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The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2, with an optional accessory for capnography (ETCO2, RR). It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer.

The monitor is intended to be used by trained healthcare providers.

The WVSM Patient Monitor is a device that monitors physiological parameters associated with Electrocardiogram, Non-invasive Blood Pressure, pulse oximetry and carbon dioxide gas. The WVSM Patient Monitor is a multi-patient use non-sterile device. It utilizes embedded firmware. Patient applied parts are needed for physiological measurement and are provided via FDA cleared OEM accessories to the WVSM monitor. The modification to the WVSM includes: Adding an indication for capnography by interfacing with a FDA cleared accessory. Adding the capability to use the device while connected to the AC power adapter instead of only using the device on battery power.

This document provides information about the Athena GTX Wireless Vital Signs Monitor (WVSM) RWC + miniCap, which is a modified version of a previously cleared device. The primary modifications are the addition of capnography functionality and the ability to operate while connected to an AC power adapter.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding performance results for each parameter. Instead, it states that "Key performance specifications are listed in the table in section VI below," which refers to the comparative table between the modified device and the predicate device. This table primarily highlights differences and similarities in technological characteristics.

However, based on the text, the acceptance criterion for this 510(k) submission appears to be demonstrating that the modifications (capnography and AC power mode) do not adversely affect the safety and effectiveness of the device and that the new functionalities (capnography parameters) meet established standards.

The document implicitly refers to compliance with industry standards for safety, EMC (Electromagnetic Compatibility), and essential performance as the main performance metric for the modified device.

Implicit Acceptance Criteria and Reported Performance (Based on the provided text):

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The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index).

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:

· The ICG monitoring is applicable to the adult patients of 122229cm in height and 30159Kg (67~341 pounds) in weight only;

· NIBP measurement continual mode is not applicable to neonates;

· Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients;

The monitors are to be used in general healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. The monitors are not intended for home use.

The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index).

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
• The ICG monitoring is applicable to the adult patients of 122229cm in height and 30159Kg (67~341 pounds) in weight only;
• NIBP measurement continual mode is not applicable to neonates;
• Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients;
Those monitors provide patient monitoring capabilities by using corresponding accessories.
The multi-parameter Patient monitor, model: C50 and C80 have same design principle and technical characteristics:
But the software in the host and modules and components are different.
The differences between C50 and C80 are ICG, BIS and size of monitor.

The provided document describes the acceptance criteria and a study proving the C50 and C80 Multi-parameter Patient Monitor meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established through adherence to recognized international standards and clinical performance metrics. The document details a comparison with a predicate device (K170876, Passport Series Patient Monitors). While explicit "acceptance criteria" for each parameter are not always separately listed with a single performance value from the new device, the "Comparison" column in the table below infers if the new device meets or exceeds the predicate's performance or if sufficient justification is provided for differences.

Study that Proves the Device Meets Acceptance Criteria

The essential studies to prove the device meets acceptance criteria are divided into Non-Clinical Performance Data and Clinical Studies.

Non-Clinical Performance Data:

• Software Verification and Validation Testing: Conducted in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Risk analysis was performed, and the software was deemed a "major" level of concern.
• Electrical safety and Electromagnetic Compatibility (EMC): Testing conducted according to:
  • ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012 (IEC 60601-1:2005, MOD)
  • IEC 60601-1-2 Edition 4: 2014-02
• Bench Testing: Functional and system-level tests were performed, showing the devices meet specifications and perform equivalently to the predicate.
• Biocompatibility Testing: Performed for patient-contacting components (ECG cable, SpO2 probes, temperature probes) that were not previously cleared. Cytotoxicity, sensitization, and irritation testing were conducted based on ISO 10993-1 and FDA's 2016 biocompatibility guidance.
• Conformance with Applicable Standards: The device demonstrated compliance with numerous recognized consensus standards, in addition to those listed above for specific modules (e.g., ISO 80601-2-55 for Respiratory Gas Monitors, ISO 80601-2-56 for Thermometers, ISO 80601-2-61 for Pulse Oximeter Equipment, ANSI AAMI EC57:2012 for Cardiac Rhythm and ST-Segment measurement algorithms).

Clinical Studies:

1. NIBP Clinical Study - for adults and children

• Device Parameter: Non-invasive Blood Pressure (NIBP)
• Acceptance Criteria/Standard: Complies with ISO 81060-2 Second Edition 2013-05-01 "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
• Sample Size: 25 patients (19 adults, 6 children).
  • Demographics: 10 men, 15 women. 6 patients aged 3-12, 2 aged 12-40, 10 aged 40-60, 7 above 60.
• Data Provenance: Retrospective or Prospective not explicitly stated, but implies prospective data collection from "The Second Affiliated Hospital of Guangzhou Medical University and The First Affiliated Hospital of Guangzhou Traditional Chinese Medical University" from 2012 to 2013 (China).
• Ground Truth: Implicitly referent method (e.g., auscultation by trained observers) as required by ISO 81060-2.
• Adjudication Method: Not specified, but standard practice for NIBP clinical validation involves multiple observers for reference measurements.
• Results: "The results are accurate and reliable, and the repeated measurement consistency is in good condition, within the measurement range. Moreover, No adverse events and side effects were found in clinical trials."

2. NIBP Clinical Study - for neonate and infants

• Device Parameter: Non-invasive Blood Pressure (NIBP)
• Acceptance Criteria/Standard: Complies with ISO 81060-2 Second Edition 2013-05-01 "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
• Sample Size: 20 subjects.
  • Demographics: 10 males, 10 females. 13 subjects

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

The Masimo Root Monitoring System 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 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 (SpO-) and pulse rate to multi-parameter devices for the display of those devices.

The optional Masimo Radius-7 Wearable Pulse Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse 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+), 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 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 provided document describes the Masimo Root Monitoring System and its accessories. The submission is for a device modification and new indications for use, specifically the addition of the Masimo Radius-7 Pulse Oximeter module. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K140188).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a typical quantitative format (e.g., target specificity, sensitivity, or quantifiable error rates for a diagnostic device). Instead, the performance is evaluated through various verification and validation tests against established standards and the functionality of the predicate device. The acceptance criterion for each test appears to be "Pass," indicating successful completion and meeting predefined internal requirements.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a quantitative "sample size" in terms of patients or cases for most of the tests. The tests are described as functional verification and usability studies.

• For "Display validation of Radius-7 module" and "Display validation of Root and Radical-7, ISA, and Sedline modules": The document mentions "Clinicians (users)" participated in usability tests. The exact number of clinicians is not provided.
• For all other verification tests: "Test personnel" conducted the tests. No specific number is provided.
• Data Provenance: The studies appear to be internal, non-clinical (laboratory/in-house) verification and validation tests, not involving real-world patient data collection from a specific country or in a retrospective/prospective manner.

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

This section is not applicable in the traditional sense for this type of device submission. The "ground truth" for these functional and usability tests is established by adherence to engineering specifications, regulatory standards (like IEC 60601-1-8), and successful operation as designed.

• Usability testing: Involved "Clinicians (users)," implying healthcare professionals as experts for evaluating usability. Specific qualifications (e.g., years of experience, specialty) are not detailed.
• For other verification tests, "Test personnel" are likely engineers or technicians qualified to conduct technical evaluations.

4. Adjudication Method for the Test Set

No formal adjudication method like "2+1" or "3+1" is described. The acceptance criterion for all tests is simply "Pass," meaning the device either successfully performed the function or met the standard, or it did not. This implies a binary outcome based on whether the test objectives and endpoints were met, likely determined by the test personnel or clinicians involved.

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

No MRMC comparative effectiveness study was done or mentioned. This type of study is typically performed for diagnostic devices where human readers interpret patient data (e.g., images) with and without AI assistance to measure improvement in diagnostic accuracy. The Masimo Root Monitoring System is a monitoring system and user interface, not a diagnostic imaging AI algorithm.

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

The device itself is a "monitoring system and accessories" that functions as a user interface and communication hub for previously cleared modules. Its primary function is to display data, generate alarms, and connect to networks. Therefore, "standalone" performance in the context of an algorithm's diagnostic accuracy without human involvement is not a relevant metric for this device. The performance evaluated here is the functionality and safety of the monitoring system itself, especially its new integration with the Radius-7 module.

7. Type of Ground Truth Used

The "ground truth" is based on:

• Engineering specifications and design requirements: For successful display, connectivity, and communication functions.
• Regulatory standards: Such as IEC 60601-1-8 for alarm compliance, IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC, ISO-10993 for biocompatibility, and FDA guidances for Usability, Wireless, and Software.
• Functionality of previously cleared predicate devices/modules: The Root system primarily integrates and acts as a user interface for these existing, cleared technologies.

8. Sample Size for the Training Set

The document does not describe any machine learning or AI components that would require a "training set" in the conventional sense. The device's functionality is based on established hardware and software integration, not data-driven model training.

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

As no training set is mentioned or implied for machine learning, this question is not applicable.

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

The Masimo Root Monitoring System 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 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 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 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.

Here's an analysis of the provided text regarding the Masimo Root Monitoring System's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document refers to "test cases" for various verifications. However, the exact sample sizes (number of test cases or specific data points) for the test sets are not explicitly mentioned for most tests. The provenance of the data is not specified in terms of country of origin, nor is it explicitly stated whether the data was retrospective or prospective. The tests appear to be laboratory/engineering verification tests rather than clinical studies with patient data.

For "Display validation of Radical 7, ISA and Sedline modules" and "Display validation" related to human factors/usability, it states "Clinicians (users) started and completed the usability test cases...". This suggests prospective testing with users.

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

For the majority of the tests (display verification, interface verification, alarm verification, etc.), the ground truth was established based on the expected functional behavior of the device according to its design specifications and relevant standards (e.g., IEC standards). The document indicates "Test personnel began and ended test cases... and recorded the test results per test procedures." These "test personnel" would be the experts verifying against the predetermined criteria. Their specific qualifications (e.g., experience level, specific certifications) are not detailed.

For the "Display validation (human factors/usability)" tests, the ground truth was established by "Clinicians (users)." Their specific number or qualifications (e.g., "radiologist with 10 years of experience") are not detailed, beyond being identified as "clinicians."

4. Adjudication Method for the Test Set

The document states that "Test personnel began and ended test cases... and recorded the test results per test procedures." This implies that the results were observed and recorded, likely against a predefined set of expected outcomes for each test case. There is no mention of an adjudication method like "2+1" or "3+1" that would typically involve multiple independent reviewers resolving discrepancies through consensus or a tie-breaker. This suggests a direct pass/fail determination by the test personnel.

5. 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 MRMC comparative effectiveness study was done. The device (Masimo Root Monitoring System) is a patient monitor, essentially an alternative user interface and aggregation system for existing cleared modules. It is not an AI-assisted diagnostic tool that would typically undergo an MRMC study comparing human reader performance with and without AI. The studies focused on verifying the functionality, usability, and compliance of the Root system itself.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the device itself, functioning independently. The tests for "Display verification," "Wireless interface verification," "Docking station function verification," "MOC-9 interface verification," "Root and ISA module verification," "Root and Sedline module verification," "Visual/audio alarm verification," "Alarm limit controls verification," and "Wired connection verification" all assess the standalone performance of the Root system and its integration with modules.

The overall conclusion is that "the subject device, Masimo Root Monitoring System, is substantially equivalent to its predicates with respect to safety and effectiveness, based on the nonclinical tests discussed above." This implies that its standalone performance was deemed acceptable and comparable to existing devices.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for these tests was primarily:

• Design Specifications and Expected Functional Behavior: For tests like display verification, interface verification, communication, and alarm functionalities, the device's output and behavior were compared against predefined engineering and operational specifications.
• Compliance with Standards: For alarms and wireless functionalities, the ground truth was adherence to international standards like IEC60601-1-8 and FDA Wireless Guidance.
• User Feedback/Usability: For the human factors/usability tests, the ground truth was established by the "clinicians (users)" validating the "ease of use." This could be considered a form of expert feedback.

No pathology or outcomes data was used as ground truth, as this device itself does not diagnose or determine clinical outcomes independently, but rather displays data from other monitoring modules.

8. The Sample Size for the Training Set

The document explicitly states "No clinical testing was done." This implies that there was no "training set" in the context of a machine learning or AI algorithm that typically requires large datasets for training. The device's functionality is based on established engineering principles and interaction with pre-cleared modules, rather than models trained on clinical data.

9. How the Ground Truth for the Training Set was Established

Since "No clinical testing was done" and there's no mention of a training set, this question is not applicable in the context of this submission. The device's functionality relies on established principles and integration with pre-existing, cleared technologies, rather than being a novel algorithm requiring a training phase with a specific ground truth.

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