(30 days)
The OSI Medical Dolphin Stand-Alone Pulse Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and public of any hominaste monitoring of theilence bygon only and the end Accessories are indicated for use with adult, by an Spoz sensor, The OOT Medion Dolphill Faloo Oximo conditions and for patients who are well or poorly perfused in hospitals, hospital-type facilities and home environments.
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. The monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpOz value, the high and low SpO2 and pulse rate 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 function 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 describes a 510(k) submission for the OSI Medical Dolphin Stand-Alone Pulse Oximeter, Model No. 2100. It asserts substantial equivalence to a predicate device and lists compliance with various standards. However, it does not contain a detailed study report with specific acceptance criteria and performance data for the device itself. The document mainly focuses on regulatory compliance and substantial equivalence to a previously cleared device.
Therefore, many of the requested details about acceptance criteria, specific performance results, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from the provided text.
Here's an analysis of what can be inferred or is explicitly stated, with limitations noted:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the provided document. The document states that the device has been "designed to comply with ... standards" (section 1), implying that performance criteria would be defined by these standards, but it doesn't list specific performance metrics or the device's results against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided document. The text mentions "Additional testing has been performed on the OSI Medical Dolphin Stand-Alone Pulse Oximeter to validate the performance of the motion artifact rejection under the worst-case scenario, involving the disposable sensors" (section 1). However, it does not provide details about the sample size, data provenance, or the nature of this "testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not present in the provided document. Pulse oximeters typically compare their readings to invasive blood gas measurements. The document does not describe human expert involvement in establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided document.
5. 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 present in the provided document. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the device is described as a "Stand-Alone Pulse Oximeter" (sections 0, 1, 4). The performance discussed (albeit vaguely) refers to the device's direct measurement capabilities. Thus, any performance claims would inherently be "standalone" performance. The text states: "The OSI Medical Dolphin Pulse Oximeter and Accessories is a portable stand-alone device... to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." (section 0).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly stated in the provided document for the "additional testing." For pulse oximeters, the accepted ground truth for accuracy is typically arterial blood gas analysis (co-oximetry). While the document states the device "has been designed to comply with ... standards" (section 1), these standards would implicitly dictate the ground truth methodology for performance testing, but the document does not elaborate on the specific ground truth used for its own testing.
8. The sample size for the training set:
This information is not present in the provided document. Pulse oximeters primarily rely on hardware and signal processing algorithms based on known physiological principles (e.g., Beer-Lambert law), rather than machine learning models that require a "training set" in the common AI sense. While there is "software" for the device, the document states it was "fully specified and validated" (section 1), not "trained."
9. How the ground truth for the training set was established:
This information is not present in the provided document, for the reasons outlined in point 8.
In summary, the provided submission focuses on regulatory compliance and substantial equivalence to predicate devices, rather than a detailed report of a new clinical study with explicit acceptance criteria and corresponding performance data for the device itself.
§ 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).