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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 major brands of pulse oximeter monitors. They are Nellcor and 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 and development an adhesive bandage that is connected to the cable assombly. "The consortient by wrapping it around a finger backing that allows the sensor to be upplied to the End (Colphin 2000 Oximetry Sensors are of toe (measurement site). Tour sizes of aloposes, infant and neonatal application available, which are indicated for doc for duall, positive, mon-sterile for single patient use.

The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespin-The re-usable Dolphil 2005 Finger Olip Oximony Consor consists of the style clip that is placed on the one on anyon one on anyon maintained in mild emitter and detector components mounted in opposing clip halves, mainter and consected emitter and delection components mounted in opposing only his house the optiolection in complession by a spring mings. The montain contact with the patient's finger. Clear components within contoured paids that the read to pass through the finger for the measurements.

The Re-usable Y sensor is for use on the ear, finger, hand, or neonatal foot and held in The Re-usable 1 Sensor is for use on the sensor can also be used on the adult ear with the place with a disposable bandage. The concer or enounted in a sealed pouch (same ear clip accessory." The emitter and other cructed in a Y shape. All Dolphin sensors are provided non-sterile.

Here's an analysis of the provided text regarding the Dolphin 2000™ Pulse Oximetry Y Sensor, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The given text does not explicitly state quantitative acceptance criteria for SpO2 accuracy that Dolphin Medical Inc. aims to meet. Instead, it states that "The labeled accuracy of the Dolphin 2000 sensors is equivalent to those of the predicate devices." For the purpose of this analysis, we will infer the de-facto acceptance criteria based on standard pulse oximeter testing practices and the reported performance.

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "Volunteers participated in breathing down protocols," indicating human subjects.
• Data Provenance:
  • Country of Origin: USA (VA Hospital of Wisconsin - Milwaukee).
  • Retrospective or Prospective: Prospective, as it involved "breathe-down protocols" with "volunteers" specifically for the validation.

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

• Number of Experts: Not explicitly stated. The study was overseen by "Dr. Phillip Clifford, MD." It is common for a physician or a team of physicians to oversee such clinical studies and approve the ground truth, but the exact number establishing the ground truth is not specified.
• Qualifications of Experts: Dr. Phillip Clifford, MD. His specific specialization (e.g., pulmonologist, anesthesiologist) is not mentioned, but an MD degree suggests appropriate medical expertise for overseeing oxygen saturation studies.

4. Adjudication Method for the Test Set

Not specified. The clinical testing involved comparing SpO2 values to functional SaO2 values, implying a direct comparison to a gold standard, rather than a consensus-based adjudication of the device's 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 explicitly done. This device is a sensor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. The study focused on the standalone accuracy of the sensor itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The "Clinical Testing" section describes a study where "Dolphin 2000 SpO2 values" were statistically compared to "functional SaO2 values," which is a direct measurement of the sensor's accuracy in a human clinical setting without human interpretation of the sensor's raw output.

7. The Type of Ground Truth Used

The ground truth used was functional SaO2 values. This is typically measured using arterial blood gas analysis (CO-oximetry), which is considered the gold standard for measuring arterial oxygen saturation.

8. The Sample Size for the Training Set

Not applicable. The Dolphin 2000 Oximetry Sensor is a hardware device (sensor) and not an AI/Machine Learning algorithm that requires a training set. Its "performance" is based on its physical design and electro-optical properties.

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

Not applicable, as this device does not use a training set in the context of AI/ML. Its ground truth for performance validation (as described in point 7) was established through clinical measurements against a gold standard.

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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:

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