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Radius T wearable thermometer is intended for single-use, continuous noninvasive measurement of body temperature on the upper chest via wireless communication to a smart device application or compatible patient monitor (i.e., Masimo Root, Masimo Rad-97).

The Radius T is indicated for single-use, continuous body temperature measurements of persons 5 years of age or older in hospitals, hospital-type facilities, and home environments.

Radius T is a wearable, battery powered thermometer that is applied to the body to continuously provide body temperature measurements. The Radius T continuously approximates based upon the surface temperature at the application site. The body temperature data from the Radius T is transferred wirelessly to a monitoring device (e.g., Root, Rad-97) or smart device application for continuous display and monitoring.

As part of this submission, the software of the Root (K191882) and Rad-97 (K193626) is being modified to support the communication and display compatibility for the Radius T.

The provided text is a 510(k) Premarket Notification from Masimo Corporation for their Radius T Wearable Thermometer. While it mentions clinical testing and provides performance specifications, it does not contain the detailed information required to fully answer all aspects of your request, particularly regarding the specifics of the clinical study, sample size for test datasets, expert qualifications, or adjudication methods.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (FeverScout Continuous Monitoring Thermometer, K181013) rather than a comprehensive, detailed report of a study proving the device meets specific acceptance criteria in the way an AI/ML device study might.

However, based on the information available, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document specifies performance characteristics for the Radius T. It does not explicitly state these as "acceptance criteria" in a dedicated section with pre-defined pass/fail thresholds for clinical efficacy, but rather as "specifications" and the results from a clinical validation study in accordance with a standard.

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

• Sample Size: The document states that a "clinical validation study was performed" to support the performance of the Radius T and evaluated its clinical performance to a reference clinical thermometer in accordance with ISO 80601-2-56. However, the exact sample size for this clinical study (test set) is not provided in the supplied text. It only mentions the "indicated population of the subject device was narrowed to align to the clinically tested population, age group C (older than 5 years) in accordance with ISO 80601-2-56."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the nature of a clinical validation study for a wearable thermometer implies a prospective collection of data from enrolled subjects.

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document. For a thermometer, "ground truth" would typically refer to a highly accurate reference thermometer measurement, not necessarily expert radiologist interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: This information is not applicable/not provided as the ground truth for a clinical thermometer study would be objective measurements from a reference device, not expert consensus requiring adjudication.

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: No, an MRMC comparative effectiveness study was not done. This type of study design is typically used for AI/ML diagnostic imaging devices where human interpretation is a key component. This document describes a clinical electronic thermometer, where the device itself provides the measurement. AI assistance for human "readers" (in this context, users) is not relevant for a direct temperature measurement device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes, the core clinical validation study described is a standalone performance study of the Radius T Wearable Thermometer. It evaluates the device's ability to measure body temperature itself against a reference clinical thermometer. The specifications provided (clinical bias and limits of agreement) are measures of this standalone performance. The device provides a direct measurement, and its "algorithm" refers to its internal logic for deriving body temperature from skin surface temperature.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical study was established using a reference clinical thermometer in accordance with ISO 80601-2-56. This is a form of objective, gold-standard measurement.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This information is not applicable/not provided. This device is a traditional medical device (thermometer) and does not appear to employ machine learning that would require a separate "training set" for an algorithm in the way an AI/ML imaging device would. Its "principle of action" is based on established biophysical principles (heat flux, skin surface temperature correlation to body temperature) and uses a thermistor. Any internal calibration would be based on engineering design rather than a large data-driven training set.

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

• Ground Truth for Training Set: This information is not applicable/not provided as there is no mention of an ML training set.

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