.2°C | ± 0.3°C (± 0.6°F) |
| Clinical Bias | Met the acceptance criteria of the clinical validation protocol |
| Clinical Repeatability | Met the acceptance criteria of the clinical validation protocol |
| Operation Condition (Temperature) | 15°C ~ 40°C |
| Operation Condition (Humidity) | 15% ~ 90% (Passed humidity testing exceeding 95% per ASTM E1965-98 standards) |
| Storage & Transport Condition (Temperature) | -20°C ~ 50°C (Aligns with ASTM E1965-98) |
| EMC/Electrical Safety | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 (Passed) |
| Biocompatibility | ISO 10993-5, ISO 10993-10, ISO 10993-23 (Passed) |
| Bluetooth RF Test | EN 300 328 V.2.2.2 (2019-07) (Met requirement of data transfer) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 140 subjects. This population was broken down as:
- 50 Infants
- 45 Children
- 45 subjects greater than five years old
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical study" and "clinical investigation," implying it was specifically conducted for this purpose, making it prospective data.
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 refers to the ground truth as "clinical bias" and "clinical repeatability" derived from a "clinical accuracy validation" study, which would typically involve comparison to a gold standard temperature measurement method, often supervised by qualified medical professionals. However, the number and specific qualifications of experts for establishing this ground truth are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document. The study is described as a "randomization, simple blind homologous control, pairing design of clinical investigation," but details on ground truth adjudication are absent.
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
- No, an MRMC comparative effectiveness study was not done. This device is a standalone thermometer, not a diagnostic AI tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, the device itself performs the measurement and displays the temperature. The "clinical accuracy validation was conducted in according to ISO 80601-2-56:2017+A1:2018, EN ISO 80601-2-56:2017+A1:2020." This standard focuses on the accuracy and performance of the thermometer itself. While there is a mobile app, its use is described as "an option for the additional function to provide the users" and for managing "recorded patient temperature history," not as part of a human-in-the-loop diagnostic process for core thermometry.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical accuracy validation was established through comparison with a reference method for body temperature measurement, as implied by compliance with ISO 80601-2-56. This standard typically requires comparing the device's readings to a precisely calibrated reference thermometer, often in an oral or rectal site, depending on the standard's specific requirements, to establish "clinical bias" and "clinical repeatability." The document specifies "The reference body site of the output temperature is the axilla," indicating the device's forehead measurements are calibrated to infer axillary temperature, which would then be compared to a gold standard measurement at the axilla or a conversion from another core body site.
8. The sample size for the training set
This information is not applicable and therefore not provided. This device is a hardware medical device (a thermometer), not an AI/ML algorithm that requires a "training set" in the computational sense. The "software" mentioned refers to firmware controlling the device's functions and a companion mobile application, which would undergo traditional software verification and validation, not machine learning model training.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for an AI/ML algorithm. The device's performance is based on its physical design, sensors, and firmware, validated against established metrological standards for temperature measurement.
§ 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.