(102 days)
The Infrared Ear Thermometer, models IR-04MT are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD(display) unit. The device is a reusable and intended for home use on people at all ages.
The Infrared Ear Thermometer, models IR-04MT is a 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(2xAAA batteries) 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 IR-04MT, they were designed and verified according to the US standard ASTM E 1965-2003.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Infrared Ear Thermometer, models IR-04MT:
1. Table of Acceptance Criteria and Reported Device Performance
Despite multiple references to performance and compliance with ASTM E1965-2003, the document does not explicitly state specific numerical acceptance criteria for accuracy (e.g., a specific deviation tolerance) or the exact reported performance metrics from the clinical study in an easily quantifiable format. It broadly states the device "was designed and verified according to the US standard ASTM E 1965-2003" and that "The results of the Clinical Test Report could positively support the claim of Substantial Equivalence."
To fulfill this section accurately, I can only infer the acceptance criteria are met by compliance with the referenced standard.
| Acceptance Criterion (Inferred from ASTM E1965:2003 compliance) | Reported Device Performance |
|---|---|
| Compliance with ASTM E1965:2003 for Infrared Ear Thermometers | Device "designed and verified" and "performance compliance test conducted" according to ASTM E1965:2003. |
| Clinical Test Report "positively support[s] the claim of Substantial Equivalence." | |
| Electrical Compliance (IEC 60601-1) | "Electrical Compliance Test according to IEC 60601-1 by accredited laboratory." |
| EMC Compliance (IEC 60601-1-2) | "EMC Compliance Test according to IEC 60601-1-2 by accredited laboratory." |
| Operability within specified range | The document implies the device met its specified operation range, though the range itself is not detailed. (Implied by "the measuring specification (including operation range, accuracy, measurement time)") |
| Accuracy within specified limits | Implied to meet limits set by ASTM E1965:2003. No specific deviation or error range reported. (Implied by "the measuring specification (including operation range, accuracy, measurement time)") |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "A Clinical Test Report conducted according to ASTM E1965:2003" but does not provide the number of subjects or measurements included in this test.
- Data Provenance: The study was conducted by the "manufacturer," which is DONGGUAN DALANG VIGOR ELECTRONICS MFY in China. Therefore, the data provenance is China. It is a prospective study, as it was a "Clinical Test Report conducted... performed by the manufacturer" as part of the device's validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not provide information on the number or qualifications of experts used to establish ground truth. The nature of an ear thermometer's ground truth (e.g., a reference rectal or oral temperature measured by a calibrated clinical thermometer) typically doesn't involve "experts" in the sense of radiologists or pathologists. Instead, it relies on the accuracy of the reference device and the methodology for its use.
4. Adjudication Method for the Test Set
- The document does not mention any adjudication method. For a device like an ear thermometer, "adjudication" in the traditional sense of multiple reviewers resolving discrepancies is not typically applicable. The ground truth is generally a single, objectively measured value from a reference method.
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, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is relevant for diagnostic imaging devices where human readers interpret medical images, sometimes with AI assistance. The Infrared Ear Thermometer is a direct measurement device, not an interpretative one, and does not involve AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this is effectively a standalone performance study. The device itself is an "algorithm only" (ASIC-controlled circuit) device that measures and displays temperature. Human involvement is limited to operating the device (placing it in the ear canal and reading the display), not interpreting complex output that would require a "human-in-the-loop" interaction in the typical sense of AI-assisted diagnostics. The clinical test measured the device's accuracy against a recognized standard without a human interpretation component that would require comparison to human-in-the-loop scenarios.
7. The Type of Ground Truth Used
- The ground truth used would be a reference temperature measurement obtained by a calibrated clinical thermometer following the guidelines of ASTM E1965:2003. This standard details how to conduct clinical performance evaluations for infrared thermometers. It implies a direct comparison to a known accurate temperature measurement from a standard clinical method (e.g., a rectal thermometer) under controlled conditions.
8. The Sample Size for the Training Set
- The document does not mention a specific training set or its sample size. This device is described as having an "ASIC (Application Specific IC) – controlled circuit," which is a "hard-wire control instead of programmable control." This implies a fixed, hardware-based algorithm rather than a software algorithm that would undergo a separate "training" phase with a dataset. Therefore, the concept of a "training set" as understood in machine learning/AI (which wasn't the focus of this device) does not apply here.
9. How the Ground Truth for the Training Set Was Established
- As there is no indicated "training set" in the context of an ASIC-controlled, hard-wired device that is not an AI/machine learning product, this question is not applicable. The device's fundamental function is governed by its hardware design and integrated circuit, which are designed to comply with physical principles of thermometry.
§ 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.