(281 days)
PG-IRT1612 & PG-IRT1618
Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead. The device can be used on people of all ages at home or in hospital environment.
PG-IRT1613 & PG-IRT1615
Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead. The device can be used on people of all ages at home or in hospital environment.
The proposed device includes 4 models, which are PG-IRT1613, PG-IRT1613, PG-IRT1615 and PG-IRT1618. All models of infrared thermometers are intended for people of all age.
The proposed devices, Infrared Forehead Thermometers, Model PG-IRT1612 and PG-IRT1618, are hand-held, reusable, battery powered device, which are intended to measure human body temperature by measuring forehead. They are non-contact infrared thermometers. The distance of the measurement is 3~5cm.
The proposed devices, Infrared Ear/Forehead Thermometers, Model PG-IRT1613 and PG-IRT1615, are hand-held, reusable, battery powered device, which are intended to measure human body temperature by measuring ear canal or forehead. The ear cavity mode is contact measurement. The forehead mode is non-contact measurement and the measurement distance is 1~5mm.
The proposed devices are operated in adjusted mode. The body site used to reference the adjusted temperature value displayed on the proposed device of each model is oral.
Principle of operation
The proposed device uses a temperature sensor, which can detect the object temperature (OBJ) [human body temperature], environment temperature (NTC) and temperature of sensor itself (AMB); these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module (signal conversion module) in MCU (Microcontroller Unit) of the proposed device. MCU will calculate the body temperature based on OBJ, NTC and AMB, and then transfer to screen for display.
The provided text describes the acceptance criteria and a clinical study conducted for the Shenzhen Pango Medical Electronics Co., Ltd. Infrared Thermometers (Models: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the infrared thermometers are primarily based on the standards ISO 80601-2-56 and ASTM E1965-98. The reported device performance indicates compliance with these standards.
| Feature / Criteria | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Accuracy | ±0.2°C (0.4°F) at 35.0°C ~ 42.0°C (95.0°F ~ 107.6°F); Others ±0.3°C (0.5°F) (per ISO 80601-2-56 and ASTM E1965-98) | Achieved; clinical accuracy not inferior to predicate device and complies with ASTM E1965-98. |
| Measurement Range | 34.0°C ~ 43.0°C (93.2 ~ 109.4°F) | Achieved |
| Display Resolution | 0.1°C (0.1°F) | Achieved |
| Response Time | 1s | Achieved |
| Biocompatibility | Compliant with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) | Complied; no adverse effect observed. |
| Electrical Safety | Compliant with IEC 60601-1 | Complied; no performance degradation or safety issue. |
| EMC | Compliant with IEC 60601-1-2 | Complied; no performance degradation or safety issue. |
| Clinical Bias | Evaluated per clinical validation for infrared thermometer (implied within ASTM E1965-98) | Not inferior to the predicate device. |
| Clinical Uncertainty | Evaluated per clinical validation for infrared thermometer (implied within ASTM E1965-98) | Not inferior to the predicate device. |
| Clinical Repeatability | Evaluated per clinical validation for infrared thermometer (implied within ASTM E1965-98) | Not inferior to the predicate device. |
| Software Validation | Compliant with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Met requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): A total of 120 subjects were used for each clinical study, split into three age groups:
- Age 0-1: 40 subjects
- Age 1-5: 40 subjects
- Age above 5: 40 subjects
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It does state that "Controlled human clinical studies were conducted in accordance with ASTM E1965-98 (Reapproved 2016)," but the location of these studies is not specified. It is likely a prospective study as it involved actively recruiting subjects to test the device.
3. Number of Experts Used to Establish the 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 study.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No information about a Multi Reader Multi Case (MRMC) comparative effectiveness study is provided in the document. The study was a comparison to a predicate device's performance, not specifically focusing on human reader improvement with or without AI assistance.
6. Standalone Performance Study
Yes, the clinical study performed can be considered a standalone performance study for the algorithm embedded within the device, as it evaluates the device's accuracy, bias, and repeatability against established clinical standards (ASTM E1965-98). The device itself is an "algorithm only" in the sense that it automatically calculates and displays temperature based on sensor readings without human interpretation of raw data.
7. Type of Ground Truth Used
The ground truth for the clinical study was established by comparison with a predicate device and compliance with standardized clinical validation methods (ASTM E1965-98). While not explicitly stated as "expert consensus" or "pathology," the ASTM E1965-98 standard defines methods for clinical accuracy assessment of intermittent thermometers, which usually involves comparing the device's readings to highly accurate reference thermometers or established clinical methods as the ground truth. The statement that "febrile persons" were included implies that actual body temperatures, including elevated ones, were measured.
8. Sample Size for the Training Set
The document does not provide any information about a "training set" or its sample size. This type of device (infrared thermometer) typically relies on engineering calibration and validation against physical standards and clinical studies rather than machine learning training sets in the AI sense.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned for this device, a method for establishing its ground truth is also not applicable or not provided. The development process likely involves engineering design, component selection, calibration, and then validation through the non-clinical and clinical tests described.
§ 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.