(438 days)
The Braun ThermoScan Thermometer, Model IR-6000 is intended for the intermittent measurement and monitoring of human body temperature in the home. It is intended for use on people of all ages.
The Braun ThermoScan Thermometer, Model IR-6000 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
Here's a breakdown of the acceptance criteria and study information for the Braun ThermoScan Thermometer, Model IR-6000, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM Standard E1112) | Reported Device Performance (Laboratory Error) |
|---|---|
| Patient Temperature Range: | |
| 98.0 to 102.0°F (37.0 to 39.0°C) | ±0.2°F (±0.1°C) |
| 96.4 to 102.0 to 106.0°F (>39.0 to 41.0°C) | ±0.3°F (±0.2°C) |
| 106.0°F (41.0°C) | ±0.5°F (±0.3°C) |
| Meets laboratory accuracy requirements specified in ASTM Standard E1112 for infrared thermometers. | Passed |
Note: The document states "Accuracy is determined under laboratory conditions in calibrate mode with a typical lens filter installed."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for the accuracy testing. However, for the clinical comparison study and repeatability testing, four age groups were used: 0-3 years, 4-10 years, 11-65 years, and >65 years. The number of participants within each group is not provided.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective clinical and laboratory tests conducted to support the device's efficacy.
3. Number of Experts and Qualifications for Ground Truth for Test Set:
- Not Applicable / Not Specified: The ground truth for the accuracy testing appears to be based on laboratory conditions and established standards (ASTM Standard E1112-86), rather than expert consensus on individual readings. For the clinical comparison, the predicate devices (IR-2000 and IR-4000) serve as the comparison point, implying their established accuracy as a form of ground truth for comparison. No specific "experts" for ground truth establishment are mentioned in this context.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Specified: Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where multiple readers provide interpretations. For temperature measurement, which is objective, such methods are not relevant. The accuracy is determined by comparing device readings to a known standard or predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is more common for diagnostic imaging devices where human readers interpret medical images. The ThermoScan is a measurement device, and its performance is evaluated based on accuracy against a reference, not on human interpretive improvement.
- Comparison Study: A "comparison study" was performed, demonstrating that the IR-6000 measured ear temperature equivalently to the IR-2000 and IR-4000 in all age groups. This is a comparison against predicate devices, not an MRMC study with human readers assessing AI vs. no AI.
- Effect size of human readers improving with AI vs without AI assistance: Not applicable, as no MRMC study with AI assistance was conducted.
6. Standalone (Algorithm Only) Performance:
- Yes, standalone performance was done. The "Accuracy characteristics" table and the statement "Accuracy is determined under laboratory conditions in calibrate mode" describe the standalone performance of the device's measurement capabilities. The device is intended for direct measurement, so its primary functionality is its standalone operation.
7. Type of Ground Truth Used:
- Laboratory Standard / Predicate Device Comparison:
- For the accuracy characteristics, the ground truth is based on meeting the requirements of ASTM Standard E1112-86. This implies comparison against a highly accurate reference thermometer or controlled temperature environments.
- For the clinical comparison study, the ground truth for comparison was the measurements obtained from the predicate devices, the ThermoScan Instant Thermometer, Models IR-2000 and IR-4000.
8. Sample Size for the Training Set:
- Not applicable / Not specified. Infrared thermometers like the Braun ThermoScan IR-6000 are not typically "trained" in the machine learning sense. Their accuracy is based on the physics of infrared detection and calibration, not on learning from a dataset. Therefore, there is no "training set" in this context. The manufacturing process involves calibration against known temperature sources.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no "training set" for this type of device, the concept of establishing ground truth for it does not apply. The device's inherent accuracy is validated through the methods described above (ASTM standards and comparison to predicate devices).
§ 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.