(195 days)
Non-conact Infrared Themometer, model JPD-FR 100, can measure for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
The Non-contact Infrared Thermometer, Model JPD-FR100, uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The predicated device KI-8280, use the same detection principle to measure the patient's temperature.
The subject device also use the focusing design to collect the infrared emitted from nearby area of patient's forehead. This mechanism make the subject device have the ability to detect the forehead temperature in the distance of 1-6cm. The subject device intended to detect the temperature of patients. The temperature is converted to the oral temperature. The temperature reading shown in the device display after measuring is the patient's oral temperature.
The compact, small and light-weight design, the Shenzhen Jumper Medical Equipment Co., Ltd. Non-contact Infrared Thermometer, model JPD-FR100, enables to provide safe and reliable result and offers a very good clinical accuracy for human body temperature measurements.
The medical device in question is a Non-contact Infrared Thermometer, Model JPD-FR100.
Here's an analysis of the provided text for acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The primary acceptance criterion mentioned is compliance with the ASTM E1965-98 (2009) standard for infrared thermometers.
| Acceptance Criteria (from ASTM E1965) | Reported Device Performance (JPD-FR100) |
|---|---|
| Measurement Accuracy (forehead temperature mode) | ±0.2°C (0.4°F) |
Further details about the specific accuracy requirements within ASTM E1965 for different temperature ranges, as well as repeatability and other performance metrics, are not explicitly detailed in the provided summary. However, the study "complied with the requirements of ASTM E1965."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for the clinical test set. It mentions "the clinical performance test protocol and data analysis followed the requirements of ASTM E 1965."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). ASTM E1965 specifies clinical testing, implying prospective data collection on human subjects, but the location is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For a thermometer, the "ground truth" for temperature measurement is typically established using a reference thermometer or a controlled environment, not through expert human interpretation. The ASTM E1965 standard defines the methodology for this.
4. Adjudication Method for the Test Set
Not applicable. Temperature measurement through a device like a thermometer does not involve human adjudication in the way medical image analysis or diagnostic studies do. The ground truth is a direct measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. For a thermometer, the device provides a direct measurement, and human interpretation is not the primary factor of interest in its performance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The document states: "The test report showed the clinical performance of subject device complied with the requirements of ASTM E1965. It is acceptable to measure patient's temperature." This indicates that the device's accuracy was assessed independently against the ASTM standard.
7. Type of Ground Truth Used
The ground truth used for the clinical performance test would be simultaneous measurements from a calibrated reference thermometer as per the methodology defined in ASTM E1965. The standard dictates how to compare the device's readings to highly accurate ground truth measurements.
8. Sample Size for the Training Set
Not applicable. The device is a non-contact infrared thermometer, which is a sensor-based measurement device. It does not employ machine learning or AI models that would require a "training set" in the conventional sense. Its function is based on physical principles of infrared radiation detection.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.