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The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),

· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources.

The CARESCAPE B650 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.

The CARESCAPE B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Contraindications for using CARESCAPE B650:

The CARESCAPE B650 is not intended for use in a controlled MR environment.

CARESCAPE B650 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650 includes the monitor with built-in CPU, power unit, a 15 inch touch display, the CARESCAPE Software and the battery. CARESCAPE B650 is equipped with two module slots where patient data acquisition modules (E-Module type) can be connected to perform patient monitoring. CARESCAPE B650 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition devices. In addition to the ePort interface the PDM module can be also connected directly to the CARESCAPE B650 via special slide mount connector which is in the back of the monitor. The CARESCAPE B650 includes features and subsystems that are optional or configurable.

The provided text is a 510(k) Summary for the GE Healthcare CARESCAPE B650 patient monitor. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of acceptance criteria and device performance. Therefore, the information requested in your prompt is largely not available within this document.

Here's a breakdown of what can and cannot be extracted based on the provided text:

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

The document does not provide a specific table of acceptance criteria with corresponding reported device performance values in the format you requested. It states: "Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B650, demonstrating the design meets the specifications." This is a general statement about testing without specific criteria or performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "Bench testing related to software, hardware and performance," but does not detail the nature of the test sets, their size, or their origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As this is a 510(k) submission for a patient monitor, the primary evidence relies on engineering and performance testing against established standards, not typically on expert consensus for "ground truth" in the way it might be for an AI diagnostic device.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done, and it is not applicable to this submission. The device is a patient monitor, not an AI-assisted diagnostic tool that would involve human readers. The document explicitly states: "The subject of this premarket submission, CARESCAPE B650 did not require clinical studies to support substantial equivalence."

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

The document describes "Bench testing related to software, hardware and performance" and "Software testing included software design, development, verification, validation and traceability." This implies standalone testing of the device's algorithms and functionality. However, specific details about the results of such standalone performance are not provided in a quantifiable manner against acceptance criteria.

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

Given the nature of the device (a multi-parameter patient monitor), "ground truth" would likely be established through:

• Reference measurement devices/standards: For parameters like ECG, blood pressure, oxygen saturation, temperature, etc., the device's measurements would be compared against validated reference devices or established physical standards.
• Simulated physiological signals: For arrhythmia detection, the device would be tested with simulated ECG waveforms containing known arrhythmias.

However, the specific types of "ground truth" used are not explicitly elaborated beyond "bench testing" and "applicable consensus standards."

8. The sample size for the training set

This information is not provided and is generally not applicable in the context of a patient monitor's 510(k) submission unless specific machine learning algorithms requiring training data were a novel aspect of the submission, which is not indicated here. The document describes modifications to software and hardware, implying updates to existing functionalities rather than the introduction of new, data-trained AI models.

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

This information is not provided and is not applicable for the reasons stated in point 8.

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The CARESCAPE B850 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.

The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of:

• · hemodynamic (including ECG, ST segment, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
• · respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
• · neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources.

The CARESCAPE B850 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.

The CARESCAPE B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Contraindications for using the monitor

The CARESCAPE B850 is not intended for use in a controlled MR environment.

CARESCAPE B850 is a new version of a modular multi- parameter patient monitoring system. The monitor includes a separate 19-inch touchscreen display, the central processing unit (also called CPU), the CARESCAPE Software, and a module frame F5 or F7. CARESCAPE B850 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. In addition, the F5 module frame has five module slots, and the F7 module frame has seven module slots where patient data acquisition modules (E-Module type), can be connected to perform patient monitoring. The CARESCAPE B850 includes features and subsystems that are optional or configurable.

This looks like a 510(k) summary for the GE Healthcare CARESCAPE B850 patient monitor. I will extract information related to the acceptance criteria and study that proves the device meets them.

Based on the provided text, the CARESCAPE B850 is a multi-parameter patient monitor. The 510(k) submission is for a new version with updated software and minor hardware modifications. The submission refers to a primary predicate device, also named CARESCAPE B850 (K191323), and additional predicate/reference devices for specific parameters (INVOS PM7100 and MASIMO RADICAL Y PULSE CO-OXIMETER).

The key takeaway is that the device did not require clinical studies to support substantial equivalence because it is a modified version of an already cleared device and incorporates previously cleared parameters. Therefore, the "study that proves the device meets the acceptance criteria" primarily refers to non-clinical bench testing.

Here's a breakdown of the requested information 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 corresponding performance metrics for the new CARESCAPE B850 compared to a specific threshold. Instead, it relies on the concept of substantial equivalence to a predicate device.

The "acceptance criteria" are implied to be that the performance of the new device is "as safe, as effective, and the performance to be substantially equivalent to the predicate device." The reported "device performance" is primarily that it passed various non-clinical tests.

Implied Acceptance Criteria (based on substantial equivalence concept):

Note: The document states that the fundamental function and operation of the proposed CARESCAPE B850 monitor are unchanged compared to its predicate (K191323), except for the addition of an E-musb Interface module and the capability to display previously cleared hemodynamic parameters from OEM devices (regional oxygen saturation and total hemoglobin concentration).

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing related to software, hardware and performance." This typically involves testing prototypes or production units, but a "sample size" in the context of patient data is not applicable here as no clinical studies were performed for this submission.
• Data Provenance: Not applicable, as no external data (e.g., patient data from a specific country, retrospective or prospective) was used for this 510(k) submission to demonstrate substantial equivalence. The testing was internal bench testing.

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

• Number of Experts: Not applicable. For bench testing of hardware and software, "ground truth" is typically established by engineering specifications, validated test protocols, and adherence to consensus standards, rather than expert clinical consensus on patient data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept applies to clinical studies where discrepancies in observations or diagnoses need to be resolved. For bench testing, test results are typically compared against predefined specifications.

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

• MRMC Study: No. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers. The new version mostly focuses on software updates, minor hardware changes, and display of previously cleared parameters from other OEM devices.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: The core functionality of the device (e.g., ECG, arrhythmia detection, various physiological measurements) operates in a "standalone" fashion in that the algorithms process patient data collected by the sensors. The document doesn't detail specific "algorithm-only" performance metrics as would be seen for a novel AI algorithm. Instead, it relies on the previous clearance of the predicate device and the fact that the algorithms (like EK-Pro arrhythmia detection algorithm V14) are identical. The newly added parameters (regional oxygen saturation and total hemoglobin concentration) are sourced from OEM devices that would have their own standalone performance data from their original clearances.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical bench testing, the ground truth would be the engineering specifications of the device and adherence to relevant consensus standards (e.g., for electromagnetic compatibility, electrical safety, environmental performance). For the physiological parameters, the "ground truth" for the algorithms (e.g., arrhythmia detection) was established during the development and clearance of the predicate device (K191323) and the OEM devices for rSO2 and SpHb.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. As this is not an AI/ML device that requires a distinct "training set" for model development for this 510(k) submission, this information is not relevant here. The update involves existing algorithms and integration of existing cleared parameters.

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

• How Ground Truth for Training Set Was Established: Not applicable, for the same reason as point 8.

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The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B450 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE B450 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B450 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B450 also shows alarms from other ECG sources.
The CARESCAPE B450 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B450 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility

CARESCAPE B450 is a new version of a portable multiparameter patient monitoring system. The CARESCAPE B450 includes the monitor itself with built-in CPU, power unit, a 12 inch touch display, the CARESCAPE Software and one or two batteries. CARESCAPE B450 is equipped with an ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B450 is also equipped with one module slot where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B450 includes features and subsystems that are optional or configurable.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

The document describes the CARESCAPE B450, a multiparameter patient monitor. This submission is for a new version of the device, primarily focusing on updated software and minor hardware modifications.

The document does not contain details about specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) or a study proving the device meets those criteria with statistical significance. Instead, it primarily focuses on demonstrating substantial equivalence to a predicate device (K191249 CARESCAPE B450) and compliance with general safety and performance standards through non-clinical testing.

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

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

   This information is not explicitly provided in the document. The submission aims to show that the new CARESCAPE B450, with its updated software and minor hardware, is "substantially equivalent" to its predicate device. This implies that its performance is expected to meet the same standards as the predicate, but specific performance metrics and acceptance thresholds for those metrics are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   This information is not provided. The document states that "Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B450, demonstrating the design meets the specifications." It also notes that "The subject of this premarket submission, CARESCAPE B450 did not require clinical studies to support substantial equivalence." This indicates that the primary validation was through non-clinical bench testing, not through studies on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   This information is not provided. As clinical studies were not required and the validation was primarily non-clinical bench testing, the concept of "ground truth" derived from expert consensus on patient data (as would be typical for AI/ML performance studies) is not applicable or described in this document.

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

   This information is not provided. Since no clinical studies or evaluations of diagnostic performance against a "ground truth" established by experts on a test set are detailed, adjudication methods are not mentioned.

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 or reported. The device is a patient monitor with arrhythmia detection, not an AI-assisted diagnostic tool for human readers in the context of an MRMC study.

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

   The document states that "Bench testing related to software, hardware and performance... was conducted," implying that the device's inherent functional performance was tested. The phrase "algorithm only" isn't explicitly used, but the testing would effectively assess the device's standalone operation. However, no specific performance metrics (like those one would expect for an AI algorithm, e.g., sensitivity/specificity for specific arrhythmias) are reported. The device features "EK-Pro arrhythmia detection algorithm EK-Pro V14", and its performance is assumed to be equivalent to the predicate using the same algorithm version.

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

   For the non-clinical bench testing, the "ground truth" would likely be based on established engineering specifications, simulated physiological signals, and validated test protocols inherent to medical device performance testing, rather than expert consensus, pathology, or outcomes data from human subjects. This type of detail is not further elaborated in the document.

8. The sample size for the training set

   This information is not provided. As the submission is for a new version of an existing device primarily involving software updates and minor hardware changes, and the algorithm (EK-Pro V14) itself is listed as "Identical" to the predicate, details about a training set for a new or significantly retrained algorithm are not discussed.

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

   This information is not provided, for the same reasons as point 8.

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CARESCAPE ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. CARESCAPE ONE is indicated for the monitoring of hemodynamic and respiratory physiological parameters. When the CARESCAPE ONE is operated as a standalone multi-parameter physiological patient monitor, it provides the following physiological parameters: - · ECG (heart rate, ST segment, and arrhythmia detection) - · Pulse oximetry (pulse rate, functional oxygen saturation [SpO2]) - · Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures) - · Invasive pressure (pulse rate and systolic, diastolic, and mean pressures) - · Temperature - · Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate) - · Impedance respiration When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, it provides the following physiological parameters to the host monitor: - · ECG (heart rate, ST segment, and arrhythmia detection) - · Pulse oximetry (pulse rate, function [SpO2], and total hemoglobin concentration [SpHB]] - · Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures) - · Invasive pressure (pulse rate and systolic, diastolic, and mean pressures) - · Regional oxygen saturation (rSO2) - · Temperature - · Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate) - · Impedance respiration When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, visual and audible alarms, user controls, and user interface are provided on the compatible host monitor and not on CARESCAPE ONE. CARESCAPE ONE is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. Regional oxygen saturation (rSO2) is an adjunct parameter for nonitoring of cerebral/somatic regional oximetry of blood in the brain or other tissue beneath the sensor. It is intended to be used on patients greater than 40 kg (88 lbs) at risk for reduced-flow or no-flow ischemic states. CARESCAPE ONE is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility. Contraindications for using CARESCAPE ONE: The CARESCAPE ONE is not intended for use within a controlled MR environment.

CARESCAPE ONE belongs to the CARESCAPE patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only the parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular vital sign, currently there are ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, CO2, and rSO2 (rSO2 monitoring is only supported when CARESCAPE ONE is operating as an acquisition device. rSO2 values are not displayed on CARESCAPE ONE). The only exception is the Non-Invasive Blood Pressure (NIBP) measurement which does not require a separate ACM since the capability to measure NIBP is built-in to the CARESCAPE ONE monitor itself. CARESCAPE ONE provides the users the acquired display values, waveforms, alarms and status messages in compact footprint monitor that runs on an internal battery as well as AC power when connected to the docking station. When connected to a compatible host monitor, CARESCAPE ONE operates as an acquisition device. In this mode, CARESCAPE ONE screen and user interface is effectively disabled and it transmits data received form the Active Cable Modules to the host monitor, which is responsible for managing clinical configuration settings, and displaying values, waveforms, alarms, and status messages.

The provided text is a 510(k) Summary for the GE Medical Systems Information Technologies, Inc.'s CARESCAPE ONE device. It outlines the device's characteristics, intended use, and a comparison to a predicate device (K200494). However, it explicitly states that clinical studies were not required to establish substantial equivalence for this submission.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and the study that proves the device meets them, specifically in the context of human reader performance or ground truth established by experts beyond what is implied by general device performance testing. The focus of this 510(k) submission is on demonstrating substantial equivalence to a previously cleared device through non-clinical bench testing, not through a clinical study involving human readers and a robust ground truth determination process.

Here's what can be extracted from the document regarding "acceptance criteria" and "device performance" in a general sense, based on the non-clinical tests performed:

Summary of Non-Clinical Tests and Implied Acceptance Criteria:

The non-clinical tests performed demonstrate that the device meets its own specifications and relevant consensus standards. The "acceptance criteria" implicitly refer to compliance with these standards and the device's design specifications.

Implied Acceptance Criteria and Reported Device Performance (based on Non-Clinical Tests):

Here's why the other requested information cannot be provided from this document:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • This document focuses on non-clinical bench testing and compliance with standards. It does not mention clinical test sets, patient data, country of origin, or retrospective/prospective study design.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • No clinical user studies are mentioned that would require ground truth established by experts.

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

  • Not applicable as there are no clinical test sets or expert reviews mentioned for adjudication.

• 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

  • The document explicitly states: "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." Therefore, no MRMC study or AI assistance effect size is discussed.

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

  • While the device has algorithms (e.g., EK-Pro arrhythmia algorithm), the document focuses on the device's performance in meeting safety and compatibility standards, not on a standalone algorithm's performance where "human-in-the-loop" is a distinct variable to be tested. The algorithms themselves are "identical" to the predicate, implying their performance was previously accepted.

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

  • Not relevant to the non-clinical bench testing described. Ground truth is not established in the context of clinical accuracy for this submission.

• 8. The sample size for the training set

  • The document does not describe the development or training of any AI/ML components or algorithms. It states that the measurement algorithms are "identical" to the predicate, suggesting they were already developed and validated.

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

  • Not applicable as there is no mention of a training set or its associated ground truth.

In summary, this 510(k) submission for the CARESCAPE ONE device relies on demonstrating "substantial equivalence" to a previously cleared predicate device (K200494) through non-clinical bench testing and adherence to recognized standards, rather than new clinical studies involving human performance or ground truth established by experts.

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The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters.

The CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.

The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility.

Contraindications for using CARESCAPE ONE:

The CARESCAPE ONE is not intended for use within a controlled MR environment.

CARESCAPE ONE is a new patient monitor device based on GE Healthcare predicate devices, the Patient Data Module (K071073) and the CARESCAPE B450 (K132533).

CARESCAPE ONE, with CARESCAPE Software version 3 belongs to the CARESCAPE V3 patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only the parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular parameter, including ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, or CO2. The only exception is the Non-Invasive Blood Pressure (NIBP) measurement which does not require a separate ACM since the capability to measure NIBP is built-in to the CARESCAPE ONE monitor itself. The ACM's are CARESCAPE TEMP, CARESCAPE PRES, CARESCAPE ECG, CARESCAPE SpO2 (TruSignal), CARESCAPE SpO2 -Nellcor, CARESCAPE SpO2 - Masimo and CARESCAPE CO2 - LoFlo. CARESCAPE SpO2 - Nellcor, CARESCAPE SpO2 -Masimo, and CARESCAPE CO2 - LoFlo have been developed by their respective companies/manufacturers (OEM) for use with the CARESCAPE ONE. The technology from each OEM has received 510(k) clearance and is adapted to function with the CARESCAPE ONE. The OEM technologies are not new and are not a part of this submission, only their integration into the Parameters/Active Cable Modules for use with the CARESCAPE ONE is covered in this 510(k).

CARESCAPE ONE provides the users the acquired display values, waveforms, alarms and status messages in compact footprint monitor that runs on an internal battery as well as AC power when connected to the docking station.

Here's an analysis of the acceptance criteria and supporting studies for the CARESCAPE ONE device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a direct table of specific acceptance criteria with corresponding performance values for all features. However, it does highlight performance claims and comparisons for key components, specifically arrhythmia detection and SpO2.

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

• Arrhythmia (EK-Pro V14): The document references ANSI/AAMI EC57:1998 (R)2012. This standard specifies databases (e.g., AHA, MIT-BIH) that are used for testing arrhythmia algorithms. The specific sample size from these databases used for EK-Pro V14 testing is not explicitly stated in this 510(k) summary, but it would be derived from the standard's requirements.
  • Data Provenance: The databases mentioned in EC57 are typically retrospective, internationally recognized ECG databases. The exact country of origin for the data used for this specific EK-Pro V14 validation is not specified, but the standard's databases often compile data from various global sources.
• SpO2 (TruSignal V3): The document states a "controlled desaturation study." The sample size is not explicitly stated in this summary.
  • Data Provenance: A controlled desaturation study is a prospective clinical study designed to test pulse oximeter accuracy. The country of origin for this study is not specified.

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

• Arrhythmia (EK-Pro V14): When using standard databases like those referenced by ANSI/AAMI EC57, the ground truth (arrhythmia annotations) is typically established by multiple, highly experienced cardiologists or cardiac electrophysiologists. The exact number and qualifications for the original annotation of the standard databases are not specified in this document, as the standard itself defines these.
• SpO2 (TruSignal V3): For controlled desaturation studies, the "ground truth" for SpO2 is provided by a CO-oximeter measurement, which itself is a highly accurate laboratory method for oxygen saturation. This is an objective measurement rather than expert consensus. Therefore, "experts" in the traditional sense for establishing ground truth are not directly applicable here.

4. Adjudication Method for the Test Set

• Arrhythmia (EK-Pro V14): For standard databases, ground truth annotation often involves multiple experts reviewing and adjudicating discrepancies, sometimes with a "majority rules" or senior expert decision process. The specific adjudication method for the creation of the databases referenced by EC57 is not detailed in this summary, but would adhere to the methodologies defined by the creators of those databases.
• SpO2 (TruSignal V3): As the ground truth comes from CO-oximetry, an objective measurement, adjudication by experts is not applicable.

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

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." This indicates that human-in-the-loop performance with or without AI assistance was not assessed in this submission for primary equivalence.

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

• Yes, standalone performance was assessed for key algorithms:
  • EK-Pro V14 Arrhythmia Detection algorithm: Its performance was evaluated against the ANSI/AAMI EC57 standard, comparing it to the predicate's EK-Pro V13 algorithm. This is a standalone algorithm performance evaluation.
  • TruSignal V3 SpO2 algorithm: Its accuracy was validated in a controlled desaturation study against CO-oximetry. This is also a standalone algorithm performance evaluation.

7. The Type of Ground Truth Used

• Arrhythmia (EK-Pro V14): The ground truth would be expert consensus annotations of ECG waveforms from standard arrhythmia databases (e.g., those specified in ANSI/AAMI EC57).
• SpO2 (TruSignal V3): The ground truth was objective laboratory measurement using CO-oximetry in a controlled study. This is considered a gold standard for blood oxygen saturation.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size used for training the EK-Pro V14 arrhythmia detection algorithm or the TruSignal V3 SpO2 algorithm. In 510(k) submissions, training set details (especially for existing, updated algorithms) are often not required to be as extensively disclosed as test set performance, particularly when demonstrating equivalence to a predicate.

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

• The document does not explicitly state how the ground truth for the training sets of the EK-Pro V14 or TruSignal V3 SpO2 algorithms was established. For complex algorithms like these, training data is typically meticulously annotated by a combination of clinical experts (for arrhythmia) or using highly accurate reference methods (for SpO2) and then verified. Again, in a 510(k) for an updated algorithm or component, the full developmental history and training data specifics may not be detailed if the focus is on demonstrating equivalent performance post-modifications.

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The Masimo Rad-97 and Accessories are indicated for hospital-type facilities, mobile, and home environments.

The Masimo Rad-97 and Accessories can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).

The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Rad-97 and Accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused. In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi-parameter devices for the display on those devices.

The Masimo Rad-97 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 optional Nomoline Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The Nomoline Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatric and infant patients.

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

The subject device, Masimo Rad-97 System and Accessories (Rad-97) product family, features a touchscreen display that continuously displays numeric values for the measured monitoring parameters. The Rad-97 product family can be operated on AC power or internally rechargeable battery.

The Rad-97 product family comprises the same measurement technologies as cleared in the predicate, Root (with connected external Radical-7 and capnography (ISA) and internal NIBP modules), which includes the Masimo Rainbow SET technology, capnography technology and noninvasive blood pressure (NIBP) technology. These technologies enable the Rad-97 product family to provide noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (PI), Pleth Variability Index (PVI), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa) and/or optional capnography parameters or optional noninvasive blood pressure (NIBP) parameters.

The Rad-97 product family is available with different measurement parameter configurations, ranging from a fully loaded configuration to a simplified configuration with pulse oximetry parameters only. In a fully loaded configuration, the Rad-97 model includes all parameters provided by the Masimo Rainbow SET technology including SpO2, PR, PI, PVI, SpCO, SpMet, SpHb, SpOC and RRa. Additionally, this fully loaded version can be optionally available with either NIBP or capnography technology.

The Rad-9 model, an instrument model within the Rad-97 product family, is an embodiment with a simplified configuration. The Rad-9 model includes the Masimo SET technology (a subset of Masimo Rainbow SET technology), which provides pulse oximetry parameters of SpO2, PR, PI and PVI. The Rad-9 model can be optionally available with NIBP technology.

Same as the predicate, the Rad-97 product family includes inout/output interfaces for connection to external devices. Furthermore, same as the predicate, the Rad-97 product family can communicate through wired/wireless connection with networked systems such as Patient SafetyNet (K071047) and/or hospital electronic medical/health record (EMR) systems.

The RD SET Disposable Sensors, listed with other cleared accessories in Section 11.7, are the same as the currently marketed product. The only change is the added labeling information regarding the sensors' performance in terms of limits of agreement (LOA) as defined by Bland-Altman.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported performance for "Upper 95% LOA" (3.15%) indicates that the device did not meet the specified acceptance criterion of "= -3%".

The document also lists other accuracy specifications for various parameters, but it does not explicitly state an "acceptance criteria" alongside them in the same format as the LOA for SpO2. These are presented as general "Accuracy (ARMS)" specifications.

Accuracy (ARMS) Specifications (not explicitly presented as acceptance criteria vs. performance in the provided text, but rather device specifications):

• ARMS defined as a statistical calculation of the difference between device measurements fell within +/- ARMs of the reference measurements in a controlled study.

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

• Sample Size: Not explicitly stated as a number. The study was conducted on "healthy adult volunteers."
• Data Provenance: Retrospective or Prospective is not explicitly stated, but clinical studies are generally prospective. The data is from "healthy adult volunteers," implying a clinical study setting. Country of origin is not specified, but the Masimo Corporation is based in Irvine, CA, USA, suggesting the study likely took place in the USA or under its regulations.

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

• This information is not provided in the text. The ground truth for SpO2 was established by "blood measurements from a laboratory CO-Oximeter," which is an instrument, not human experts.

4. Adjudication Method for the Test Set

• Not applicable. The ground truth was established by an instrument (laboratory CO-Oximeter) comparing directly to the device measurements; there was no human adjudication process involved for establishing the ground truth.

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

• No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers interpreting cases with and without AI assistance. This document describes the performance of a medical device (oximeter) and its various physiological monitoring capabilities, not an AI-powered diagnostic imaging tool that would typically undergo MRMC studies.

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

• Yes, a standalone performance study was done. The clinical study described "evaluate the sensor's performance for no motion condition, in the range of 70% to 100% in comparison to blood measurements from a laboratory CO-Oximeter." This evaluates the device directly against a reference standard, which is a standalone performance assessment.

7. Type of Ground Truth Used

• The ground truth used for SpO2 was instrumental measurement / reference standard. Specifically, it was "blood measurements from a laboratory CO-Oximeter."

8. Sample Size for the Training Set

• This information is not provided in the text. The document describes a clinical study for validating the device's accuracy, not for training a new algorithm. The device incorporates "Masimo Rainbow SET technology," which is a pre-existing technology, and the study is for the performance of the integrated product and its sensors.

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

• This information is not provided in the text, as no specific training set or new algorithm development is detailed. The technology itself (Masimo Rainbow SET) is described as utilizing principles of spectrophotometry and photoplethysmography, implying established scientific principles rather than a continuously trained machine learning model.

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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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Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU, CCU, OR, ER, or Recovery areas of the hospital or clinic. Patient ages from neonates to adults can all be monitored. Waveforms, numeric and trend data from these patients are available to the clinician on the systems display or may be printed on the system's recorder.

The DS-8100N/8100M provides monitoring of ECG (Up to 7lead), heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), plethysmograph, and parameters in combination of invasive blood pressure (IBP) (max. 2ch.), temperature (max. 4ch.), and cardiac output (max. 1ch.) using the multiparameter connector. In addition, the DS-8100M provides monitoring of carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb). The DS-8100N for SpO2 measurement utilizes a technology of an OxiMax N-600x Pulse Oximeter manufactured by Nellcor and previously cleared under 510(k) # K060576. The DS-8100M for SpO2, SpCO, SpMet, and SpHb measurement utilizes a technology of a Masimo RADICAL 7 Pulse CO-Oximeter manufactured by Masimo and previously cleared under 510(k) # K110028. All parameter connectors are on the front panel and are labeled on the left side of the main unit. By connecting the optional CO2 Gas Unit (HCP-800/HCP-810) or Gas Unit I/F (HPD-800/HPD-810) to the AUX Connector on the rear side of the main unit, it provides monitoring of carbon dioxide concentration (CO2) The CO2 Gas Unit (HCP-800/HCP-810) that utilizes Oridion Medical 1987 Ltd. technology "Microstream"" and previously cleared under 510(k) #K094012. The Gas Unit I/F (HPD-800/HPD-810) allows to connect the Capnostat 5 Mainstream CO2 Sensor, 510(k) #K042601, manufactured by Respironics Novametrix, LLC. to the main unit with serial communication protocol for CO2 monitoring.

The DS-8100N/8100M is a self-contained monitor, which includes a 10.2 inch TFT color LCD display which can display up to 14 waveforms and up to 14 numeric displays. The user interfaces, the touch screen panel, is located on the front of the main unit. The transparent area covering the display has a variable number of keys that are activated by software and depend on the display/function that the user selects. And there are five (5) fixed keys (Alarm Silence, NIBP Start/Stop, Home, Menu, and Prev. Disp.) and Jog Dial on the right side of the front of the main unit. The infrared remote-control command is also available (optional). By attaching the optional Recorder Unit (HR-800) or Recorder/Expansion Port Unit (HR-811), a dot matrix thermal printer, on the bottom of rear of the main unit, it provides hard copy recordings of all monitored parameters and can print up to three (3) waveforms simultaneously. In addition, the Recorder/Expansion Port Unit (HR-811) contains the Analog Output Connector that outputs the ECG and BP waveforms, including the ORS SYNC output signal, VGA Output Connector, and Module-LAN Connector, which connects to other patient monitor. By attaching the Expansion Port Unit (CU-810) on the bottom of rear of the main unit, it provides the VGA Output Connector, and Module-LAN Connector, which connects to other patient monitor or connects to the laser printer as general LAN.

Additional standard features include DS-LAN connection, which is a proprietary network system based on an Ethernet LAN (#K970585), through a built in Ethernet LAN, and a wireless connection using the optional telemetry transmitting module (Model: HLX-801) and a wireless bidirectional communication using the optional Bidirectional Wireless Communication Module (Model: HTC-702) allow remote monitoring when combined with Fukuda Denshi Central Station Monitors. An option battery operation allows a patient to continue to be monitored during intra-hospital transport.

The DS-8100N/8100M is small and lightweight at 3.5 kg. The physical dimensions of the device are 300 mm (W) x 265 mm (H) x 75 mm (D).

The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is a multi-parameter patient monitor. The provided document doesn't detail specific acceptance criteria and the associated study results for each parameter within the device. Instead, it offers a general statement that the device has undergone "extensive safety, environmental and performance testing" to ensure all functional and performance specifications are met. It also states that OEM engineering test facilities confirmed the performance and functional specifications for their supplied modules.

The conclusion asserts that the device is "as safe and effective and performs as well as the legally marketed predicate devices" based on "laboratory testing, validation, and risk analysis." This implies a comparative study against predicate devices and adherence to various safety and performance standards, rather than proving performance against predefined quantitative acceptance criteria with specific metrics.

Here's a breakdown of the available information based on your request, even though specific quantitative acceptance criteria are not provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria are not explicitly stated in the provided text for each parameter (ECG, NIBP, SpO2, etc.), a table cannot be fully constructed with precise numbers. The document generally states that "all functional and performance specifications were met."

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "various performance tests" and "OEM engineering test facility" testing.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the number of experts used to establish ground truth or their qualifications. The testing appears to be primarily technical and performance-based against established standards and predicate device performance, not reliant on expert clinical interpretation for ground truth.

4. Adjudication Method

The document does not describe any adjudication method. This is typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The device is a patient monitor, and its evaluation would generally focus on the accuracy of its physiological measurements against reference standards, rather than the improvement of human reader performance with AI assistance. The document focuses on performance specifications and equivalency to predicate devices.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was implicitly done for various parameters (e.g., SpO2, CO2, ECG performance) by testing against relevant standards (e.g., ANSI/AAMI EC13 for ECG, ISO 9919 for pulse oximeters). The document states: "Final testing for the device included various performance test for the device designed to insure that all functional and performance specifications were met." This refers to the device's ability to accurately measure and display physiological data.

7. Type of Ground Truth Used

The ground truth for the performance testing appears to be based on:

• Reference standards/simulators: This is typical for physiological monitors, where the device's measurements are compared against highly accurate reference instruments or simulated physiological signals.
• Performance of predicate devices/OEM modules: The document explicitly states the device utilizes technologies "incorporated into previously cleared devices and OEM manufactured module" and that performance was confirmed by OEM test facilities. This implies comparison against the established performance of those components.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is likely because the device is a patient monitor that measures physiological parameters, not an AI/ML device that requires a large dataset for training a diagnostic algorithm. The algorithms for signal processing and measurement in patient monitors are typically deterministic or based on established physiological models, not machine learning that would involve a "training set."

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned (as the device is not described as using machine learning that requires one), the document does not describe how ground truth for a training set was established.

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The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series. The X Series is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The X Series unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

Manual Defibrillation: Use of the X Series in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

Semiautomatic Operation (AED): X Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the X Series in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.

ECG Monitoring: The X Series is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients.

External Transcutaneous Pacing: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology; As a standby when standstill or bradycardia might be expected; Suppression of tachycardia; Pediatric pacing.

Non-Invasive Blood Pressure Monitoring: The X Series is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg.

Temperature Monitoring: The X Series is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.

SpO2 Monitoring: The X Series pulse CO-oximeter with Masimo Rainbow SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), pleth variability index (PVI), and perfusion index (PI).

Respiration Monitoring: The X Series is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor.

CO2 Monitoring: The X Series is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath rate.

Invasive Pressure Monitoring: The X Series is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply.

12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data.

Web Console: X Series Web Console functionality allows medical personnel to view physiological data available on a connected X Series device. Physiological data may include ECG, noninvasive blood pressure, SpO2/SpCO/SpMet, end-tidal carbon dioxide, respiration rate, invasive blood pressure, temperature, and Heart Rate.

The X Series (reviewed and cleared under K133269 and K133484) is a lightweight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitors (including ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and respiration monitoring). The currently marketed ZOLL X Series device (K133269 and K133484) uses the Masimo Rainbow SET technology to offer the SpO2, SpCO and SpMet functionality. With the current application, we are proposing to revise the X Series software to optionally support additional monitoring parameters - Total Hemoglobin (SpHB), Oxygen Content (SpOC), Pleth Variability Index (PVI) and Perfusion Index (PI), offered by the Masimo Rainbow SET Technology board that is installed in the currently marketed X Series device (K133269 and K133484).

The provided text describes ZOLL X Series device and its substantial equivalence to predicate devices, particularly concerning new monitoring parameters. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the ZOLL X Series (K142915) is an update to an existing device (K133269 and K133484) to include additional monitoring parameters: Total Hemoglobin (SpHB), Oxygen Content (SpOC), Pleth Variability Index (PVI), and Perfusion Index (PI). These parameters are enabled by the Masimo Rainbow SET Technology board, which was already installed in the device, through new software and licenses.

The key acceptance criterion is demonstrating substantial equivalence to the predicate device, the Masimo Radical 7 Pulse CO-Oximeter and Accessories (K110028), for these new monitoring parameters. The reported performance is that the ZOLL X Series, utilizing the same Masimo Rainbow SET Technology, has the same performance specifications as the predicate device for SpHB, SpOC, PVI, and PI.

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

The document does not specify a separate "test set" for the new parameters in the context of a prospective clinical study directly for K142915. Instead, it relies on the performance of the Masimo Rainbow SET Technology, which was already established in the predicate device (K110028).

• Sample Size for Test Set: Not applicable/not explicitly stated for K142915. The evaluation for the new parameters leverages the performance data from the predicate device (Masimo K110028).
• Data Provenance: The performance of the Masimo Rainbow SET Technology board and its software for these parameters was "established and subsequently cleared by the agency under K110028." This implies the original data for K110028 would have included clinical or performance data for these specific parameters. The provenance of that original data (country, retrospective/prospective) is not detailed in this document.

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

Not applicable. The substantial equivalence argument for the new monitoring parameters within K142915 hinges on the fact that the underlying technology and software for these parameters were already cleared under K110028 (Masimo Radical 7 Pulse CO-Oximeter). There is no mention of a new expert panel or ground truth establishment specifically for the K142915 submission regarding these parameters.

4. Adjudication method for the test set

Not applicable. As noted above, the submission relies on previously cleared technology and software.

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 device is a medical monitoring and defibrillation system, not an AI-assisted diagnostic imaging or interpretation tool that would typically involve human readers.

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

The performance of the algorithm (Masimo Rainbow SET Technology software) for the additional parameters (SpHB, SpOC, PVI, PI) was established as part of the clearance for the predicate device, Masimo Radical 7 Pulse CO-Oximeter (K110028). The current submission states that the ZOLL X Series incorporates this same "relevant license and the software code" whose "performance of which was established under K110028." This implies a standalone evaluation of the algorithm's performance for these parameters occurred within K110028.

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

The document does not explicitly state the type of ground truth used for the original Masimo K110028 clearance related to SpHB, SpOC, PVI, and PI. For physiological monitoring parameters like these, ground truth typically involves a reference standard measurement method (e.g., laboratory blood analysis for hemoglobin, or invasive continuous measurement for pressure/perfusion indices).

8. The sample size for the training set

The document does not provide information about a "training set" for the software in K142915. The evaluation relies on the already established performance of the Masimo Rainbow SET Technology from K110028. If machine learning was involved in the development of the Masimo algorithm, such information would have been part of the K110028 submission, but it's not referenced here for K142915.

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

Not applicable, as no training set information is provided in this document for the K142915 submission.

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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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