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

The Dolphin 2000 Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with Nellcor pulse oximeter monitors. They represent a design change to the Dolphin 2000 BCI Compatible Sensors.

The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to predicate devices. The emitter and detector diodes are embedded in a laminate of tapes that is connected to the cable assembly. The sensors have an adhesive bandage backing that allows the sensor to be applied to the patient by wrapping it around a finger or toe (measurement site). Four sizes of disposable Dolphin 2000 Oximetry Sensors are available, which are indicated for use for adult, pediatric, infant and neonatal application sites. The Dolphin 2000 disposable sensors are provided non-sterile for single patient use.

The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespinstyle clip that is placed on the end of a finger. The finger clip sensor consists of the emitter and detector components mounted in opposing clip halves, maintained in mild compression by a spring hinge. The molded outer components house the optoelectric components within contoured pads that maintain contact with the patient's finger. Clear windows within these pads permit the optical energy to pass through the finger for the measurements. The Dolphin 2000 re-usable sensors are provided non-sterile.

The Dolphin 2000 Oximetry Sensors were validated in clinical testing to demonstrate their accuracy in measuring arterial oxygen saturation (SpO2).

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly stated how many volunteers participated, but the study implies a group of "Volunteers."
• Data Provenance: Prospective (breathe-down protocol in a clinical setting), conducted at the VA Hospital of Wisconsin - Milwaukee, USA.

3. Number of Experts and Qualifications:

• Number of Experts: One expert is explicitly named: Dr. Phillip Clifford, MD.
• Qualifications: "Dr. Phillip Clifford, MD." implies a medical doctor, likely with expertise in physiology or critical care relevant to oximetry. Specific years of experience or specialization are not detailed.

4. Adjudication Method:

• Not applicable as the ground truth (functional SaO2) was established by direct measurement from arterial blood gas analysis, not expert consensus or review.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone accuracy of the device against a physiological ground truth.

6. Standalone Performance:

• Yes, a standalone study was performed. The device's SpO2 values were statistically compared to functional SaO2 values obtained from volunteers during a breathe-down protocol.

7. Type of Ground Truth Used:

• Physiological Ground Truth: Functional SaO2 values, likely obtained through co-oximetry via arterial blood gas analysis, are implied as the comparison standard ("statistically comparing Dolphin 2000 SpO2 values to functional SaO2 values").

8. Sample Size for the Training Set:

• The document does not explicitly mention a separate "training set" or its size. The described "Clinical Testing" focuses on validation. It is common for such medical devices to be developed and refined using internal data, but details of that process are not provided in this 510(k) summary.

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

• As a separate training set is not explicitly mentioned, the method for establishing its ground truth is not detailed in this document.

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