(152 days)
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
| Monitored Parameter | Test Description | Test Objective | Study Endpoints (Acceptance Criteria) | Results Summary (Reported Performance) | Conclusion |
|---|---|---|---|---|---|
| SpO2, PR, SpCO, SpMet, SpHb and RRa | Display verification | To verify Root user interface | Test personnel began and ended test cases for the Root user interface, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from the connected modules. |
| SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Display validation of Radical 7, ISA and Sedline modules | To validate human factors/ usability | Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures. | Pass | Root's ease of use was validated by the clinicians. |
| SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Display validation | To validate human factors/ usability | Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures. | Pass | Root's ease of use was validated by the clinicians. |
| EEG and PSI | Display verification of Sedline module | To verify Sedline indicator and display | Test personnel began and ended test cases for indicator/display verification, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from the Sedline module. |
| Breathing Gases and RR | Display verification of ISA module | To verify ISA module indicator and display | Test personnel began and ended test cases for indicator/display verification, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from the ISA module. |
| N/A. General wireless functions | Wireless interface verification of information from any connected module | To verify the wireless communication between a module fixture and Root | Test personnel began and ended test cases for the wireless interface verification, and recorded the test results per test procedures. | Pass | A module fixture wirelessly connected to Root in the similar communication as a wired connection. |
| N/A. General docking functions | Docking station function verification | To verify battery management | Test personnel began and ended battery management test cases, and recorded the test results per test procedures. | Pass | Root docking station interfaced correctly with the Radical 7. |
| EEG and PSI | MOC-9 interface verification | To verify MOC-9 Port EEPROM | Test personnel began and ended MOC-9 EEPROM verification test cases, and recorded the test results per test procedures. | Pass | The MOC-9 interface functioned correctly in EEPROM identification. |
| N/A. Breathing gases, RR, EEG and PSI | MOC-9 interface verification | To verify EEPROM Identification for Iris and MOC-9 | Test personnel began and ended EEPROM Identification test cases for Iris and MOC-9, and recorded test results per test procedures. | Pass | The MOC-9 and Iris interfaces functioned correctly in EEPROM identification for connected modules. |
| Breathing Gases and RR | Root and ISA module verification | To verify Root/PhaseIn (ISA) capnography module integration | Test personnel began and ended ISA integration test cases, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from the ISA module. |
| EEG and PSI | Root and Sedline module verification | To verify Root/Sedline integration | Test personnel began and ended Sedline integration test cases, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from the Sedline module. |
| EEG and PSI | Root and Sedline module verification | To verify Sedline board communication | Test personnel began and ended Sedline board communication test cases, and recorded test results per test procedures. | Pass | Root correctly communicated with the Sedline module. |
| N/A. General display and speaker functions | Visual/audio alarm verification | To verify visual/audio alarm compliance to IEC 60601-1-8 | Test personnel began and ended visual/audio alarm test cases per the IEC standards, and recorded test results. | Pass | Root visual/audio alarms are compliant to IEC60601-1-8. |
| SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Visual/audio alarm verification | To verify visual/audio alarm acknowledgment | Test personnel began and ended visual/audio alarm acknowledgment test cases, and recorded the test results per test procedures. | Pass | Root correctly generated visual/audio alarms from the connected modules. |
| SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Visual/audio alarm verification | To verify audio and visual alarms | Test personnel began and ended audio/visual alarm verification test cases, and recorded test results per test procedures. | Pass | Root correctly generated visual/audio alarms from the connected modules. |
| SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Alarm limit controls verification | To verify alarm limit controls | Test personnel began and ended alarm limit controls verification test cases, and recorded test results per test procedures. | Pass | Root correctly generated alarm limits from the connected modules. |
| N/A. General wired connection | Wired connection verification | To verify Ethernet connection | Test personnel began and ended Ethernet verification test cases, and recorded test results per test procedures. | Pass | Root functioned correctly in its connectivity via the Ethernet. |
| N/A. General wired connection | Wired connection verification | To verify Iris connectivity to network system | Test personnel began and ended Iris/Patient SafetyNet connectivity test cases, and recorded test results per test procedures. | Pass | Root's Iris interface functioned correctly in its connectivity to system networks such as the Patient SafetyNet. |
| N/A. General wireless connection | Wireless connection verification | To verify internal radio module | Test personnel began and ended radio module verification test cases, and recorded test results per test procedures. | Pass | Root's internal radio module performed correctly. |
| N/A. General wireless connection | Wireless co-existence per FDA Wireless Guidance | To verify wireless co-existence per FDA Wireless Guidance | Test personnel began and ended wireless co-existence testing per FDA Guidance, and recorded the test results. | Pass | Root met FDA Wireless Guidance requirements for wireless co-existence testing. |
| N/A. General wireless connection | Wireless quality of service per FDA Wireless Guidance | To verify wireless quality of service per FDA Wireless Guidance | Test personnel began and ended wireless quality of service testing verification per FDA Guidance, and recorded test results. | Pass | Root met FDA Wireless Guidance requirements for wireless quality of service testing. |
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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).