(183 days)
The Infrared thermometer model A200 is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature by Forehead mode for people of all ages.
The Infrared thermometer model A201 is a multi-function infrared thermometer intended for the intermittent measurement of human body temperature by Ear mode or Forehead mode for people of all ages.
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead.
The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection of contact or no-contact use and compensation of the temperature reading.
The device consists of the MCU, enclosure and LED and the device is powered by 2 AAA alkaline batteries.
The device has a memory function that automatically stores 25 sets data of the latest measurements. It can also display the latest measurement result.
The Infrared thermometer included A200 & A201. A200 unit is a no- contact Infrared forehead thermometer, A201 unit is multifunction infrared thermometer and it can be selected Ear mode or Forehead mode.
The provided text describes the 510(k) Summary for the Infrared thermometer models A200 and A201. It includes a comparison to predicate devices and discusses performance data but does not provide a comprehensive study proving the device meets specific acceptance criteria in the format requested.
The document discusses conformance to standards as evidence of performance, but does not present a detailed study with acceptance criteria and results for each.
However, based on the provided text, here's an attempt to extract and infer the closest information to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily refers to compliance with established standards rather than specific acceptance criteria thresholds in a direct table format. The "Accuracy" section under the predicate comparisons acts as the closest representation of performance.
Model A200 (Forehead Mode)
| Acceptance Criteria (from standard/predicate) | Reported Device Performance (Model A200) |
|---|---|
| +/- 0.2°C (0.4°F) within 36.0°C ~39.0°C (96.8°F ~102.2°F) | +/- 0.2°C (0.4°F) within 36.0°C ~39.0°C (96.8°F ~102.2°F) |
| +/- 0.3°C (0.5°F) for other ranges | +/- 0.3°C (0.5°F) for other ranges |
Model A201 (Ear/Forehead Mode)
| Acceptance Criteria (from standard/predicate) | Reported Device Performance (Model A201) |
|---|---|
| +/- 0.4°F (0.2°C) within 96.8 | +/- 0.4°F (0.2°C) within 96.8 |
| +/- 0.5°F (0.3°C) for other ranges | +/- 0.5°F (0.3°C) for other ranges |
Note: The document states that "the measurement range of subject devices meet the requirements of ISO80601-2-56" and that the "performance test result of A200 & A201 shows the accuracy meets the requirements within the distance range." This implies that the device met the requirements outlined in these standards for accuracy and measurement distance, which serve as the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions:
- Clinical data: "According to the ASTM E 1965-98, the clinical trial was performed for people of all ages."
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). It is inferred to be prospective as it's a "clinical trial."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The reference to a "clinical trial" implies expert involvement in temperature measurement (e.g., using a reference thermometer), but details about these experts (number, qualifications) are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document.
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
This is not applicable as the device is an infrared thermometer for direct measurement, not an AI-assisted diagnostic tool that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device operates in a standalone manner as an infrared thermometer. Its performance is evaluated intrinsically through various tests and a clinical trial. The "Performance Data" section details compliance to standards and verification of:
- Measurement Range & Accuracy
- Measurement distance
- Response time
The "Clinical data" section further confirms its standalone performance: "The test report shows clinical accuracy meets the range claimed by manufacturer. It can conclude that the subject devices, model A200 & A201, are acceptable to measure human body's temperature."
7. The Type of Ground Truth Used
The ground truth for the clinical trial would likely be established using a (reference) clinical thermometer considered the gold standard for body temperature measurement, against which the infrared thermometer's readings are compared. This is implied by "clinical accuracy" evaluation. It is not pathology or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable as the device is not described as involving machine learning or AI algorithms requiring a training set. It is a traditional medical device based on established physical principles (infrared radiation detection).
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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.