(101 days)
Actherm Infrared Ear Thermometers ACT8000 Series are used to measure body temperature from auditory canal. This device is intended for household and hospital use on people of all age, and is used with or without probe cover medACCU2010.
Infrared Ear Thermometers (Model ACT8000 Series) are electronic Actherm thermometers using a thermopile as the temperature sensor's electric signal is then calculated and displayed by a MicroController. These thermometers display the temperature decimal. Model ACT8000 Series has the same indication for use. However, appearance difference exists between ACT8000 Series. 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.
The digital 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.
The system uses two 1.5V DC batteries for the power supply and the battery power is automatically checked by the MicroController and displayed in LCD if the battery is exhausted.
Actherm Infrared Ear Thermometers ACT8000 Series can be combined with accessories, weighting base and wall mount. For the weighting base, the whole set of body temperature measurement devices, including infrared ear thermometer, digital thermometer, and probe cover, can be put on it, For the wall mount, it can be fixed on the wall and the cradle of infrared ear thermometer can be put on this wall mount. Also, the probe cover boxes can be hanged on the hook that under the wall mount or put inside the cradle.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Actherm Infrared Ear Thermometer (K090031):
Device: Actherm Infrared Ear Thermometer ACT8000 Series and its Probe Cover medACCU2010
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet ASTM Standard Specification for Infrared Thermometer for Intermittent Determination of Patient Temperature (ASTM E 1965-98: 2003) | Confirmed to meet ASTM E 1965-98: 2003 |
| Meet EN60601-1 requirements | Confirmed to meet EN60601-1 |
| Meet EN60601-1-2 requirements | Confirmed to meet EN60601-1-2 |
| Meet EN12470-5 requirements | Confirmed to meet EN12470-5 |
| Accuracy | Confirmed to meet specified accuracy |
| Precision | Confirmed to meet specified precision |
| Repeatability | Confirmed to meet specified repeatability |
| Biological Compatibility | Identical materials used in other legally marketed devices under the same use conditions (implies biological compatibility is met) |
Note: The document explicitly states that "Bench testing confirmed accuracy, precision and repeatability measurements specified in the labeling." However, the specific quantitative values for these criteria (e.g., ± 0.2°C) are not provided in this summary. It simply states they were met according to the labeling.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for any of the studies (bench or clinical).
- Data Provenance: Not explicitly stated. The document mentions "bench testing contained in this submission and clinical testing supplied." It does not specify the country of origin or if these studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Experts: Not explicitly stated.
- Qualifications: Not explicitly stated.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported in this summary. This device is a thermometer, which typically does not involve human readers interpreting AI output in the same way imaging devices might.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
- Standalone Performance: Yes, the performance criteria listed (accuracy, precision, repeatability) are inherently standalone performance measures for the device itself.
- "Bench testing confirmed accuracy, precision and repeatability measurements specified in the labeling."
- The thermometer operates autonomously to measure temperature.
7. Type of Ground Truth Used:
- Ground Truth: For the bench testing (accuracy, precision, repeatability), a "ground truth" would typically be established using a reference thermometer or a calibrated temperature source with known accuracy (e.g., a blackbody radiator for infrared thermometers).
- For "clinical testing," the ground truth for body temperature would likely be established by a highly accurate reference method, such as a rectal thermometer or an oral thermometer with known accuracy, under controlled clinical conditions. The document does not specify the exact method used for clinical testing ground truth.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This device is an infrared ear thermometer, a hardware medical device that measures temperature. It does not use "training sets" in the context of machine learning or AI algorithms. Its performance is based on its physical design, calibration, and adherence to established engineering and medical device standards.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no "training set" in the context of 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.