(195 days)
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 designed for use with BCI pulse oximeter monitors. They represent a redesign and updating of the Aristo Sensor Line.
The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to the disposable Dolphin 2000 Oximol. Joth diodes are embedded in a laminate of tapes predicate devious. The cable assembly. The sensors have an adhesive bandage that is connected to the oable doomapplied to the patient by wrapping it around a finger backling that allows the other to see of disposable Dolphin 2000 Oximetry Sensors are or toe (measurement ofto). I our else for adult, pediatric, infant and neonatal application available, which are indication for the sensors are provided non-sterile for single patient use.
The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespin-. The re-usuale Dolphin 2000 Finger. The finger. The finger clip sensor consists of the style clip that is placed on the end on opposing clip halves, maintained in mild entiter and delection of the molded outer components house the optoelectric compression by a sping mings. The nentain contact with the patient's finger. Clear components within these pads the optical energy to pass through the finger for the windows within those pade perminents on one provided non-sterile.
The Dolphin 2000™ Pulse Oximetry Sensor was evaluated through clinical testing involving breathe-down protocols. Scientific accuracy was demonstrated by statistically comparing Dolphin 2000 SpO2 values to functional SaO2 values.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (ARMS) for SaO2 values in the range of 70-100% for adults, pediatrics, and infants | Less than 2.0% ARMS in the range of 70-100% SaO2 |
| Accuracy (ARMS) for SaO2 values in the range of 70-100% for neonates | Less than 3% ARMS in the range of 70-100% SaO2 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Sixteen volunteers.
- Data Provenance: Prospective, conducted at the University of California at San Francisco ('UCSF') Department of Anesthesiology and the VA Hospital of Wisconsin - Milwaukee, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Two primary medical experts are mentioned for overseeing the studies: John W. or Gallerma at UCSF and Dr. Phillip Clifford, MD. at VA Hospital of Wisconsin - Milwaukee. Their specific qualifications (e.g., years of experience) are not detailed beyond their medical doctor (MD) designation at prominent institutions.
4. Adjudication Method for the Test Set
- The document does not explicitly state an adjudication method (like 2+1, 3+1). The "scientific accuracy was demonstrated by statistically comparing Dolphin 2000 SpO2 values to functional SaO2 values," suggesting a direct comparison to a reference standard rather than multi-reader adjudication of the device output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the device's accuracy against a physiological reference, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the performance testing described is a standalone evaluation of the device's accuracy in measuring SpO2 values. The volunteers were "fully conscious" and their SaO2 values were measured by the device and compared to functional SaO2 values.
7. The Type of Ground Truth Used
- Type of Ground Truth: Functional SaO2 values, likely obtained through direct arterial blood gas analysis, which is considered a gold standard for blood oxygen saturation measurement.
8. The Sample Size for the Training Set
- The document does not mention a separate training set or its sample size. The description pertains to the validation of the device, implying a pre-existing algorithm or design. Pulse oximeters generally rely on established physiological principles and calibration, rather than machine learning models that require explicit training sets for each device iteration in the way AI algorithms do.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no explicit training set for a machine learning algorithm is described. The device's underlying principles are based on non-invasive optical assessment of tissue oxygenation.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).