(176 days)
The Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1 device, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
The Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.
Mode of operation:
The unit measures the infrared energy emitting from the middle ear and the surrounding tissue. This energy is absorbed by lenses and converted into temperature values.
The Microlife Digital Infrared Ear thermometer, Model IR1DR1-1, consists of the following parts: a) Thermopile Sensor b) Application-Specific Integrated Circuit d) Lens e) LCD and Backlight f) 2 Keys (Start key, O/I key) g) 1 battery 3.0V
Here's an analysis of the provided text regarding the Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1, based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device's accuracy are based on the ASTM E1965-98 (2009) standard for infrared thermometers. The reported performance for accuracy matches these criteria.
| Acceptance Criteria (from ASTM E1965-98 (2009)) | Reported Device Performance (Blackbody Test) |
|---|---|
| 42.0°C ±0.3°C | >42.0°C ±0.3°C |
Other acceptance criteria implicitly met by the "Passed all testing requirements" statements for the listed standards (e.g., electrical safety, EMC, biocompatibility) are:
- Electrical Safety: Complies with IEC 60601-1: 2005 and A1:2012, ANSI/AAMI ES60601-1:2005/(R2012) and A1:2012, C1:2009/(R)2012 and A2:2010/(R2012), IEC 60601-1-11:2010.
- Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2: 2014.
- Biocompatibility: Complies with ISO 14971: 2007 (risk management), AAMI/ANSI/ISO 10993-1: 2010, AAMI/ANSI/ISO 10993-5: 2010, AAMI/ANSI/ISO 10993-10: 2010, AAMI/ANSI/ISO 10993-12: 2012 (biocompatibility standards).
- Software Verification and Validation: Complies with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Controlled human clinical studies were conducted in accordance with ASTM E1965-98, IEC80601-2-56 Test Report." However, specific sample sizes (number of subjects/measurements) for the clinical test set are not provided in the document. The data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated, though the nature of "Controlled human clinical studies" implies a prospective design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a clinical thermometer, the "ground truth" (reference temperature) is typically established by another calibrated reference thermometer, not by human experts adjudicating readings.
4. Adjudication Method for the Test Set
This information is not applicable in the context of a clinical thermometer's performance evaluation, as "adjudication" typically refers to the resolution of disagreements among expert reviewers for image-based diagnostics. The ground truth for temperature measurement is an objective reading from a reference device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., images), which is not the case for a digital ear thermometer. The comparison is against a reference temperature.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the device performance was evaluated in a standalone manner. The "Accuracy Tested (blackbody)" refers to testing the device in a controlled environment against known temperature sources without human interpretation influencing the measurement itself. The clinical studies also evaluate the device's ability to measure temperature in humans without human intervention in the device's measurement process, though a human operates the device.
7. The Type of Ground Truth Used
For the accuracy testing, the ground truth was established using blackbody radiators (controlled temperature sources) for in-vitro testing. For clinical studies, the ground truth would typically be established by simultaneously taking readings with a calibrated reference thermometer – most likely a traditional clinical thermometer known for high accuracy or another accepted medical standard. The document states "Clinical data was presented evaluating clinical uncertainty and clinical repeatability," which implies comparison against a reference.
8. The Sample Size for the Training Set
The document describes the device as a physical thermometer using an infrared sensor and an Application-Specific Integrated Circuit (ASIC). It does not mention any machine learning or AI algorithms that would require a "training set" in the conventional sense. The device's operation is based on physical principles of infrared measurement and conversion to temperature values. Therefore, a "training set" as understood in AI/ML is not applicable.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, a "training set" is not applicable for this 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.