(81 days)
The OSI Medical Dolphin Stand-Alone Pulse Oximeter and Accessories and indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The OSI Medical Dolphin Pulse Oximeter and Accessories are indicated for use with adult, pediatric and neonatal patients in hospital, institutional, industrial and home environments.
The OSI Medical's sensor(s) are intended/indicated for use only with the OSI Medical Dolphin Stand-Alone Pulse Oximeter, and consist of the following:
Digital Dolphin Disposable Sensors
Digital Dolphin 210 Reusable Finger Clip intended for adults / pediatrics greater than 66.14 lbs. (30kg).
Digital Dolphin 110 Extension Cable
The OSI Medical extension cable is intended/indicated for use only with the OSI Medical sensor(s) and the OSI Medical Dolphin Stand-Alone Pulse Oximeter.
The OSI Medical Dolphin Pulse Oximeter and Accessories is a portable stand-alone device, connecting cable, and oximetry sensor(s) to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric and neonatal patients.
The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value, the high and low SpO2 and pulse rate alarm limits, alarms, trends and status messages. It contains the electronic hardware and software that receives and calculates the signals from the LEDs within the sensor to determine the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, and provide for the connection to the connecting cable.
The OSI Medical Dolphin Pulse Oximeter is available in one configuration as a portable stand-alone oximeter that is 10 cm / 3.94 inches high, 27.5 cm / 10.83 inches wide, 25 cm / 9.84 inches deep and weighs about 4 kg / 8.8 lbs. The unit is powered either with a voltage input of 100-240 Vac, 50-60 Hz or with a sealed lead-acid battery with an operating time of approximately 4 hours based upon 2 Ampere hour battery (200mA OEM Module, 300mA System Module) and a charge time of about 4.5 hours to 80% capacity.
The extension cable connects between the monitor and oximetry sensor(s) and transfers LED drive power and the calibration drive to the oximetry sensor from the monitor receives the detector signal from the oximetry sensor.
The extension cable is available in one configuration and is approximately 8 feet / 2.44m in length, and the sensor(s) are approximately 18 inches / 45.72 cm in length.
The sensor(s) measure light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently as compared to unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.
The oximetry sensor is available in a disposable or reusable configuration, and with one configuration for the extension cable (8 feet).
The provided text does not contain specific acceptance criteria, detailed study information, or a table of acceptance criteria and reported device performance. It primarily focuses on the regulatory submission and approval of the OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100, and mentions compliance with various standards.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study details.
- Standalone (algorithm only) performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
The document states that "Additional testing has been performed for the disposable sensors including biocompatibility and performance validation which has been included in this submission," but it does not provide the results or methodologies of this performance validation. It lists various standards the device complies with (e.g., ISO 9919: 1992, EN 865: 1997, FDA Guidance Document for Pulse Oximeters: 9/7/1992, ASTM 1415:1992). These standards likely define performance criteria for pulse oximeters, but the specific acceptance criteria and the device's measured performance against them are not present in this summary.
§ 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).