(237 days)
Infrared Thermometer is intended to detect body temperature from the forehead or auditory canal in the population including infant (above 6 months), child, adolescent, and adult
The proposed device, Infrared Thermometers IFR 600 is hand-held, reusable, battery powered device, which is intended to detect body temperature from forehead or auditory canal in the pediatric and adult population.
IFR 600 infrared thermometer can measure human body temperature by both ear and forehead measurement.
The provided document describes the acceptance criteria and a clinical study conducted for the Infrared Thermometer Model IFR 600 by Shenzhen Jiacom Technology Co., Ltd.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on compliance with specific international standards and the clinical accuracy of the device. The reported performance confirms this compliance.
Acceptance Criteria for Infrared Thermometer Model IFR 600
| Acceptance Criteria Category | Specific Criteria (Standard/Requirement) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Complied with ISO 10993-5 |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Complied with ISO 10993-10 | |
| Electrical Safety | AAMI / ANSI ES60601-1:2005/(R) 2012 (General requirements for basic safety and essential performance) | Complied with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 (Requirements and Tests) | Complied with IEC 60601-1-2 |
| Performance (Clinical Thermometers) | ISO 80601-2-56:2009 (Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers) | Complied with ISO 80601-2-56 |
| Performance (Infrared Thermometers) | ASTM E1965-98 (R 2016) (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature) | Complied with ASTM E1965-98 (2003) |
| Clinical Accuracy (Ear Mode) | ±0.2°C at 35.5°C-42.0°C; ±0.3°C at 32.0-35.0°C and 42.0°C-42.9°C (Aligned with ASTM E1965-98) | Achieved; clinical accuracy not inferior to predicate device and complies with ASTM E1965-98. |
| Clinical Accuracy (Forehead Mode) | ±0.2°C at 35.5°C-42.0°C; ±0.3°C at 34.0-35.4°C and 42.1°C-42.9°C (Aligned with ASTM E1965-98) | Achieved; clinical accuracy not inferior to predicate device and complies with ASTM E1965-98. |
| Clinical Bias | Not explicitly stated as a numerical limit, but evaluation per ASTM E 1965-98(2003) | Not inferior to predicate device. |
| Clinical Uncertainty | Not explicitly stated as a numerical limit, but evaluation per ASTM E 1965-98(2003) | Not inferior to predicate device. |
| Clinical Repeatability | Not explicitly stated as a numerical limit, but evaluation per ASTM E 1965-98(2003) | Not inferior to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study (Test Set): "40 of each age range of subjects" were included. The document specifies the population as "infant (above 6 months), child, adolescent, and adult". It's unclear how many distinct age ranges were used, so the total exact sample size is not precisely specified but would be 40 multiplied by the number of age ranges. For example, if there were 4 age ranges (infant, child, adolescent, adult), the total would be 160.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "Controlled human clinical studies," suggesting it was prospective research.
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 for the clinical study. It refers to "clinical validation for infrared thermometer" and compliance with ASTM E 1965-98 for evaluating clinical bias, uncertainty, and repeatability.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study compared the device's clinical accuracy, bias, uncertainty, and repeatability to that of a predicate device, but not in the context of human readers improving with or without AI assistance. The device itself is a standalone infrared thermometer, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The clinical tests were performed to evaluate the performance of the Infrared Thermometer Model IFR 600 by itself, specifically its clinical accuracy, bias, uncertainty, and repeatability, in comparison to a predicate device and against the requirements of ASTM E 1965-98.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established by comparison with established methods or references for body temperature measurement, implicitly defined by the clinical validation requirements of ASTM E 1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature). The document refers to evaluating "clinical bias, clinical uncertainty and clinical repeatability." The ASTM standard typically outlines how to establish reference body temperatures against which the infrared thermometer's readings are compared.
8. The Sample Size for the Training Set
This question is not applicable as the device is a medical device (infrared thermometer) and not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. The "training" here refers to product development and testing, where the device's design is refined to meet the performance standards.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8. The "ground truth" for the device's performance was established through compliance with recognized standards (ISO, ASTM) and clinical validation against these standards.
§ 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.