(133 days)
The Infrared thermometer is a non-contact infrared 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 Thermometer, Models RN-50A and RN-50B are hand-held device powered by 2*AA batteries and designed to measure human body temperature without contacting patient' forehead. The Infrared Thermometers RN-50A and RN-50B measure the temperature by using the principle of receiving infrared. An object with a temperature higher than absolute zero will radiate a certain amount of infrared energy. According to the infrared energy and wavelength, the surface temperature of the object can be determined. The temperature of human forehead is relatively constant, so the temperature of human forehead can be measured according to this principle. The thermometer adopts a new CMOS compatible thermopile sensor with good sensitivity. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then display on the LCD screen in digital form. The measurement distance of the subject device is 3~5 cm from the forehead. The only differences among the RN-50A and RN-50B thermometers are size, weight, shape of enclosure.
The provided document is a 510(k) premarket notification for an Infrared Thermometer (Models RN-50A, RN-50B). It describes the device, its intended use, a comparison to a predicate device, and the non-clinical and clinical testing performed 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:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the infrared thermometer are primarily based on its accuracy and adherence to specific standards.
| Acceptance Criterion | Reported Device Performance (as stated or implied) |
|---|---|
| Accuracy (Forehead mode) | "$±0.2°C (0.4°F)$ within $36.0°C ~ 39.0°C (96.8°F ~ 102.2°F)$, $±0.3°C(0.5°F)$ other range" (Page 5) |
| "the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016)." (Page 9) | |
| Measurement Range (Forehead mode) | "$32.0°C ~42.9°C (89.6 to 109.2 °F)$" (Page 5) |
| "the measurement range of subject devices meet the requirements of ASTME1965-98." (Page 6) | |
| Measurement Distance | "3~5 cm from the forehead." (Page 5) |
| "the clinical trial report of the subject device demonstrates the device meets the clinical accuracy requirements of the standards ISO 80601-2-56 and ASTM E1965-98 within the distance range" (Page 7) | |
| Compliance with ISO 80601-2-56 | "Clinical tests were conducted per ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature." (Page 9) |
| "the device meets the clinical accuracy requirements of the standards ISO 80601-2-56 and ASTM E1965-98 within the distance range" (Page 7) | |
| Compliance with ASTM E1965-98 | "Clinical tests were conducted per ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature." (Page 9) |
| "the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016)." (Page 9) | |
| Biocompatibility | Tested and compliant with ISO 10993-1, -5, -10 regarding Cytotoxicity, Irritation, and Sensitization. (Page 8-9) |
| Electrical Safety (IEC 60601-1) | Complies with IEC 60601-1: 2012 (Page 7) |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2:2014 (Page 7) |
| Home Healthcare Environment (IEC 60601-1-11) | Complies with IEC 60601-1-11:2015 (Page 7) |
| Software Validation (Moderate Level of Concern) | Software validation conducted in accordance with FDA guidance. (Page 9) |
Study Details:
The document describes a "Clinical Accuracy Validation Test" as the primary study to prove the device meets acceptance criteria for accuracy.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "consists of a 161 subjects which were divided into three group age ranges- A Infant group (Group A- (A1) 1 month up to 3 months; (A2)- 3 months up to 1 year), B Child group (greater than 1 to 5 years old) and C Over 5 years old (Above 5 years old). Each group at least has 35 subjects." (Page 9)
- Data Provenance: Not explicitly stated, but given the manufacturer's address (Ningbo, China) and the correspondent's address (Shanghai, China), it can be inferred the study was likely conducted in China. The document does not specify if it was retrospective or prospective, but clinical trials are typically prospective.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. For a thermometer, the "ground truth" would typically come from a highly accurate reference thermometer (e.g., a rectal thermometer for core body temperature, or a calibrated black-body source for non-contact measurements), not human experts.
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Adjudication Method for the Test Set:
- This is not applicable as the "test set" here refers to patient measurements compared to a reference standard, not images requiring expert interpretation and adjudication.
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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:
- This is not applicable to this device. An infrared thermometer measures temperature; it does not involve human readers interpreting images or AI assistance.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This is not applicable in the traditional sense of an "algorithm" in AI. The device itself is the "standalone" entity that measures temperature. Its performance is evaluated against a clinical standard.
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The Type of Ground Truth Used:
- The ground truth for the clinical accuracy validation test was derived from a reference standard as defined by ASTM E1965-98 (Reapproved 2016). This standard outlines procedures for determining the accuracy of infrared thermometers against a "core body temperature" reference, often involving concurrent measurements with highly accurate methods like rectal thermometers in a controlled clinical setting. While not explicitly stated as "rectal" or "oral" in this document, adherence to the ASTM standard implies the use of a validated, highly accurate measurement method as the ground truth.
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The Sample Size for the Training Set:
- This device is a physical thermometer, not a machine learning model that requires a distinct "training set." The concept of a "training set" is not applicable here. The 161 subjects are for the validation of the device's accuracy.
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How the Ground Truth for the Training Set Was Established:
- As there is no "training set" in the context of an AI/ML model for this device, this question is not applicable. The device's design and calibration would have been based on physics principles and engineering, not data-driven training.
§ 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.