(92 days)
Actherm Infrared Ear Thermometers ACT 8000R Series are used to measure body temperature from auditory canal. This device is intended for household and hospital use on pcople of all age, and is used with or without probe cover medACCU2010.
Actherm Infrared Ear Thermometers (Model ACT 8000R Series) are electronic thermometers using a thermopile as the temperature sensor. The sensor's electric signal is then calculated and displayed by a Micro-Controller. These thermometers display the temperature decimal. To compare with ACT 8000 Series, Model ACT 8000R Series has the same indication for use. ACT 8000R Series can be made with various functions, such as Dual scale, Backlight, Scan LED, W/O cover, following with the model number indicates scale switchable, with Backlight, with Scan completed indicator, without probe cover, will be added following the model number. The infrared ear thermometer comprises: a thermopile for temperature sensing, a buzzer for sounding effect, a Micro Controller and a LCD display for calculating and displaying the target temperature digitally. Actherm Infrared Ear Thermometers ACT 8000R Series can be combined with accessories, base, wall mount and power adapter. The base is a tray for holding probe cover box, power input, power/charge indicator, portable/ fixed probe-cover dispenser and the area for placing digital thermometer and its probe cover. For the wall mount, it can be fixed on the wall and the base can be put on this wall mount. The system uses two 1.5V DC alkaline rechargeable batteries for the power supply and the battery power is automatically the Micro-Controller and displayed in LCD if the battery is exhausted. The batteries can be recharged only when the ear thermometer ACT8000R put on the base. ACT 8000R cannot be used when recharging.
This document is a 510(k) summary for the Actherm Infrared Ear Thermometer ACT 8000R Series. It describes how the device meets acceptance criteria through conformance to various standards and provides limited information regarding specific study details.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM E 1965-98: 2003 (Standard Specification for Infrared Thermometer for Intermittent Determination of Patient Temperature) | Fulfilled testing requirements; clinical test results conform to requirements. |
| EN 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Fulfilled testing requirements. |
| EN 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests) | Fulfilled testing requirements. |
| EN 12470-5 (Clinical thermometers - Part 5: Performance of infrared ear thermometers (with maximum device) | Fulfilled testing requirements; clinical test results conform to requirements. |
| ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | Requirements met. |
| ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity) | Requirements met. |
| ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization) | Requirements met. |
| Electrical Safety (Performed test) | Passed electrical safety performed test. |
2. Sample size used for the test set and the data provenance
The document states "The clinical test results of Actherm Infrared Ear Thermometer ACT 8000 and Probe Cover medACCU 2010 conform to the requirements of ASTM E 1965-98 and EN 12470-5 that are the same performance for ACT 8000R Series." This implies that the testing was carried out on the predicate device (ACT 8000) and the results were deemed applicable to the ACT 8000R Series due to substantial equivalence.
- Sample size for the test set: Not explicitly stated. The text refers to "clinical test results" but does not provide details on the number of subjects or measurements.
- Data provenance: Not explicitly stated, but given that the submitter is Actherm Inc. in Taiwan, R.O.C., it is likely that the data originated from studies conducted in that region or through certified testing facilities. The study type (retrospective or prospective) is not mentioned.
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 standards mentioned define performance requirements for device accuracy, but the method for establishing "ground truth" (e.g., using a reference thermometer and standard clinical protocols) and the involvement of specific experts are not detailed.
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 device is an infrared ear thermometer, a standalone measurement device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The entire summary describes the device's technical specifications and its performance against established medical device standards (ASTM, EN, ISO). The device operates independently to measure temperature, meaning its performance is evaluated in a standalone manner without human subjective input affecting the measurement itself. The clinical tests mentioned (conforming to ASTM E 1965-98 and EN 12470-5) are standalone performance evaluations of the thermometer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a thermometer, the "ground truth" typically involves reference temperature measurements from highly accurate and calibrated devices. The ASTM E 1965-98 standard, which the device conforms to, outlines methods for clinical accuracy studies, usually involving comparing the device's readings against a known, highly accurate reference thermometer in a controlled clinical setting. The document does not explicitly state the specific type of ground truth used beyond conformity to these standards.
8. The sample size for the training set
This device is a traditional electronic thermometer, not an AI/machine learning device that requires a "training set." Therefore, the concept of a training set sample size does not apply.
9. How the ground truth for the training set was established
As mentioned above, this device does not utilize a training set in the context of machine learning.
§ 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.