(201 days)
The Microlife Digital Infrared Ear Thermometer, Model IRIDNI (IR210) device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediation used in the home setting.
The Microlife Digital Infrared Ear Thermometer, Model IR1DN1 (IR210) 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.
The provided text describes the Microlife Digital Infrared Ear Thermometer, Model IR1DN1 (IR210), and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Standard or Requirement) | Reported Device Performance (Compliance) |
|---|---|
| Measurement Range (Body Mode): 32.0-43.0 °C (89.6-109.4 °F) | Subject device achieved this range, wider than predicate. This did not introduce new risks. |
| Accuracy (Blackbody Mode): | Passed all testing requirements per ASTM E1965-98 and ISO 80601-2-56. |
| - ±0.2 °C: 35.0 ~ 42.0 °C | Achieved this accuracy. |
| - ±0.3 °C: 32.0 ~ 34.9 °C & 42.1 ~ 43.0 °C | Achieved this accuracy. |
| - ±0.4 °F: 95.0 ~ 107.6 °F | Achieved this accuracy. |
| - ±0.5 °F: 89.6 | Achieved this accuracy. |
| Biocompatibility (Measuring probe material - PCTG) | Tested per ISO 10993 standard; proven biocompatible. |
| Biocompatibility (Probe cover - Rigid PP) | Tested per ISO 10993 standard; proven biocompatible. Clinical study showed no effect on accuracy/performance. |
| Biocompatibility ("Start"/"Power" button material - PMMA) | Tested per ISO 10993 standard; proven biocompatible. |
| Position Indication Feature | Validated and verified through performance testing and clinical testing. |
| Integrated Circuitry (IC) Changes | Verified through performance testing. |
| General Safety and Essential Performance (AAMI/ANSI ES60601-1:2005/(R2012) and A1:2012, C1:2009/(R)2012 and A2:2010/(R2012)) | Passed all testing requirements. |
| Electromagnetic Compatibility (AAMI/ANSI/IEC 60601-1-2:2014) | Passed all testing requirements. |
| Infrared Thermometer Performance (ASTM E1965-98 (2016)) | Passed all testing requirements. |
| Risk Management (AAMI/ANS/ISO 14971:2007/(R)2010) | Passed all testing requirements; risk assessment conducted due to modifications. |
| Biological Evaluation (AAMI/ANSI/ISO 10993-1: 2009/(R)2013) | Passed all testing requirements. |
| Cytotoxicity (AAMI/ANSI/ISO 10993-5:2009/(R)2014) | Passed all testing requirements. |
| Irritation and Skin Sensitization (AAMI/ANSI/ISO 10993-10: 2010/(R)2014) | Passed all testing requirements. |
| Sample Preparation and Reference Materials (AAMI/ANSI/ISO 10993-12: 2012) | Passed all testing requirements. |
| Specific Requirements for Clinical Thermometers (ISO 80601-2-56: 2017) | Passed all testing requirements. |
| Requirements for Medical Electrical Equipment and Medical Electrical Systems in the Home Healthcare Environment (AAMI/ANSI HA60601-1-11:2015) | Passed all testing requirements. |
| Clinical Study Protocol Acceptance Criteria | Clinical data (clinical bias, uncertainty of bias, clinical repeatability) met these criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 114 subjects.
- Data Provenance: The study was a clinical investigation, implying prospective data collection specifically for this study. The location of the clinical study is not explicitly stated, but it's a "clinical investigation" and a "clinical study" was conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth. It states that "clinical data, represented by clinical bias, with uncertainty of bias, and clinical repeatability, met the acceptance criteria of the clinical study protocol," which implies a comparison against a reference standard or method for temperature measurement, likely managed by clinical professionals, but their specific roles, number, or qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes the clinical study as a "randomization, simple blind homologous control, pairing design," but this refers to the study design rather than a reader adjudication process. For temperature measurement, ground truth is typically established by high-precision reference thermometers rather than expert consensus on interpretation.
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 device is a digital infrared ear thermometer, and its performance is evaluated directly against known temperature standards and clinical correlations, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the performance testing described in the various standards (e.g., ASTM E1965-98, ISO 80601-2-56) and the accuracy in blackbody mode inherently represent standalone performance. The device provides a direct temperature reading. The clinical study then validated this standalone reading in a real-world setting.
7. The Type of Ground Truth Used
The ground truth for the device's accuracy is established through objective measurement against:
- Blackbody mode accuracy: For measuring the device's inherent precision against a controlled and known temperature source.
- Clinical Study Protocol: Which would involve comparing the device's readings to established clinical reference temperature measurement methods. The document mentions "clinical bias, with uncertainty of bias, and clinical repeatability," which are standard metrics for comparing a device to a reference measurement in a clinical setting.
8. The Sample Size for the Training Set
The document does not mention a training set or machine learning models. This device is a traditional electronic thermometer that uses an infrared sensor and an algorithm to convert infrared energy into a temperature value. It doesn't appear to use learning-based AI or require a training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established
As no training set is indicated, this question is not applicable.
§ 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.