Search Results

The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

The Dolphin 2000 Y Oximetry Sensor is a fully compatible re-usable replacement sensor for use with Nellcor pulse oximeter monitors. The Re-usable Y sensor is for use on the ear, finger, hand, or neonatal foot and held in place with a disposable bandage. The sensor can also be used on the adult ear with the ear clip accessory. The emitter and detector are mounted in a sealed pouch (same material as in the re-usable clip sensor above) constructed in a Y shape. The sensor is provided non-sterile.

Here's a summary of the acceptance criteria and study details for the Dolphin 2000™ Pulse Oximetry Y Sensor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a number of volunteers. The document mentions "Volunteers participated in the breathe-down protocol."
• Data Provenance: Prospective clinical study conducted in the USA. (VA Hospital of Wisconsin - Milwaukee).

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

• Number of Experts: Not explicitly stated. The study was conducted at the "VA Hospital of Wisconsin - Milwaukee, (Dr. Phillip Clifford, MD.)." Dr. Clifford, as an MD, would be considered an expert. It's unclear if other experts were involved in establishing the ground truth.
• Qualifications of Experts: Dr. Phillip Clifford, MD.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The document refers to "statistically comparing Dolphin 2000 SpO2 values to functional SaO2 values." This suggests a direct comparison method rather than an adjudication process involving multiple human interpretations of the ground truth.

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

• MRMC Study Done? No, a MRMC comparative effectiveness study was not done. The study focuses on the device's accuracy against a physiological reference, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done? Yes, the clinical validation described focused on the direct performance of the Dolphin 2000 sensors (the "algorithm/device only") compared to functional SaO2 values. There's no mention of a human-in-the-loop component in this specific accuracy testing.

7. Type of Ground Truth Used

• Type of Ground Truth: Functional SaO2 values. This is a direct physiological measurement, likely obtained through co-oximetry, considered the gold standard for arterial oxygen saturation.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not stated. The document describes a medical device, not an AI/Machine Learning algorithm that would typically have a separate training set. The device's underlying principles are based on established oximetry technology, not on machine learning trained on large datasets.

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

• How Ground Truth for Training Set was Established: Not applicable. As mentioned above, this is a hardware medical device using established photoplethysmography principles, not an AI system requiring a 'training set' with associated ground truth in the typical machine learning sense. The device's calibration and design would be based on fundamental scientific principles and existing validated technologies.

Ask a specific question about this device