(154 days)
The FT-100A Electronic thermometer is an Infrared thermometer which uses an infrared sensor to detect human body temperature of patients of all ages. It is intended to detect body temperature. The FT-100A is intended for home use.
The Universal Infrared Forehead Thermometer, Model FT-100A is a non-contact thermometer which infers temperature from the blackbody radiation emitted from the patient. Temperature is calculated from the knowledge of the amount of infrared energy emitted from the human body. The design consists of a lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal that can be displayed in units of temperature after being compensated for ambient temperature. This permits temperature measurement from a distance without contact with the object to be measured.
The provided text describes the 510(k) premarket notification for the Infrared Forehead Thermometer, FT-100A. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a standalone study for the device's performance against specific statistical targets commonly seen in AI/ML medical devices.
However, I can extract information related to the device's accuracy and the clinical investigation performed.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for accuracy are implicitly derived from the comparison to the predicate device and the standards met. The table below combines the stated accuracy for the new device and the predicate, implying that the new device aims to meet or exceed the predicate's accuracy.
| Characteristic | Acceptance Criteria (implied from predicate/standards) | Reported Device Performance (FT-100A) |
|---|---|---|
| Accuracy (Body Mode) | ±0.2°C (±0.36°F) from 36.0°C (96.8°F) to 39.0°C (102.2°F) | |
| ±0.3°C (±0.54°F) from 32.0°C (89.6°F) to 35.9°C (96.6°F) and from 39.1°C (102.4°F) to 43.0°C (109.4°F) (From Predicate) | FOR BODY MODE: | |
| ± 0.2°C (±0.4°F) from 36.0°C (96.8°F) to 39.0°C (102.2°F) | ||
| ± 0.3°C (±0.5°F) from 32.0°C (89.6°F) to 35.9°C (96.6°F) and from 39.1°C (102.4°F) to 43.0°C (109.4°F) |
Clinical investigation demonstrated: "bias less than predicate device when compared to reference." This implies the FT-100A met or exceeded the accuracy of the predicate against the reference.
"clinical repeatability... statistically and clinically acceptable (less than 0.3 deg C or 0.58 deg F)." |
| Accuracy (Object Mode) | ± 1°C (±2°F) from 0°C (32°F) to 100°C (212°F) (From Predicate) | FOR OBJECT MODE:
± 4°C (±7.2°F) from 0°C (32°F) to 4.9°C (40.8°F)
± 1°C (±2°F) from 5.0°C (32°F) to 60.0°C (140.0°F)
± 4°C (±7.2°F) from 60.1°C (140.1°F) to 100°C (199.9°F) |
| Clinical Repeatability | Defined in ASTM E1965-98 (Reapproved 2009) as "clinical acceptability" (not explicitly quantified for predicate, but implied by standard compliance). | "statistically and clinically acceptable (less than 0.3 deg C or 0.58 deg F)." |
| Compliance with Standards | ISO 80601-2-56:2009, ASTM E1965-98(Reapproved 2009) (and others for biocompatibility, electrical safety, EMC) | Passed all listed standards (ISO 10993-5, ISO 10993-10, ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-56, ASTM E1965-98). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The text states, "A clinical investigation was performed to evaluate the clinical accuracy and clinical repeatability on the following three age groups: 0-12 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.