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The IT2CA1 is used in a home use environment to make an accurate prediction of a febrile, or afebrile compliant patients oral temperatures after a measurement time (in the sublingual pocket) of only 4 seconds, and axillary temperatures in approximately 10 seconds in the Rapid mode. In Normal mode, the IT2CA1 provides accurate determination of actual, oral and axillary temperatures of compliant patients. The IT2CA1 is intended for lay or home use only; in a home use environment. It is not intended for use by the clinical professional, such as those utilized in the hospital, clinical, or mobile environment use.

The MicroLife IT2CA1 Digital 4-Sec Predictive Thermometer is the first predictive "Consumer Version" of the clinical thermistor thermometer for use in adults and children. Consumer thermometers currently available do not utilize the predictive technique, and acquire oral and axillary temperature in the standard mode, in which the measurement period is approximately one minute. The IT2CA1 consumer version 4-Sec predictive thermometer, embodies the predictive algorithm of the SureTemp® from Welch Allyn, San Diego, which provides a safe, simple, rapid and accurate method for determining clinical temperature using the traditional body sites and proven technology. The IT2CA1 can be used in either "Rapid" (predictive) mode or "Normal" mode. In Normal mode, the IT2CA1 indicates the actual temperature sensed by the thermistor in the probe. In Normal mode, the measurement ends when temperature rise is

Here's a breakdown of the acceptance criteria and the study information for the Microlife IT2CA1 thermometer, based on the provided text:

Acceptance Criteria and Device Performance

Note: The provided text compares the Microlife IT2CA1 to the predicate device (Welch Allyn SureTemp®), and these values are presented as specifications for both. The text implies that the Microlife IT2CA1 meets these standards because it is stated to comply with them and shares the same core technology and accuracy claims as the predicate.

Study Information:

The provided document is a 510(k) summary, which is a premarket notification to the FDA. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent clinical study with novel acceptance criteria and extensive performance data generation. The information about the "study" is therefore framed in the context of demonstrating this equivalence.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document refers to the device embodying "the predictive algorithm of the SureTemp® from Welch Allyn," implying a reliance on the predicate device's established performance. The clinical test standard (ASTM E1112-86) would typically specify required sample sizes for clinical accuracy testing, but the results for the IT2CA1 itself are summarized and not presented in detail as a separate study.
   • Data Provenance: The document does not specify the country of origin for any specific test data for the IT2CA1, nor does it explicitly state whether it was retrospective or prospective. Given that the device "embodies the predictive algorithm of the SureTemp®," it's highly likely that the underlying algorithm's validation data stems from the predicate device's development.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. This level of detail is typically found in a full clinical study report, not a 510(k) summary focused on substantial equivalence. The "clinical test standard" (ASTM E1112-86) would outline methods for establishing ground truth, which would likely involve controlled temperature measurements by trained personnel, but specific expert qualifications for the IT2CA1's validation are not provided.

3. Adjudication method for the test set: Not explicitly stated.

4. 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:

   • An MRMC study was not done. This device is a thermometer, not an AI-assisted diagnostic imaging device or a system requiring human interpretation comparison. It provides a direct temperature reading.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in essence. The device itself (the thermometer with its predictive algorithm) operates in a standalone manner to provide a temperature reading. The accuracy claims are for the device's output. The "Rapid" (predictive) mode relies entirely on the internal algorithm to calculate the temperature.

6. The type of ground truth used:

   • The ground truth for thermometer accuracy is typically established through precisely controlled temperature baths or comparison against highly accurate reference thermometers in a clinical setting. The mention of "technical measuring accuracy in normal (standard) mode and in water bath: ± 0.1°C" suggests that controlled water bath testing was a method for establishing ground truth for the core temperature sensing. For the predictive algorithm, it would involve comparison to actual stabilized body temperatures (clinical ground truth, likely obtained by leaving a standard thermometer in place until stable).

7. The sample size for the training set: Not explicitly stated. The "training set" for the predictive algorithm would have been developed during the creation of the SureTemp® device, and its details are not provided here.

8. How the ground truth for the training set was established:

   • The document states that the IT2CA1 "embodies the predictive algorithm of the SureTemp® from Welch Allyn." Therefore, the ground truth for training the algorithm would have been established during the development of the SureTemp® device. This would typically involve:
     • Clinical Data Collection: Prospective studies where the probe is placed, initial temperature changes are recorded, and then the probe is left in place for a prolonged period to obtain the actual, stable "converged-to" temperature (the ground truth).
     • Controlled Environment Data: Possibly using physical models or simulations with known temperature characteristics to calibrate and refine the algorithm.

   The specifics of how Welch Allyn established this ground truth for their SureTemp® algorithm are not detailed in this 510(k) for Microlife.

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