(8 days)
Indicated use- Measure of individual temperature
Measurements- Oral, Axillary -under arm, Rectal
Range of measurement- 90.0 degrees - 109.9 degrees F (32.0 degrees - 43 degrees C)
Accuracy- +/-0.2 degrees F
Targeted population- Individuals requiring temperature measurements
Environment of use- Hospital and home
Disposable / reusable- Reusable, clean with alcohol
The intended product is an electronic digital thermometer for measuring patient temperature.
{
"acceptance_criteria_and_study": {
"acceptance_criteria_table": {
"headers": [
"Parameter",
"Acceptance Criteria",
"Reported Device Performance"
],
"rows": [
[
"Temperature range",
"Not explicitly stated as an acceptance criterion for the subject device but compared to predicate device's 89.6-109.4° F",
"90.0-109.9° F"
],
[
"Ambient temperature",
"Not explicitly stated as an acceptance criterion for the subject device but compared to predicate device's 60.8-104° F",
"60.8-104° F"
],
[
"Response time",
"Not explicitly stated as an acceptance criterion for the subject device but compared to predicate device's ~1 minute",
"About 20 seconds"
],
[
"Accuracy and Performance",
"Meets ASTM E1112",
"Meets ASTM E1112"
],
[
"Accuracy (for indications for use)",
"+/- 0.2° F",
"+/- 0.2° F (stated in Indications for Use, implies conformance)"
],
[
"Material safety",
"Non-toxic and in compliance with EN ISO 10993",
"All materials used are non-toxic and in compliance with EN ISO 10993"
]
]
},
"study_details": {
"sample_size_test_set": "Not specified. The document states \"Performance testing,\" and notes that the device \"meets ASTM E1112,\" but does not detail the sample size for this testing.",
"data_provenance": "Not specified. The testing was conducted to meet ASTM E1112 standards.",
"number_of_experts_ground_truth": "Not applicable. The ground truth for performance and accuracy is based on compliance with a recognized standard (ASTM E1112) rather than expert interpretation of data.",
"qualifications_experts": "Not applicable.",
"adjudication_method": "Not applicable.",
"mrmc_comparative_effectiveness_study": "No. This is a digital thermometer, not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.",
"standalone_performance_study": "Yes, a standalone performance study was conducted to demonstrate compliance with ASTM E1112. The data provenance and sample size are not explicitly detailed beyond the standard reference.",
"type_of_ground_truth": "Standard compliance (ASTM E1112) for accuracy and performance, and safety standard compliance (EN ISO 10993) for materials.",
"sample_size_training_set": "Not applicable. This is a physical device, not an AI algorithm requiring a training set.",
"ground_truth_training_set_established": "Not applicable."
}
}
}
§ 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.