(185 days)
The infrared forehead Thermometer DPT-IFT100 is a non-contact thermometer intended for the intermittent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use.
The infrared forehead thermometer, Model DPT-IFT100, is an electronic thermometer using an infrared temperature sensor to measure infrared energy radiated from the forehead. This energy is collected through the infrared temperature sensor convert to a voltage signal. The signal is measured by the main microcontroller, calculated by the internal algorithm, finally converted into a digital temperature value to display on the LCD.
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 displayed in units of temperature after being compensated for ambient temperature. This permits temperature measurement from a 3~5 cm distance without contact with the object to be measured.
The Infrared forehead thermometer, Model DPT-IFT100, consists of the following parts:
a) Thermopile Sensor
b) Application-Specific Integrated Circuit
c) Housing
d) LCD and Backlight
e) 1 button (Power on/Power off/Measurement)
f) Alkaline batteries; size AAA, 2 x 1.5 V
g) LCD cover
This document (K202420) is a 510(k) summary for the Conmo Electronic Company Limited's Infrared Forehead Thermometer, Model DPT-IFT100. It details the device's characteristics, comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Infrared Forehead Thermometer DPT-IFT100 are primarily defined by adherence to recognized performance standards and demonstrated substantial equivalence to a predicate device. The performance data presented focuses on accuracy and the clinical study results.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| Accuracy (Laboratory) | |
| ±0.2°C : 35.0°C ~ 42.0°C | Achieved: Matches predicate device's specified accuracy. |
| ±0.3°C : 34.0°C ~ 34.9°C , 42.1°C ~ 43°C | Achieved: Matches predicate device's specified accuracy. |
| ±0.4°F: 95°F ~ 107.6°F | Achieved: Matches predicate device's specified accuracy. |
| ±0.5°F: 93.2°F ~ 94.8°F, 107.8°F ~ 109.4°F | Achieved: Matches predicate device's specified accuracy. |
| Accuracy (Clinical Repeatability) | |
| Meets acceptance criteria of clinical study protocol (implied from statement) | Reported: 0.1°C. The test report demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical study protocol. (Specific numerical acceptance criterion not explicitly stated, but conformance is affirmed). |
| Compliance with Performance Standards | |
| ASTM E1965-98 (Reapproved 2016) | Clinical study conducted according to this standard. Subject device "passed all test criteria" for this standard. Conforms. |
| ISO 80601-2-56 (2nd Edition 2017-03, and Amendment 1 2018) | Clinical study demonstrates clinical accuracy requirements of this standard within the distance range. Subject device "passed all test criteria" for this standard. Conforms. |
| Compliance with Safety and EMC Standards | |
| AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Testing performed to verify basic safety and essential performance. Subject device conforms. |
| IEC 60601-1-2:2014 | Testing performed to verify basic safety and essential performance. Subject device conforms. |
| IEC 60601-1-11 Edition 2.0 2015-01 | Testing performed to verify basic safety and essential performance. Subject device conforms to this standard for home healthcare environment. |
| Biocompatibility (ISO 10993-1: 2009 & sub-parts) | Testing performed to demonstrate compliance for cytotoxicity, skin irritation, and sensitization. "Test results confirm compliance with the requirements of the standards." |
| Software Verification and Validation | Software documentation was provided following FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern. (Implied acceptance by FDA clearance). |
| Cleaning Validation | Device checked for performance following cleaning and "met all performance requirements." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 150 subjects.
- Breakdown: 50 infants (newborn to one year), 50 children (greater than one to five years), and 50 adults (greater than five years old).
- Data Provenance: Not explicitly stated regarding country of origin. The study was conducted for a device manufactured by Conmo Electronic Company Limited, based in Guangxi Province, China, and submitted through a US Agent in Arizona. Clinical studies are typically conducted where the product is intended for market or where clinical trial infrastructure exists. The document does not specify if it was retrospective or prospective, but clinical studies for regulatory submissions are generally prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This document describes a clinical study for a medical device (thermometer) where the "ground truth" is the actual body temperature measurements. This is a direct measurement, not a subjective interpretation requiring multiple experts. The document does not mention the use of experts to establish a "ground truth" in the way one would for an AI-powered diagnostic image analysis system. The ground truth for temperature measurement would be established by the reference temperature measurement method used in the clinical setting, typically a calibrated device.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is a temperature measurement device, not an interpretative diagnostic device requiring adjudication of expert opinions.
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
Not applicable. This is a standalone medical device (thermometer) and not an AI-assisted diagnostic tool that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, implicitly. The performance of the Infrared Forehead Thermometer DPT-IFT100 is its standalone measurement accuracy, clinical bias, and clinical repeatability. The device operates independently to measure temperature. The "algorithm" mentioned (CM3.1 Algorithm) is internal to the device for processing the infrared signal into a temperature reading. The clinical study directly assesses this standalone performance against accepted standards.
7. The Type of Ground Truth Used
The ground truth used for the clinical study was the actual body temperature, presumably measured by a reference thermometer, against which the DPT-IFT100's readings were compared to determine clinical bias and repeatability. This is akin to outcomes data or a highly accurate reference standard measurement. The study report stated: "The test report demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical study protocol."
8. The Sample Size for the Training Set
Not applicable. This device is a traditional electronic thermometer, not an AI/machine learning device that requires a separate training set. The "algorithm" (CM3.1) refers to its internal firmware/logic for temperature calculation, not a learned model from a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned for this type of device. The device's internal algorithm (CM3.1) is a fixed computational process, not an AI model that learns from a training set.
§ 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.