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The GE Healthcare anesthesia machines are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The GE Healthcare anesthesia machines are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

The GE Healthcare anesthesia machines are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The GE Healthcare anesthesia machines are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

The GE Healthcare anesthesia systems supply set flows of medical gases to the breathing system. Gas flows are selected by the user and displayed on the display unit or through pneumatic flow meters. A large selection of options may be available to configure the system, including frames, brake style, gases, and anesthetic agents.

The GE anesthesia machines include a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure, and inhaled and exhaled volume. Flow, gas, and pressure 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. 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. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).

This is a 510(k) premarket notification for a medical device family (GE Healthcare anesthesia machines) and not a study describing a new algorithm or AI. Therefore, much of the requested information regarding AI-specific acceptance criteria and study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or available in this document.

However, based on the provided text, I can infer the acceptance criteria for substantial equivalence and summarize the study that proves the device meets those criteria.

The primary purpose of this 510(k) submission is to demonstrate that the modified GE Healthcare anesthesia machines, incorporating two alternate flow sensors, are substantially equivalent to their previously cleared predicate devices. The "study" here refers to the non-clinical testing performed to establish this substantial equivalence.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implicitly tied to the performance requirements of the predicate devices. The goal is to show that the modified devices perform equivalently and raise no new questions of safety or effectiveness.

Study Details (Non-AI Specific)

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

   • The document describes a series of non-clinical tests (component-level and system-level testing, biocompatibility testing, reprocessing validation). It does not specify a "test set" in the context of patient data or algorithm performance. Instead, it refers to tests on the device's components and the complete system.
   • Data provenance: Not explicitly stated as country of origin, but the submission is from GE Healthcare, Datex-Ohmeda, Inc., located in Madison, Wisconsin, USA. The testing is described as occurring prior to the submission date (September 2017). This is a retrospective analysis of engineering, functional, and safety tests performed on the device.

2. 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. This submission does not involve clinical data that would require expert ground truth labeling in the context of an AI/algorithm study. The "ground truth" for these tests are engineering specifications, validated test methods, and compliance with industry standards.

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

   • Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image review), not for objective engineering tests on a physical device.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is not an AI/software device that assists human readers. It is a modification to an anesthesia gas machine.

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

   • Not applicable. This is not an AI/algorithm. Performance tests were conducted on the modified physical device.

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

   • The ground truth for these tests are established engineering specifications, validated test methods, and compliance with relevant voluntary industry standards (e.g., ISO 10993 for biocompatibility) that define the expected performance and safety characteristics of an anesthesia gas machine.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning model that undergoes training with a dataset.

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

   • Not applicable. See #7.

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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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The GE Datex-Ohmeda Aisys CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide 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, Aisys, 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 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 CS 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 CS comes with up to two optional gases (air, N2O). Safety features and devices within the Aisys are designed to decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures. The Aisys CS system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above cleared via K001814) and E-Gas Module (E-CAiOVX software revision 4.5 and above cleared via K051092). CARESCAPE Modules are also available for Aisys CS' (EsCAiO, E-sCAiOV cleared via K123195). 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 cassette (also cleared as part of K973895) or Aladin, is inserted into the active cassette bay. The cassette holds the agent to be delivered - Halothane. Enflurane. Isoflurane. Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys 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 Anesthesia System. 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 Mode, Pressure Control Mode, Pressure Support with Apnea Backup Mode (Optional) and Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional) and Continuous Positive Airway Pressure / Pressure Support Ventilation (CPAP/PSV) Mode (Optional). Aisys CS2 also supports optional Pressure Control Ventilation - Volume Guarantee mode with spontaneous breath pressure support (SIMV PCV-VG) mode (Optional). 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 CS. The arm is counter balanced and capable of moving vertically and/or horizontally, and also 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 CS 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 CS.

The provided text is for a 510(k) Premarket Notification for the GE Datex-Ohmeda Aisys CS2 Anesthesia System. This document describes a new version of an already marketed device and focuses on demonstrating substantial equivalence to the predicate device (GE Datex-Ohmeda Aisys, K110213).

Therefore, the document does not contain the kind of acceptance criteria, study details (like sample sizes, expert qualifications, adjudication methods), or performance metrics associated with a de novo device or a groundbreaking algorithmic performance study. Instead, the focus is on verification and validation of changes relative to a predicate device.

Here's an analysis based on the information available in the provided text, and explicit statements about what is not available due to the nature of this submission:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or numerical performance metrics in the way one would for an AI/algorithm-driven diagnostic device. Instead, the acceptance is based on demonstrating that the updated device continues to meet its specifications and performs as safely and effectively as the predicate device.

The study that "proves" the device meets acceptance criteria is a series of non-clinical tests.

1. Table of acceptance criteria and the reported device performance:

Study Details

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

• Test Set Sample Size: Not applicable/not specified in the context of this 510(k) submission. There isn't a "test set" in the sense of a medical image or patient data set used for algorithmic evaluation. The testing involved various engineering and software validation tests.
• Data Provenance: Not applicable. The testing was non-clinical (e.g., in-house verification and validation).

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

• Number of Experts: Not applicable. Ground truth, in the context of an anesthesia machine, would refer to its functional correctness, safety, and performance according to engineering specifications and regulatory standards, not expert interpretation of medical data.
• Qualifications of Experts: Not applicable. The "ground truth" was established by engineering specifications, regulatory standards, and internal quality assurance processes.

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

• Adjudication Method: Not applicable. This concept is typically relevant for studies involving human interpretation or clinical endpoints, not for the engineering verification and validation of an anesthesia system.

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, an MRMC study was not done. This device is an anesthesia system, 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:

• Standalone Performance: Not applicable in the context of an anesthesia system as a "standalone algorithm" performance. The device's performance was evaluated through non-clinical verification and validation testing of its hardware and software functions (e.g., gas mixing, ventilation modes, display accuracy, safety features).

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

• Type of Ground Truth: The ground truth for this device's evaluation was based on engineering specifications, regulatory standards compliance, and internal quality assurance requirements. This includes:
  • Functional requirements (e.g., gas flow rates, ventilation parameters).
  • Safety requirements (e.g., hypoxic mixture prevention, alarm accuracy).
  • Performance requirements (e.g., display accuracy, response times).
  • Compliance with voluntary standards.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This device is an anesthesia system developed through traditional engineering and software development processes, not an AI/machine learning model that requires a "training set" of data.

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

• Ground Truth for Training Set: Not applicable. There is no "training set" in the context of this device's development.

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