(89 days)
The Braun ThermoScan® PRO 3000 Infrared Thermometer is intended for the intermittent measurement and monitoring of human body temperature, by medical professionals. It is intended for use on people of all ages.
The Braun ThermoScan® PRO 3000 Infrared Thermometer is a hand held instrument that measures temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Braun ThermoScan® PRO 3000 Infrared Thermometer.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (ASTM Laboratory Accuracy Requirements for IR Thermometers in the range 36°C-39°C) | Reported Device Performance (Accuracy characteristics) |
|---|---|
| ±0.2°C (±0.4°F) | For patient temperature range 96.8°F to 102.2°F (36°C to 39°C): ±0.4°F (±0.2°C) |
| Outside this range: ±0.5°F (±0.3°C) |
The device also states it "meets the requirements established in ASTM Standard E 1965-98, 'Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature'."
2. Sample size used for the test set and the data provenance
- Sample Size: "Approximately 39% of the patients participating in the study were considered febrile." While a specific total number of patients is not provided, the study indicates it covered four age groups: 0-3 yrs, 4-10 yrs, 11-65 yrs, and >65 yrs.
- Data Provenance: Not explicitly stated, but based on the submitter's address (San Diego, CA) and assuming a clinical trial setting, it is likely prospective data collected in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study compared the PRO-3000 to a predicate device (ThermoScan® IR-2000) rather than establishing ground truth against a specific expert reference.
4. Adjudication method for the test set
This information is not provided in the document. The study was a "comparison study" and "clinical repeatability testing."
5. 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
A MRMC comparative effectiveness study was not performed. The device is a standalone thermometer, not an AI-assisted diagnostic tool. The study was a comparison of the new device against a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of standalone performance was done for the device's accuracy characteristics, as it is a medical device that provides a direct measurement. The "Accuracy characteristics" table directly reports the device's accuracy against defined temperature ranges. The "Five Environment Accuracy Test" is also a standalone test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the accuracy assessment seems to be a comparison against the predicate device (ThermoScan® IR-2000) and adherence to ASTM laboratory accuracy requirements. The clinical study specifically states: "The comparison study demonstrated that the Braun ThermoScan® PRO-3000 Instant Thermometer measured ear temperature equivalently to the ThermoScan® IR-2000(PRO-1) in all age groups." For laboratory accuracy, it refers to "ASTM laboratory accuracy requirements."
8. The sample size for the training set
This device does not utilize a "training set" in the context of machine learning or AI. It is a measurement device, and its performance is based on inherent design and calibration, not learned parameters.
9. How the ground truth for the training set was established
Not applicable as there is no training set for this type of device.
§ 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.