(295 days)
The NMB-200MP is a portable Oximetry monitor which may be used in low perfusion conditions. It non-invasively and continuously monitors and displays arterial blood oxygen saturation (SpO2), temporary occluded arterial blood oxygen saturation (SoO2), pulse rate (P.R.) and plethysmogram waveform.
Temporary occluded arterial blood oxygen saturation (SoO2) is intended for use under any conditions that will cause poor signal quality. It is not intended for use under motion conditions.
It may be used on adult patients in the hospital or clinical environments.
The NBM-200MP permits continuous patient monitoring with adjustable alarm limits for oximetry, as well as visible and audible alarm signals.
The NBM-200MP is NOT intended for home use.
OrSense NBM-200MP device is a pulse oximetry device, measuring SpO2 and Pulse Rate. In addition to a regular operating mode, it also includes an "occlusion spectroscopy" mode, which is activated during low-perfusion conditions. A pneumatic cuff placed around a finger temporarily inflates and deflates; the resulting changes in blood behavior within the occluded finger are measured and analyzed to provide accurate measurements of blood oxygen saturation during low-perfusion conditions.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes the NBM-200MP Pulse Oximetry device, focusing on its accuracy for blood oxygen saturation (SpO2) and temporary occluded arterial blood oxygen saturation (SoO2).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for pulse oximeters are typically defined by regulatory standards, such as ISO9919:(2005), which specifies accuracy requirements. While the document states that the study was performed in compliance with ISO9919:(2005), it doesn't explicitly list the numerical acceptance criteria from the standard. However, it does provide the measured performance in terms of Root Mean Square (RMS) accuracy, correlation, and bias.
| Parameter | Acceptance Criteria (from ISO9919:2005 implied) | Reported Device Performance (NBM-200MP) |
|---|---|---|
| SpO2 Accuracy (RMS) - Pulse Mode | (Implied by compliance with ISO9919:2005) | 2.5% |
| SpO2 Correlation - Pulse Mode | (Implied by compliance with ISO9919:2005) | 0.95 |
| SpO2 Bias - Pulse Mode | (Implied by compliance with ISO9919:2005) | 0.2% |
| SoO2 Accuracy (RMS) - Occlusion Mode | (Implied by compliance with ISO9919:2005) | 2.2% |
| SoO2 Correlation - Occlusion Mode | (Implied by compliance with ISO9919:2005) | 0.96 |
| SoO2 Bias - Occlusion Mode | (Implied by compliance with ISO9919:2005) | 0.05% |
| Safety (Adverse Events) | No device-related adverse events | No adverse events reported |
| Skin integrity (cuff mechanism) | No marks, significant differences in color/shape | No marks, or any significant differences |
Study Proving Device Meets Acceptance Criteria:
The document describes two clinical studies:
- Hypoxia Study: This study validated SpO2 and SoO2 accuracy against a reference co-oximeter.
- Safety Study: This study evaluated the safety of the inflation/deflation mechanism in an Intensive Care Unit (ICU) environment.
2. Sample Size and Data Provenance for the Test Set
-
Hypoxia Study (Accuracy Validation):
- Sample Size: 10 healthy individuals.
- Data Points: 388 pairs of data points for pulse mode, 438 data pairs for occlusion mode.
- Data Provenance: Not explicitly stated, but the study was performed to validate accuracy, implying it served as the primary test set for performance. The use of "consenting healthy individuals" suggests a prospective controlled study. Country of origin is not specified.
-
Safety Study (Cuff Mechanism):
- Sample Size: 32 patients.
- Data Provenance: Conducted in an Intensive Care Unit (ICU) environment. The patient profiles (pneumonia, pancreatitis, GI Bleeding, etc.) indicate a prospective clinical observation in a hospital setting. Country of origin not specified.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Hypoxia Study: The "reference measurements of blood SaO2 by a cooximeter" are considered the ground truth. A co-oximeter is a laboratory device, and its operation and results are typically interpreted by trained medical laboratory professionals, but the exact number and qualifications of experts interpreting the co-oximeter data are not specified in the document.
- Safety Study: The ground truth for safety was established by "investigators observ[ing] the fingers" for changes. The number and specific qualifications of these investigators are not specified, beyond being based in an ICU environment, implying medical professionals.
4. Adjudication Method for the Test Set
- Hypoxia Study: No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for the co-oximeter readings or the comparison. The co-oximeter is likely considered the gold standard, so its readings would be directly used.
- Safety Study: The investigators "observed the fingers." The method for ensuring consistent evaluation among multiple observers (if there were more than one) or an explicit adjudication process is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study evaluating how much human readers improve with AI vs. without AI assistance was reported. This device is a measurement device (a pulse oximeter) rather than an image interpretation or diagnostic aid that would typically involve human readers.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was done for the NBM-200MP device. The reported accuracy, correlation, and bias for both pulse mode and occlusion mode (SpO2 and SoO2) represent the algorithm's performance independent of human intervention in the measurement process, aside from initial sensor placement.
7. Type of Ground Truth Used
- Hypoxia Study: The ground truth for SpO2 and SoO2 accuracy was established using reference measurements of blood SaO2 by a co-oximeter. This is considered a highly accurate, objective, and quantitative physiological measurement.
- Safety Study: The ground truth for safety was based on clinical observation of patient outcomes (skin integrity) by investigators.
8. Sample Size for the Training Set
The document does not specify the sample size for any training set. As this is a 510(k) submission for a non-AI device relying primarily on established physiological principles and signal processing, the concept of a "training set" in the machine learning sense might not be explicitly relevant or documented in the same way. The device's algorithms were likely developed and validated using engineering principles, bench testing, and pilot studies, but specific "training set" sizes are not mentioned.
9. How the Ground Truth for the Training Set Was Established
Since no specific "training set" is mentioned in the context of machine learning, the method for establishing its ground truth is not provided. Device development typically involves a variety of engineering and pre-clinical testing, where ground truth would be established through calibrated instruments, known physiological models, or expert evaluation to refine the device's algorithms and hardware before formal clinical validation.
§ 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).