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The Microlife MT 1811 Instant Digital Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is for the adult and pediatric population.

This predictive (instant) digital electronic thermometer enables very fast and reliable measurements. With its predictive technology, this thermometer offers very high clinical accuracy and, has been designed to provide maximum userfriendliness.

With Microlife patented fast probe, others being equal, temperature curve of sensor varies with sites ( oral, underarm, rectal ) , this thermometer can use of temperature detected in the first few seconds to predict body temp using a well established physical model.

The Microlife Instant Digital Electronic Thermometer, Model MT1811, was studied to demonstrate its substantial equivalence to a predicate device (Microlife Instant Digital Electronic Thermometer, Model QT1JA1, K#031958). The study focused on clinical accuracy, repeatability, and bias.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states compliance with standards and outlines clinical evaluations but does not explicitly list quantitative acceptance criteria tables or specific numerical performance metrics for clinical bias, uncertainty, or repeatability from the clinical study itself. It only states that these were "evaluated per the Microlife Clinical Test Protocol outline."

Note: The document references compliance with ASTM E1112, which specifies performance requirements for clinical electronic thermometers, including accuracy and precision. The detailed acceptance criteria would be defined within that standard and the "Microlife Clinical Test Protocol outline" which is not provided.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states that "Controlled human clinical studies were conducted," but does not specify the sample size (number of subjects) used for these studies.
• Data Provenance: Not explicitly stated. The submission is from Microlife Intellectual Property GmbH, Switzerland, but the location of the clinical studies (e.g., country of origin for the data) is not mentioned. The studies were "clinical" and "human," indicating prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information regarding the number of experts or their qualifications used to establish ground truth. For thermometer validation, ground truth is typically established by highly accurate reference thermometers or invasive temperature monitoring (e.g., pulmonary artery catheter for core temperature).

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. Given the nature of a thermometer study, "adjudication" in the traditional sense (e.g., for subjective image interpretation) is generally not applicable. Instead, the comparison is typically made against a physical reference standard measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically relevant for diagnostic imaging interpretation where multiple human readers assess cases. This submission is for a digital electronic thermometer, which is a direct measurement device rather than an interpretive one.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was implicitly done. The device itself is an algorithm-driven electronic thermometer designed to provide a direct temperature reading. The clinical studies evaluated the performance of this device in "intermittent measurement and monitoring of human body temperature," which is its standalone function. There is no "human-in-the-loop" component for its primary function of temperature measurement.

7. The Type of Ground Truth Used

The document indicates that clinical bias, uncertainty, and repeatability were evaluated. For electronic thermometers, the ground truth is typically established using:

• Reference standard thermometers: Highly accurate and calibrated thermometers (e.g., mercury-in-glass or electronic readouts traceable to national standards).
• Invasive temperature measurements: For core body temperature, this might involve measurements from pulmonary artery catheters or esophageal probes, especially in hospital settings to validate different body sites (oral, rectal, axillary).

The specific nature of the reference standard used for ground truth is not explicitly detailed in the provided summary.

8. The Sample Size for the Training Set

The document does not specify a separate training set sample size. The "well established physical model" mentioned for predictive temperature calculation suggests that a model was developed, likely using clinical data, but the details of this development/training set are not provided in this 510(k) summary. For predictive algorithms, a training set is used to "learn" the relationship, and a separate test set (the "controlled human clinical studies") is used for validation.

9. How the Ground Truth for the Training Set Was Established

The document states that the device uses "temperature detected in the first few seconds to predict body temp using a well established physical model." It does not explicitly describe how the ground truth for the training set (or the development of this physical model) was established. It can be inferred that earlier clinical data or physiological models would have been used to establish the "well-established physical model" and its ground truth, but the details are absent from this summary.

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