(155 days)
Infrared thermometer is a non-sterile, reusable, handheld and non-contact device. It can be used by consumers in home care environment and doctors in clinic as reference. It is intended for measuring human body temperature of one month of age and above by detecting infrared heat from the forehead.
The Infrared Thermometer, Model E127, is a light weight, handhold and non-contact Infrared Thermometer that measures temperatures of people ages 1 month and above by detecting the infrared energy radiated directly from the forehead without physical contact from a measurement distance of 1-5cm. . It uses 3.0V alkaline batteries. The device can measure temperature in direct and adjusted mode.
The provided document describes the Bioland Technology Ltd. Infrared Thermometer (Model E127) and its clearance through the FDA 510(k) pathway, asserting its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from international and national standards, specifying performance limits for accuracy and repeatability.
| Test Item | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1: 2005/A1: 2012 | Complies with applicable requirements |
| EMC Testing | IEC 60601-1-2: 2014 | Complies with applicable requirements |
| Electrical Safety (Home Use) | IEC 60601-1-11: 2015 | Complies with applicable requirements |
| Performance (General) | ISO 80601-2-56: 2017 | Complies with applicable requirements |
| Biocompatibility | ISO 10993-1: 2018, ISO 10993-5: 2009, ISO 10993-10: 2010 | Complies with applicable requirements |
| Clinical Accuracy | ASTM E1965-98: 2016 | Meets the requirements of clinical accuracy (Passed) |
| Clinical Repeatability | ISO 80601-2-56: 2017 | Meets the requirements of clinical repeatability (Passed) |
| Measuring Accuracy | ±0.3 °C (32.0 °C -34.9 °C) ±0.2 °C (35-42.0 °C) ±0.3 °C (42.1 °C -43.0 °C) (matched predicate) | Implied to meet these criteria, as it's stated as "Same" as predicate device. |
| Measurement Range | 32.0~43.0 °C (89.6 °F ~109.4 °F) (matched predicate) | Implied to meet this range, as it's stated as "Same" as predicate device. |
| Display Resolution | 0.1 °C / °F (matched predicate) | Implied to meet this resolution, as it's stated as "Same" as predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 150 subjects for clinical testing, divided into three age groups:
- Infants (0-1 year): 50 subjects
- Children (1-5 years): 50 subjects
- Adults (>5 years): 50 subjects
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "clinical accuracy and repeatability testing had been clinically assessed."
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 on the number of experts used or their qualifications for establishing the ground truth in the clinical accuracy and repeatability testing. Clinical trials for thermometers, especially for substantial equivalence, often compare the device's readings against established reference methods, which serve as the ground truth.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. For clinical thermometer studies, the reference method (e.g., rectal or oral thermometer readings) typically serves as the "ground truth" against which the new device's readings are compared.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on the device's accuracy and repeatability against a reference standard, not on human reader performance with or without AI assistance. The device in question is an Infrared Thermometer, which is a standalone measurement device, not an AI-powered diagnostic tool requiring human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance assessment was done. The clinical accuracy and repeatability testing evaluated the Infrared Thermometer's ability to measure temperature directly, without human interpretation of complex data or AI assistance in a diagnostic context. The device itself is the "algorithm" in this context, directly providing a temperature reading.
7. The Type of Ground Truth Used
The ground truth for the clinical accuracy and repeatability testing would have been established by a reference method for body temperature measurement, likely an invasive or highly accurate contact thermometer (e.g., rectal temperature for infants or oral temperature for adults). The document implies this by stating the device was "clinically assessed to meet the requirements of clinical accuracy per the referenced standards" (ISO 80601-2-56 and ASTM E1965-98). These standards typically outline the methodologies for establishing such ground truth.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" or "training data" as would be relevant for machine learning algorithms. This device is an infrared thermometer, relying on physical principles of infrared radiation detection rather than a machine learning model that requires training data in the same sense. Therefore, there's no stated training set size.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of machine learning, there is no discussion of how ground truth for a training set was established. The device measures temperature based on established physics principles and its design, which is then validated through clinical testing as described above.
§ 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.