(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 IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290 are electronic 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) Kev "2. Buzzer" 1.
Here's a breakdown of the acceptance criteria and study information for the Microlife Digital Infrared Ear Thermometer, Models IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290, based on the provided text:
Summary of Device Acceptance and Study Information
The provided 510(k) summary focuses on demonstrating substantial equivalence of the new models to a previously cleared predicate device (Microlife Digital Infrared Ear Thermometer, Model IR1DE1, K#020725). The key claim is that the new models are identical in functionality and performance to the predicate, with only differences in external shape, PCB layout, and some user interface ergonomics/features.
The document explicitly states that controlled human clinical studies were not conducted for the modified devices. This implies that the acceptance criteria and performance data for these new models are not directly derived from new clinical trials. Instead, the substantial equivalence relies on the unchanged core technology and performance specifications, and compliance with voluntary standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Voluntary Standards Compliance: | |
| ASTM E1112 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) | Compliant |
| ASTM E1104 (Standard Specification for Clinical Thermometers, Infrared and Radiation, for Intermittent Determination of Patient Temperature) | Compliant |
| ASTM E-1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature) | Compliant |
| IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) | Compliant |
| IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests) | Compliant |
| Performance Specifications (Implicity same as predicate): | "Accuracy performance, reliability and EMC testing is only applicable." - Implied to meet predicate's performance. |
| Working Environmental Specification: | 5-40°C (Unchanged from predicate) |
| Temperature Measurement Algorithm: | Unchanged from predicate |
| Software Codes: | Unchanged from predicate |
| Intended Use: | Same as predicate (neonatal, pediatric, and adult populations in the home setting) |
Important Note: The document does not explicitly list quantitative acceptance criteria for accuracy, reliability, or specific performance metrics for the new devices. It relies on the predicate device's established performance and the claim that the core technology and algorithm remain unchanged. The compliance to the ASTM and IEC standards serves as the primary acceptance criteria for the modified devices, indicating they meet established design and safety requirements for electronic clinical thermometers.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/not specified. The document explicitly states that "Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices." The evaluation of these new models relies on non-clinical tests (compliance to standards, engineering verification) and the assertion that their performance is identical to the predicate.
- Data Provenance: Not applicable, as no new clinical test data was generated for these modified devices. The regulatory submission leverages the performance data of the predicate device, which is not detailed in this excerpt regarding its own clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable, as no new clinical studies were conducted for the modified devices requiring expert-established ground truth.
4. Adjudication Method for the Test Set
- Not applicable, as no new clinical studies were conducted for the modified devices requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
- No MRMC comparative effectiveness study was done. The document states: "Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices".
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- The document implies that "Accuracy performance, reliability and EMC testing" was done for the modified devices. While not detailing 'standalone algorithm testing' in the modern sense of AI, it refers to the unchanged temperature measurement algorithm and software codes from the predicate device. This suggests that the core measurement logic itself was considered "standalone" and its performance was established with the predicate devices and considered directly transferable due to no changes.
7. The Type of Ground Truth Used
- For the modified devices, the "ground truth" for demonstrating substantial equivalence is primarily based on:
- Compliance with established voluntary standards (ASTM, IEC).
- The assertion of identical functionality and performance to the predicate device whose performance was previously established.
- Engineering verification and validation tests (not detailed) to confirm that the modifications did not alter original safety and effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This device is an infrared thermometer, not an AI/machine learning model in the context that requires a "training set." The temperature measurement algorithm is described as "unchanged" from the predicate device, implying it was developed based on general physics and engineering principles for infrared thermometry, not through machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set" in the context of an AI/machine learning model for this electronic thermometer. The core measurement algorithm's "ground truth" would have been established through a combination of physical principles, calibration against known temperature sources, and validation against clinical reference methods during the development of the predicate device (which is not detailed in this submission).
§ 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.