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The Dolphin ONE Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

The Dolphin ONE Model 420 oximetry sensor is indicated for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate.

The Dolphin ONE Forehead Oximetry Sensor is a reusable sensor for use with approved Dolphin ONE pulse oximeter monitors.

The reusable forehead sensor is for use on the forehead and held in place with a disposable adhesive disc and headband. The emitter and detector are mounted in a sealed pouch (same materials as in the reusable Y sensor above) constructed in a flat cylindrical shape. The sensor is provided non-sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dolphin ONE Pulse Oximetry Forehead Sensor:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only explicitly states one clear acceptance criterion (accuracy) and its corresponding performance. Other tests (biocompatibility, environmental, pulse rate, skin temperature) are mentioned as having been "complied with" or having "no reports of biocompatibility issues," but specific quantitative acceptance criteria for those tests are not detailed in the provided text.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Volunteers participated in the breathe-down protocol," but does not provide the number of volunteers.
• Data Provenance: Prospective clinical testing. The study was conducted at the "VA Hospital of Wisconsin - Milwaukee," indicating data from the USA.

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

• Number of Experts: One expert is explicitly named: "Dr. Phillip Clifford, MD." It is unclear if he was the sole expert establishing ground truth or if others were involved but not named.
• Qualifications of Expert(s): "Dr. Phillip Clifford, MD." His specific specialty (e.g., anesthesiologist, pulmonologist) or years of experience are not provided.

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method. The ground truth seems to have been established by Dr. Clifford at the VA Hospital.

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

• No, an MRMC comparative effectiveness study was not done. The document describes a standalone clinical validation study comparing the device's readings to functional SaO2 values. There is no mention of human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was done. The clinical validation describes directly comparing the device's SpO2 values to functional SaO2 values, indicating an assessment of the device's performance independent of human interpretation or AI assistance.

7. Type of Ground Truth Used

• Functional SaO2 values. The text states, "Scientific accuracy was demonstrated by statistically comparing Dolphin ONE SpO2 values to functional SaO2 values." This suggests a reference method (likely involving blood gas analysis) was used to determine the true arterial oxygen saturation.

8. Sample Size for the Training Set

• The document does not mention a training set. Pulse oximeters are typically hardware devices that implement established physiological principles; they do not usually involve machine learning models that require a "training set" in the conventional AI sense. The testing described is for validation of the device's accuracy.

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

• As no training set is mentioned or implied for this type of device, this question is not applicable.

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