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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.

Ask a specific question about this device

The GE Datex-Ohmeda Aisys 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 Aisys is not suitable for use in a MRI environment.

The GE Datex-Ohmeda Aisys 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 GE Datex-Ohmeda Aisys Carestation supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then displayed as electronic flow indicators on the svstem display unit. The Aisvs is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. The Aisys is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have 02. The Aisys 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 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) which can be physically integrated into the Aisys, receive electronic power from the Aisys and communicate measured values to the Aisys for display on the system display unit.

The anesthetic agent delivery for the Aisys 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 2 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 Aisvs 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 on to 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 requlated 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 Ventilation (VCV), Pressure Control Ventilation (PCV) (optional), Synchronized Intermittent Mandatory Ventilation/Pressure Support (SIMV/PSV) (optional), Pressure Support Ventilation (PSVPro) (optional), Synchronized Intermittent Mandatory Ventilation-Pressure Control (SIMV-PC) (optional), Pressure Control Ventilation-Volume Guaranteed (PCV-VG) (optional) and Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV). Ventilator parameters and measurements are displayed on the system display unit.

The provided text describes a premarket notification (510(k)) for the GE Datex-Ohmeda Aisys Anesthesia System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as would be found for a novel device.

The submission states that the modifications made did not require clinical testing, and the functionality was evaluated through nonclinical tests of design verification and validation testing. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria for a new clinical claim is not present in this document.

However, I can extract information about the type of testing performed and the conclusion regarding substantial equivalence.

Here's a breakdown of the available information based on your request, with an emphasis on what is not present:

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

• Not explicitly provided in the document. The document states "The GE Datex-Ohmeda Aisys has been thoroughly tested through verification of specifications and validation, including software validation," but it does not list specific, quantitative acceptance criteria or corresponding reported performance metrics for clinical efficacy or diagnostic accuracy.
• The overall "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to predicate devices. The conclusion states: "The performance data demonstrates the device is substantially equivalent to the predicates."

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

• Not applicable/Not provided. No clinical test set or patient data is mentioned as the basis for the 510(k) in this document. The testing was non-clinical.

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/Not provided. No clinical ground truth was established as no clinical testing was performed for this 510(k). Non-clinical testing would involve engineering and quality assurance experts.

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

• Not applicable/Not provided. No clinical test set or adjudication method is 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

• Not applicable. This device is an anesthesia system, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

• Not applicable. This device is an anesthesia system. The software updates relate to user interface, control of gas delivery, and ventilator modes, not standalone algorithmic performance in a diagnostic context. "Standalone" performance testing would be more relevant to the device's functional operation (e.g., accuracy of gas delivery, ventilator parameters) which was covered by non-clinical verification and validation.

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

• Not applicable/Not provided in a clinical sense. For the non-clinical testing, the "ground truth" would be the device's technical specifications and established engineering standards, against which its performance was verified and validated.

8. The sample size for the training set

• Not applicable/Not provided. This document is not describing a machine learning or AI model that requires a training set in the conventional sense. The "software updates" are likely improvements to existing control algorithms and user interface logic.

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

• Not applicable/Not provided. As above, no training set for a machine learning model is mentioned.

Summary of what is present regarding testing:

The document states:

• Reason for 510(k): Updates to the software for the GE Datex-Ohmeda Aisys Anesthesia System, introducing several new features (e.g., pediatric improvements, new ventilation mode CPAP/PSV with backup breaths, lung mechanics procedure options, UI enhancements).
• Basis for Substantial Equivalence: Comparison to legally marketed predicate devices (GE Datex-Ohmeda Aisys (K090233) and GE Datex-Ohmeda Engstrom ventilator (K093886)). No changes to intended use or fundamental scientific technology.
• Testing Performed:
  • Nonclinical Testing: "thoroughly tested through verification of specifications and validation, including software validation."
  • Quality Assurance Measures applied:
    • Risk Analysis
    • Requirements Reviews
    • Design Reviews
    • Testing on unit level (Module verification)
    • Integration testing (System verification)
    • Performance testing (Verification)
    • Safety testing (Verification)
    • Simulated use testing (Validation)
  • Clinical Testing: "The modifications made to the GE Datex-Ohmeda Aisys did not require clinical testing. The functionality of the modified software features were completely evaluated by performing nonclinical tests of design verification and validation testing."
• Conclusion: The performance data (nonclinical) demonstrates the device is substantially equivalent to the predicates, with no new questions of safety and effectiveness.

In essence, this 510(k) leverages the predicate devices' established safety and effectiveness, and for the software updates, relies on rigorous non-clinical engineering verification and validation testing rather than new clinical trials or performance studies against specific acceptance criteria for a novel claim.

Ask a specific question about this device

The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

The GE Datex-Ohmeda Aisys is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. 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 GE Datex-Ohmeda Aisys Carestation supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then 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 vaporizers are available to give the user control of the system configuration. The Aisys is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have O2. The Aisys 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 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 K# 001814) and E-Gas Module (E-CAiOVX cleared via K051092) which can be physically intecrated into the Aisys, receive electronic power from the Aisys and communicate measured values to the Aisys for display on the system display unit.

The anesthetic agent delivery for the Aisys 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 2 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 requlated 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). 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. 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 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 Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). 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 frame. An additional ootion allows the S/5 AM to be linked to the power supply of the Aisys such that when the Aisys is turned on, the S/5 AM is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Aisys.

The provided text describes the 510(k) premarket notification for the GE Datex-Ohmeda Aisys Anesthesia System. The key information regarding acceptance criteria and study details is presented in the "SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)" and "SUMMARY OF CLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(2)" sections.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GE Datex-Ohmeda Aisys Anesthesia System are compliance with various international and national standards related to medical electrical equipment, anesthesia workstations, and gas cylinders. The reported device performance is that it meets these standards.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "test set" in the context of a clinical study with a defined sample size for evaluating performance against an explicit statistical endpoint. Instead, the evaluation focuses on non-clinical testing, including verification of specifications and software validation, and compliance with established international standards.

The term "data provenance" is not applicable in the traditional sense of clinical data here, as the testing described is primarily engineering and regulatory compliance testing rather than clinical study data from patients.

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

This information is not applicable as the evaluation relies on compliance with technical standards and internal verification/validation processes rather than expert-established ground truth from clinical cases. No external "experts" in the context of clinical ground truth determination are mentioned for the non-clinical testing.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a test set requiring adjudication in the context of human expert review. The evaluation is based on meeting technical specifications and standards.

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

An MRMC comparative effectiveness study was not performed, and is not applicable. The 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

The device itself is a standalone anesthesia system. While it has embedded software and automated functions, the evaluation is of the complete system's compliance with safety and functional standards, not a standalone algorithm's performance in isolation from the hardware or human operator interaction. The "software validation" performed addresses the functionality of the algorithms within the system.

7. The type of ground truth used

The "ground truth" for this device's evaluation is primarily compliance with established international and national engineering, safety, and performance standards (e.g., EN, IEC, ISO standards) and internal product specifications. For the software, it's defined by the software requirements and design specifications.

8. The sample size for the training set

This information is not applicable. The device is an anesthesia system, and its development and testing do not involve a "training set" in the context of machine learning model development. The software development follows traditional engineering verification and validation processes.

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

This information is not applicable as there is no "training set" in the context of AI/machine learning. The "ground truth" for the device's functionality is established by its design specifications and the requirements of the relevant industry standards.

Ask a specific question about this device

Ask a specific question about this device

The GE Datex-Ohmeda Aisys is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

The GE Datex-Ohmeda Aisys Carestation supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then 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 vaporizers are available to give the user control of the system configuration. The Aisys is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have O2. The Aisys 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, agent mixtures and complete power or sudden gas supply failures. The Aisys 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 K# 001814) which is physically integrated into the Aisys, receives electronic power from the Aisys and communicates measured values to the Aisys for display on the system display unit. The anesthetic agent delivery for the Aisys 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 2 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). 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. 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 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 Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). 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 frame. An additional option allows the S/5 AM to be linked to the power supply of the Aisys such that when the Aisys is turned on, the S/5 AM is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Aisys.

The provided text is a 510(k) summary for the GE Datex-Ohmeda Aisys Carestation, an anesthesia gas machine. It primarily focuses on demonstrating substantial equivalence to a predicate device and lists voluntary standards the device complies with.

Crucially, this document does not contain explicit acceptance criteria or detailed study results proving the device meets those criteria in the format requested.

Instead, the document states: "The GE Datex-Ohmeda Aisys Carestation has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Aisys Carestation to the standards listed above." This indicates that verification and validation testing was performed to ensure compliance with the referenced voluntary standards, but the specifics of that testing (acceptance criteria, reported performance, sample sizes, ground truth, etc.) are not included in this summary.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here's an attempt to answer based on the information available and what can be inferred, with clear indications of what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified in the provided document. Testing would have been conducted on prototypes or production units of the Aisys Carestation, but the number of units or test cases is not detailed.
• Data Provenance: Not applicable in the context of data provenance for AI/ML models. This is a hardware/software medical device. Testing would be performed in a controlled laboratory environment by the manufacturer.

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

• This is not applicable to the type of device and testing described. The "ground truth" for this medical device's performance would be objective measurements against engineering specifications and voluntary standards, not expert consensus on medical images or patient outcomes. Engineering and quality assurance professionals would perform the testing.

4. Adjudication method for the test set

• Not applicable as explained above. Device performance is typically evaluated against pre-defined specifications and regulatory requirements, not through a consensus-based adjudication process.

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. This is not an AI/ML diagnostic or assistive device that would involve human "readers" or an MRMC study. The device is an anesthesia gas machine and ventilator.

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

• The device itself is a standalone medical device in its function as an anesthesia gas machine and ventilator. Its performance as an independent system would be evaluated against the technical specifications and standards it claims to meet. There is no "algorithm only" component in the context of AI/ML performance being studied here; rather, it's the integrated system's functionality.

7. The type of ground truth used

• For this type of device, the "ground truth" would be established by:
  • Engineering specifications and design requirements: The device's performance is measured against its intended technical capabilities (e.g., gas flow rates, pressure accuracy, alarm thresholds).
  • Voluntary standards: Compliance is demonstrated against the requirements of standards like UL, EN, IEC, ASTM, and ISO, which often involve specific test methods and performance criteria.
  • Predicate device performance: Substantial equivalence relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model that would use "training data" in the conventional machine learning sense. Its functionality is based on established engineering principles, hardware, and embedded software.

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

• Not applicable, as there is no "training set" in the context of AI/ML data for this device. The design and development of the device would follow medical device design control processes, where requirements are defined and verified.

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The GE Datex-Ohmeda Aisys Carestation is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys Carestation is not suitable for use in a MRI environment.

The GE Datex-Ohmeda Aisyis Carestation supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and system comg crecurence gain display unit and then 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 vaporizers are available to give the user control of the system configuration. The Aisys is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have 02. The Aisys 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, agent mixtures and complete power or sudden gas supply failures. The Aisys 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 K# 001814) which is physically integrated into the Aisys, receives electronic power from the Aisys and communicates measured values to the Aisys for display on the system display unit.

The anesthetic agent delivery for the Aisys is controlled via an anesthesia computer through user I ho unesthetie central display. The vaporization technology is based upon the electronic itiput from the collinar display. The x-Ohmeda Anesthesia Delivery Unit (ADU) cleared via Vaportzer etcared as part of the Bacer as part of K973895) is inserted into the active cassette 15715765. An Indin bassette (as to be delivered - Halothane, Enflurane, Isoflurane, Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys is designed to allow of be ronature. I rigent to a time. Per the user input into the main display, valves within the only one actry cassette bay will opent to be delivered. The agent is mixed with gas from athe 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 The Dates Onlined 1900 tronically controlled, pneumatically driven ventilator that provides microprocessor based, erections of ocedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the montoning 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 on for concentration "Prakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in merory. 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 feature obeats is ournaler vees. 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). 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. The arm is counter I he system display and 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 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 Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). 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 frame. An additional from the monitor S/5 AM to be linked to the power supply of the Aisys such that when the Aisyis is turned on, the S/5 AM is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Aisys.

This document pertains to the 510(k) summary for the GE Datex-Ohmeda Aisys Carestation, a type of Anesthesia Gas Machine. As such, it describes a medical device, not an AI/ML-driven solution or a diagnostic tool that would typically undergo the types of studies you've inquired about (e.g., those involving performance metrics like sensitivity/specificity, reader studies, or ground truth establishment by experts).

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types. These aspects are specific to the validation of diagnostic or AI-powered devices, which the Aisys Carestation is not.

The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant voluntary standards for medical electrical equipment and anesthesia workstations. The "acceptance criteria" in this context refer to compliance with these standards and established regulatory pathways for anesthesia machines.

Here's what can be inferred from the provided text regarding the closest equivalents to your request:

1. Acceptance Criteria (in the context of a medical device 510(k) application):

   • Substantial Equivalence: The primary acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices.
   • Compliance with Voluntary Standards: The device was designed to comply with applicable portions of specific voluntary standards. This compliance serves as an "acceptance criterion" for safety, performance, and functionality.

2. Study/Evidence that Proves the Device Meets Acceptance Criteria:

   • The document states: "The GE Datex-Ohmeda Aisyis Carestation in accept vehicled through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Aisyis Carestation to the standards listed above."
   • While specific study details (like sample sizes or statistical results) are not provided in this 510(k) summary, the "rigorous testing" mentioned typically includes:
     • Bench testing: To verify technical specifications, safety features, and functional performance against engineering requirements and the chosen voluntary standards (e.g., verifying gas flow accuracy, ventilator performance, alarm functionality, electromagnetic compatibility).
     • Software validation: Given the electronic controls and microprocessor-based components, software validation would have been performed.
     • Biocompatibility testing: For patient-contacting materials, though not explicitly mentioned here.
     • Electrical safety testing: To meet standards like UL 2601 and EN/IEC 60601-1.
     • Electromagnetic compatibility (EMC) testing: To meet EN/IEC 60601-1-2.

Summary of available information as per your requested format (with caveats):

• Substantial Equivalence to K040743, K032803, K973985
• UL 2601
• EN 740
• EN/IEC 60601-1
• EN/IEC 60601-1-2
• EN 475
• ASTM F1463-93
• ASTM F1208-94
• ASTM F1101-90
• ISO 5358

Reported Device Performance:
The document states that compliance to these standards was supported by "rigorous testing." No specific performance metrics (e.g., statistical results, accuracy values) are provided in this summary. |
| 2. Sample size and Data Provenance (Test Set) | Not applicable. This is a medical device approval, not a diagnostic algorithm study. Testing involved engineering and regulatory compliance, not typically "test sets" in the AI/ML sense. |
| 3. Number of experts and Qualifications (Ground Truth) | Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on imaging) is not relevant for this device. Safety and performance were assessed against engineering specifications and voluntary standards. |
| 4. Adjudication Method (Test Set) | Not applicable for this type of device and submission. |
| 5. MRMC Comparative Effectiveness Study Effect Size | Not applicable. This is not an AI-assisted diagnostic device. |
| 6. Standalone performance (algorithm only) | Not applicable. This is a physical medical device, not an algorithm. |
| 7. Type of Ground Truth Used | Not applicable in the context of diagnostic/AI ground truth. Device performance verified against technical specifications, engineering requirements, and voluntary standards. |
| 8. Sample Size for Training Set | Not applicable. This is a hardware/software medical device, not an AI/ML model that undergoes "training." |
| 9. How Ground Truth for Training Set was Established | Not applicable. |

The 510(k) summary focuses on demonstrating that the Aisys Carestation is safe and effective for its intended use, based on substantial equivalence to existing devices and compliance with recognized standards, rather than proving diagnostic accuracy via clinical trials or AI performance studies.

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