(76 days)
The Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
The Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature, then get a reading and display it on the LCD. Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces. The Microlife Digital Infrared Forehead Thermometer, consists mainly of five parts: a) IR Thermopile Sensor, b) ASIC, c) E2PROM IC, d) LCD and Blacklight, e) Kev2, Buzzer1
The provided 510(k) summary for the Microlife Digital Infrared Forehead Thermometer, Model FR1DM1, mentions clinical studies but does not detail the acceptance criteria or reported device performance in a table format. It also lacks specific details on sample sizes, ground truth establishment, or expert qualifications beyond a high-level statement that "Controlled human clinical studies were conducted using the Microlife Infrared forehead thermometer FR1DM1. Clinical data was presented evaluating clinical bias, clinical uncertainty and clinical repeatability per Microlife clinical test protocol for infrared forehead thermometer."
Therefore, I cannot provide a table of acceptance criteria or many of the requested details based solely on the provided text. However, I can extract the information that is present and indicate where details are missing.
Here's a breakdown of the available information and what is not provided:
Acceptance Criteria and Device Performance:
The document explicitly states that the device complies with ASTM E1965-98. This standard defines requirements for infrared thermometers and would include accuracy specifications. While the specific numerical acceptance criteria (e.g., maximum bias, uncertainty, and repeatability) from ASTM E1965-98 are not explicitly stated in this document, the submission implies adherence to them.
The document reports that clinical data "evaluating clinical bias, clinical uncertainty and clinical repeatability per Microlife clinical test protocol for infrared forehead thermometer" was presented. However, the actual values for these performance metrics are not included in this summary.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (from ASTM E1965-98, implied) | Reported Device Performance (not provided in this summary) |
|---|---|---|
| Clinical Bias | (Defined by ASTM E1965-98) | Not provided |
| Clinical Uncertainty | (Defined by ASTM E1965-98) | Not provided |
| Clinical Repeatability | (Defined by ASTM E1965-98) | Not provided |
Other Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only states "Controlled human clinical studies were conducted."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For a thermometer, "ground truth" typically involves a reference thermometer (e.g., a rectal thermometer) rather than expert interpretation of images. The document refers to "clinical test protocol," which would describe the methodology for establishing a reference temperature, but the details are absent here.
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Adjudication method for the test set:
- Not applicable or not specified. For a thermometer, adjudication in the sense of multiple expert reviews of a complex finding (like an image) is generally not relevant. The "ground truth" (reference temperature) is established through standardized measurement.
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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 device is a standalone thermometer, not an AI-assisted diagnostic tool that would involve human readers or interpretation of complex cases.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device is a digital infrared thermometer that outputs a temperature reading directly. Its performance evaluation (clinical bias, uncertainty, repeatability) inherently assesses its standalone algorithmic performance in converting infrared radiation to a temperature display. There is no human interpretation component in its fundamental operation or evaluation as described.
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The type of ground truth used:
- Implied Reference Standard (likely another thermometer): For a thermometer, ground truth is typically established by simultaneously measuring body temperature using a highly accurate, accepted reference method (e.g., a rectal thermometer, an oral thermometer, or potentially another validated infrared thermometer) for comparison. The document mentions "clinical test protocol for infrared forehead thermometer," which would define this reference method.
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The sample size for the training set:
- Not applicable/Not provided. The document describes clinical validation studies in item 8. It does not explicitly mention a separate "training set" in the machine learning sense for the device's core temperature measurement algorithm, as the technology relies on established physical principles (infrared thermometry) and calibration, rather than deep learning requiring large training datasets in the same way. Development would involve calibration and testing, but not necessarily a "training set" as defined for AI models.
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How the ground truth for the training set was established:
- Not applicable/Not provided, as there's no explicit mention of a training set as would be found in AI/ML development. Calibration and engineering validation would have occurred during device development using precise temperature standards and reference measurements.
§ 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.