(78 days)
The Masimo SET® Intellivue Pulse Oximeter Module is intended for the continuous noninvasive monitoring of functional oxygen saturerial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals and hospital-type facilities.
The IntelliVue Pulse Oximeter Module is indicated for the continuous nonitoring of functional organization of financed for I ne ment vice culse oximicle moduced by an Spo-sensor). The Intellivie Pulse Oximeter Module is indicated for are with adult, pediatric and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
The Masimo SET® IntelliVue Pulse Oximeter Module is a continuous noninvasive, arterial oxygen saturation and pulse rate montor. The Masimo SET Intellivue Module features Masimo SET algorithms in a Philips single-width Intellivae compatible module.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (from "Specifications and Operating Ranges") | Reported Device Performance (from "Clinical Tests" and "Nonclinical Tests") |
|---|---|---|
| Saturation (% SpO2) - No Motion | ||
| Adults, Pediatrics | 70% - 100% ± 2 digits | ± 2 digits (when compared to CO-Oximeter) |
| Neonates | 70% - 100% ± 3 digits | ± 3 digits (when compared to CO-Oximeter) |
| Saturation (% SpO2) - Motion | ||
| Adults, Pediatrics | 70% - 100% ± 3 digits | ± 3 digits (when compared to CO-Oximeter) |
| Neonates | 70% - 100% ± 3 digits | ± 3 digits (when compared to CO-Oximeter) |
| Pulse Rate (bpm) - No Motion | ||
| All Patients | 25 to 240 ± 3 digits | ± 3 digits (when compared to ECG) |
| Pulse Rate (bpm) - Motion | ||
| All Patients | 25 to 240 ± 5 digits | ± 5 digits (when compared to ECG) |
| Low Perfusion Performance | ||
| Saturation (% SpO2) | ± 2 digits (> 0.02% Pulse Amplitude and % Transmission > 5%) | ± 2 digits (when compared to simulators for bench testing) |
| Pulse Rate (bpm) | ± 3 digits (> 0.02% Pulse Amplitude and % Transmission > 5%) | ± 3 digits (when compared to simulators for bench testing) |
Note on "0% - 69% unspecified": For saturation below 70%, the device's accuracy is not specified in the "Specifications and Operating Ranges" table for any patient group or condition. The text later reiterates this as "0% - 69% unspecified".
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description:
- Motion and No Motion Studies: "healthy adult volunteer subjects during no motion and motion conditions who were subjected to a progressive induced hypoxia"
- Low Perfusion Studies: "healthy adult volunteer subjects to low perfusion conditions and to a progressive induced hypoxia"
- Neonates (Accuracy Basis): "clinical studies on adult volunteers and 1% was added to account for the properties of fetal hemoglobin"
- Sample Size: The exact number of subjects for the clinical studies (test set) is not specified in the provided text.
- Data Provenance: The studies were conducted on "healthy adult volunteer subjects" and involved "human blood studies." The country of origin is not explicitly stated, but the context of an FDA submission (K040259, U.S. Department of Health & Human Services) strongly suggests the studies were conducted in the United States or overseen by US regulations. The studies were prospective, involving induced hypoxia and real-time monitoring.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable in the traditional sense for this type of medical device study.
- Qualifications of Experts: The ground truth was established by objective medical instruments, not by expert interpretation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by direct measurement with reference devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a primary component of the diagnostic process.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done. The studies explicitly compare the device's readings (algorithm only output) to established reference measurements (CO-Oximeter and ECG) without human intervention in interpreting the device's output. The device itself is an automated measurement tool.
7. The Type of Ground Truth Used
- Ground Truth Type:
- For Saturation (% SpO2): Arterial blood samples measured by a CO-Oximeter. This is an objective laboratory measurement.
- For Pulse Rate (bpm): Measurements from an ECG monitor. This is an objective physiological measurement.
- For Low Perfusion (Bench Testing): The "Biotek Index 2 simulator and Masimo's simulator" were used, which are controlled bench test environments designed to simulate physiological conditions with known outputs.
8. The Sample Size for the Training Set
- Training Set for Empirical Data: The text states, "The values in the look-up table are based upon human blood studies against a mu the Masmo 021 - miedir as betwarers in induced hypoxia states during motion and non-motion conditions."
- Sample Size: The exact sample size for the training set (the "human blood studies" used to derive the look-up table) is not specified in the provided text.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: The ground truth for the empirical look-up table was established through "human blood studies against a CO-Oximeter" in "induced hypoxia states during motion and non-motion conditions." This indicates that, similar to the test set, the reference measurements for oxygen saturation were obtained from a CO-Oximeter. The mechanism for grounding the pulse rate data in the training set is not explicitly detailed but would logically follow similar objective physiological measurements.
§ 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).