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The Dolphin Medical Voyager Pulse Oximeter and Accessories are indicated for the non-continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an oximetry sensor). The oximeter is indicated for use with a Pocket PC (with Windows CE Operating System).

The Pocket PC based Dolphin Medical Voyager Pulse Oximeter and Accessories, is fully functional handheld device to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate through a Compact Flash (CF) Card. The Voyager consists of a CF card, and a connecting cable and is sold with the Dolphin ONE reusable and disposable sensors and the Dolphin Voyager Software as accessories. The user is required to load the Dolphin Voyager Software on a Pocket PC. The Voyager is intended for battery use only using the internal Pocket PC battery. The oximeter must not be used when connected to any other device, or when placed in the recharging cradle provided by the Pocket PC manufacturer. The Dolphin Voyager software will disable the oximetry function and display a message "Unit Charging - Do Not Use" when external power is detected. The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value, the high and low SpO2 and pulse rate trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provide for the connection to the connecting cable. The connecting cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration driver to the oximetry sensor from the the monitor receives the detector signal from the oximetry sensor. The sensor(s) measure light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.

Here's a breakdown of the acceptance criteria and study information for the Dolphin Medical Voyager Pulse Oximeter, based on the provided text:

Acceptance Criteria and Device Performance

Note: ARMs (Accuracy, Root Mean Square) is a measure of the statistical accuracy of the pulse oximeter readings compared to reference values.

Study Details

1. Sample sized used for the test set and the data provenance:
* Sample Size: 14 volunteers.
* Data Provenance: Prospective, clinical data collected at the VA Hospital of Wisconsin - Milwaukee (USA).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not explicitly stated. However, the study was conducted under the direction of Dr. Philip Clifford, MD, implying medical expertise was involved in the clinical validation, including potentially obtaining functional SaO2 values.

3. Adjudication method for the test set:
* Not explicitly mentioned. The text states "Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpOz values to functional SaO2 values," suggesting direct comparison to a reference standard rather than multi-reader adjudication as typically seen in image-based diagnostics.

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:
* No. This type of study (MRMC) is not relevant for a pulse oximeter, which is a standalone device measuring physiological parameters, not interpreting images or clinical cases requiring human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes. The study assessed the accuracy of the Dolphin Medical Voyager Pulse Oximeter itself by comparing its readings (SpO2 values) to a reference standard (functional SaO2 values) during breathe-down protocols. This is a standalone performance evaluation.

6. The type of ground truth used:
* Physiological Ground Truth: Functional SaO2 values, likely obtained through co-oximetry, which is considered the gold standard for measuring arterial oxygen saturation. The breathe-down protocol specifically generated a range of SaO2 values for comparison.

7. The sample size for the training set:
* Not specified. The document describes the clinical validation study (test set) but does not provide details on any separate training set used for the device's development or internal calibration.

8. How the ground truth for the training set was established:
* Not specified, as details about a training set are not provided. However, generally, for pulse oximeters, initial calibration and development would also rely on comparisons to known physiological oxygen saturation levels, often from similar breathe-down studies or controlled laboratory settings.

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