(161 days)
Infrared Ear Thermometers are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.
The Infrared Ear Thermometers are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. It's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane.DET-103 and DET-105 include probe cover that is optional.
The Infrared Ear Thermometers include probe which used to measure ear canal temperature,plastic enclosed the display window,buttons and the battery cover.
The provided text describes the 510(k) premarket notification for an Infrared Ear Thermometer. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed acceptance criteria and studies in the same way one might for a novel AI/ML device or a device requiring a PMA.
Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set information are not available in this document. The document primarily focuses on explaining how the new device is similar to an existing one (the predicate device).
However, I can extract the safety and performance standards the device is stated to conform to, which serve as the "acceptance criteria" for this type of device based on regulatory standards.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a thermometer, "acceptance criteria" refer to the performance specifications defined by recognized standards.
| Acceptance Criteria (from conformity to standards) | Reported Device Performance (from comparison table) |
|---|---|
| Measurement Range: | |
| Per ISO 80601-2-56 and ASTM E1965-98 | DET-101, DET-102: 32.0°C |
| DET-103, DET-105: Ear mode:32.0°C | |
| Accuracy: | |
| Per ISO 80601-2-56 and ASTM E1965-98 | DET-101, DET-102: ±0.2°C (0.4°F) during 35.0°C |
| DET-103, DET-105: ±0.2°C (0.4°F) during 35.5°C | |
| Operating Temperature Range: | 10°C |
| Per IEC 60601-1-11 | |
| Biocompatibility: | Comply with ISO 10993-5 and ISO 10993-10 |
| Per ISO 10993-5, ISO 10993-10 | |
| Electrical Safety: | Complied with IEC 60601-1 |
| Per IEC 60601-1 | |
| EMC: | Complied with IEC 60601-1-2 |
| Per IEC 60601-1-2 | |
| Software Validation: | Software Validation passed. |
| Per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions that "The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2016)." However, it does not state the specific sample size used in this test, nor the country of origin of the data or whether it was retrospective or prospective. For a 510(k) for a thermometer, the clinical test usually involves human subjects to demonstrate accuracy against a reference method (e.g., oral/rectal mercury thermometer or a highly accurate electronic thermometer).
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. For a thermometer, "ground truth" for temperature is typically established by comparing the device's reading to a laboratory-calibrated reference thermometer or medical device known for its accuracy in measuring body temperature (e.g., a rectal thermometer in a clinical setting). It does not involve expert readers like radiologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like "2+1" are relevant for subjective image interpretation tasks, not for objective measurements like temperature.
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 not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a traditional, non-AI medical device. Its "standalone" performance is its direct measurement output, as evaluated against the stated standards. The clinical test confirms its performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a clinical thermometer, the ground truth for temperature measurement is typically derived from a reference standard thermometer (e.g., a highly accurate, calibrated electronic thermometer or sometimes a rectal mercury thermometer in a controlled clinical study).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this traditional 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.