(179 days)
The Braun ThermoScan pro-2000 Instant 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-2000 Instant 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 510(k) summary describes a non-AI device. Therefore, categories relating to AI/ML devices such as sample size for test set, provenance of data, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone algorithm performance, and sample size for training set are not applicable.
Here's the information regarding the acceptance criteria and study for the Braun ThermoScan pro-2000 Instant Thermometer:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM Standard E1112-86 for IR thermometers) | Reported Device Performance (Braun ThermoScan pro-2000) |
|---|---|
| Patient Temperature Range (Error °F) | |
| 102.0 to 106.0°F (>39.0 to 41.0°C): ±0.3°F (±0.2°C) | Meets ASTM standards |
| >106.0°F (>41.0°C): ±0.5°F (±0.3°C) | Meets ASTM standards |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated. The study mentions "four age groups; 0-3 yrs, 4-10 yrs, 11-65 yrs, and >65 yrs." However, the number of participants within each group or the total number of participants is not provided.
- Data Provenance: Not specified. It doesn't mention the country of origin or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This is a medical device for temperature measurement, not an AI/ML diagnostic device relying on expert interpretation for ground truth. Ground truth would be established through a reference temperature measurement method.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a medical device for temperature measurement, not an AI/ML diagnostic device requiring adjudication of expert opinions.
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:
- Not applicable. This is a standalone medical device and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone study was performed. The device's accuracy was evaluated against the ASTM standard E1112-86, and its clinical repeatability was also assessed. The "comparison study" also evaluated its equivalence to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for accuracy would be an objectively measured temperature using a reference standard thermometer or method that complies with relevant metrology standards. The 510(k) summary states it "Meets American Society for Testing and Materials (ASTM) Standard E1112-86 as it pertains to IR thermometers," implying that the ground truth was established by comparison to a method meeting this standard.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that requires a training set.
§ 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.