(141 days)
The No Touch + Forehead Thermometer (Model NTF3000US) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch on the centre of the forehead as the measurement site on people of all ages.
The No Touch+Forehead Thermometer ( Model NTF3000US) is a hand-held, battery powered device designed to measure human body temperature. The NTF3000 is an Infrared thermometer that converts a user's forehead temperature using the infrared energy emitted in the area around the user's forehead to an oral equivalent temperature when placed in contact with the subject's forehead or up to two (2) inches away. The NTF 3000 thermometer uses 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 non-contact use and compensation of the temperature reading.
Here's a breakdown of the acceptance criteria and study information for the KAZ USA, Inc. No Touch+ Forehead Thermometer (Model NTF3000US), based on the provided text:
Acceptance Criteria and Reported Device Performance
The primary acceptance criteria for the No Touch+ Forehead Thermometer are established by its conformance to the ASTM E1965-03 standard for clinical accuracy and repeatability. The device needed to demonstrate non-inferiority or substantial equivalence to the predicate device against a gold standard.
| Acceptance Criteria (from ASTM E1965-03) | Reported Device Performance (No Touch+ Forehead Thermometer) |
|---|---|
| Bias: Clinical acceptability (less than predicate device when compared to reference) | Within clinical acceptability |
| Clinical Repeatability: Less than 0.3 °C (0.58 °F) | Statistically acceptable (less than 0.3 °C or 0.58 °F) |
Study Details
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document states that a comparison study was performed across four age groups: 0-12 months, 12 months-
§ 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.