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The IQvitals Zone is intended to be used by clinicians and medically qualified personnel for measuring and monitoring:

· Noninvasive blood pressure for adult and pediatric patients (3 years and above)

• · Pulse rate for adult and pediatric patients
• · Noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) for adult and pediatric patients
• · Body temperature measured at Temporal Artery for adult and pediatric patients

The most likely location for IQvitals Zone device to be used is for monitoring patient in general medical locations, hospitals and alternative care environments.

The IQvitals Zone is designed to be used for measuring and monitoring systolic and diastolic blood pressure, pulse rate, temperature and oxygen saturation (SpO2) for adult and pediatric patients. All functions of the device are performed via the touch screen display, except the power on/off function, which is a separate button on the back of the device.

The IQvitals Zone can be wirelessly connected with low energy Bluetooth to mobile computers or be connected with a USB cable to computers and has the ability to send the measurement results to the computers.

The device has a rechargeable lithium ion battery and two mounting options: a mobile cart and a wall mount. All vitals parameters can be simultaneously measured and easily viewed on the touch screen display or the connected computer. Temperature is measured at Temporal Artery and the Temperature Probe is connected serially to the IQvitals Zone.

The IQvitals Zone is a multi-parameter vital signs monitor intended for use by clinicians and medically qualified personnel for measuring and monitoring noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature at the temporal artery for adult and pediatric patients (3 years and above).

1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:

The provided document presents the performance characteristics of the IQvitals Zone and compares them to predicate devices. This comparison implicitly serves as the acceptance criteria for the device, demonstrating that its performance is substantially equivalent to legally marketed devices. Since the device is a vital signs monitor designed to directly measure physiological parameters, the "algorithm only" or "standalone" performance is inherent in these functional specifications.

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

The document states that the clinical validation of the Midmark Non-invasive Blood Pressure (NIBP) module was conducted per ANSI / AAMI / ISO 81060-2:2013. This standard "specifies requirements for the clinical investigation of all automated sphygmomanometers, with the exception of those for neonates." It typically requires a minimum of 85 participants for NIBP clinical investigations to ensure statistically meaningful data for accuracy and precision against a reference measurement. The document does not explicitly state the exact number of participants in their study or the country of origin of the data. Given it's a 510(k) submission to the FDA, it is likely the studies either followed international standards that are acceptable to the FDA or were conducted in the US or in a region that meets FDA requirements. The clinical validation would be prospective.

For the SpO2 and temperature modules, the document relies on the prior clearance of the OEM modules (Nellcor NELL-1, Masimo MX-5 OEM board, and Exergen TemporalScanner) and their established performance characteristics, indicating that these components have already undergone their own clinical validations. Therefore, specific new clinical studies for these modules within the IQvitals Zone device are not detailed in this submission.

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

For the NIBP clinical validation conducted according to ANSI / AAMI / ISO 81060-2:2013, the ground truth is established by two or more trained observers who simultaneously take conventional auscultatory blood pressure measurements (using a mercury or other validated sphygmomanometer and stethoscope) without knowledge of the device's readings. These observers are highly trained healthcare professionals (e.g., physicians, nurses, or technicians) with demonstrated proficiency in indirect blood pressure measurement. Their qualifications and training for consistency across readings are crucial and typically outlined in the study protocol. The document does not specify the exact number of observers or their detailed qualifications, but adherence to the standard implies these criteria were met.

For the SpO2 and temperature modules, the ground truth would have been established during their original clinical validations using appropriate reference methods (e.g., CO-oximetry for SpO2, and calibrated thermometers for temperature).

4. Adjudication Method for the Test Set:

For NIBP validation under ANSI / AAMI / ISO 81060-2:2013, if there are discrepancies between the two trained observers' readings that exceed predefined limits, a third independent adjudicator or reading typically intervenes, or the measurement is discarded. This "2+1" or similar method ensures the accuracy of the reference blood pressure. The document does not explicitly state the adjudication method, but adherence to the standard implies a method for resolving observer discrepancies was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, the provided documentation describes a 510(k) premarket notification for a vital signs monitor. This type of device directly measures physiological parameters and is not an AI-assisted diagnostic imaging tool that would typically undergo MRMC comparative effectiveness studies to evaluate human reader improvement with AI assistance. Therefore, this section is not applicable.

7. The Type of Ground Truth Used:

• Noninvasive Blood Pressure (NIBP): The ground truth for NIBP was established through concurrent auscultatory measurements by trained human observers, as required by the ANSI / AAMI / ISO 81060-2:2013 standard. This is a form of expert consensus/reference measurement.
• SpO2 and Temperature: The ground truth for the SpO2 and temperature modules would have been established during their original clinical validations. For SpO2, this typically involves CO-oximetry as a reference method. For temperature, it involves highly accurate calibrated reference thermometers.

8. The Sample Size for the Training Set:

The document does not explicitly state a "training set" as it would for a machine learning algorithm. For vital sign monitors, the core algorithms (e.g., oscillometric for NIBP, pulse oximetry principles) are typically developed and refined using extensive engineering and physiological data, rather than being "trained" on a discreet dataset in the same way modern AI algorithms are. The "training" in this context refers to the development and internal validation of the algorithms and hardware, which predates the clinical validation detailed. The NIBP clinical validation study serves as the primary external validation of the device's accuracy.

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

As elaborated in point 8, the concept of a "training set" in the context of this traditional medical device is different from that of modern AI. The ground truth for initial algorithm development and internal validation would involve:

• NIBP: Use of reference pressure manometers and simulated pulse waveforms, as well as testing on human subjects where reference auscultatory and/or invasive blood pressure measurements are simultaneously obtained.
• SpO2: In vitro testing against known oxygen saturation levels and in vivo testing with reference CO-oximetry.
• Temperature: Calibration against known temperature sources and clinical studies comparing to reference thermometers (e.g., rectal, internal core temperature).

This ground truth is established through rigorous engineering and physiological testing, often involving controlled environments and direct comparison to highly accurate reference standards.

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