(30 days)
The device is an digital infrared Ear 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, Models IR1DA1-2 and IR1DE1-2 are Digital Infrared Ear Thermometers using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Their 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: a) IR Thermopile Sensor, b) ASIC, c) E2 PROM IC, d) LCD and Blacklight, e) Key "2, Buzzer" 1.
The provided text is a 510(k) summary for a Digital Infrared Ear Thermometer. It describes the device, its intended use, and compares it to a predicate device. However, it explicitly states that "Controlled human clinical studies were not conducted" and refers only to "Accuracy performance, reliability and EMC testing" as applicable.
Therefore, I cannot provide information on acceptance criteria for device performance based on clinical studies, sample sizes, expert ground truth, adjudication methods, or MRMC studies, as these types of studies were not conducted for this device submission.
Here's what can be extracted from the document regarding acceptance criteria and testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM E1112 (Clinical thermometers) | Compliance claimed |
| ASTM E1104 (Temperature measuring) | Compliance claimed |
| ASTM E-1965-98 (Infrared thermometers) | Compliance claimed |
| IEC 60601-1 (Medical electrical equipment) | Compliance claimed |
| IEC 60601-1-2 (EMC for medical electrical equipment) | Compliance claimed |
| Performance specifications | Maintained original safety and effectiveness after modifications |
| Reliability | Demonstrated after modifications |
| EMC testing | Demonstrated after modifications |
2. Sample size used for the test set and the data provenance:
- None specified for clinical studies. The document explicitly states: "Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices, as well as no low power test as miral studies/low power testing were conducted for the original unmodified device and remain unchanged."
- Data provenance for the engineering tests (accuracy, reliability, EMC) is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical studies requiring expert ground truth were conducted.
4. Adjudication method for the test set:
- Not applicable, as no clinical studies requiring adjudication were conducted.
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:
- Not applicable. This device is a thermometer, not an AI-assisted diagnostic tool involving human readers. No MRMC study was mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies that engineering tests (accuracy, reliability, EMC) were conducted on the device itself ("algorithm only" in the context of device performance) to demonstrate compliance with standards. It does not provide specific metrics or results from these tests beyond claiming compliance.
7. The type of ground truth used:
- For the engineering tests, the ground truth would typically be established by calibrated reference standards used in laboratories conforming to the respective ASTM and IEC standards for thermometer performance. The document does not explicitly state the ground truth methodology, but adherence to these standards implies such a methodology.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.