(86 days)
Masimo SET® MS-1 P Pulse Oximeter and the LNOP® Series of Series of Patient Cables are indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rates during both no motion motion conditions for adult, pediatric, and neonatal patients in a hospital and mobile environment.
The Masimo LNOP® Series of Sensors are indicated for the following:
- A single use oximetry sensor intended for adults and pediatrics greater than 30 kg
- A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg
- A single use oximetry sensor intended for neonates greater than 2,000 gms
- A single use oximetry sensor intended for neonates less than 2,000 gms
- A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg
The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SETT MS-1P Pulse Oximeter.
The Masimo SET® MS-1P pulse oximeter and accessories is a device consisting of the Masimo SET technology in an Ohmeda 400 monitor, connecting cable, and oximetry sensors to nonivasively calculate the functional or fractional oxygen saturation of ancrial hemoglobin (SpO.) and pulse rate. It features two easy-to-read displays that present patient data and status information: a numeric LED (light-emitting diode) display that shows the SpO2 and phethysmographic LCD (liquid r stal display) that shows the waveform, the current high and low SpO2, and pulse rate limit setting, and messages as appropriate.
Here's an analysis of the provided document regarding the Masimo SET® MS-1P Pulse Oximeter, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Claimed Accuracy) | Reported Device Performance (Clinical Study Results) |
|---|---|---|
| Saturation (% SpO2) - No Motion | 70% - 100% ± 2 digits (Adults) | 70% - 100% ± 2 digits |
| Saturation (% SpO2) - Motion | 70% - 100% ± 3 digits (Adults) | 70% - 100% ± 4 digits |
| Pulse Rate (bpm) - No Motion | 25 - 240 ± 3 digits | 25 - 240 ± 3 digits |
| Pulse Rate (bpm) - Motion | 25 - 240 bpm ± 5 digits (Adults) | 25 - 240 bpm ± 5 digits |
Note: The document only provides specific acceptance criteria and reported performance for adults. For neonates, the accuracy during no motion and motion is ± 2 digits and ± 3 digits respectively for 70%-100% SpO2, but 0%-69% is unspecified. The study explicitly mentions healthy adult volunteers.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of subjects. The document states: "human blood studies on healthy adult volunteers in induced hypoxia states."
- Data Provenance: Prospective clinical studies. The studies were conducted on healthy adult volunteers in induced hypoxia states. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the studies were likely conducted in the US or under protocols adhering to US regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The ground truth was established using a "laboratory CO-oximeter and ECG monitor," implying the involvement of trained laboratory personnel, but their specific qualifications (e.g., years of experience, certifications) are not provided.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method involving multiple human readers for the test set. The validation is against objective measurements from a laboratory CO-oximeter and ECG monitor.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study typically involves comparing human reader performance with and without AI assistance. The Masimo SET® MS-1P is a standalone measurement device, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone (algorithm only) performance study was performed. The clinical studies directly measured the device's accuracy against a laboratory CO-oximeter for SpO2 and an ECG monitor for pulse rate. This demonstrates the algorithm's performance without direct human interpretation influencing the measurement.
- "The Masimo MS-1P pulse oximeter with LNOP Adt sensors has been validated for no motion accuracy... against a laboratory co-oximeter and ECG monitor."
- "The Masimo MS-1P pulse oximeter with LNOP-Adt sensors has been validated for motion accuracy... against a laboratory co-oximeter and ECG monitor."
7. Type of Ground Truth Used
- The ground truth used was:
- Laboratory CO-oximeter: For arterial hemoglobin saturation (SpO2). This is a highly accurate, invasive measurement often considered a gold standard for blood oxygen saturation.
- ECG monitor: For pulse rate.
8. Sample Size for the Training Set
- The document states that the look-up table used by the Masimo SET® MS-1P's software "are based upon human blood studies against a laboratory CO-oximeter on healthy adult volunteers in induced hypoxia states." However, the actual sample size for these studies (which effectively form the training/calibration data for the look-up table) is not explicitly provided.
9. How the Ground Truth for the Training Set Was Established
- The ground truth for the training set (which informed the device's internal look-up table) was established through "human blood studies against a laboratory CO-oximeter on healthy adult volunteers in induced hypoxia states." This means:
- Subjects: Healthy adult volunteers.
- Conditions: Induced hypoxia states (where oxygen levels are intentionally lowered).
- Reference Method: A laboratory CO-oximeter was used to measure the true arterial hemoglobin saturation from blood samples. This invasive, highly accurate measurement served as the ground truth against which the pulse oximeter's readings were correlated to build its internal calibration (look-up table).
§ 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).