(159 days)
The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the forehead for clinical or home use.
The thermometers are powered by AAA 1.5V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or ºF. The measurement distance of the subject device is no more than 3cm.
The Infrared thermometer included DT-8836T, DT-8836P. These two models are identical on hardware and software except the physical dimensions and appearance.
The Infrared Thermometer (Model DT-8836T, DT-8836P) has undergone testing to demonstrate its performance against established acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Standard | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Accuracy | ±0.2°C (0.4°F) within 36.0°C ~39.0°C (96.8°F ~102.2°F), ±0.3°C (0.5°F) other range (per ASTM E1965-98 and ISO 80601-2-56) | ±0.2°C (0.4°F) within 35.0°C ~ 42.0°C (95.0°F ~ 107.6°F), ±0.3°C (0.5°F) other range (demonstrated compliance with IEC 80601-2-56 and ASTM E 1965-98 Reapproved 2009) |
| Measurement Range | 32.0°C ~42.9°C (89.6 to 109.22°F) | 32.0°C ~42.5°C (89.6 to 108.5°F) (demonstrated compliance with IEC 80601-2-56) |
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10 | Passed Cytotoxicity, Sensitization, and Irritation tests based on ISO 10993-1 guidance |
| Electrical Safety | Compliance with IEC 60601-1 (General requirements for basic safety and essential performance) | Demonstrated compliance with IEC 60601-1 |
| EMC | Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Demonstrated compliance with IEC 60601-1-2 |
| Home Healthcare Environment | Compliance with IEC 60601-1-11 (Requirements for medical electrical equipment and systems used in home healthcare) | Demonstrated compliance with IEC 60601-1-11 |
| Software Validation | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005 | Software validation and verification conducted according to FDA guidance |
| Clinical Performance | Compliance with ASTM E 1965-98 (Reapproved 2009) for clinical accuracy | Clinical study demonstrated compliance with ASTM E 1965-98 (Reapproved 2009) |
2. Sample Size Used for the Test Set and Data Provenance
The clinical study was a randomization, simple blind homologous control, pairing design of clinical investigation.
- Sample Size: Minimum of 150 subjects.
- 1/3 Infants (newborn to one year)
- 1/3 Children (greater than one to five years)
- 1/3 Adults (greater than five years old)
- Data Provenance: The document does not explicitly state the country of origin for the clinical data. It also does not specify if the data was retrospective or prospective, but the description of a "clinical investigation" strongly suggests a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. It refers to the "clinical performance of the subject device [having] complied with the requirement of standard ASTM E 1965-98 (Reapproved 2009)," which dictates methods for determining accuracy against a reference thermometer, but does not detail the roles of experts in this process.
4. Adjudication Method for the Test Set
The document describes the clinical study as a "randomization, simple blind homologous control, pairing design of clinical investigation." It does not provide details on an adjudication method involving multiple readers. The accuracy is assessed by comparing the device's readings to a reference thermometer as per ASTM E 1965-98.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is an infrared thermometer, and its performance is evaluated against a reference standard for temperature measurement, not through human reader interpretation of images or data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
Yes, a standalone performance evaluation was conducted. The non-clinical data and the clinical data sections describe tests performed on the device itself against established standards:
- Non-clinical data: Testing to IEC 60601-1, IEC 60601-1-2, ISO 80601-2-56, and IEC 60601-1-11, and software validation. These are tests of the device's technical specifications and performance without human interpretation in the loop.
- Clinical data: Evaluation against ASTM E 1965-98 for accuracy. This standard defines how a clinical thermometer's readings are compared to a reference standard thermometer (e.g., a rectal thermometer for core body temperature), essentially assessing the device's standalone accuracy in a clinical setting.
7. Type of Ground Truth Used
The ground truth for the clinical performance evaluation was established by a reference standard thermometer (as per ASTM E 1965-98 requirements) which defines the true body temperature against which the infrared thermometer's readings are compared. This is a form of outcomes data or reference standard comparison.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" for the device. The device is an Infrared Thermometer, which typically relies on pre-calibrated sensors and algorithms based on physical principles, rather than machine learning models that require extensive training data. Therefore, the concept of a training set as used in AI/ML is not directly applicable here. The development and calibration of the device would involve engineering and physical testing, not a "training set" in the common sense of data-driven models.
9. How Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" in the context of AI/ML is not applicable to this device as described. The "ground truth" for the device's inherent accuracy and performance characteristics would have been established through laboratory calibration against highly accurate reference thermometers and physical standards during its design and manufacturing process, in accordance with standards like ISO 80601-2-56 and ASTM E 1965-98 for the initial development and calibration.
§ 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.