(114 days)
Infrared Ear/Forehead Thermometer DET-218 is intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.
The Infrared Ear/Forehead Thermometer is a hand-held, battery powered device designed to measure human body temperature from the auditory canal or forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or forehead.
The Infrared Ear/Forehead Thermometer use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a thermopile collect, the infrared energy emitted from the forehead.The results can be displayed on LCD. And, the results measured by DET-218 can also be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application APP installed on a mobile device using the iOS system or the Android system. The thermometer is reusable for home use on people of all ages with adult supervision. The device can be used with as a stand-alone device or in conjunction with the App on a compatible BLE enabled smartphone.
The purpose of data transfer to a mobile device is convenient for users to view the measured data through the APP. The APP operating system is IOS 9.0+ system , Android 5.0+ system.
The name of APP is "Healthforyou",it adopts AES+RSA combination to encrypt and decrypt interface parameters and the data transmission between APP and server adopts HTTP+SSL mode to ensure the security of information.
The App only visualizes the Measurements from the device via. bluetooth to smart phone. The APP receives and records data, and displays measurement on smart phone in correspondence with DET-218 Measurement site (Ear/Forehead) set. The App has the following functions:
l. data recording;
II. curve display;
III. alarm functions.
The light bar of DET-218 turns on green light when the measurement is
Here's an analysis of the provided text to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the infrared ear/forehead thermometerDET -218 are established by relevant international standards, particularly ASTM E1965-98 (2016) for clinical performance. The reported device performance is stated to comply with these requirements.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Accuracy (Ear/Forehead mode) | ASTM E1965-98 (2016) defines accuracy requirements for infrared thermometers. | ±0.2°C (0.4°F) during 35.5°C ~ 42.0°C (95.9°F ~ 107.6°F) at 15°C ~ 35°C (59.0°F ~ 95.0°F) operating temperature range. |
| ±0.3°C (0.5°F) for other measuring and operating temperature range. | ||
| Electrical Safety and Performance | AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 Medical Electrical Equipment | |
| ISO 80601-2-56:2017 Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement | ||
| ASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature | Results of these tests demonstrate compliance to the requirements of the standards. | |
| Home-Used Medical Equipment & Environmental | IEC 60601-1-11:2015 General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | Compliance demonstrated. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | |
| EN300328:Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; | ||
| ETSI EN 301489-1: Electromagnetic compatibility and Radio spectrum Matters(ERM); ElectroMagnetic Compatibility (EMC)standard for radio equipment and services;Part 1:Common technical requirements; | ||
| ETSI EN 301489-17: Electromagnetic compatibility and Radio spectrum Matters (ERM);ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions or Broadband Data Transmission Systems; | Compliance demonstrated; FCC, EN301489-1, EN301489-17, EN 300328 and wireless coexistence test passed for the Bluetooth transmission. | |
| Biocompatibility | ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | |
| ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | Compliance demonstrated. | |
| Software/Firmware Verification and Validation | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. | Software Validation Passed (for memory set changes and lack of voice function). |
| Response Time | Implied functional requirement (not explicitly given as an acceptance criterion from a standard, but noted as a difference from the predicate). | Approx. 1s (shorter than predicate, and all tests passed, indicating this difference "does not raise new performance questions"). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Performance Test: 150 subjects.
- Data Provenance: The document does not explicitly state the country of origin for the clinical test data. It only mentions that "clinical tests were conducted on the DET-218." It is reasonable to assume it was a prospective study, as it was conducted to evaluate the device's performance against a standard. The study included three groups based on age:
- Infants: newborn to one year
- Children: greater than one to five years
- Adults: greater than five years old
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical performance test. The ground truth method is described below.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. The clinical performance test protocol and data analysis were conducted as per the requirements of ASTM E1965-98 (2016). This standard typically outlines the methods for comparison against a reference thermometer, implicitly defining the ground truth measurement process rather than an adjudication among multiple readings of the device under test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a thermometer, and its performance is evaluated against reference measurements rather than subjective human interpretation of cases.
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 focuses on the device (Infrared Ear/Forehead Thermometer DET-218) and its conformance to standards. The "clinical tests" described are for the device itself, not for an algorithm where human input is part of the performance metric. The device also has an associated app, but the app's function is for data visualization, recording, and alarm, not for independent diagnostic or measurement capabilities requiring a human in the loop for its core function.
7. The Type of Ground Truth Used
The ground truth for the clinical performance test was established by a reference measurement method as defined by ASTM E1965-98 (2016). This typically involves comparing the device's readings against highly accurate reference thermometers or established clinical measurement techniques to determine accuracy. It is not expert consensus, pathology, or outcomes data in the usual sense for diagnostic imaging or similar devices.
8. The Sample Size for the Training Set
The document describes a clinical performance test, which is a test set evaluation. It does not mention a "training set" or any machine learning model training process for the core measurement functionality of the thermometer. The device's operation is based on physical principles (measuring thermal radiation), not a data-trained algorithm for its primary measurement.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for the primary measurement function of the device, this question is not applicable based on the provided text.
§ 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.