(123 days)
PRO 4000 series: The Braun Thermoscan PRO 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by professionals in a professional use environment.
IRT 4000 series: The Braun Thermoscan IRT 4000 series infrared ear thermometers are 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 enerqy that is emitted from the tympanic membrane and surrounding tissue.
Here's an analysis of the provided text regarding the Braun ThermoScan IRT/PRO 4000 series, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy ranges, repeatability standard deviations) for the device's performance. Instead, it refers to compliance with consensus standards and clinical acceptability.
| Acceptance Criteria (Implied/Referenced) | Reported Device Performance |
|---|---|
| Compliance with Consensus Standards | The Braun Thermoscan IRT/PRO 4000 series conform to: |
- ASTM E1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- IEC 60601-1:1988 Cor 1 1995 Medical Electrical Equipment Part 1 General requirements for Safety
- IEC 60601-1:1998 Medical Electrical Equipment Part 1 General requirements for Safety, 1998; Amendment 1, 1991-11, Amendment 2, 1995-03
- IEC 60601-1-4:2000 Medical Electrical Equipment Part 1-4 General requirements for Safety - Collateral Standard: Programmable Electrical Medical Electrical Systems
- IEC 60601-1-2:2001 Medical Electrical Equipment Part 1 General requirements for Safety; Electromagnetic Compatibility - Requirements and Tests
- AAMI/ISO 14971:2000 -- Medical Devices -- Application of Risk Management to Medical Devices
- AAMI/ISO 14971-1:2000 - Medical Devices - Risk Management - Part 1: Application of Risk Analysis
- EN 540:1993 Clinical Investigation of Medical Devices for Human Subjects
- EN 980:1997+ A1:1999 Graphical Symbols for Use in the Labeling of Medical Devices
- ISO 15223:2000 Symbols Used with Medical Device Labels, Labeling, and Information to be Supplied |
| Clinical Equivalence/Performance | "This clinical comparison study demonstrated that the Braun ThermoScan IRT 4000 measures ear canal temperature as well as the previously approved model IRT 3000 in all age groups."
"The ear temperatures obtained with the IRT 4000 were highly related to temperatures measured at the oral and axillary sites. Differences were within clinical acceptability."
"The clinical repeatability of the device is statistically and clinically acceptable." |
| Consumer vs. Professional Comparability | "Consumers' measurements obtained were comparable to the professional measurements, collectively, for pooled professionals, and each individual category of professionals."
"The repeatability of temperatures obtained from the consumers was comparable to the repeatability of the temperatures obtained from the professionals." |
| Safety and Effectiveness | "Therefore the IRT/PRO 4000 series thermometers do not raise any significant questions of safety or effectiveness." |
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: The document states that a comparison study and clinical repeatability testing were performed on "the following four age groups; 0-3 years, 4-10 years, 11-65 years, and >65 years." However, specific numerical sample sizes for each group or the total test set are not provided.
- Data Provenance: The document does not specify the country of origin for the data.
- Prospective/Retrospective: The language "A comparison study and clinical repeatability testing was performed" suggests a prospective study design.
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)
The document mentions "health care professionals" in the context of the consumer vs. professional comparability study, but does not specify the number or qualifications of experts (e.g., physicians, nurses) used to establish ground truth or conduct the clinical comparisons. It only states that "pooled professionals" and "each individual category of professionals" were compared.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for establishing ground truth or resolving discrepancies in measurements.
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
- MRMC Study: This is not applicable to this device. An infrared ear thermometer is a diagnostic tool that provides a direct measurement, and its operation does not involve "readers" in the sense of interpreting complex images or data fields that would typically require multi-reader studies or AI assistance for human improvement. The closest comparison is the "Consumer vs. Healthcare Professional Comparability Study," which assessed if different users (consumers vs. professionals) achieved comparable results, not how professionals improved with AI.
- Effect Size of AI improvement: No AI component is described in the device, and therefore no effect size of AI assistance for human readers is mentioned or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an infrared ear thermometer, which is inherently a "standalone" device in its functional output of a temperature reading. It does not involve complex algorithms or human interpretation of an algorithm's output in the way that an AI diagnostic tool would. The device provides a direct measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document implicitly refers to traditional "gold standard" temperature measurement methods for comparison:
- "The ear temperatures obtained with the IRT 4000 were highly related to temperatures measured at the oral and axillary sites." This implies that oral and axillary temperature measurements were used as a reference or a type of "ground truth" to which the ear thermometer's readings were compared.
8. The sample size for the training set
The document does not describe a "training set" as would be relevant for a machine learning model. This device is a physical measurement instrument, not an AI/ML system requiring a dedicated training phase with labeled data in the typical sense.
9. How the ground truth for the training set was established
As there is no described training set for an AI/ML model, this question is not applicable. The device's operation relies on established physics of infrared measurement and calibration, not on a data-driven training process.
§ 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.