(57 days)
The Infinity Nellcor OxiMax SmartPod is intended for use under the direct supervision of a licensed healthcare practitioner (i.e. Physicians, Nurses, and Technicians). It is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
The Infinity Nellcor OxiMax SmartPod is indicated for use with adult, pediatric, and neonatal patients.
The Infinity Nellcor OxiMax SmartPod and accessories are indicated for use with patients who are well or poorly perfused in hospitals and hospital type facilities.
The Infinity Nellcor OxiMax SmartPod is not compatible for use in home care environment and in hospitals where CT, Hyperbaric chambers and MRI equipment are in use.
The Infinity Nellcor OxiMax SmartPod is an addition to Draeger Medical System's Infinity patient monitoring series that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, pediatric, and neonatal patients. The Infinity Nellcor OxiMax SmartPod is manufactured by Draeger Medical Systems, Inc. and contains the Nellcor OxiMax Pulse Oximeter's Nell-1 circuit board with Nellcor's SpO2 measurement algorithm.
The Infinity Nellcor OxiMax SmartPod works as a component of the Infinity Patient Monitoring series and does not function on its own. The Infinity Nellcor OxiMax SmartPod is connected externally via RS232 using X8 connector on the Infinity Delta series monitors. The Infinity Nellcor OxiMax SmartPod is powered by the patient monitor. A Nellcor OxiMax Pulse Oximetry sensor is attached to a patient finger and one end of the patient cable is connected to the sensor and the other end connected to the Infinity Nellcor OxiMax SmartPod. The monitor will begin continuously displaying the patient's pulse rate and SpO2 value. Hi/Low SpO2 and pulse rate alarm limits, alarms, trends, and status messages are all controlled by the bedside monitor.
The provided text describes the regulatory submission for the "Infinity Nellcor OxiMax SmartPod," a pulse oximeter. However, it does not contain specific acceptance criteria or a detailed study report proving the device meets acceptance criteria.
Instead, it states that the device was deemed "substantially equivalent" to a predicate device (Infinity Masimo SET® SpO2 pod). The documentation focuses on regulatory compliance, intended use, and comparison to the predicate, rather than detailed performance metrics and their acceptance thresholds.
Therefore, I cannot fulfill all parts of your request based on the provided text. I will, however, extract all available information relevant to your questions.
Information Extracted from the Document:
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A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria or provide a table of reported device performance metrics for the Infinity Nellcor OxiMax SmartPod. It primarily asserts substantial equivalence to a predicate device.
It states: "Verification and validation testing performed indicate that the software modifications described in this submission are as safe and effective as previous versions and have not altered the fundamental technology of the device(s). Additionally, testing demonstrates that SpO2 and pulse rate values calculated by the third party (OEM) device (Nellcor OxiMax Pulse Oximeter N-600x) are identical to the values displayed on the Draeger Medical Infinity Delta series monitors." This indicates internal testing was done to confirm identical values between the integrated OEM component and the display, but it doesn't provide specific performance numbers or acceptance thresholds. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not specified in the provided text. -
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):
Not specified in the provided text, as detailed ground truth establishment methods are not described for performance testing. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified in the provided text. -
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:
Not applicable. This device is a pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is a standalone hardware component that integrates an OEM algorithm (Nellcor OxiMax Pulse Oximeter's Nell-1 circuit board with Nellcor's SpO2 measurement algorithm). The testing mentioned was to ensure the values from this integrated OEM component were "identical" to what was displayed on the Draeger monitor.
This is a standalone algorithm performance in the sense that its output is directly displayed, but the document does not detail specific performance studies of that algorithm itself (e.g., accuracy against a reference method) but rather focuses on its integration and equivalence. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not explicitly stated for performance testing. For a pulse oximeter, ground truth for SpO2 accuracy would typically be arterial blood gas analysis (co-oximetry) in controlled hypoxia studies. The document mentions tests demonstrating "SpO2 and pulse rate values calculated by the third party (OEM) device (Nellcor OxiMax Pulse Oximeter N-600x) are identical to the values displayed on the Draeger Medical Infinity Delta series monitors," implying the OEM device's output is the reference, but not how that OEM device's output was validated against a primary ground truth. -
The sample size for the training set:
Not applicable. This is not an AI/machine learning device that would have a distinct training set in the conventional sense. -
How the ground truth for the training set was established:
Not applicable (see point 8).
§ 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).