(21 days)
The device measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.
The Mesure ear thermometer, models ST61, ST62, ST63, ST64, and ST64, are the handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control.
From the construction point of view, the ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared.
This system uses a 3.0 V DC battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of ST61, ST62, ST63,ST64 and ST65, they were designed and verified according to the US standard ASTM E 1965-00.
This 510(k) submission describes the Mesure Technology Co., Ltd. Ear Thermometer, Models ST61, ST62, ST63, ST64, and ST65.
Here's an analysis based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The device was designed and verified according to the US standard ASTM E 1965-00. While the specific acceptance criteria values of ASTM E 1965-00 are not explicitly stated in the provided text, compliance with this standard implies that performance metrics such as accuracy, precision, and response time were evaluated and met the established thresholds within that standard for infrared thermometers.
The document states that the devices (ST61-ST65) were developed from a cleared predicate device (ST613C & ST613F) with "only the small change in dimension, device housing, and some non-performance and safety related features." The conclusion is that these engineering differences do not affect intended use or alter the fundamental scientific technology, thereby maintaining the same safety and effectiveness as the predicate.
| Acceptance Criteria (Based on ASTM E 1965-00) | Reported Device Performance (Implied by Compliance) |
|---|---|
| Accuracy of temperature measurement | Compliant with ASTM E 1965-00 |
| Precision/Reproducibility | Compliant with ASTM E 1965-00 |
| Response Time | Compliant with ASTM E 1965-00 |
| Safety requirements (e.g., electrical safety) | Compliant with EN 60601-1, EN 60601-1-1, EN 60601-1-2 |
| Electromagnetic compatibility (EMC) | Compliant with EN 60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set. It mentions "verification and validation tests," but the number of subjects or measurements is not provided.
The data provenance is not explicitly stated. Given that the company is based in Taiwan (Mesure Technology Co., Ltd., Taipei Hsien, Taiwan, R.O.C.), it's plausible the testing was conducted there, but this is not confirmed. There is no information on whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the submission. For a medical device like a thermometer, the "ground truth" for temperature measurement would typically be established by highly accurate reference thermometers and controlled environments, rather than human experts, though clinicians might be involved in evaluating performance in clinical settings. The document focuses on compliance with a technical standard, ASTM E 1965-00.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a thermometer performance test, an adjudication method in the sense of expert consensus on ambiguous cases is not typically applicable. Performance is usually assessed against a known reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for image interpretation or diagnostic tasks where human readers' performance is influenced by AI assistance. For a standalone thermometer, this is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was conducted. The assessment focused on the device itself against established standards (ASTM E 1965-00, EN 60601-1, EN 60601-1-1, EN 60601-1-2). The device is a "hard-wire control" system, not programmable, implying that its performance is inherent to its design and hardware, without a human-in-the-loop for its basic function of temperature measurement.
7. The Type of Ground Truth Used
The ground truth for temperature measurement would be established by reference standards (e.g., highly accurate standard thermometers, temperature-controlled environments) as specified within ASTM E 1965-00. The document indicates compliance with this standard, which dictates how temperature accuracy and other metrics are determined.
8. The Sample Size for the Training Set
Not applicable. The device described uses an ASIC (Application Specific IC) - controlled circuit, which is characterized as "hard-wire control instead of programmable control." This implies it's not an AI/ML device that requires a "training set" in the conventional sense. The device's logic is fixed in hardware.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this device does not use a training set for an AI/ML algorithm.
§ 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.