(189 days)
The Dolphin Medical 2150 Handheld Pulse Oximeter is indicated for use for spot checking and/or continuous noninvasive monitoring of fractional oxygen saturation of arterial hemoglobin, pulse rate, and patient temperature. The 2150 is for use with adult pediatric and neonatal patients in hospitals and hospital type facilities.
The Dolphin Medical 2150 Pulse Oximeter consists of the Dolphin ONE™ OEM 701 Module technology, and works with existing Dolphin ONE extension cables, and oximetry sensors to non-invasively calculate the functional saturation of arterial hemoglobin (SpO2) and pulse rate. It also includes a thermistor port which accepts off the shelf approved YSI 400 series patient temperature sensors for the reading of patient temperature. It features an easy-to-read display that presents patient data and status information: an LCD (liquid crystal display) display that shows the SpO2, pulse rate values, patient temperature, and other messages as appropriate. A Dolphin ONE Extension Cable connects the sensor to the 2150. The cable is available in two configurations, three foot or eight in length. The oximeter can be operated off either an internal rechargeable battery or with use of a medical grade AC power supply which is fumished with the unit. The Dolphin Medical Model 2150 Pulse Oximeter will be used for continuous noninvasive monitoring and spot checking of SpO2, pulse rate, and patient temperature for adult, pediatric, infant and neonatal patients in hospital-type facilities. Typical acute-care uses are the Operating Room, Recovery Room and the Adult and Neonatal Intensive Care Units. The Dolphin Medical Model 2150 Pulse Oximeter and accessories will be used for adult, pediatric and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The user responsible for the operation of the Dolphin Medical Model 2150 will normally be a licensed clinical professional such as a physician, nurse, or respiratory therapist.
Here's a summary of the acceptance criteria and the study that proves the Dolphin Medical 2150 Handheld Pulse Oximeter meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Accuracy) |
|---|---|
| Accuracy of SpO2 for adults, pediatrics, and infants in the range of 70-100% SaO2 | Less than 2.0% ARMS |
| Accuracy of SpO2 for neonates in the range of 70-100% SaO2 | Less than 3.5% ARMS |
Study Details
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Sample Size used for the test set and the data provenance: The document states that the validation involved "Volunteers participated in the breathe-down protocol." However, the exact number of volunteers (sample size) for the test set is not explicitly mentioned in the provided text. The data provenance is stated as the "VA Hospital of Wisconsin - Milwaukee." The study design (breathe-down protocol) indicates it was a prospective study where participants' oxygen saturation was controlled.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The study was conducted by "Dr. Phillip Clifford, MD." It does not specify the number of additional experts used or their qualifications for establishing ground truth beyond Dr. Clifford's involvement and the medical facility where the study was conducted.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: The document does not mention any specific adjudication method for the test set. It primarily discusses comparing the device's SpO2 values to "functional SaO2 values."
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not applicable as the device is a pulse oximeter, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the clinical testing described is a standalone performance study of the Dolphin Medical 2150 Handheld Pulse Oximeter. It evaluates the device's ability to accurately measure SpO2 and pulse rate independently. Human users operate the device and interpret its display, but the accuracy assessment is of the device's output against a reference.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth used was "functional SaO2 values." In the context of pulse oximetry breathe-down studies, this typically refers to arterial blood gas (ABG) analysis performed by a CO-Oximeter, which is considered the gold standard for measuring arterial oxygen saturation (SaO2).
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The sample size for the training set: The document does not provide any information regarding a separate training set or its sample size. The description of the device's internal technology (Dolphin ONE™ OEM 701 Module, patented Digital Signal Processing technology) suggests that algorithms were developed, but the details of their training are not disclosed in this summary.
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How the ground truth for the training set was established: As no training set information is provided, how its ground truth was established is not discussed in this document.
§ 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).