(17 days)
The 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 IR1DE1-1 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.
The Microlife Digital Infrared Ear Thermometer, consists mainly of five parts:
- IR Thermopile Sensor a)
- b) ASIC
- E2 PROM IC C)
- LCD and Blacklight d)
- Key "2, Buzzer" 1 e)
Here's a breakdown of the acceptance criteria and study information for the Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1, based on the provided text:
Important Note: The provided text is a 510(k) summary for a device seeking substantial equivalence to a predicate device. It primarily discusses non-clinical tests for compliance with standards and a clinical study to validate a specific change (probe cover-free use). It does not provide detailed acceptance criteria and performance data in the way a clinical study report for a novel device would. Many of the requested details are therefore not available from this document.
Acceptance Criteria and Reported Device Performance
The document refers to compliance with ASTM E-1965-98 as an applicable voluntary standard. This standard likely outlines the performance requirements for infrared thermometers, including accuracy specifications. However, the exact numerical acceptance criteria and the device's reported performance against these criteria are not explicitly stated in this 510(k) summary. The summary only generally states that "verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness."
| Acceptance Criteria (Based on ASTM E-1965-98 - details not provided in text) | Reported Device Performance (not explicitly stated in text) |
|---|---|
| e.g., Accuracy within +/- 0.2°C for specified temperature ranges | Stated to maintain original safety and effectiveness after modification |
| e.g., Repeatability within specified limits | Stated to maintain original safety and effectiveness after modification |
| e.g., Readout resolution | Stated to maintain original safety and effectiveness after modification |
Study Details where Information is Available:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document states "Controlled human clinical studies were conducted," but does not give the number of subjects.
- Data Provenance: Not specified (e.g., country of origin). The studies were "controlled human clinical studies," implying prospective data collection in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided. This type of information is typically relevant for studies involving image interpretation or complex diagnostic assessments. For a thermometer, "ground truth" would typically come from a highly accurate reference thermometer, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. Adjudication methods are used when multiple experts are interpreting data and their opinions need to be reconciled. This is not relevant to a thermometer's performance testing where accuracy is measured against a reference standard.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not relevant. The device is a thermometer, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implied. The "clinical studies" mentioned are to "validate the effectiveness of use without a probe cover." This implies testing the device's performance (i.e., its algorithm and sensor) in a standalone manner, measuring its output directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied Reference Standard. For a thermometer, the "ground truth" would be established using a highly accurate reference thermometer (e.g., a laboratory-grade precision thermometer or a rectal thermometer) with known calibration. This is not explicitly stated in the document but is the standard practice for thermometer validation.
8. The sample size for the training set
- Not applicable. This device is a traditional electronic thermometer, not an AI/ML-based device that requires a distinct "training set." The phrase "temperature measurements algorithm and its software codes of the modified devices remains unchanged" suggests the core algorithm was already established.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/ML model 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.