(14 days)
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO- sensor) for adult, pediativ, and neonatal patients in hospitals, hospital-type facilities, mobile, 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, for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring 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
A reusable oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 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 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 (SpO-) 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.
Here's a breakdown of the acceptance criteria and study information for the Masimo SET® Radical Pulse Oximeter with SatShare™, based on the provided document:
Acceptance Criteria and Device Performance
| Parameter | Acceptance Criteria (Stated Performance) | Reported Device Performance |
|---|---|---|
| Saturation (% SpO2) - No Motion Conditions | ||
| Adults, Pediatrics (70% - 100% SpO2) | ± 2 digits | Adult and pediatric: 70% - 100% ± 2 digits (against laboratory co-oximeter and ECG monitor), 68% of population within this range (one standard deviation) |
| Neonates (70% - 100% SpO2) | ± 3 digits (down to 83% from clinical studies, extrapolated to 70% based on adult studies) | Neonatal: 70% - 100% ± 3 digits (against laboratory co-oximeter and ECG monitor) based on clinical studies down to 83% and adult studies, 68% of population within this range (one standard deviation) |
| Saturation (% SpO2) - Motion Conditions | ||
| Adults, Pediatrics (70% - 100% SpO2) | ± 3 digits | Adult and pediatric: 70% - 100% ± 3 digits (against laboratory co-oximeter and ECG monitor, during rubbing and tapping motions at 2-4 Hz and non-repetitive motion 1-5 Hz), 68% of population within this range (one standard deviation) |
| Neonates (70% - 100% SpO2) | ± 3 digits (down to 83% from clinical studies, extrapolated to 70% based on adult studies) | Neonatal: 70% - 100% ± 3 digits (against laboratory co-oximeter and ECG monitor, while moving foot at 2-4 Hz) based on clinical studies down to 83% and adult studies, 68% of population within this range (one standard deviation) |
| Pulse Rate (bpm) - No Motion Conditions | ||
| Adults, Pediatric, Neonates (25 to 240 bpm) | ± 3 digits | Adult, pediatric, neonates: 25 to 240 ± 3 digits (against ECG) |
| Pulse Rate (bpm) - Motion Conditions | ||
| Adults, Pediatric, Neonates (25 to 240 bpm) | ± 5 digits | Adult, pediatric, neonates: 25 to 240 ± 5 digits (against ECG) |
| Low Perfusion Performance | Saturation (% SpO2) ± 2 digits, Pulse Rate ± 3 digits | Saturation (% SpO2) ± 2 digits, Pulse Rate ± 3 digits (in bench top testing with > 0.02% Pulse Amplitude and % Transmission > 5% for saturations 70-100% against a Biotek Index 2 simulator and Masimo's simulator), 68% of population within this range (one standard deviation) |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Test Set (Clinical Studies): The document does not specify the exact number of subjects/cases used for each clinical study (adult, pediatric, neonatal, motion, no-motion, low perfusion). It only refers to "human blood studies on healthy adult volunteers" and "human blood studies on neonates."
- Data Provenance: The provenance is not explicitly stated in terms of country of origin of the data. However, the studies were conducted by Masimo Corporation, located in Irvine, CA, USA, and followed US regulatory standards (21CFR, Part 812, Part 50, Part 56). The studies were prospective, involving induced hypoxia in healthy volunteers and directly measuring performance in neonates.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth for the test set in the conventional sense of human readers interpreting images. Instead, the ground truth for oxygen saturation (SpO2) was established using a laboratory co-oximeter on arterial blood samples. For pulse rate, an ECG monitor served as the ground truth. These are objective gold-standard measurements rather than subjective expert consensus.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The ground truth was established by objective laboratory instruments (co-oximeter, ECG), not through human adjudication of differing interpretations.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This type of study (MRMC comparative effectiveness with/without AI assistance) is not relevant for a pulse oximeter, which is a standalone measurement device, not an AI-assisted diagnostic imaging tool that requires human interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the entire clinical validation effectively demonstrates the standalone performance of the Masimo SET® Radical Pulse Oximeter. The device directly provides SpO2 and pulse rate readings, which were then compared against the established ground truth from co-oximeters and ECG monitors. There is no human-in-the-loop component in the primary function or performance evaluation described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Physiological Measurement:
- For SpO2: Laboratory co-oximeter measurements from arterial blood samples.
- For Pulse Rate: ECG monitor.
- For Low Perfusion: Bench top testing against simulators (Biotek Index 2 simulator and Masimo's simulator).
- Objective Physiological Measurement:
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The sample size for the training set:
- The document states that the values in the device's 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, it does not specify the sample size for this training data.
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How the ground truth for the training set was established:
- The ground truth for the training set (used to develop the empirically derived equation and look-up table) was established using human blood studies on healthy adult volunteers in induced hypoxia states, with comparisons made against a laboratory co-oximeter. This process involved collecting data under both motion and non-motion conditions.
§ 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).