(509 days)
The device measures the human body temperature from oral, armpit, and rectal. The device is reuseable and intended for clinical or home use on people of all ages.
The Clinical Electronic Thermometer is a thermometer intended for the determination of oral, axillary, and rectal body temperature determination in humans.
The provided text describes a 510(k) premarket notification for a Clinical Electronic Thermometer. Here's a breakdown of the acceptance criteria and study information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ASTM E1112 ("Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature") | The Clinical Electronic Thermometer conforms to ASTM E1112. |
| Conformance to IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment) | The Clinical Electronic Thermometer conforms to IEC 60601-1. |
| Conformance to IEC 60601-1-2 (Collateral Standard: Electromagnetic compatibility – Requirements and tests) | The Clinical Electronic Thermometer conforms to IEC 60601-1-2. |
Note: The document states that these standards were met "In terms of physical requirements and operating parameters."
2. Sample Size Used for the Test Set and Data Provenance
No information is provided regarding the sample size used for any test set or the provenance of any data. The document explicitly states: "Controlled human clinical studies were not conducted using the Clinical Electronic Thermometer and predicate devices." This indicates that the device's performance was not evaluated through human clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no human clinical studies were conducted, there was no test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. No human clinical studies were conducted.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a thermometer, not an AI-assisted diagnostic tool for image interpretation, and no MRMC studies are mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, an algorithm-only standalone performance study was not done in the context of an AI device. The device is a thermometer, and its performance was assessed against established engineering and safety standards (ASTM E1112, IEC 60601-1, IEC 60601-1-2).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for demonstrating the device's performance was conformance to established industry standards for electronic thermometers (ASTM E1112, IEC 60601-1, IEC 60601-1-2). These standards define acceptable performance characteristics for such devices.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (thermometer) and not an AI/machine learning model that typically involves training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/machine learning model, there was no training set or corresponding ground truth to establish.
§ 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.