(87 days)
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is intended for continuous 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, and home environments.
The Masimo SET Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous monitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multiparameter devices for display on those devices.
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 with good skin integrity less than 10 kg
- A single use oximetry sensor intended for neonates with poor skin integrity less than 1 kg
- 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 SET™ Radical Pulse Oximeter with SatShare™.
The Masimo MC connecting cable is indicated for connection to Nellcor sensor compatible cables.
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liquid crystal display) display that shows the SpO2, pulse rate values, and a plethysmographic waveform, the current high and low SpO2 and pulse rate limit setting, and messages as appropriate.
Features
- Ability to perform as a stand alone monitor and a detachable portable monitor
- Several types of Masimo LNOP® sensors for flexibility.
- An automatic self-test at start-up.
- Ability to be connected to the sensor port of multi-parameter devices that allows the multi-parameter device to share the Masimo SET® Radical Pulse Oximetry measurements
- Ability to be connected to digital communication modules
- Backlit display for excellent visibility in subdued lighting conditions.
- Direct access to user-selectable high and low alarm limits for SpO2 and pulse rate.
- An audible pulse indicator with an adjustable volume
- Visual and audible (adjustable volume) alarms.
- An alarm-silence feature; silences audible alarms for 120 seconds or continuously until deactivated.
- Status and alarm informational messages appear on the LCD.
- 8, 12, or 16 second SpO2 response averaging modes.
- Trend data storage of up to 8 hours.
- Automatic scaled plethysmographic waveform
- Large SpO2 digital display for clear differentiation from the pulse rate value.
The PC series of connecting cables connects the monitor to the oximetry sensors and transfers LED drive power to the oximetry sensors from the monitor receives the detector signals from the oximetry sensor.
A MC connecting cable that attaches to the docking station and the multi-parameter device's oximeter enabling the SatShare™ feature of the Radical Pulse Oximeter.
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 than 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.
This document describes the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria (Accuracy) and Reported Device Performance
| Parameter | Patient Group | Condition | Acceptance Criteria (Range and Accuracy) | Reported Device Performance (Range and Accuracy) |
|---|---|---|---|---|
| Saturation (% SpO2) | Adults, Pediatrics | No Motion | 70% - 100% ± 2 digits | 70% - 100% ± 2 digits (as reported by clinical studies) |
| Neonates | No Motion | 70% - 100% ± 3 digits | Not explicitly stated; implied to meet acceptance criteria through clinical studies. | |
| Saturation (% SpO2) | Adults, Pediatrics | Motion | 70% - 100% ± 3 digits | 70% - 100% ± 3 digits (as reported by clinical studies) |
| Neonates | Motion | 70% - 100% ± 3 digits | 70% - 100% ± 3 digits (as reported by clinical studies) | |
| Pulse Rate (bpm) | Adults, Pediatrics, Neonates | No Motion | 25 to 240 ± 3 digits | 25 to 240 ± 3 digits (as reported by clinical studies) |
| Pulse Rate (bpm) | Adults, Pediatrics, Neonates | Motion | 25 to 240 ± 5 digits | 25 to 240 ± 5 digits (as reported by clinical studies) |
| Low Perfusion Performance | > 0.02% Pulse Amplitude, > 5% Transmission | Saturation (% SpO2) ± 2 digits, Pulse Rate ± 3 digits | Saturation (% SpO2) ± 2 digits, Pulse Rate ± 3 digits (bench testing) |
Note: The document specifies that for saturation accuracy, 0% - 69% is "unspecified." The table focuses on the ranges for which acceptance criteria and performance are explicitly given.
2. Sample Size Used for the Test Set and the Data Provenance
The document broadly refers to "human blood studies on healthy adult volunteers" and "clinical studies... on neonates." However, specific sample sizes for these test sets are not explicitly mentioned in the provided text.
- Provenance: The data for the clinical studies involving healthy adult volunteers and neonates appears to be prospective as it describes "induced hypoxia states" and "moving the neonate's foot." 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 U.S. or followed U.S. regulatory guidelines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document states that the SpO2 values were measured "against a laboratory co-oximeter" and pulse rate values were measured "against the ECG."
- The ground truth for SpO2 was established using a laboratory co-oximeter. This instrument itself serves as the reference standard.
- The ground truth for pulse rate was established using an ECG monitor. This instrument itself serves as the reference standard.
The involvement of human experts in establishing the ground truth for the test set in terms of interpreting co-oximeter or ECG results is not explicitly mentioned. These are typically instrumental measurements.
4. Adjudication Method for the Test Set
This information is not provided in the document. The ground truth is described as being established by reference instruments (co-oximeter and ECG), not via expert human adjudication of observed data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study involving human readers is not mentioned. The studies described focus on the standalone performance of the device against reference standards (co-oximeter, ECG).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The document describes clinical studies where the Masimo SET® Radical Pulse Oximeter directly measured SpO2 and pulse rate against a laboratory co-oximeter and ECG monitor, respectively. This demonstrates the algorithm's performance without direct human intervention in the measurement process beyond sensor placement. The "bench testing using a simulator" also represents a standalone evaluation.
7. The Type of Ground Truth Used
The ground truth used was instrument-based reference standards:
- SpO2: Measured by a laboratory co-oximeter from arterial blood samples.
- Pulse Rate: Measured by an ECG monitor.
- Low Perfusion: Evaluated against a Biotek Index 2 simulator.
8. The Sample Size for the Training Set
The document mentions that "The look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and nonmotion conditions." However, the specific sample size for this training set is not provided.
9. How the Ground Truth for the Training Set Was Established
The ground truth for the training set (used to develop the lookup tables) was established by:
- Conducting human blood studies on healthy adult volunteers.
- Subjects were placed in induced hypoxia states.
- Measurements were compared "against a laboratory co-oximeter."
This implies that arterial blood samples were taken from these volunteers in various induced hypoxia and motion conditions, and their SpO2 was precisely determined by a co-oximeter to create the reference data for the device's algorithms and lookup tables.
§ 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).