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Indications for Use for CARESCAPE Canvas 1000:

CARESCAPE Canvas 1000 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.

CARESCAPE Canvas 1000 is intended for use on adult, pediatric, and neonatal patients one patient at a time.

CARESCAPE Canvas 1000 is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia 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).

CARESCAPE Canvas 1000 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, 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. CARESCAPE Canvas 1000 also shows alarms from other ECG sources.

CARESCAPE Canvas 1000 also provides other alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

CARESCAPE Canvas 1000 can interface to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

CARESCAPE Canvas 1000 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 Canvas 1000 is not intended for use in an MRI environment.

Indications for Use for CARESCAPE Canvas Smart Display:

CARESCAPE Canvas Smart Display is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.

CARESCAPE Canvas Smart Display is intended for use on adult, pediatric, and neonatal patients one patient at a time.

CARESCAPE Canvas Smart Display is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution), and temperature, and · respiratory (impedance respiration, airway gases (CO2)

CARESCAPE Canvas Smart Display is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, 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. CARESCAPE Canvas Smart Display also shows alarms from other ECG sources.

CARESCAPE Canvas Smart Display also provides other alarms, trends, snapshots and events. CARESCAPE Canvas Smart Display can use CARESCAPE ONE or CARESCAPE Patient Data Module (PDM) as patient data acquisition devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

CARESCAPE Canvas Smart Display 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 Canvas Smart Display is not intended for use in an MRI environment.

Indications for Use for CARESCAPE Canvas D19:

CARESCAPE Canvas D19 is intended for use as a secondary display with a compatible host device. It is intended for displaying measurement and parametric data from the host device and providing visual and audible alarms generated by the host device.

CARESCAPE Canvas D19 enables controlling the host device, including starting and discharging a patient case, changing parametric measurement settings, changing alarm limits and disabling alarms.

Using CARESCAPE Canvas D19 with a compatible host device enables real-time multi-parameter patient monitoring and continuous evaluation of the patient's ventilation, oxygenation, hemodynamic, circulation, temperature, and neurophysiological status.

Indications for Use for F2 Frame; F2-01:

The F2 Frame, module frame with two slots, is intended to be used with compatible GE multiparameter patient monitors to interface with two single width parameter modules, CARESCAPE ONE with a slide mount, and recorder.

The F2 Frame is intended for use in multiple areas within a professional healthcare facility. The F2 Frame is intended for use under the direct supervision of a licensed healthcare practitioner, or by person trained in proper use of the equipment in a professional healthcare facility.

The F2 Frame is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

Hardware and software modifications carried out on the legally marketed predicate device CARESCAPE B850 V3.2, resulted in new products CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display, along with the CARESCAPE Canvas D19 and F2 Frame (F2-01) all of which are the subject of this submission.

CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are new modular multi-parameter patient monitoring systems. In addition, the new devices CARESCAPE Canvas D19 and F2 Frame (F2-01) are a new secondary display and new module frame respectively.

The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display patient monitors incorporates a 19-inch display with a capacitive touch screen and the screen content is user-configurable. They have an integrated alarm light and USB connectivity for other user input devices. The user interface is touchscreen-based and can be used also with a mouse and a keyboard or a remote controller. The system also includes the medical application software (CARESCAPE Software version 3.3). The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display include features and subsystems that are optional or configurable.

The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are compatible with the CARESCAPE Patient Data Module and CARESCAPE ONE acquisition device via F0 docking station (cleared separately).

For the CARESCAPE Canvas 1000 patient monitor, the other type of acquisition modules, E-modules (cleared separately) can be chosen based on care requirements and patient needs. Interfacing subsystems that can be used to connect the E-modules to the CARESCAPE Canvas 1000 include a new two-slot parameter module F2 frame (F2-01), a five-slot parameter module F5 frame (F5-01), and a seven-slot parameter module F7 frame (F7-01).

The CARESCAPE Canvas 1000 can also be used together with the new secondary CARESCAPE Canvas D19 display. The CARESCAPE Canvas D19 display provides a capacitive touch screen, and the screen content is user configurable. The CARESCAPE Canvas D19 display integrates audible and visual alarms and provides USB connectivity for other user input devices.

Please note that the provided text is a 510(k) summary for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and adherence to various standards. It explicitly states that clinical studies were not required to support substantial equivalence. Therefore, some of the requested information regarding clinical studies, human expert involvement, and ground truth establishment from patient data will likely not be present.

Based on the provided text, here's the information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific, quantifiable acceptance criteria alongside reported performance data. Instead, it states that various tests were conducted to demonstrate that the design meets specifications and complies with consensus standards. The performance is generally reported as "meets the specifications," "meets the EMC requirements," "meets the electrical safety requirements," and "fulfilled through compliance."

However, we can infer some "acceptance criteria" based on the standards and tests mentioned:

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

• Test Set Sample Size: The document implies that the "test set" for performance evaluation was the device itself and its components as described ("CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19 and F2 Frame (F2-01)").
  • For usability testing, "16 US Clinical, 16 US Technical and 15 US Cleaning users" were involved.
• Data Provenance: The testing described is non-clinical bench testing.
  • For usability testing, the users were located in the US.
  • No direct patient data or retrospective/prospective study data is mentioned beyond the device's inherent functional characteristics being tested according to standards.

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

• Number of Experts: Not applicable in the context of establishing "ground truth" for patient data, as no clinical studies with patient data requiring expert adjudication were conducted or reported to establish substantial equivalence.
• For usability testing, "16 US Clinical, 16 US Technical and 15 US Cleaning users" participated. Their specific qualifications (e.g., years of experience, types of healthcare professionals) are not detailed in this summary.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical studies with patient data requiring adjudication were conducted or reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC study was done, as the document explicitly states: "The subjects of this premarket submission... did not require clinical studies to support substantial equivalence." The device is a patient monitor, not an AI-assisted diagnostic tool for image interpretation or similar.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The performance evaluations mentioned (e.g., for general device functionality, electrical safety, EMC, specific parameter measurements like ECG/arrhythmia detection) represent the device's standalone performance in a bench setting, demonstrating its adherence to established standards and specifications. There is no separate "algorithm only" performance study reported distinctly from integrated device testing. The EK-Pro V14 algorithm, which is part of the device, is noted as "identical" to the predicate, implying its performance characteristics are maintained.

7. The Type of Ground Truth Used

• For the non-clinical bench testing, the "ground truth" was established by conformance to internationally recognized performance and safety standards (e.g., IEC, ISO, AAMI/ANSI) and the engineering specifications of the device/predicate. These standards define the acceptable range of performance for various parameters.
• For usability testing, the "ground truth" was the successful completion of tasks and overall user feedback/satisfaction as assessed by human factors evaluation methods.
• No ground truth from expert consensus on patient data, pathology, or outcomes data was used, as clinical studies were not required.

8. The Sample Size for the Training Set

• Not applicable. This document describes a 510(k) submission for a patient monitor, not a machine learning or AI model trained on a dataset. The device contains "Platform Software that has been updated from version 3.2 to version 3.3," but this refers to traditional software development and not a machine learning model requiring a "training set" in the AI sense.

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

• Not applicable, as there is no mention of a "training set" in the context of machine learning. The software development likely followed conventional software engineering practices, with ground truth established through design specifications, requirements, and verification/validation testing.

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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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The CARESCAPE Respiratory Modules, (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOVX, E-sCAiOE, E-sCAiOVE) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric patients.

When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy.

These modules are intended for use by qualified medical personnel only.

The CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate), ventilatory parameters (airway pressure, flow and breathing volumes) and gas exchange parameters (oxygen consumption and carbon dioxide production) of hospital patients.

Parameters measured by the CARESCAPE Respiratory Modules are CO2, N2O, O2, Anesthetic agents, Agent ID, Spirometry, oxygen consumption (VO2) and carbon dioxide production (VCO2) depending on the model used. The CARESCAPE Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPE Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE Respiratory Modules acquire the signals detected by the module sensors, calculate the parameter values and communicate them to the host device. The CARESCAPE Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system.

The CARESCAPE Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host devices based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.

This 510(k) introduces two new module models in the CARESCAPE Respiratory Modules family: E-sCAiOE and E-sCAiOVE. These new module models include added hardware compared to the modules cleared in K183394. The operation, measured parameters and performance specifications of the E-sCAiOE and E-sCAiOVE is identical to E-sCAiO and E-sCAiOV when used with the current module host devices cleared in the USA. The added modules E-sCAiOE and E-sCAiOVE have the same software as CARESCAPE Respiratory Modules cleared in K183394.

The provided text is a 510(k) Summary for the GE Healthcare CARESCAPE Respiratory Modules. This document describes the device and its claimed substantial equivalence to a predicate device. It does not contain information about an AI/ML-driven device or a study involving human readers or expert ground truth adjudication for image analysis. Therefore, based on the provided text, I cannot answer the questions related to AI/ML device acceptance criteria and study details.

The document focuses on:

• Device Description: Respiratory modules that measure various parameters like CO2, O2, N2O, anesthetic agents, and ventilatory parameters.
• Predicate Device: K183394 CARESCAPE Respiratory Modules.
• Key Change: Introduction of two new module models (E-sCAiOE and E-sCAiOVE) with added hardware (fresh gas sample connector) but identical operation, measured parameters, and performance specifications when used with current host devices.
• Non-Clinical Tests: Bench testing related to software, hardware, and performance, including compliance with various IEC and ISO standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-49, ISO 80601-2-55). Biocompatibility and environmental testing were also conducted. Software was considered "Major" level of concern.
• Clinical Tests: The document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence."

Therefore, I cannot extract the following information that would be relevant to an AI/ML device study:

• Table of acceptance criteria and reported device performance for an AI/ML model.
• Sample size for a test set or data provenance for AI/ML validation.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• MRMC comparative effectiveness study results or effect size of AI assistance.
• Standalone performance of an algorithm.
• Type of ground truth used (expert consensus, pathology, outcome data).
• Sample size for the training set.
• How ground truth for the training set was established.

This document pertains to traditional medical device clearance, not an AI/ML device.

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The CARESCAPE B850 is a multi-parameter patient montor 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 ECC, ST segment, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, 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.

The 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) and the module frame F5 or F7. CARESCAPE B850 V3 is equipped with an "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 V3 includes features and subsystems that are optional or configurable.

The provided document, [K191323](https://510k.innolitics.com/search/K191323), is a 510(k) premarket notification for the GE Healthcare CARESCAPE B850 patient monitor. It describes the device and compares it to a predicate device ([K131414](https://510k.innolitics.com/search/K131414) CARESCAPE Monitor B850). This document outlines non-clinical testing and explicitly states that clinical studies were not required.

Therefore, I cannot fully answer your request for acceptance criteria and a study proving the device meets those criteria from this specific document, as it indicates clinical studies were not performed. The document focuses on demonstrating substantial equivalence through non-clinical bench testing, including software, hardware, and performance tests, and usability studies.

However, I can extract the information related to the device's performance and the types of tests conducted, even if they aren't presented as a structured "acceptance criteria" table with "reported device performance" against them in a clinical study context.

Here's a breakdown of what can be extracted and what cannot:

What Can Be Inferred/Extracted from the Document:

• Device Performance (as demonstrated by non-clinical testing):

  • The CARESCAPE B850's hardware, software, and overall performance met specifications through bench testing.
  • The device demonstrated electromagnetic compatibility, electrical safety, environmental resilience, and usability.
  • Software testing covered design, development, verification, validation, and traceability.
  • The device addressed patient safety, security, and privacy risks, including cybersecurity measures.
  • It can withstand network storm conditions without rebooting.

• Test Set Description (for non-clinical testing):

  • Data Provenance: Not explicitly stated for specific datasets, but testing was conducted on the aformentioned device, manufactured by GE Healthcare Finland Oy. This implies internal testing. The nature of "bench testing" suggests controlled environments rather than real-world patient data for performance validation against specific clinical thresholds.
  • Retrospective/Prospective: Not specified. Bench testing is typically a controlled laboratory process.

• Ground Truth (for non-clinical testing):

  • The "ground truth" for the technical specifications and performance of the device (e.g., accuracy of parameter measurements, robust alarms) would have been established by engineering and quality standards, internal specifications, and applicable consensus standards (e.g., IEC 60601-1-8 for alarms).

What Cannot Be Answered From the Document (specifically regarding clinical studies/acceptance criteria as implied by clinical outcomes or human reader performance):

1. A table of acceptance criteria and the reported device performance (in a clinical context): The document explicitly states "CARESCAPE B850 did not require clinical studies to support substantial equivalence." Therefore, no clinical performance acceptance criteria or reported clinical performance is provided. The acceptance criteria for the non-clinical tests are implicit in the statement "demonstrating the design meets the specifications" for hardware, software, and performance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) for a clinical study: Not applicable, as no clinical study was performed.

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): Not applicable, as no clinical study was performed. Ground truth for technical performance would be against engineering benchmarks, not expert clinical assessment in a study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study was performed.

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 patient monitor, not an AI-assisted diagnostic tool for image interpretation or similar. The "EK-Pro arrhythmia detection algorithm" is an internal algorithm, not a separate AI for human assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The EK-Pro V14 arrhythmia analysis algorithm operates within the device as a standalone component for its intended function. Its performance would have been validated against a set of ECG waveforms with established ground truth for arrhythmias, but details of such testing (like sample size or specific metrics) are not in this 510(k) summary. The document states "EK-Pro V14 arrhythmia analysis algorithm compared to the EK-Pro V13 used in the predicate monitors," implying internal validation of the updated algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the arrhythmia detection algorithm, the ground truth would typically be established by expert cardiologists reviewing ECG recordings. However, the details of how EK-Pro V14's ground truth was established are not provided in this 510(k). For general device performance, the ground truth is adherence to technical specifications and relevant standards.

8. The sample size for the training set: Not applicable, as this is a 510(k) submission for a patient monitor, not an AI/ML device requiring a training set in the typical sense. While the EK-Pro algorithm may have been "trained" or developed using data, the document does not mention details about this.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary Table of Available Information (based on non-clinical context):

Conclusion from Document:

The acceptance criteria for the CARESCAPE B850, as presented in this 510(k) submission, were met through extensive non-clinical bench testing, hardware and software verification/validation, and usability studies. The submission asserts the device's substantial equivalence to its predicate based on these non-clinical activities, stating explicitly that clinical studies were not required or performed.

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The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital 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, 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 V3 is a new version of a portable multiparameter patient monitoring system. The CARESCAPE B450 V3 includes the monitor itself with built-in CPU, power unit, a 12 inch touch display, the CARESCAPE Software version 3 and one or two batteries. CARESCAPE B450 V3 is equipped with so called ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B450 V3 is also equipped with one module slot where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B450 V3 includes features and subsystems that are optional or configurable.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the CARESCAPE B450, based on the information provided in the 510(k) summary.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study report with specific acceptance criteria and performance metrics for the novel aspects. Therefore, much of the requested information (like specific quantitative acceptance criteria or detailed study methodologies for new features) is not explicitly present. The summary explicitly states that no clinical studies were required to support substantial equivalence for this particular submission.

Acceptance Criteria and Device Performance for CARESCAPE B450

Given that this is a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance outlined refers to the device's ability to maintain existing functionalities and integrate new ones without compromising safety or efficacy, primarily through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit, quantitative acceptance criteria for each individual parameter for this 510(k) are not provided in the document (as it's a "substantial equivalence" claim based on existing technology), the table below reflects what can be inferred. The "acceptance criteria" here are largely implicit: that the new device performs equivalently or better than the predicate, or that new features function as intended and safely.

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

• Sample Size: Not explicitly stated in the 510(k) summary for specific performance tests. The review relies on "bench testing" and "extensive usability work" without providing specific numbers of test cases, patients, or data points.
• Data Provenance: Not explicitly stated. The nature of "bench testing" suggests a controlled, laboratory environment. For usability, it would involve participants, but their origin is not specified. The arrhythmia algorithm (EK-Pro V14) likely draws from large, existing ECG databases typically used in device development, but this is not detailed here.

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

• Number of Experts & Qualifications: Not specified in the provided text. For arrhythmia algorithms (EK-Pro), ground truth is typically established by multiple cardiologists or electrophysiologists. However, for this 510(k), since the EK-Pro V14 is considered "equivalent" to a previously cleared version, the detailed ground truth establishment for it is likely from prior submissions or internal development, not explicitly reported here.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified. For tasks like arrhythmia detection, typically multiple experts review and label data, and disagreements are resolved through consensus, majority vote, or a super-reader.

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 document explicitly states: "The subject of this premarket submission, CARESCAPE B450 did not require clinical studies to support substantial equivalence." This means no clinical MRMC studies were conducted for this submission. The device is a patient monitor, not primarily an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance Study: The document does not explicitly present a standalone performance study for the EK-Pro V14 arrhythmia algorithm. It states that EK-Pro V14 is an update to V13 and is "equivalent." Implied is that internal validation of the algorithm's performance against ground truth would have occurred during its development, but the results are not detailed in this 510(k) summary. The gas exchange parameters are also noted as "identical" in calculation to previously cleared predicate devices, implying their standalone performance is already established.

7. The Type of Ground Truth Used:

• Ground Truth Type: Not explicitly stated for any of the tested features within this document.
  • For Arrhythmia Detection (EK-Pro V14): Typically, expert-annotated ECG waveforms (clinical data) serve as ground truth.
  • For Gas Exchange Parameters: Likely derived from high-precision laboratory measurements or established physiological models.
  • For Hardware/Software Functional Testing: System specifications and expected behavior as defined during development serve as ground truth.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not specified. Training sets are primarily relevant for machine learning algorithms. While the EK-Pro algorithm may have some adaptive or learning components from its development, the document doesn't detail its training set.

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

• Ground Truth Establishment for Training Set: Not specified. As mentioned above, for arrhythmia detection, this would typically involve expert cardiological review and annotation of large datasets.

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The GE EEG module, E-EEGX, the GE EEG headbox, N-EEGX, and accessories are intended to be used with the compatible CARESCAPE monitors for the monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP) of all hospital patients. The device is intended for use by qualified medical personnel only.

The E-EEGX module is a single-width plug-in interface module to be used with CARESCAPE Bx50 V3 patient monitors. It is used with N-EEGX headbox and accessories for monitoring neurophysiological status of all hospital patients by measuring the electroencephalogram (EEG), frontal electromyogram (FEMG) and auditory evoked potentials (AEP).

The E-EEGX module is used with the N-EEGX headbox for monitoring of EEG. FEMG. to stimulate the brain with auditory stimuli, and to measure AEP. The E-EEGX module connects to a N-EEGX headbox which further connects to accessories that connect to the patient.

The EEG, FEMG and AEP measurements are performed by the N-EEGX headbox. The N-EEGX headbox measures the raw EEG waveform data from four real-time EEG waveform channels, FEMG from one channel and AEP from two channels. The N-EEGX headbox is connected to the patient with EEG accessories.

The E-EEGX module transfers the digitized EEG data received from the N-EEGX headbox to the host monitor. The module also generates the stimuli used in the AEP measurement and performs part of the AEP measurement data processing.

Here's a breakdown of the acceptance criteria and the study information for the E-EEGX module, N-EEGX headbox, and accessories, based on the provided FDA 510(k) summary:

The document does not detail specific quantitative acceptance criteria or a study designed to explicitly "prove" the device meets these criteria in the way a clinical trial would for a new therapeutic. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K051883 Datex-Ohmeda S/5 EEG Module, E-EEG and Headbox, N-EEG and Accessories) through non-clinical testing.

The "acceptance criteria" can be inferred from the comparison table and the list of standards the device complies with. The "reported device performance" is essentially that the new device's specifications are either identical or acceptably equivalent to the predicate, and that it meets relevant safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

Since specific "acceptance criteria" with numerical targets and a performance study against them aren't explicitly presented, I've constructed a table based on the comparative effectiveness information provided, which serves as the basis for demonstrating substantial equivalence. The "Acceptance Criteria" column reflects the predicate device's specifications (which the new device aims to match or improve within acceptable limits), and the "Reported Device Performance" column shows the new device's specifications.

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

The document does not describe "test sets" or "data" in the context of clinical or performance data from patients. The evaluation performed was largely based on non-clinical testing (e.g., engineering verification, design validation, safety testing) and comparison of specifications to a predicate device. Therefore, no information on sample size, data provenance, or retrospective/prospective nature of a dataset is provided for this type of submission.

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 applicable to this 510(k) submission. No expert review of patient data to establish ground truth was conducted or reported, as the submission focused on non-clinical testing and substantial equivalence to a predicate device.

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

This information is not applicable to this 510(k) submission, as there was no test set involving expert adjudication of patient data.

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

This information is not applicable to this 510(k) submission. The device (E-EEGX module, N-EEGX headbox and accessories) is an electroencephalograph system, not an AI-assisted diagnostic tool that would typically undergo MRMC studies comparing human reader performance. The submission makes no mention of AI.

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

This information is not applicable to this 510(k) submission. The device is a hardware module and headbox for physiological measurement, not a standalone algorithm.

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

This information is not applicable to this 510(k) submission, as there was no patient outcome or diagnostic ground truth required for its submission based on substantial equivalence and non-clinical testing. The "ground truth" for showing substantial equivalence was the specifications and validated performance of the predicate device and compliance with recognized international standards (e.g., IEC 60601 series) for medical electrical equipment.

8. The sample size for the training set

This information is not applicable to this 510(k) submission. The device does not appear to involve machine learning or AI that would require a "training set."

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

This information is not applicable to this 510(k) submission, as there was no training set for an AI/ML algorithm.

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The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital 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 analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, 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, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, 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 events, 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.

CARESCAPE B650 V3 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650 V3 includes the monitor with built-in CPU, power unit, a 15 inch touch display, the CARESCAPE Software version 3 and the battery. CARESCAPE B650 V3 is equipped with so called ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B650 V3 is also equipped with two module slots where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B650 V3 includes features and subsystems that are optional or configurable.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device meets those criteria, specifically concerning the CARESCAPE B650 medical monitor.

It's important to note that this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance against specific pre-defined acceptance criteria for a novel AI algorithm. The device here is a multi-parameter patient monitor with an updated arrhythmia detection algorithm (EK-Pro V14) as one of its changes. The document states that no clinical studies were required to support substantial equivalence, meaning the proof of meeting acceptance criteria for its functions comes from bench testing and comparison to the predicate, rather than a prospective clinical trial.

Therefore, the answers will reflect this context, particularly the lack of a traditional "AI algorithm" study with specific statistical performance metrics against a defined ground truth derived from expert consensus or pathology, as one might expect for a new AI diagnostic tool.

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

The document does not present a formal table of acceptance criteria with corresponding performance metrics in the way one might expect for a novel AI component. Instead, it demonstrates equivalence through:

• Identical specifications: Many features (patient type, use environments, size & weight, module housing, display/screen, waveforms/parameter windows, available parameters, printing, mounting options) are stated as "Identical" to the predicate. This implies that the performance for these aspects meets the original predicate's established performance, which implicitly acts as the "acceptance criteria."
• Equivalent specifications with justification: For changed components like the CPU, modules, EK-Pro arrhythmia algorithm, graphical user interface, alarms, remote alarm device, and networking capability, the document justifies the "equivalence" or improvement. The acceptance criteria here are implicitly that the new component performs at least as well as, or better than, the predicate, without introducing new safety or effectiveness concerns.

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

The document does not specify a "test set" in the context of a dataset for validating an AI algorithm's performance on clinical data. Since no clinical studies were required or conducted for this 510(k) submission, there is no mention of sample sizes of patient data for a test set.

The testing involved:

• Bench testing: "software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B650, demonstrating the design meets the specifications."
• Usability testing: Formative and summative usability testing.
• Network testing: "Testing was completed on CARESCAPE B650 to show the device can withstand network storm..."

The data provenance for these internal engineering and usability tests would be the manufacturer's own internal testing environment. No information on country of origin or retrospective/prospective nature of data is provided because it's not a clinical study on patient data.

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

Not applicable. As no clinical "test set" from patient data was used against which the device's diagnostic performance (e.g., AI algorithm accuracy) was measured by external experts, there is no mention of experts establishing ground truth for such a set. The "ground truth" for demonstrating substantial equivalence primarily lies in adherence to performance specifications validated through engineering bench testing and comparison to the predicate device's established performance.

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

Not applicable, for the same reasons as #3. No external "test set" requiring expert adjudication was utilized to demonstrate the device's performance characteristics.

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. The document explicitly states: "The subject of this premarket submission, CARESCAPE B650 did not require clinical studies to support substantial equivalence." Therefore, no MRMC study was performed, and no effect size on human reader improvement with AI assistance is provided. The device integrates an EK-Pro arrhythmia detection algorithm, but the submission focuses on its equivalence to the previous version and the monitor's overall functionality, not on its assistance to human readers via a comparative effectiveness study.

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

The EK-Pro V14 arrhythmia detection algorithm is a component of the multi-parameter patient monitor. The submission states that the EK-ProV14 arrhythmia analysis algorithm is a change from the predicate's EK-Pro V13. The "standalone" performance of such internal algorithms is typically validated through internal testing against standardized datasets (e.g., annotated ECG databases for arrhythmia detection), which would fall under "Summary of Non-Clinical Tests: Bench testing related to software...". While the specific details of this internal algorithmic validation are not provided in the summary, the clearance implies it met the necessary performance and safety standards in a standalone manner as an embedded function.

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

For the arrhythmia detection algorithm, the ground truth would typically be established by:

• Expert consensus: Review of ECG waveforms by cardiologists or electrophysiologists.
• Annotated databases: Use of publicly available or proprietary ECG databases with expertly adjudicated arrhythmia annotations.
  However, since this is a 510(k) for substantial equivalence and not a de novo submission requiring extensive clinical validation, the specific ground truth methodology for the EK-Pro V14 algorithm's development or internal testing is not detailed in this public summary. The "ground truth" implicitly aligns with the performance established by the predicate device and relevant industry standards.

For the overall device, the "ground truth" for demonstrating equivalence relies on:

• Predicate device performance: The previously cleared CARESCAPE Monitor B650 with ESP V2 software (K131223) serves as the benchmark.
• Design specifications: The device is manufactured to meet predefined internal design specifications, which are validated through rigorous bench testing.
• Applicable consensus standards: Compliance with relevant international and national standards for medical devices (e.g., electrical safety, EMC, usability).

8. The sample size for the training set

The document does not mention the sample size for a training set. This is not a submission for a de novo AI device where such details for machine learning model training would be critical. The EK-Pro algorithm is likely a rule-based or traditional signal processing algorithm, or at least one iterated and improved over time, for which a distinct "training set" in the deep learning sense might not be explicitly defined or described in this type of regulatory document.

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

Not applicable. As no training set is described or required for this type of 510(k) (which primarily relies on substantial equivalence and bench testing), the method for establishing its ground truth is not provided. If the EK-Pro V14 algorithm did indeed involve machine learning, its ground truth for training would have been established internally by GE Healthcare, likely through methods similar to those described in point 7 (expert annotations on ECG data), but these details are not part of the publicly available 510(k) summary.

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The CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOV, E-sCAiOVX) are indicated for use with a host device for monitoring respiratory parameters (CO2, O2, N2O, anesthetic agent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VCO2, VO2) of adult and pediatric patients.

When monitoring neonatal or other patients that have high respiration rate or low tidal volume these modules shall be used within the limits of respiration rates and tidal volumes to ensure specified measurement accuracy.

These modules are intended for use by qualified medical personnel only.

The CARESCAPE Respiratory Modules E-sCO, E-sCOV, EsCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories measure respiratory parameters (concentrations of Carbon Dioxide, Oxygen, Nitrous Oxide and anesthetic agents in the patient's breath, as well as the patient's respiration rate), ventilatory parameters (airway pressure, flow and breathing volumes) and gas exchange parameters (oxygen consumption and carbon dioxide production) of hospital patients.

Parameters measured by the CARESCAPE Respiratory Modules are CO2, N2O, O2, Anesthetic agents, Agent ID, Spirometry, oxygen consumption (VO2) and carbon dioxide production (VCO2) depending on the model used. The CARESCAPE Respiratory Modules is a family of single-width plug-in parameter modules for modular monitoring systems. The CARESCAPE Respiratory Modules are of the diverting type, which means that a small continuous flow of gas is sampled from the patient's breath to the module for measuring the gas concentrations. The CARESCAPE Respiratory Modules acquire the signals detected by the module sensors, calculate the parameter values and communicate them to the host device. The CARESCAPE Respiratory Modules measure the patient's respiration rate and activate a status signal if no breaths are detected in 20 second time and the modules activate relevant status signals upon detecting failures or anomalies in the operation of the module hardware, software or gas sampling system.

The CARESCAPE Respiratory Modules do not trigger or issue any physiological or technical alarms by themselves. All management of alarms is entirely performed by the host devices based on parameter and status data received from the modules, as well as on the alarm condition data stored in the host device.

This Special 510(k) introduces two new spirometry accessories: 2104297-001 D-lite++ Patient Spirometry Set. 2m/7ft and 2104297-002 D-lite++ Patient Spirometry Set, 3m/10ft. The design of the D-lite++ Patient Spirometry Sets is based on the design of previously cleared accessories 8004381 D-lite+ Spirometry Kit, adult, 2m/7ft and 8004382 D-lite+ Spirometry Kit, adult, 3m/10ft (510(k) K171028) used for spirometry, gas exchange and gas measurement and owned by GE Healthcare Finland Oy. The main modifications are in the design of the spirometry sensor part of the product; the gas sampling line connector shape and location have been modified and spirometry connector internal volumes have been expanded. The only new material introduced is cyanoacrylate glue CB 2011 used for attaching the spirometry connector to the sensor body. The only new manufacturing method introduced is ultrasonic welding used for attaching the gas sampling line connector to the sensor body. The CARESCAPE Respiratory Module measurement specifications are unaffected except for a minor decrease in gas exchange VO2 and VCO2 accuracy specifications with respiration rates above 30 breaths/min when the measurement is performed using the D-lite++ Patient Spirometry Sets. The specification change does not raise different questions of safety or effectiveness of the CARESCAPE Respiratory Modules.

There are no changes to indications for use, hardware, software, mechanics or electrical safety of the CARESCAPE Respiratory Modules due to the D-lite++ Patient Spirometry Sets. The introduction of the D-lite++ Patient Spirometry Sets does not add or change the functionality or fundamental scientific technology of the CARESCAPE Respiratory Modules. The D-lite++ Patient Spirometry Sets employ the same fundamental scientific technology as the existing accessories 8004381 D-lite+ Spirometry Kit, adult, 2m/7ft and 8004382 D-lite+ Spirometry Kit, adult, 3m/10ft used for spirometry, gas exchange and gas measurement with the CARESCAPE Respiratory Modules.

The provided text describes a Special 510(k) submission for the CARESCAPE Respiratory Modules, focusing on the introduction of new spirometry accessories (D-lite++ Patient Spirometry Sets). The crucial aspect for this request is that no clinical studies were conducted, as noted in "Summary of Clinical Tests: The subject of this premarket submission... did not require clinical studies to support substantial equivalence."

Instead, the submission relies on bench testing to demonstrate that the modified device performs as intended and within specifications, particularly concerning spirometry, gas exchange, and gas accuracy measurements when the new accessories are used. The report explicitly states, "Bench testing supports the substantial equivalence determination of the modified CARESCAPE Respiratory Modules when compared to the predicate device."

Therefore, many of the requested elements, such as the number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for a clinical test set, are not applicable to this submission because no clinical study was performed.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "The CARESCAPE Respirator Module measurement specifications are unaffected except for a minor decrease in gas exchange VO2 and VCO2 accuracy specifications with respiration rates above 30 breaths/min when the measurement is performed using the new accessories." It also states that the device "perform[s] as intended and within specification." However, specific quantitative acceptance criteria and their corresponding reported performance values for spirometry, gas exchange, and gas accuracy are not detailed in the provided text. The text implies that the device meets its own specifications with the minor adjustment mentioned.

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

• Sample Size for Test Set: Not specified, as "bench testing" was performed rather than a human-patient-based clinical test set. The testing involved verification of spirometry, gas exchange, and gas accuracy measurements, and tightness of ultrasonic welding.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory or manufacturing environment, likely in Finland where GE Healthcare Finland Oy is located. It is retrospective in the sense that it evaluates the modified device's performance against existing specifications.

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

• Not applicable. No clinical test set requiring expert ground truth was performed.

4. Adjudication method for the test set:

• Not applicable. No clinical test set requiring adjudication was performed.

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. No MRMC comparative effectiveness study was done. This device is a respiratory module and accessories, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable in the typical sense of an algorithm's standalone performance. The testing performed was related to the device's measurement accuracy and physical integrity. The device itself (CARESCAPE Respiratory Modules) operates in conjunction with a host device and is intended for use by qualified medical personnel, but its primary function is measurement, not algorithmic interpretation requiring human-in-the-loop comparison.

7. The type of ground truth used:

• For the bench testing, the "ground truth" would be the known, precise values generated by calibration equipment or reference standards against which the device's measurements (spirometry, gas exchange, gas concentrations) were compared. This is a scientific, instrument-based ground truth.

8. The sample size for the training set:

• Not applicable. This submission describes modifications to an existing device and its accessories, not a new AI/ML algorithm that requires a training set.

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

• Not applicable. No training set was used.

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