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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 Aisys CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide ride range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

The GE Datex-Ohmeda Aisys CS2 is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). It represents one of the systems in a long line of products based on the Datex-Ohmeda Excel, Aestiva, Aespire, and Avance Anesthesia Systems. It is to be used only by trained and qualified medical professionals.

The Aisys CS2 supplies set flows of medical gases to the breathing system using electronic gas mixing. Interfaces to control the system include the touch screen, keypad and rotary controller on the main display unit. Selected gas flows are displayed as electronic flow indicators on the system display unit. The Aisys CS2 is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames, gases, and vaporizer cassettes are available to give the user control of the system configuration. The Aisys CS4 systems are also available in pendant models. The system shall support a maximum of two-cylinder supply connections mounted inboard on the machine and supported by cylinder yokes. All models have O2. The Aisys CS2 comes with up to two optional gases (air, N20). Safety features and devices within the Aisys CS2 are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Aisys CS2 system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the CARESCAPE Modules cleared via K123195 (E-sCAiO, EsCAiOV) and K150245 (E-sCAiOVX). The Aisys CS2 is also compatible with legacy M-Gas and E-Gas modules which are in the installed base but are no longer in forward production (M-CAiO and M-CAiOV cleared via K001814, and E-CAiOVX cleared via K051092).

The above modules can be physically integrated into the Anesthesia device, receive electronic power from the said device and communicate measured values to the said device for display on the system display unit.

The anesthetic agent delivery for the Aisys CS2 is controlled via an anesthesia computer through user input from the central display. The vaporization technology is based upon the electronic vaporizer cleared as part of the Datex-Ohmeda Anesthesia Delivery Unit (ADU) cleared via K973985. An Aladin 2 is inserted into the active cassette bay. The cassette holds the agent to be delivered - Isoflurane, Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys CS2 is designed to allow only one active cassette at a time. Per the user input into the main display, valves within the active cassette bay will open and allow agent to be delivered. The agent is mixed with gas from the FGC unit. After mixing, the combination of gases and agent is delivered to the breathing system and then onto the patient.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aisys CS2. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices.

Ventilator modes for the device include Volume Control (VCV) Mode, Pressure Control (PCV) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control Ventilation -Volume Guaranteed (SIMV/PCV-VG) Mode, Synchronized Intermittent Mandatory Ventilation with Pressure Support Ventilation (SIMV/PSV) Mode, Pressure Support with Apnea Backup (PSVPro) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control (SIMV-PC) Mode (Optional), Pressure Control Ventilation- Volume Guaranteed (PCV-VG) mode (Optional), and Continuous Positive Airway Pressure/ Pressure Support Ventilation (CPAP-PSV).

Ventilator parameters and measurements are displayed on the system display unit.

The system display unit is mounted to an arm on the top shelf of the Aisys CS2. The arm is counter balanced and capable of moving vertically and/or horizontally, and tilting the display, enabling the user to position the display to the most advantageous viewing position. The arm length is limited such that the display position is always within the footprint of the Aisys CS2 frame. The arm also supports the mounting of additional display units for a variety of patient monitors.

Several frame configurations are available, including one that allows for the physical integration of the GE Monitors (cleared Carescape B850 via K092027 and B650 cleared on K102239). This configuration also provides cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Aisys CS2 frame. An additional option allows the monitor to be linked to the power supply of the Aisys CS2 such that when the Aisys CS2 is turned on, the monitor is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Aisys CS2.

This document is a 510(k) premarket notification for the Aisys CS2 anesthesia system (version 11). It primarily focuses on demonstrating substantial equivalence to a predicate device (Aisys CS2 version 10) through non-clinical testing. Therefore, it does not contain the detailed information about acceptance criteria and a study that proves the device meets those criteria in the way typically found for a diagnostic or AI-driven device.

Based on the provided text, here's a breakdown of what is and is not available:

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

No explicit table of acceptance criteria and reported device performance in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) is provided. This is because the submission is for an anesthesia system, and the "performance" is related to its functional capabilities and compliance with safety standards, rather than a diagnostic accuracy.

The document lists various verification tests and what they verify. For example:

• Privacy and Security: Verifies functionality including an option to disable viewing patient identifiable information.
• Duplicate Interface Detection: Verifies functionality including that the system continues communication with its clients even if a duplicate IP condition is detected.
• Ethernet Interface: Verifies functionality including that the system supports 100Mbps speed and full duplex settings.
• Network Hazard Mitigation: Verifies that the system has no open ports except for specific clients.
• Network Requirements: Verifies that the system supports clock synchronization with a network device.
• Sapphire and HL7: Verifies communication protocols.
• Address Resolution Protocol Requirements: Verifies correct system subnet mask functionality.
• Respiratory Gas Monitors: Verifies all requirements related to Respiratory Gas Monitors, including functionality of the Sample Gas Return option.
• Monitoring Only Mode: Verifies functionality including O2 being administered through the auxiliary O2 port when the mode is enabled.
• System Hazard Mitigations: Verifies functionality including that the system performs as intended during a recovery state.
• Materials Testing: Includes Volatile Organic Compounds, Particulate Matter Testing, Bacterial Filter Efficiency Testing, Viral Filter Efficiency Testing.
• Reprocessing Instructions Validation Testing
• Verification testing for electrical safety and electromagnetic compatibility: Compliance to AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2: 2014, and ISO 80601-2-13: 2011.

For each of these, the implicit "acceptance criterion" is that the system successfully performs or complies with the stated function or standard. The "reported device performance" is the conclusion that these tests were passed and the system is safe and effective.

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

This information is not applicable / not provided for this type of submission. This device is an anesthesia machine, not typically tested with "test sets" of patient data in the same way an AI diagnostic device would be. The testing described is functional and safety verification.

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 / not provided. There is no "ground truth" establishment in the context of diagnostic accuracy for this device. Ground truth is usually relevant for AI/ML models being validated against expert-labeled data.

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

This information is not applicable / not provided. Adjudication methods are used to resolve discrepancies in expert labeling for ground truth, which is not relevant 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

This information is not applicable / not provided. This is an anesthesia machine, not an AI-assisted diagnostic tool for human "readers" (e.g., radiologists interpreting images). An MRMC study would not be relevant for its evaluation.

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

This information is not applicable / not provided. This is an anesthesia machine. While it contains software, it is not a standalone AI algorithm in the diagnostic sense. It is a system intended for use by trained medical professionals. The software updates mentioned are for standards compliance and usability enhancements, not for independent diagnostic decisions.

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

This information is not applicable / not provided. As explained, there is no "ground truth" akin to diagnostic accuracy for this device. The "ground truth" for its performance is its ability to meet engineering specifications, safety standards, and functional requirements.

8. The sample size for the training set

This information is not applicable / not provided. This device is not an AI/ML model that would have a "training set" of data in the typical sense. The software updates are developed and verified through standard software engineering practices.

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

This information is not applicable / not provided. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

In summary, the provided document is a 510(k) summary for an anesthesia system. The "study" proving it meets acceptance criteria consists of a comprehensive set of non-clinical verification and validation tests covering:

• Software validation (including enhancements like EcoFlow improvements, Monitory Only mode, Network Connectivity, Privacy and Security, etc.)
• Compliance with electrical safety, EMC, and specific medical device standards (e.g., IEC 60601-1, ISO 80601-2-13).
• Materials testing.
• Risk analysis and design reviews.

The acceptance criteria are implicitly that the system functions as intended, meets its specifications, and complies with all relevant safety and performance standards. The "study" is the extensive report of these non-clinical tests, and the conclusion is that the modified device is substantially equivalent to its predicate. Clinical testing was not deemed necessary for the changes introduced in version 11.

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