(20 days)
Infrared Ear Thermometer (IRT-21 and IRT-22), designed with infrared technology, is used to measure body temperature from ear canal. Press the ON/OFF button to turn on the power, insert the probe into the ear canal then press the SCAN button to measure the temperature, when you hear a beep sound, the measurement is complete. Infrared Ear Thermometer (IRT-21 and IRT-22) is intended for household and hospital use on people of all ages.
Infrared Ear Thermometer (IRT-21 and IRT-22) is used to measure body temperature from ear canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces. Probe cover is used for measuring to ensure accurate temperature measurement. For hygienic purpose, it is advised to discard the probe cover after each use. Press the ON/OFF button to turn on the power, the symbol 1888 appears immediately. Insert the probe into the ear canal then press the SCAN button to measure the temperature, when you hear a beep sound, the measurement is complete. The temperature is graduated on 0.1 Tor 0.1 ℃, reading a range of 89.6°F -- 109.2°F (32°C -- 42.9°C ). The ambient temperature environment is intended for used is 50°F -- 104°F (10°C-40°C).
The provided text describes a 510(k) submission for an Infrared Ear Thermometer (IRT-21 and IRT-22). Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Accuracy (ASTM E1965-1998, Re-approved 2003) | No individual reading was in error by more than the acceptable maximum error. |
| Electrical Safety (IEC 60601-1, IEC 60601-1-2) | Conforms to applicable voluntary standards. |
| Biocompatibility (ISO 10993-1:2003 on skin irritation, in vitro cytotoxicity, sensitivity) | Conforms to applicable voluntary standards. |
| Repeatability (Clinical Study based on ASTM E1965-98) | Reasonably small and will not pose a problem for diagnostic purposes. |
| Clinical Bias and Uncertainty (Clinical Study based on ASTM E1965-98) | Indicate that this IR thermometer can be used reliably. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 100 patients were enrolled for the clinical trial.
- Data Provenance: Not explicitly stated, but based on the overall submission from "Choice Smart Health Care Company Limited" in Hong Kong, and the study being a "clinical trial" it is likely prospective, though the exact country of origin for the patient data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention the use of experts to establish a "ground truth" in the traditional sense of medical image or diagnostic interpretation. Instead, the ground truth was established by a "reference thermometer" for comparative purposes in the clinical study. The number or qualifications of individuals using the reference thermometer are not provided.
4. Adjudication Method for the Test Set
- No adjudication method (e.g., 2+1, 3+1) is mentioned. The clinical study involved comparing the infrared thermometer to a reference thermometer, implying a direct comparison rather than an adjudication process by multiple expert reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No MRMC comparative effectiveness study was done. This device is an infrared ear thermometer, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the device performance, particularly the accuracy, electrical safety, and biocompatibility, was evaluated in a standalone manner against established standards (ASTM, IEC, ISO). The clinical study also assesses the device's performance directly against a reference thermometer, which is a standalone evaluation of the device itself.
7. The Type of Ground Truth Used
- Clinical Study: The ground truth for the clinical study was established using a reference thermometer. The study involved a "comparison study" and "clinical repeatability testing" against this reference.
- Non-Clinical Tests: For accuracy testing, a controlled environment likely provided standardized temperature points (35°C/95°F, 37°C/98.6°F, 41°C/105.8°F) as a form of ground truth for calibration and verification.
8. The Sample Size for the Training Set
- This device is a hardware device (infrared ear thermometer) and does not inherently have a "training set" in the context of machine learning or AI models. The concept of a training set is not applicable here. The manufacturing and calibration processes would involve internal quality control and testing, but these are distinct from a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- As stated above, the concept of a "training set" does not apply to 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.