(282 days)
The Root when used with the Centroid is indicated for the following:
The Masimo Root Monitoring System is 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 can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radical-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities.
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitaltype facilities, home environments, and transport within healthcare facilities.
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
The Radius-7 Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radius and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitaltype facilities, home environments, and transport within healthcare facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospitaltype facilities, home environments, and transport within healthcare 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, Sevoflurane, Sevoflurane 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 gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. 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 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:
| Patient Population | Approximate Age Range |
|---|---|
| Newborn (neonate) | Birth to 1 month of age |
| Infant | 1 month to 2 years of age |
| Child | 2 to 12 years of age |
| Adolescent | 12-21 years of age |
| Adult | 21 years of age and older |
The optional Centroid System is intended for monitoring the orientation and activity of patients. The Centroid System is intended to provide alerts when patient orientation or activity deviates from parameters set by healthcare providers. The Centroid System is indicated for monitoring the orientation and activity of patients including those susceptible to pressure ulcers. The Centroid System is intended for use in hospitals, hospital-type facilities, and healthcare facilities.
The Centroid System is indicated for the following:
The Centroid System is intended for monitoring the orientation and activity of patients. The Centroid System is intended to provide alerts when patient orientation or activity deviates from parameters set by healthcare providers. The Centroid System is indicated for monitoring the orientation and activity of patients including those susceptible to pressure ulcers. The Centroid System is intended for use in healthcare environments.
The Centroid System is also indicated for the measurement of respiration rate of adults in healthcare environments.
The Masimo Root Monitoring System (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 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;
- . 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; and
- Centroid System for monitoring the orientation and activity of patients and the measurement of respiration rate.
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 Masimo Centroid Sensor is a wearable, battery-operated, single-patient use, adhesive sensor intended for the monitoring of body orientation and activity. The Centroid Sensor wirelessly communicates with a back-end user interface, such as the Root monitor display (K171121) to display and provide alerting capabilities for orientations and activity that fall outside of parameters set by healthcare providers. The Centroid System which includes the sensor and the back-end user interface (e.g. Root) is intended to aid caregivers to identify patients who have fallen or who need to be repositioned according to the institution's guidelines. Centroid is indicated for orientation monitoring of patients including those that may be susceptible to pressure ulcers. The Centroid is also capable of detecting chest movements to provide a respiratory rate (RR). The Centroid is designed for hospital-type facilities, and healthcare facilities.
The provided text describes the performance data for the Masimo Centroid System, specifically focusing on its ability to monitor patient orientation, activity, and respiration rate. However, the document does NOT contain a table of acceptance criteria and reported device performance in a structured format with specific quantitative metrics for acceptance for all parameters. It lists general specifications in Table 5.1 but does not explicitly state acceptance criteria in the context of study results.
Based on the provided text, here's an attempt to extract and infer the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not presented in a tabular format with explicit pass/fail thresholds for each metric. The document describes various tests and states that the device "met its performance specification" or "supported the substantial equivalence."
Inferred Accepted Performance (No explicit "Criteria" given in a table):
| Feature | Reported Device Performance | Inferred Acceptance Criteria |
|---|---|---|
| Respiration Rate Accuracy | 3 rpm (respirations per minute), 8 to 35 rpm (from General Specifications Table 5.1). Bench testing "supported that the Centroid met its performance specification." Clinical studies compared against capnography and "supported the substantial equivalence of the subject device." | The device's respiration rate accuracy is expected to be within 3 rpm for rates between 8 and 35 rpm, validated through bench testing against ventilator settings and clinical comparison to capnography, demonstrating "substantial equivalence." The exact threshold for "substantial equivalence" against capnography is not explicitly quantifiable in the document. |
| Patient Incline Angle Range | -180° to 180° (from General Specifications Table 5.1). Bench testing confirmed "angular measurement performance" and "found to support the performance of the patient orientation features." | The device must accurately measure patient incline within the range of -180° to 180°, and show robust repeatability and reproducibility as proven by Gage R&R testing. The specific angular accuracy tolerance is not quantified as an acceptance criterion. |
| Orientation Detection (Clinical) | Sensitivities of 100% for turn detection, and 96.7% for posture transitions (from clinical study 1). | 100% sensitivity for turn detection and at least 96.7% sensitivity for posture transition detection. |
| Fall Detection (Bench) | Performance bench testing "supported the Centroid met its product specification" for 200 fall events. | The device must accurately detect simulated fall events according to its "product specification." (Specific metric not provided, but implies high accuracy). |
| Fall Detection (Clinical) | 93.9% sensitivity to detection of a fall from 800 falls (from clinical study 3). | At least 93.9% sensitivity for fall detection in a clinical setting. |
| Time in current position | 0 to 65,535 minutes (from General Specifications Table 5.1). No specific performance study details are given. | The device must accurately track time in current position within the stated range. No specific accuracy criterion is provided. |
| Biocompatibility | "The testing performed and submitted supports these patient contacting materials are biocompatible in accordance with the approach described in the ISO 10993-1." | Compliance with ISO 10993-1 for biocompatibility. |
| EMC/Electrical Safety/Mechanical | "Testing was performed and submitted with respect to IEC 60601-1-2 standard for EMC compliance, IEC 60601-1 standard for electrical safety, environmental, and mechanical." "Found to support there are no new questions of safety and effectiveness." | Compliance with IEC 60601-1-2 (EMC) and IEC 60601-1 (electrical safety/mechanical/environmental). |
| Software V&V | "Found to support the substantial equivalence of the subject device" and "met the specifications of the subject device." Level of concern: "moderate." Documentation provided as recommended by FDA's Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Compliance with FDA software guidance for a "moderate" level of concern, ensuring no new questions of safety and effectiveness, and meeting device specifications. |
| Wireless & Cybersecurity | "Found to support there are no new questions of safety and effectiveness for that of the subject device." Conducted according to FDA Guidance for Industry and Food and Drug Administration Staff. Tier 2 device for Cybersecurity. | Compliance with FDA guidance for wireless and cybersecurity for a Tier 2 device, ensuring no new questions of safety and effectiveness. |
| Human Factors Usability | "Found to support there are no new questions of safety and effectiveness from that of the subject device." Evaluated and mitigated in accordance with FDA Guidance. | Compliance with FDA Human Factors and Usability Guidance, ensuring no new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
- Clinical Study 1 (Orientation, Posture, Activity, Respiration Rate):
- Sample Size: 40 adult, healthy volunteer subjects (22 female, 18 male).
- Age Range: 18 - 67 years (median 42 years).
- Data Provenance: Not explicitly stated (e.g., country of origin), but implies a controlled clinical setting. The study was "single arm," which often means within a single institution. "Healthy volunteers" suggests a prospective study for data collection for device evaluation.
- Clinical Study 2 (Respiration Rate - ICU patients):
- Sample Size: 34 ICU adult, healthy volunteer subjects (18 females, 16 males).
- Age Range: 23 to 84 years (median 59 years).
- Data Provenance: Not explicitly stated (e.g., country of origin). The description "ICU patients" suggests a clinical environment, and "healthy volunteers" (though in an ICU, likely referring to subjects without the primary condition being directly studied regarding respiration rate measurement, but with other conditions) implies prospective data collection for device evaluation in a challenging, real-world setting.
- Clinical Study 3 (Fall Detection):
- Sample Size: 51 healthy volunteers (30 males, 21 females).
- Age Range: 18-45 years (median 29 years).
- Data Provenance: Not explicitly stated (e.g., country of origin). "Healthy volunteers who were requested to conduct a series of different types of falls" indicates a prospective, controlled study for device evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not specify the number or qualifications of experts used for establishing ground truth for the test sets.
- For respiration rate, "manually scoring data from a gold reference capnography" was used in Study 1, and "capnography" was used in Study 2. This implies expert interpretation of capnography data, but the number and qualifications are not detailed.
- For orientation/posture/activity and fall detection, the ground truth was presumably established by direct observation/protocol, not expert interpretation of images or other subjective data.
4. Adjudication Method for the Test Set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test sets. This is common for studies that rely on objective measurements (like capnography for respiration rate or physical observation/protocol for falls/orientation) rather than subjective human interpretation of complex data (like medical images).
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done:
- No, a Multi-reader Multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The studies primarily focused on the standalone performance of the Centroid device against a reference or established method (capnography). The device is a physiological monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI outputs.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the described studies primarily assessed the standalone performance of the Centroid device.
- For respiration rate, the Centroid's measurement was compared directly against capnography.
- For orientation, posture, activity, and fall detection, the device's algorithmic output was compared against observed events (ground truth). The human element was in the observation/protocol for ground truth, not in subjective interpretation of device output.
7. The Type of Ground Truth Used:
- Respiration Rate: "Gold reference capnography" (Clinical Study 1), and "capnography" (Clinical Study 2). This is considered a gold standard physiological measurement.
- Patient Orientation, Posture Transitions, Activity: Implied to be established by direct observation and protocol during the clinical study (e.g., subjects instructed to perform specific turns or posture changes).
- Fall Detection: Established by directly observing and requesting volunteers to conduct a series of different types of falls (Clinical Study 3). Bench testing used a "breathing simulation mannequin" subjected to simulated fall types.
8. The Sample Size for the Training Set:
- The document does not provide information on the sample size for the training set. This type of information is typically provided for machine learning or AI algorithms where a distinct training phase precedes the validation/test phase. The descriptions of the Centroid's "monitoring function" and "principle of operations" (accelerometer and gyroscope) suggest a more traditional signal processing or rule-based approach rather than a deep learning model that requires large-scale training data.
9. How the Ground Truth for the Training Set Was Established:
- As no information on a training set (in the context of an AI/ML model) is provided, there is no description of how ground truth for such a set was established. The device operates using built-in sensors (accelerometer, gyroscope) and algorithms to detect movement, orientation, and infer respiration, rather than relying on a continuously learning/retraining model from new data.
§ 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).