Search Results

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:

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.

Ask a specific question about this device

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:

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).

Ask a specific question about this device