(336 days)
Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
The Advocate Non-Contact Infrared Thermometer model EF001A measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The device is composed of a Probe of metals with infrared sensor inside to detect the infrared energy, an LCD Display, a SCAN button to start measuring temperatures, a Power switch button to switch on or off the device, a Body/Ambient button to switch between two measuring modes, and an Enclosure of ABS.
The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, 9F/℃ unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, and auto shut-off when the device is idle for 60 seconds.
The device under consideration is the Advocate Non-Contact Infrared Thermometer, Model EF001A. The provided information details its acceptance criteria and the studies conducted to prove it meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for infrared thermometers is accuracy, as defined by standards such as ASTM E1965-98.
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Measuring Accuracy | ||
| 93.2°F - 94.8°F (34.0°C - 34.8°C) | ±0.5°F / 0.3°C | Complies with ASTM E1965-98 (2016) |
| 95.0°F - 107.6°F (35.0°C - 42.0°C) | ±0.4°F / 0.2°C | Complies with ASTM E1965-98 (2016) |
| 107.8°F - 109.4°F (42.1°C - 43.0°C) | ±0.5°F / 0.3°C | Complies with ASTM E1965-98 (2016) |
| Electrical Safety | Complies with IEC 60601-1:2005/A1:2012 | Pass |
| EMC Testing | Complies with IEC 60601-1-2:2014 & FCC 47 CFR Part 18 | Pass |
| Performance Testing | Complies with ASTM E1965-98(2016) & ISO 80601-2-56:2017 | Pass |
| Biocompatibility Testing | Complies with ISO 10993-5:2009 (Cytotoxicity) & ISO 10993-10:2010 (Skin Irritation, Sensitization) | Pass |
| Software Validation and Verification | Complies with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005" | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The primary study mentioned is a "Clinical test."
- Sample Size: 120 subjects, categorized into:
- 40 infants (0-1 year)
- 40 children (1-5 years)
- 40 adults (>5 years)
- Data Provenance: Not explicitly stated from which country or location the subjects were sourced. The study is described as a "Clinical test" which typically implies prospective data collection, but it is not definitively stated whether it was prospective or retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document refers to "Clinical Test" and compliance with standards like ASTM E1965-98, which outlines methods for determining clinical accuracy. However, it does not specify the number or qualifications of experts involved in establishing the ground truth measurements against which the device was compared.
4. Adjudication Method for the Test Set
This information is not provided in the document. The clinical test section describes the assessment criteria for clinical accuracy but does not detail any adjudication methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is a thermometer, and its performance is evaluated against established temperature measurement standards, not through comparison with human readers or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone thermometer. The performance tests ("Performance testing" and "Clinical test") demonstrate the device's accuracy in measuring temperature without human intervention other than the act of taking the measurement. Therefore, the reported performance is inherently standalone performance.
7. The Type of Ground Truth Used
The ground truth for the clinical accuracy test was established by assessing the device's measurements against the requirements of specific standards. For temperature measurement, the ground truth is typically a highly accurate reference thermometer or a standardized method as outlined in the referenced clinical accuracy standards. In this case, the "Clinical test" methods and criteria were assessed to meet the requirements of clinical accuracy per the referenced standard ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometer for Intermittent Determination of Patient temperature. This standard itself would describe the method for establishing ground truth, likely involving comparative measurements with an accepted standard.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. As a non-AI/ML device (a digital infrared thermometer), there is no "training set" in the context of algorithms that learn from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, as there is no training set for this type of device.
§ 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.