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The Masimo Root Monitoring System and Accessories are indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances.

The Masimo Root Monitoring System and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).

The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multiparameter devices for the display of those devices.

The optional Masimo Radius-7 Wearable Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+) and accessories including Nomoline, intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases:

ISA CO2: CO2

ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric, infant, and neonatal patients.

The optional SEDLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

The optional temperature module is indicated to measure temperature (oral, adult axillary, pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in healthcare environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:

The Masimo Root Monitoring System and Accessories (Root) is a multifunctional device that monitors vital signs for neonatal to adult patients. Parameters monitored by Root are from cleared measurement modules and their corresponding accessories, consisting of:

• . Masimo Radical-7 and Radius-7 Pulse CO-Oximeter measurement modules and accessories (i.e. RD SET disposable sensors, RD Rainbow sensors, RAS-45 or RRa sensors) with technologies for the monitoring of non-invasive functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and respiratory rate (RRa);
• Masimo Sweden ISA-Infrared Sidestream Gas Analyzer measurement modules (ISA) and accessories (Nomoline product family) with technologies for breathing gases and respiratory rate monitoring, including inspired/expired gases during anesthesia, recovery and respiratory care;
• Masimo Sedline Sedation Monitor measurement module and accessories (i.e. RD . Sedline EEG sensor) with technologies for state of the brain by real-time data acquisition and processing of EEG signals and Patient State Index (PSI) which is an EEG variable that is related to the effect of anesthetic agents;
• Temperature measurement module and accessories (i.e. temperature probe) with technologies for oral/axillary body temperature measurements; and
• . Non-invasive blood pressure measurement module and accessories (i.e. reuse and disposable pressure cuffs) with technologies for systolic, diastolic and mean arterial pressure (MAP) measurements.

Root is intended to be used as a user interface to facilitate access control and monitoring device functions. Root displays patient monitoring information from the connected modules. Visual alarms are shown on the Root display and audible alarms are generated through the Root internal speaker. The user accesses the wired or wirelessly connected modules' monitoring functions, using the Root display. When the module is disconnected from Root, the monitoring information from the module is no longer displayed on Root. Data from connected modules, including patient monitoring data, can be communicated to network systems such as the Patient SafetyNet (K071047) and hospital EMR. Root also functions as a pass-through means for communicating information between connected devices and network systems.

The Root under K151644 consists of various measurement modules, including the ISA product family (ISA) and corresponding accessories, Nomoline product family (Nomoline).

The provided text describes a 510(k) premarket notification for the Masimo Root Monitoring System and Accessories. It outlines the device's indications for use, technological characteristics, and a comparison to predicate devices, focusing on the ISA and Nomoline components.

No clinical studies are mentioned for the subject device to support acceptance criteria within this document. The document explicitly states: "Clinical testing was not performed with the subject device, Root with ISA and Nomoline, to support substantial equivalence."

Therefore, I can only provide information based on the non-clinical testing and general specifications mentioned.

Here's a breakdown of the requested information based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

The document provides "Specifications" for the Root system and the ISA module, which can be interpreted as acceptance criteria for the non-clinical tests conducted. The "reported device performance" is implicitly that the device met these specifications, as the conclusion states the non-clinical testing "demonstrates that the subject device...is substantially equivalent to its predicate."

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The Masimo Root Monitoring System and Accessories are indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments.

The Masimo Root Monitoring System and Accessories can transmit data for supplemental remote viewing and alarming (e.g., at a central station).

The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.

The optional Masimo Radius-7 Wearable Pulse CO-Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases:

ISA CO2: CO2

ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.

The optional SEDLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

The Root Monitoring System (Root) is a multifunctional device that monitors vital signs of patients from neonates to adults. Parameters monitored by Root include non-invasive functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), respiratory rate (RRa), inspired/expired gases during anesthesia, recovery and respiratory care, state of the brain by real-time data acquisition and processing of EEG signals, and Patient State Index (PSI) which is an EEG variable that is related to the effect of anesthetic agents.

Root is intended to be used with the previously FDA cleared measurement technologies for the modules of:

• . Masimo Radical-7 Pulse CO-Oximeter (Radical-7 module), with cleared technologies of SpO2, pulse rate, SpCO, SpMet, SpHb and RRa monitoring per K110028.
• Masimo Radius-7 Pulse Oximeter (Radius-7 module), with cleared technologies of ● SpO2, pulse rate, SpCO, SpMet, SpHb and RRa monitoring per K110028.
• . ISA-Infrared Sidestream Gas Analyzer (ISA module), with cleared technologies of breathing gases and respiratory rate monitoring per K103604.
• Sedline Sedation Monitor with Frontal PSI and SEDTrace EEG Electrode Set ● (Sedline module), with cleared technologies of EEG and PSI monitoring per K051874.

Root is intended to be used as an alternative user interface to facilitate access control and monitoring device functions and to connect system networks such as the Patient SafetyNet (K071047).

Root displays patient monitoring information from the connected modules. Visual alarms are shown on the Root display and audible alarms are generated through the Root internal speaker. When the module is disconnected from Root, the monitoring information from the module is no longer displayed on Root.

Data from connected modules, including patient monitoring data, can be communicated to network systems. Root also functions as a pass-through means for communicating information between connected devices and network systems.

The predicate device, Masimo Root Monitoring System (Root) was cleared in K142394, is the same as the subject device, Masimo Root Monitoring System (Root). Both the predicate and subject devices include the option to connect the Masimo Radius-7 Pulse Oximeter (Radius-7) module. The main difference is that the Radius-7 in the subject device now provides the same measurement functionality as the Radical-7 module.

The Masimo Root Monitoring System and Accessories is a multifunctional device designed for monitoring multiple physiological parameters in healthcare environments.

Here's an analysis of its acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance in terms of compliance with various standards and successful completion of verification and validation activities. It doesn't list specific quantitative acceptance criteria for each physiological parameter (e.g., accuracy ranges for SpO2, pulse rate, etc.) for the Root system itself, as these are attributed to the individual modules (Radical-7, Radius-7, ISA, Sedline). The Root system primarily acts as an interface and data aggregator.

2. Sample Size Used for the Test Set and Data Provenance:

The document is for a 510(k) premarket notification, which often relies on non-clinical testing and substantial equivalence to a predicate device rather than extensive clinical trials for the primary monitor system itself.

The document indicates that for the Root Monitoring System and the modified Radius-7 Module, "thoroughly tested through verification and validation" was performed. This suggests a series of engineering and performance tests on the device hardware and software.

• Sample Size: Not explicitly stated in numerical terms within the provided text. The testing appears to be primarily laboratory-based and engineering verification rather than a patient-based test set.
• Data Provenance: The nature of the tests (electrical, mechanical, software, etc.) implies that the data was generated internally by Masimo Corporation during product development and validation phases. No information about country of origin of data or whether it was retrospective or prospective is given, as it is non-clinical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is typically relevant for clinical studies or studies involving human judgment (e.g., image interpretation). Since the testing described is non-clinical (electrical safety, software verification, mechanical, etc.), the concept of "experts establishing ground truth for a test set" in the context of clinical outcomes or diagnostic accuracy doesn't directly apply.

Instead, the "ground truth" for these engineering and performance tests would be established by:

• Engineering specifications and design documents.
• Applicable voluntary standards (e.g., IEC, ISO, Mil-Std).
• FDA guidances (e.g., Human Factors, Wireless, Software).

The "experts" would be the engineering and quality assurance teams responsible for designing, conducting, and evaluating these tests against established requirements and standards. Their qualifications would involve expertise in relevant engineering disciplines, regulatory compliance, and quality assurance.

4. Adjudication Method for the Test Set:

Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or studies where human interpretation or endpoint determination is subjective and requires consensus. As the described testing is non-clinical, an adjudication method for a test set in this sense is not directly applicable.

The verification and validation processes would involve:

• Test protocols defining clear pass/fail criteria.
• Independent review of test results.
• Conformity assessment against standards.

Any discrepancies or failures would likely be resolved through engineering review, root cause analysis, and retesting, rather than an adjudication panel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was done." The Masimo Root system functions as an interface and aggregator for other FDA-cleared modules; its primary mode of submission is through substantial equivalence based on non-clinical tests and its role not altering the intended use of the connected modules.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The concept of "standalone" performance, often used for AI algorithms, isn't directly applicable here in the same way. The Masimo Root Monitoring System is a hardware device with software that integrates and displays data from other cleared modules. Its "performance" is in correctly displaying data, processing alarms, and interacting with devices and networks.

• The non-clinical performance testing described (electrical, EMC, software, etc.) essentially assesses the system's "standalone" functional performance relative to its design specifications and applicable standards, without human intervention in the data generation process, but with a human-in-the-loop for monitoring.
• However, if "standalone" refers to an algorithm making a diagnostic decision without human input, then no such study was done because this device is a monitoring system and not a diagnostic AI algorithm.

7. Type of Ground Truth Used:

For the non-clinical tests specified:

• Engineering specifications and design requirements: For software verification, functional testing, mechanical characteristics, and interface performance.
• Compliance with harmonized standards: For electrical safety (IEC60601-1), EMC (IEC-60601-1-2), alarm systems (IEC-60601-1-8), biocompatibility (ISO-10993).
• Compliance with FDA Guidances: For Usability (Human Factors) and Wireless performance.
• Predicate Device Equivalence: The foundation of the 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device (K142394 Masimo Root Monitoring System). The performance of the predicate device serves as an implicit "ground truth" for overall device function and safety. The modifications to the Radius-7 module were then tested to ensure they achieved the same performance as the Radical-7 module's existing cleared functionalities.

8. Sample Size for the Training Set:

This question is related to machine learning models. The Masimo Root Monitoring System is described as a medical device for monitoring and data integration, not as a device utilizing a machine learning algorithm that requires a "training set." Therefore, this information is not applicable and not provided in the document.

9. How the Ground Truth for the Training Set Was Established:

As there is no indication of a machine learning algorithm or a "training set" in the context of this device, this question is not applicable. The device's foundational components (Radical-7, Radius-7, ISA, Sedline modules) are previously cleared technologies with their own established ground truths for their respective physiological measurements, which the Root system then displays and manages.

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