(28 days)
The Braun ThermoScan IRT 2000 infrared ear thermometer is indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.
Braun Thermoscan infrared ear thermometers are hand-held, battery-powered devices that are intended to be used for the intermittent measurement and monitoring of human body temperature of people of all ages. They measure infrared energy that is emitted from the tympanic membrane and surrounding tissue.
Here's a breakdown of the acceptance criteria and study information for the Braun ThermoScan IRT 2000, based on the provided text:
Acceptance Criteria and Device Performance
The submission states that the Braun ThermoScan IRT 2000 has the same accuracy and reliability specifications as its predicate device, the Braun ThermoScan IRT 4000 Series. It also explicitly states: "The accuracy and reliability specifications are the same for the IRT 2000 and IRT 4000 series thermometers." The document does not provide specific numerical acceptance criteria (e.g., a ± tolerance for temperature readings). Instead, it relies on substantiating that the new device performs at least as well as the legally marketed predicate.
The primary performance claim is that the device "measures ear canal temperature as well as the previously 510(k) cleared IRT 4000 series thermometers in all age groups" and that "Differences were within clinical acceptability." Its clinical repeatability is also stated as "statistically and clinically acceptable."
While no explicit table is provided in the document, here's a representation of what can be inferred:
| Acceptance Criteria | Reported Device Performance (Braun ThermoScan IRT 2000) |
|---|---|
| Accuracy | Measures ear canal temperature as well as the predicate device (IRT 4000 series). |
| Differences (compared to oral/axillary sites) within clinical acceptability. | |
| Reliability | Same reliability specifications as the predicate device (IRT 4000 series). |
| Repeatability | Statistically and clinically acceptable. |
| Age Group Performance | Performance maintained across all four age groups (0-3 years, 4-10 years, 11-65 years, >65 years). |
| Consensus Standards Compliance | Conforms to relevant portions of ASTM E1965-98. |
| Conforms to relevant ISO and IEC consensus standards. |
Study Details
The document describes a clinical comparison study rather than an isolated standalone performance study with predefined numerical thresholds. The study's main goal was to demonstrate equivalence to the predicate device.
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Sample sizes used for the test set and data provenance:
- Test set sample size: Not explicitly stated as a single number. The study was performed on "four age groups: 0-3 years, 4-10 years, 11-65 years, and >65 years." The exact number of participants within each group or total participants is not provided.
- Data provenance: Not explicitly stated, but clinical studies for medical devices are generally prospective when compared to a predicate like this. No mention of country of origin.
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Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable/Not stated. The ground truth for this device (body temperature) is established through comparison with other established temperature measurement methods (ear canal, oral, and axillary sites), not through expert consensus on images or interpretations.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used when subjective interpretations (e.g., image reading) need to be reconciled. For temperature measurements, the readings are direct.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is not relevant for an infrared thermometer. The study performed was a clinical comparison of the new device to a predicate and to other established temperature measurement sites.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted device for interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The clinical comparison and repeatability testing described is the standalone performance of the device without human interpretation of its output (beyond reading the displayed temperature). The device itself measures and displays the temperature. While a human uses the device, the performance being evaluated is the device's accuracy and repeatability in measuring temperature.
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The type of ground truth used:
- The "ground truth" was established by comparing the IRT 2000's ear temperature readings to:
- Readings from the predicate device (Braun ThermoScan IRT 4000 Series).
- Temperatures measured at "oral and axillary sites." These are considered standard clinical methods for temperature measurement.
- The "ground truth" was established by comparing the IRT 2000's ear temperature readings to:
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The sample size for the training set:
- Not applicable. The Braun ThermoScan IRT 2000 is a hardware device that measures infrared energy; it does not utilize machine learning or AI that would require a "training set" in the conventional sense. Its "training" is inherent in its design and calibration processes.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of machine learning. The device's calibration and design would have been based on physical principles of infrared measurement and established temperature references, but not a data-driven "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.