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The Prizma device is indicated for home users to measure, record, display and/or transmit ECG one-lead data, heart rate, peripheral oxygen saturation, pulse rate and body temperature data. The device utilizes a mobile platform to initiate user actions (test, display and data transfer by email) through the mobile application.

Intended population: adult patients.

The Prizma device described in this submission is based on the cleared Prizma device (K170181), and its physical design has not been modified.

The following algorithm functions have been added to the system, thereby extending the indications for use:

a) conversion of the previously cleared and reported skin temperature measurement into body temperature

b) Pulse rate calculation using the oximeter function.

The sensor capabilities of the new Prizma are as follows:

• . One lead ECG sensor - ECG rhythm recording and heart rate measurement
• . Photo-plethysmography - Peripheral capillary Oxygen Saturation (SPO2) measurement, pulse rate:
• . IR thermometer - skin temperature converted into body temperature.

Here's a summary of the acceptance criteria and the study details for the Prizma device, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it refers to compliance with specific ISO standards related to device performance and outlines the comparison against reference measurements in a clinical validation.

However, based on the information provided, we can infer the primary performance evaluation was for the Prizma IR measured skin temperature to body temperature conversion.

The study aimed to demonstrate:

• Clinical bias
• Limits of agreement
• Clinical repeatability

These were "calculated in accordance with requirements in ISO 80601-2-56: 1st edition 2009."

Since the document concludes that "Performance data demonstrate that the Prizma is as safe and effective as the predicate devices," it implies that the device met the requirements of this ISO standard for these statistical characteristics.

Study Details:

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria (Implicit, based on ISO 80601-2-56): Adherence to statistical characteristics (clinical bias, limits of agreement, clinical repeatability) as defined by ISO 80601-2-56 for body temperature measurement.
   • Reported Device Performance: The document states that these statistical characteristics "were calculated" and that "Performance data demonstrate that the Prizma is as safe and effective as the predicate devices," implying successful adherence to the standard's requirements. No specific numerical values for bias, limits of agreement, or repeatability are provided in this document.

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

   • Sample Size: 167 patients.
   • Percentage of Febrile Patients: 57% of the patient cohort were febrile.
   • Data Provenance: Not explicitly stated, but clinical validation suggests prospective data collection in a clinical setting. No country of origin is mentioned for the patient data.

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

   • Not applicable. The ground truth method described does not involve expert consensus on interpretations but rather direct measurement comparisons.

4. Adjudication Method for the Test Set:

   • Not applicable. The ground truth method involved a direct measurement comparison against a reference device, not an adjudication of interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

   • No. This was a clinical validation study focused on the accuracy of a physiological measurement (temperature conversion), not a comparative effectiveness study involving human readers and AI assistance for diagnostic interpretation.

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

   • Yes, for the temperature conversion aspect. The Prizma IR measured skin temperature was compared against a reference (mercury thermometer) to validate the algorithm's conversion to body temperature. The device is for home users to measure, record, display, and/or transmit data, suggesting standalone measurement capability.

7. The Type of Ground Truth Used:

   • Clinical Validation / Reference Standard: Auxiliary temperature (under armpit) measured by a mercury thermometer over a 10-minute period.

8. The Sample Size for the Training Set:

   • Not provided. The document focuses on the validation of the temperature conversion algorithm and does not detail the training phase or its dataset size.

9. How the Ground Truth for the Training Set was Established:

   • Not provided. The document does not discuss the training set or its ground truth establishment.

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