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The DynoSense Vital Sign Measuring System is intended to record, transfer, store and display of single lead electrocardiography (ECG), heart rate (HR), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), and oral body temperature (TEMP). The device comes in contact with the patient for approximately 60 seconds at each use. This system is for spot checking and does not have continuous monitoring capability or any alarm features.

This system is intended for patients 18 years and older in the home environment. It is intended for use with patients who are well perfused and during no motion condition.

This system makes no specific diagnosis. The device is for single patient use.

Users with implanted pacemakers and/or implanted cardio-defibrillators (ICDs) are not recommended to use the device.

The DynoSense Vital Sign Measuring System is a battery-powered, handheld, personalized single patient use vital sign measuring apparatus. The user must hold the Device with their left hand. Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements are based on transmittance of light through the index finger. Respiration rate (RR) measurements are based on pressure change at the aperture opening during breathing. Oral temperature (TEMP) is measured via sublingual and lingual contact with the thermometer tip. ECG and heart rate (HR) measurements are obtained via completing an electrical path across the left side of the chest. Vital sign data are communicated to a Bluetooth-capable mobile platform for forwarding to the cloud application for processing and storage.

Here's a breakdown of the acceptance criteria and the study details for the DynoSense Vital Sign Measuring System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria & Reported Device Performance

The document provides performance data for several vital signs, primarily referencing compliance with ISO standards and clinical/bench agreement studies, rather than explicit numerical acceptance criteria for each measurement. However, accuracy claims are stated for some parameters.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not explicitly state the numerical sample size for the test set for any of the studies (clinical agreement or bench agreement). It generally refers to "a clinical agreement study" or "bench agreement testing."
• Data Provenance: Not specified. It's unclear if the data was collected nationally or internationally, or if it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the use of experts to establish ground truth.
• The ground truth for most vital sign measurements in these types of studies is typically established by comparing the device's readings against a highly accurate reference standard (e.g., a calibrated simulator for bench tests, or established clinical methods/devices for clinical studies).

4. Adjudication Method for Test Set

• Not applicable. The document describes direct performance testing against standards or reference devices, not a scenario requiring expert adjudication of qualitative data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device measures vital signs directly and is not an imaging AI diagnostic aid that would typically involve human readers interpreting AI results.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Yes, the performance studies described are essentially standalone (algorithm only) performance studies. The device measures vital signs automatically. The studies validate the device's ability to accurately measure ECG, HR, SpO2, PR, RR, and TEMP against established standards or reference methods. The usability study is about a human interacting with the system, but the core vital sign measurement performance is standalone.

7. Type of Ground Truth Used

• For Bench Agreement Studies (ECG, HR, Pulse Rate): The ground truth was established using bench agreement testing as per ISO 60601-2-47:2012 and comparison against a pulse rate simulator (for PR). This implies highly controlled, synthetic data or precise physical models.
• For Clinical Agreement Studies (SpO2, Pulse Rate, Respiration Rate, Temperature): The ground truth was established through a clinical agreement study for each parameter, adhering to relevant ISO standards (e.g., ISO 80601-2-61:2011 for SpO2/PR, ISO 80601-2-56:2012 for Temperature). This means the device's measurements were compared against accepted clinical reference methods/devices for those vital signs, usually involves real patient data.
• For Usability Study: The ground truth was the successful simulation of normal use by laypeople based on instructions for use.

8. Sample Size for Training Set

• The document does not explicitly mention the sample size for a training set. For vital signs monitoring devices, the "training" (development and calibration) might involve iterative testing and refinement, but it's not typically described in terms of a distinct, formalized "training set" as it would be for deep learning AI models. The standards compliance and clinical/bench studies primarily focus on validation/testing.

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

• Since a distinct "training set" and its ground truth establishment are not detailed in the provided document, this information is not available. Device development and calibration would typically involve laboratory measurements and comparisons to known standards, which effectively serve as the "ground truth" for the device's internal algorithms during its design and optimization phases.

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