(168 days)
The Wireless No-Touch Forehead Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can transmit the temperature to a smart device with Bluetooth and can be used by consumers in the household environment and by healthcare providers.
The iHealth PT3SBT Wireless No-Touch Forehead Thermometer is hand-held, reusable, battery operated device, which can measure human body forehead skin temperature without touching patient's skin. Its operation is based on measuring the natural thermal radiation from the central forehead. Put the probe of the thermometer at a measurement distance less than or equal to 1.18 inch (3cm) without touching the skin at the center of the patient's forehead. It uses a thermopile sensor to measure the patient's forehead temperature and convert it to the oral equivalent. Pressing the activation button to start the measurement of proposed infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LED display of the device. The thermometer can also be connected to a smart device through Bluetooth and display the measured temperature result on the smart device.
The provided text describes the regulatory clearance of a medical device, the "iHealth Wireless No-Touch Forehead Thermometer (model PT3SBT)", by the FDA. It details the device's characteristics, comparison to a predicate device, and the non-clinical and clinical tests performed to support its substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device can be inferred from the standards it claims to comply with and the performance characteristics stated. The primary acceptance criteria relate to accuracy, safety, and functionality.
| Acceptance Criteria Category | Specific Criteria (from standards/claims) | Reported Device Performance/Compliance |
|---|---|---|
| Accuracy | Specified Accuracy: | |
| ± 0.4°F (0.2°C) within 93.2°F-107.6°F (34°C-42°C) | ||
| ± 0.5°F (0.3°C) for other temperature ranges. | ||
| Clinical Accuracy: Compliance with ASTM E1965-98:2016 for clinical bias and uncertainties. | Stated Accuracy: | |
| ± 0.4°F (0.2°C) within 93.2°F-107.6°F (34°C-42°C) | ||
| ± 0.5°F (0.3°C) for other temperature ranges. | ||
| Clinical Test Results: "The clinical test report demonstrated that the clinical data, represented by clinical bias and uncertainties met the acceptance criteria of the clinical study protocol. The iHealth PT3 Infrared No-Touch Forehead Thermometer complies with the requirement of ASTM E1965-98 (2016)." | ||
| Electrical Safety | Compliance with IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) | "Electrical Safety test was performed according to IEC 60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text)" |
| EMC (Electromagnetic Compatibility) | Compliance with IEC 60601-1-2:2014 | "EMC test was performed according to 60601-1-2:2014" |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, and ISO 10993-10. | "Biocompatibility test (including cytotoxicity, sensitization, irritation) was performed according to (1) ISO 10993-1, (2)ISO 10993-5 and (3) ISO 10993-10." |
| Software Verification & Validation | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", dated May 11, 2005. | "Software verification and validation were conducted according to FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices', dated May 11, 2005." "software validation demonstrated the difference does not raise any new performance questions." |
| Cybersecurity | Evaluated according to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" guidance. | "Cybersecurity testing has been evaluated according to guidance 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices'." |
| General Performance (Non-Clinical) | Compliance with ISO 80601-2-56:2017 [Including: Amendment 1 (2018)], "Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement." | "Performance test was performed according to ISO 80601-2-56:2017 ... is the applicable standards for this device." "the performance test complied with standards." |
| Usability/Operation Environment | Stated operational conditions (0-40° C, 15%-95% RH, 70-106kPa) and acceptable performance within these. | "the performance test complied with standards." (Implied acceptance within specified operating ranges). |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The clinical investigation used a total of 130 subjects. This was broken down into:
- Infants: 40 subjects (0-1 year)
- Children: 40 subjects (1-5 years)
- Adults: 50 subjects (>5 years)
- Data Provenance: The document does not explicitly state the country of origin for the clinical test data. Given the manufacturer's address in Tianjin, China, it is highly probable the study was conducted there. The study appears to be prospective as it's described as a "clinical investigation" and "clinical test report".
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide details on the number or qualifications of experts used to establish the ground truth for human body temperature measurements in the clinical study. It refers to compliance with ASTM E1965-98 (2016), which is a standard specification for infrared thermometers, implying that the ground truth methodology would follow the requirements of this standard for comparison thermometers (e.g., rectal thermometers) and trained personnel for measurement.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth measurements. The ASTM E1965-98 standard typically involves comparing the test thermometer's readings against a reference (usually invasive, like rectal or oral) temperature obtained by trained personnel, rather than multiple expert adjudicators in the way an AI diagnostic image study might.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
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Was it done? No, an MRMC study comparing human readers with and without AI assistance was not done. This device is a thermometer, not an AI-powered diagnostic imaging tool. Its primary function is direct measurement, not interpretation by human readers.
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Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
- The study primarily focuses on the device's direct measurement performance, which is inherently "standalone" in the sense that the thermometer provides a numerical output directly. While it can connect to a smart device via Bluetooth, the core temperature measurement capability is in the device itself, making its clinical accuracy evaluation a standalone performance assessment. The "algorithm" here is the embedded software that converts infrared radiation into a temperature reading.
7. Type of Ground Truth Used
The ground truth used for the clinical accuracy study was established by comparison to a reference method (likely an invasive, highly accurate thermometer like a rectal or oral thermometer) as specified by ASTM E1965-98 (2016). This standard outlines procedures for clinical accuracy assessment for body temperature measurement. The document states "clinical bias and uncertainties met the acceptance criteria of the clinical study protocol" in relation to this standard.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" sample size. For a medical device like a thermometer, the "training" usually refers to the internal calibration and development data rather than a separate dataset for training a machine learning algorithm in the way an AI diagnostic tool would have. The performance evaluation is based on the validation (test) set described in point 2.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" for AI algorithm training is mentioned (as this is a thermometer, not an AI diagnostic model), the method of establishing ground truth for such a set is not detailed. For the internal development and calibration of the thermometer, standardized temperature sources and laboratory reference thermometers would be used to establish the ground truth for programming the device's measurement algorithm.
§ 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.