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The non-invasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors in patients in healthcare environments. The O3 Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.

When used with the O3 Adult Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40 kg.

When used with the O3 Pediatric Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in pediatrics ≥ 5 kg and < 40 kg.

When used with the O3 Neonatal Sensor, the O3 Regional Oximeter is indicated for measuring only trending regional hemoglobin oxygen saturation of blood (rSO2) in neonates < 10 kg.

The Masimo Regional Oximetry System monitors regional hemoglobin oxygen saturation of blood (rSO2) under the sensors. The O3 System includes the O3 Sensors that acquire physiological signals and the O3 Module that processes those signals. The FDA has previously cleared the O3 System in K160526 (with an O3 Adult Sensor) and K162603 (with an O3 Pediatric Sensor). In this submission, Masimo seeks clearance of its O3 System with an 03 Neonatal Sensor.

Similar to the cleared O3 Adult and Pediatric Sensors, the O3 Neonatal Sensor is a singlepatient use, adhesive sensor and is supplied non-sterile. The O3 Neonatal Sensor attaches to the patient's forehead. The sensor includes four emitters and two detectors. The emitters radiate multiple wavelengths of near infrared light, while the detectors sense the reflected light. The detector outputs are physiological signals and these signals pass through the other end of the sensor that connects to a patient cable, passing these signals to the O3 Module for processing.

The O3 Module is unchanged from K160526. It includes Masimo technology for processing those signals and outputting regional oximetry (tSO2) measurements. Specifically, the O3 Module includes Near Infra Red Spectroscopy (NIRS) technology. When O3 module is connected to an O3 Neonatal Sensor, the O3 Monitor continuously and accurately determines the trending measurement of regional blood oxygen saturation in the tissue (rSO2) in neonates. In turn, the Host/Backboard device displays this measurement. The O3 Module can connect to up to two O3 Sensors, both connected to a patient.

The O3 System does not have an internal battery or an AC power input. The O3 Module, instead, receives power via its connection to a Host/Backboard Device, such as the Root Monitoring System (Root). Root in turn receives power from either AC power or internal rechargeable batteries.

Similar to K160526, the O3 System using an O3 Neonatal Sensor provides the following key measurements:

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site, including cerebral tissue
• Delta Baseline (Abase): Relative difference in rSO2 with respect to baseline rSO2
• Area Under the Limit (AUL index): Index that quantifies the duration (amount of time the patient stays below rSO2 low alarm limit) and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the userdefined rSO2 low alarm limit (LAL)
• . Delta SpO2 (4SpO2): The difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).

Here's an analysis of the acceptance criteria and study information for the Masimo O3 Regional Oximeter System, specifically focusing on the O3 Neonatal Sensor, based on the provided text:

Acceptance Criteria and Device Performance for Masimo O3 Regional Oximeter System (O3 Neonatal Sensor)

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on the "Reported Device Performance":

• For the display ranges and resolutions, the "Reported Device Performance" can be inferred to match the "Acceptance Criteria (Specification)" as these are direct specifications of the device.
• For Trending ARMS, the document states the specification is "3% for SavO2 of 45%-85%" and explains the methodology to determine this for the Neonatal sensor, but doesn't explicitly state "the study demonstrated the device met the 3% Trending ARMS." However, it's listed as a specification, so the implication is that the outcome of the calculation supports this specification.
• Absolute accuracy was not a claim but reported as a "convenience sample," indicating it's not a formal acceptance criterion for this submission's claims.

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

• Sample Size (Clinical Study for Trending ARMS): The text indicates a combined approach:
  • One clinical study for the O3 Adult Sensor to establish its trending accuracy with respect to blood testing (sample size not specified).
  • A separate study where relative rSO2 data was collected for both the O3 Adult Sensor and O3 Neonatal Sensor on the same subject to calculate the O3 Neonatal Sensor's Trending ARMS relative to the O3 Adult Sensor (sample size for this specific part is not provided).
• Sample Size (Clinical Study for Absolute Accuracy - convenience sample): 11 hospitalized patients.
• Data Provenance: The document does not specify the country of origin. The studies appear to be prospective clinical studies conducted by Masimo to support the device's performance claims.

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

• Not applicable / Not specified. The ground truth for this device's performance is established through direct physiological measurements (blood testing/SavO2), not through expert interpretation of images or other data that would require multiple human experts for ground truth establishment.

4. Adjudication Method for the Test Set:

• None. As the ground truth is established via quantitative physiological measurements (SavO2 from blood draws), there is no need for expert adjudication methods in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size:

• No. An MRMC comparative effectiveness study was not performed. This device is a diagnostic/monitoring tool that directly measures a physiological parameter, not an AI-assisted diagnostic imaging tool where human reader performance would be a relevant metric for comparison.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Yes. The performance of the O3 Regional Oximeter System (including the O3 Neonatal Sensor) is evaluated as a standalone device. Its "Trending ARMS" and "Absolute Accuracy" are measured against physiological ground truth (SavO2 from blood). There is no "human-in-the-loop" component in its core functional performance evaluation described here, as it directly outputs rSO2 measurements.

7. The Type of Ground Truth Used:

• Physiological Ground Truth:
  • For Trending ARMS: Blood testing (specifically SavO2, which is defined as "0.3 SaO2 + 0.7 SjvO2"). This is considered the gold standard for blood oxygen saturation. The Neonatal Sensor's performance was also compared relative to the O3 Adult Sensor, which was previously validated against blood testing.
  • For the absolute accuracy convenience sample: Invasive SavO2 blood draws.

8. The Sample Size for the Training Set:

• Not specified. The document describes clinical studies performed for performance validation (test set), but does not provide information about any training sets used for the development or calibration of the device's algorithms. As an oximetry device, its core algorithms are likely based on established biophotonics principles and may not involve a separate "training set" in the same way machine learning algorithms do, but rather extensive calibration and verification data.

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

• Not specified. Since details about a specific "training set" are not provided, the method for establishing its ground truth is also not mentioned. It is generally understood that the algorithms for such devices are developed and calibrated using a controlled experimental setup with known ground truth parameters for oxygen saturation.

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The BeneVision N12/N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• The arrhythmia detection, RM, CCO, SvO2/ScvO2, PAWP, and NMT monitoring are intended for adult and pediatric patients only;
• C.O. monitoring is intended for adult patients only;
• ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
• rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use.

The BeneVision N1 Patient Monitor is intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• The arrhythmia detection and PAWP is intended for adult and pediatric patients only
  The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

The subject BeneVision N Series Patient Monitors includes six monitors:

• BeneVision N12 Patient Monitor
• BeneVision N15 Patient Monitor
• BeneVision N17 Patient Monitor
• BeneVision N19 Patient Monitor
• BeneVision N22 Patient Monitor
• BeneVision N1 Patient Monitor

The BeneVision N Series Patient Monitors are Mindray's new generation monitoring product family with ergonomic and flexible design in platform of both software and hardware to meet the clinical needs of monitoring.

The provided document is a 510(k) Summary for the Mindray BeneVision N Series Patient Monitors. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with statistical endpoints.

Therefore, many of the requested elements for a detailed study description (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with specific metrics, and ground truth establishment for training data) are not present in the provided text.

The document primarily highlights changes from predicate devices and states that functional and system-level testing, along with compliance with consensus standards, demonstrate equivalence.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically seen for a new device's efficacy study. Instead, it compares the specifications of the subject device with those of predicate devices, implicitly indicating that the subject device's performance meets or exceeds the predicate's established performance or relevant cleared standards.

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for test sets. The testing mentioned is referred to as "functional and system level testing" and "bench testing." It also states Mindray conducted "clinical testing to demonstrate that the Mindray and Nellcor SpO2 modules meet relevant consensus standards."
There is no mention of data provenance (e.g., country of origin of data, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document does not describe the use of experts to establish ground truth for testing. The evaluation focused on meeting specifications and consensus standards, and demonstrating equivalence to predicate devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no mention of adjudication methods.

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

Not applicable. This is a patient monitor, not an AI-assisted diagnostic device, and no MRMC studies are mentioned.

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

The document describes performance in terms of functionality and adherence to technical specifications and consensus standards, not in terms of "algorithm-only" performance as would be relevant for an AI device. The tests performed are for the integrated device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The term "ground truth" is not used. The performance evaluation is based on meeting engineering specifications, comparing against predicate device performance, and compliance with recognized consensus standards (e.g., IEC, ISO, AAMI standards for physiological measurement accuracy).

8. The sample size for the training set

Not applicable. A "training set" is relevant for machine learning algorithms. This document describes a patient monitor, and no machine learning model training is discussed.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning model is mentioned.

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The FORE-SIGHT® Cerebral Oximeter, Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain (SctO2). It is intended for use in any individual at risk for reducedflow or no-flow ischemic states.

When used with FORE-SIGHT large sensors, the FORE-SIGHT MC-2000 Cerebral Oximeter Monitor is indicated for use with adults and children over 40Kg. When used with the FORE-SIGHT medium sensors, the FORE-SIGHT MC-2000 Cerebral Oximeter is indicated for use with small adults and children between 4 kg and 80 kg. When used with FORE-SIGHT small sensors the FORE-SIGHT MC-2000 Series Cerebral Oximeter Monitor is indicated for infants and neonates ≤ 8Kg.

The Cerebral Oximeter Monitor measures cerebral tissue oxygen saturation allowing the clinician to accurately determine absolute levels of brain tissue blood oxygen saturation and brain venous oxygen saturation in the brain. This measurement can be of significant value in numerous acute care (OR ICU, ER) situations, providing health care professionals with information to guard against neurological injuries due to compromised brain oxygenation, which can occur during many surgical and clinical procedures.

The Cerebral Oximeter Monitor consists of an optical transducer containing a laser light source and photodiode detectors, and a graphic display monitor with user interface. The non-invasive, reflection mode, optical transducer is placed on the forehead of the subject via a disposable sensor attachment to determine cerebral oxygenation. The Cerebral Oximeter Monitor is safe to use, because it is designed to operate as a Class I laser product, the safest FDA laser classification. Additional safety features include a laser interlock system designed to prevent laser operation in case the optical transducer is not securely attached to the subject. A patent-protected algorithm optimizes accuracy of the device for measurements of absolute cerebral tissue oxygen saturation.

Here's a summary of the acceptance criteria and the study details for the CASMED FORE-SIGHT® Cerebral Oximeter Monitor, Model MC-2000, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criterion for the device's performance is not explicitly stated as a target value in the document. Instead, the "Precision (1 Standard deviation)" is reported for different patient populations. This precision value reflects the agreement between the device's SctO2 measurement and the reference SctO2 derived from co-oximetry of blood samples.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Adult Subject Validation: Healthy adult volunteers. The exact number of subjects is not provided. Data collected at Duke University Medical Center in Durham, North Carolina. Prospective study design.
   • Infant & Neonate Subject Validation: 2044 hours of clinical data collected from subjects undergoing venous Extracorporeal Membrane Oxygenation (VV-ECMO) with cephalad catheterization. The exact number of subjects is not provided, but the duration of data collection suggests a significant number of data points. Data collected at Children's National Medical Center in Washington, DC, and the Children's Hospital of Atlanta (CHOA), Emory University, Atlanta, GA. Prospective study design.
   • Pediatric Subject Validation: Subjects undergoing cardiac catheterization. The exact number of subjects is not provided. Data collected at Boston Children's Hospital in Boston, MA. Prospective study design.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not mention the use of experts to establish ground truth. The ground truth was established through direct physiological measurements from blood samples analyzed by co-oximetry.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was based on objective physiological measurements (co-oximetry of blood samples) rather than expert interpretation.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a diagnostic/monitoring device, not an AI-assisted interpretation tool for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance reported (Precision of SctO2) is the standalone performance of the algorithm/device. The device directly measures and calculates SctO2, and its output is compared against a reference standard.

6. The type of ground truth used:

   • Physiological Measurement/Co-Oximetry of Blood Samples:
     • For adults and pediatric subjects: Reference SctO2 derived from co-oximetry of arterial (SaO2) and jugular bulb (SjvO2) blood samples.
     • For infant & neonate subjects: Reference SctO2 derived from pulse oximetry measured arterial oxygen saturation (SaO2) and co-oximetry measured internal jugular vein venous oxygen saturation (SjvO2) from blood samples.

7. The sample size for the training set:

   • The document does not explicitly mention a separate "training set" or its size. In the context of medical devices like oximeters, the algorithm is often developed and refined using a dataset that precedes the formal validation studies presented here. The provided clinical studies are validation studies demonstrating the device's performance against a reference standard. If algorithm development involved clinical data, it's not detailed as a distinct training set.

8. How the ground truth for the training set was established:

   • As no separate "training set" is explicitly described, the method for establishing ground truth for any potential internal development/training data is not detailed in this document. However, it can be inferred that any data used for algorithm development would likely rely on similar physiological measurement techniques as those used for validation.

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