(177 days)
The Nellcor Bedside SpO2 Patient Monitoring System is indicated for prescription use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra hospital transport, or home environments.
The Nellcor Bedside SpO2 Patient Monitoring System is a pulse oximeter designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System is intended to be used with one of a range of Nellcor OxiMax oxygen transducers (sensors). The subject device displays digital values of SpO2 and pulse rate. Pulse amplitude is displayed by means of a 'blip bar' presentation or plethysmographic waveform. The Nellcor Bedside SpO2 Patient Monitoring System can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (from 80V AC to 264V AC) or alternately by an integral sealed 7.2V, 83W/hr rechargeable lithium-ion battery.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|---|
| SpO2 accuracy (no motion) | ±2% from 70-100% | ±2% from 70-100% |
| SpO2 accuracy (with motion) | ±3% from 70-100% | ±3% from 70-100% |
| Pulse rate accuracy | ±3% from 20 to 250 BPM | ±3% from 20 to 250 BPM |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for any clinical test set. It mentions:
- "Clinical testing was conducted on a similar Nellcor pulse oximetry device utilizing the same PCBA module..." This indicates that the clinical data used was not generated directly from the subject device (Nellcor Bedside SpO2 Patient Monitoring System) but from a "similar" device with the "same PCBA module."
- The data provenance (country of origin, retrospective/prospective) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical testing.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted or reported. The document focuses solely on the device's accuracy without human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance metrics provided (SpO2 accuracy and pulse rate accuracy) are indicative of standalone (algorithm only) performance. The device provides digital values, and the 'blip bar' or plethysmographic waveform are also outputs of the algorithm. There is no mention of human-in-the-loop performance measurement.
7. The Type of Ground Truth Used
While not explicitly stated, in pulse oximetry accuracy studies, the "ground truth" for oxygen saturation (SpO2) is typically established using arterial blood gas (ABG) analysis carried out by a co-oximeter. The text refers to "functional oxygen saturation of arterial hemoglobin (SpO2)," which aligns with ABG measurements.
8. The Sample Size for the Training Set
The document does not provide any information on the sample size used for a training set. This is a medical device clearance document, not a detailed machine learning paper, so such information is typically not included unless the device's primary function is an AI/ML algorithm that was "trained." Given that the device uses "the same oximetry algorithm" as previous devices, it suggests a well-established, likely non-machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (see point 8), there's no information on how its ground truth was established.
§ 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).