(28 days)
The Masimo SET® Radical Pulse Oximeter with SatShare™ 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, pediatic, 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 (SpO-) 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 oximery sensor intended for adults and pediatrics greater than 30 kg
A single use oximetry sensor intended for nediatics 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 pediatives 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 SETº Radical Pulse Oximeter with SatShare™
The following are additional SatShare cables indicated for connection to the following multi-parameter monitors:
Ohmeda - RGM Respiratory Monitor and
Datex-Ohmeda - M-EST and M-ESTP Modlucs
Draeger - Vitalert 1000, 3200, Evita 2 dura, Julian Anesthetic Workstation, and Narcomed 4 Monitors Airshields - Multiparameter Monitor with Ohmeda SpO2
Datascope - Passport Monitor with Datascope SpO2 and Accutor Monitors with Nellcor SpO2 and Datascope SpO2 GE/Marquette - Tram 100A and Tram 500A modules with Ohmeda SpO2
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET I ho reasme of 2 - 1 the really and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial tecmoglobin (SpO2) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liguid crystal display) display 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 the study information for the Masimo SET® Radical Pulse Oximeter with SatShare™:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents accuracy as "± X digits" which typically refers to the root mean square (RMS) difference when compared to a reference method, encompassing 68% of the population.
| Metric (Accuracy) | Acceptance Criteria (Stated Performance) | Population | Conditions |
|---|---|---|---|
| Saturation (% SpO2) - No Motion Conditions | 70% - 100% ± 2 digits | Adults, Pediatrics | No Motion |
| Saturation (% SpO2) - No Motion Conditions | 70% - 100% ± 3 digits | Neonates | No Motion |
| Saturation (% SpO2) - Motion Conditions | 70% - 100% ± 3 digits | Adults, Pediatrics | Motion |
| Saturation (% SpO2) - Motion Conditions | 70% - 100% ± 3 digits | Neonates | Motion |
| Pulse Rate (bpm) - No Motion Conditions | 25 - 240 bpm ± 3 digits | Adults, Pediatrics, Neonates | No Motion |
| Pulse Rate (bpm) - Motion Conditions | 25 - 240 bpm ± 5 digits | Adults, Pediatrics, Neonates | Motion |
| Saturation (% SpO2) - Low Perfusion Performance | ± 2 digits | N/A | > 0.02% Pulse Amplitude, > 5% Transmission |
| Pulse Rate - Low Perfusion Performance | ± 3 digits | N/A | > 0.02% Pulse Amplitude, > 5% Transmission |
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size for Test Set:
- Adult/Pediatric No Motion & Motion: Not explicitly stated as a number, but studies were conducted on "healthy adult volunteers."
- Neonatal Motion: Not explicitly stated as a number, but studies were conducted on "neonates."
- Low Perfusion: Not explicitly stated, as this was primarily bench-top testing supplemented by clinical studies mentioned generically for "healthy adult volunteer subjects" and "neonates with low perfusion conditions."
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Data Provenance: Clinical studies were performed on "human blood studies on healthy adult volunteers" and "neonates." The location (country of origin) is not specified, but the studies were conducted under U.S. regulations (Title 21 of Federal Regulations (21CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects, and Part 56 - Institutional Review Boards). This suggests a U.S. origin for the clinical data. The studies were prospective as induced hypoxia and motion conditions were deliberately applied.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the traditional sense of experts interpreting images or conditions. The ground truth was established by laboratory co-oximetry and ECG monitors.
- Qualifications of Experts: Not applicable. The reference methods are objective devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established directly by comparison to objective reference devices (laboratory co-oximeter for SpO2, ECG monitor for pulse rate). There was no mention of human adjudication of the reference standards themselves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This device is a pulse oximeter, and its performance is assessed against physiological measurements, not against human reader interpretations of medical images or conditions.
- Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was performed and the device is not an AI-assisted diagnostic tool that aids human readers.
6. Standalone Performance Study
- Was a standalone performance study done? Yes. The entire description of accuracy in the document refers to the performance of the Masimo SET® Radical Pulse Oximeter with SatShare™ alone (algorithm only) compared to the reference standard. The goal was to validate the device's measurements of SpO2 and pulse rate.
7. Type of Ground Truth Used
- Type of Ground Truth:
- SpO2: Laboratory co-oximeter measurements from arterial blood samples.
- Pulse Rate: ECG monitor.
- Low Perfusion SpO2/Pulse Rate: Bench-top testing against a Biotek Index 2 simulator and Masimo's simulator.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not explicitly stated within the 510(k) summary. The document mentions that the values in the look-up table (used by the device's software to find SpO2 saturation) 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 exact sample size for these initial studies used to develop the algorithm/look-up table is not provided. The accuracy results presented are for validation/testing, not training.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: According to the "Principles of Operation" section, the device uses "an empirically derived equation in the Masimo SET® Radical II's software." The "values in 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." This indicates that the training ground truth for the look-up table was established by laboratory co-oximetry measurements from arterial blood samples under defined induced hypoxia, motion, and non-motion conditions in healthy adult volunteers.
§ 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).