(76 days)
The Masimo SET® 2000 Pulse Oximeter and accessories is intended for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo SET® 2000 Pulse Oximeter and accessories are indicated for the continuous noninvasive of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® 2000 Pulse Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo SET® 2000 pulse oximeter and accessories is a portable stand alone device, connecting cable, and oximenty sensors to nonivasively 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, SpO2 value, the high and low SpO, and pulse rate alarm limits, alarms, trends and status messages.
The monitor contains the electronic hardware and software that receives and calculates the signals from the LED's to determine the functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate and provides for the connection to the connecting cable.
The PC series connecting cables connects the monitor to the oximetry sensors and transfers LED drive power and the calibration drive to the oximetry sensors from the monitor receives the detector signal from the oximetry sensor.
The LNOP® series of oximetry sensors measure the 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 provided text does not contain detailed acceptance criteria for the Masimo SET® 2000 Pulse Oximeter or a study specifically proving the device meets said criteria in the format typically seen with AI/ML device descriptions. The document is a 510(k) summary for a pulse oximeter, focusing on its substantial equivalence to a predicate device.
However, based on the general understanding of pulse oximeter performance and similar regulatory submissions, we can infer some aspects and highlight what information is missing.
Here's an attempt to structure the answer based on the provided text, acknowledging its limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary explicitly does not include a table of acceptance criteria or detailed performance metrics against specific criteria. For a pulse oximeter, such criteria typically relate to accuracy (e.g., Accuracy Root Mean Square, APE RMS) and bias across a specified SpO2 range, especially under various conditions like motion and low perfusion.
Based on the typical requirements for pulse oximeters, and what would likely be reported in a full submission (but is absent here), a hypothetical table would look like this:
| Acceptance Criteria (Hypothetical) | Reported Device Performance (Not in document) |
|---|---|
| SpO2 Accuracy (Arms) ± X% for SpO2 Y-Z% (No Motion) | Not reported in provided text |
| SpO2 Accuracy (Arms) ± A% for SpO2 B-C% (Motion) | Not reported in provided text |
| SpO2 Accuracy (Arms) ± D% for SpO2 E-F% (Low Perfusion) | Not reported in provided text |
| Pulse Rate Accuracy | Not reported in provided text |
What the document does state regarding performance (implicitly):
The document states that the device is intended for "continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate...during both no motion and motion conditions, and for patients who are well or poorly perfused." This implies that the device should perform adequately under these various conditions, which would be demonstrated in the full submission, but specific performance metrics are not given in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided 510(k) summary.
- Data Provenance: Not specified in the provided 510(k) summary. For pulse oximeter studies, this would typically involve human subject studies where SpO2 is varied (e.g., through controlled hypoxia) and compared to a reference co-oximeter. The country of origin and whether the study was prospective or retrospective would be detailed in a full study report, but is absent in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
- This information is not applicable to a pulse oximeter 510(k) summary in the way it applies to AI/ML image analysis devices. The "ground truth" for a pulse oximeter is typically established via a laboratory co-oximeter measurement of arterial blood samples. There are no "experts" in the context of reading images or assessing interpretations for ground truth determination here.
4. Adjudication Method for the Test Set
- Not applicable in the AI/ML sense. The "ground truth" for a pulse oximeter is based on instrumental measurements (laboratory co-oximeter), not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI/ML diagnostic aids that assist human readers in interpreting medical images or data. The Masimo SET® 2000 Pulse Oximeter is a standalone measurement device, not an AI-assisted diagnostic tool that helps human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, implicitly. The very nature of a pulse oximeter is that it is a standalone device that measures and displays SpO2 and pulse rate. Its performance evaluation is inherently standalone, as it doesn't involve a human "in the loop" for its primary function of generating these measurements. The device provides "continuous noninvasive monitoring" and the "monitor consists of a screen that displays the pulse plethysmographic waveform, the pulse rate, SpO2 value," indicating it operates independently to produce these values.
7. The Type of Ground Truth Used
- Laboratory Co-oximetry. As mentioned above, the gold standard for SpO2 accuracy in pulse oximeter validation studies is typically a laboratory co-oximeter measurement of arterial blood gas samples. The summary explicitly states: "As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient's condition." This reinforces that co-oximetry is the definitive reference for blood oxygen saturation.
8. The Sample Size for the Training Set
- Not applicable in the AI/ML sense. Pulse oximeters are based on established physiological principles and optical spectroscopy, not on machine learning models trained on large datasets. While the device utilizes algorithms for signal processing and SpO2 calculation, these are typically engineered algorithms rather than learned from a "training set" in the context of contemporary AI/ML.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reasons as point 8. The algorithms are developed based on physics, physiology, and extensive calibration, not by iterative learning from a labeled training set.
§ 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).