(98 days)
The Masimo SET® Radical Pulse Oximeter and accessories is intended for continuous nonitoring 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 and accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter and accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, and home environments.
The Masimo LNOP® Series of Sensors are indicated for the following:
- A single use oximenty 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 oximery 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.
The Masimo SET® Radical pulse oximeter and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the function 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.
The Masimo SET® Radical Pulse Oximeter and accessories are designed for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult, pediatric, and neonatal patients, across various conditions (no motion, motion, well-perfused, poorly perfused) and environments (hospital, home).
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Saturation (% SpO2) - During No Motion Conditions | |
| Adults, Pediatrics: 70% - 100% ± 2 digits | Adults and Pediatrics: within ± 2 digits (against CO-Oximeter) |
| Neonates: 70% - 100% ± 3 digits | Neonates: within ± 3 digits (against CO-Oximeter) |
| Saturation (% SpO2) - During Motion Conditions | |
| Adults, Pediatrics: 70% - 100% ± 3 digits | Adults and Pediatrics: within ± 3 digits (against CO-Oximeter) |
| Neonates: 70% - 100% ± 3 digits | Neonates: within ± 3 digits (against CO-Oximeter) |
| Pulse Rate (bpm) - During No Motion Conditions | |
| Adults, Pediatric, Neonates: 25 to 240 ± 3 digits | Adults, Pediatric, Neonates: within ± 3 digits (against ECG) |
| Pulse Rate (bpm) - During Motion Conditions | |
| Adults, Pediatric, Neonates: 25 to 240 ± 5 digits | Adults, Pediatric, Neonates: within ± 5 digits (against ECG) |
| Low Perfusion Performance (> 0.02% Pulse Amplitude and % Transmission > 5% for saturations ranging from 70 to 100%) | Saturation (% SpO2): ± 2 (against Biotek Index 2 simulator and Masimo's simulator). Pulse Rate: ± 3 digits (against Biotek Index 2 simulator and Masimo's simulator). |
| Note: All accuracy values are stated as plus or minus one standard deviation, encompassing 68% of the population. | Note: All reported accuracy values are described as "within ± X digits," consistent with the acceptance criteria's definition of plus or minus one standard deviation. |
Study Information
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Sample size used for the test set and the data provenance:
- No Motion Accuracy (Adults/Pediatrics): Data collected from "healthy adult volunteers in induced hypoxia studies." Specific numerical sample size is not provided.
- Motion Accuracy (Adults/Pediatrics): Data collected from "healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm." Specific numerical sample size is not provided.
- Motion Accuracy (Neonates): Data collected from "neonates while moving the neonate's foot at 2 to 4 Hz at an amplitude of 1 to 2 cm." Specific numerical sample size is not provided.
- Low Perfusion Accuracy: Benchtop testing using a "Biotek Index 2 simulator and Masimo's simulator." This implies an experimental setup rather than human subjects for this specific test.
- Data Provenance: The studies were conducted as human blood studies, implying a prospective and controlled approach, likely within a clinical or laboratory setting. The country of origin is not explicitly stated but generally for FDA submissions, such studies are often conducted in the US. The "Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21CFR), Part 812 -Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards," suggesting adherence to US regulatory standards for human studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided. The ground truth for saturation was established using a laboratory co-oximeter, and for pulse rate using an ECG monitor, which are objective measurement devices rather than expert interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as the ground truth was established using objective measurement devices (co-oximeter and ECG monitor), not through expert consensus requiring adjudication.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a pulse oximeter, and its performance is evaluated against objective medical standards for SpO2 and pulse rate, not against human reader interpretation of images or other data. This study focuses on the device's accuracy in measuring physiological parameters.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the accuracy evaluation described for the Masimo SET® Radical Pulse Oximeter is a standalone performance assessment. The device's measurements of SpO2 and pulse rate are directly compared against established objective ground truth measurements (laboratory co-oximeter and ECG monitor). Human interpretation is not part of establishing the device's accuracy in this context.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Saturation (SpO2): Laboratory co-oximeter on arterial blood samples.
- Pulse Rate: ECG monitor.
- Low Perfusion: Biotek Index 2 simulator and Masimo's simulator (bench top testing).
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The sample size for the training set:
- The document does not explicitly mention a separate "training set" for the device's algorithm in the context of clinical studies for accuracy. The "empirically derived equation" and "look-up table" are stated to be "based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and non-motion conditions." This implies that these initial human studies contributed to the development and calibration of the device's algorithms, which could be considered the basis for its "training." However, a specific numerical sample size for this development phase is not provided, nor is it referred to as a "training set."
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How the ground truth for the training set was established:
- As mentioned above, 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 non-motion conditions." Therefore, the ground truth for the underlying algorithm (which could be likened to a training set) was established using a laboratory co-oximeter as the reference standard for blood oxygen saturation and likely an ECG monitor for pulse rate, conducted in controlled human studies involving induced hypoxia and simulated 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).