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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 Aespire View 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 Aespire View (version 7) anesthesia system with 7900 ventilator is intended to provide general inhalation anesthesia and ventilator support to a wide range of patients. The system is to be used only by trained and qualified medical professionals.

The Aespire View (version 7) supplies set flows of medical gases to the breathing system (predicate device cleared via 510k submissions K092864 and K122445). A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. It is available in trollev and pendant models, with two or three gases, two vaporizer positions and up to three cylinder connections. All models connect to oxygen and can additionally connect with up to two optional gases (air and N2O). The Aespire View system accepts Tec 6+ and Tec 7 vaporizers on a Selectatec manifold. Safety features are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Aespire View provides optional electronic Total Fresh Gas Flow (TFS) monitoring. The Aespire View also features a color display.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aespire View anesthesia machine. 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, bellow 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 using the ComWheel. 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 Support Ventilation (SIMV/PSV) Mode, Pressure Support with Apnea Backup (PSVPro) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control (SIMV-PC) Mode (Optional), and Pressure Control Ventilation- Volume Guaranteed (PCV-VG) mode (Optional).

The provided text describes a 510(k) premarket notification for the "Aespire View" anesthesia system. This device is an updated version of a previously cleared predicate device. The document explicitly states that clinical testing was NOT required for this submission. Therefore, the information requested regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning performance metrics usually derived from clinical studies (like accuracy, sensitivity, specificity, or reader improvement with AI), is not available in this document.

The submission focuses on non-clinical testing to demonstrate substantial equivalence to the predicate device, primarily due to software and hardware modifications and updated standards compliance.

Here's an analysis based on the provided text, focusing on the absence of clinical performance data:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable in the context of clinical performance for this submission. The "acceptance criteria" discussed are related to compliance with standards (e.g., IEC 60601-1) and verification/validation activities for software and hardware changes. No specific clinical performance metrics (e.g., accuracy, sensitivity) with corresponding acceptance thresholds are mentioned because clinical testing was not deemed necessary.

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

Not applicable for a clinical test set. The document refers to "testing on unit level," "integration testing," and "performance testing" but does not specify sample sizes in terms of patient data as there was no clinical study.

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

Not applicable as no clinical ground truth was established for a clinical test set.

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

Not applicable as no clinical test set requiring adjudication was used.

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 not an algorithm for diagnostic interpretation in a standalone capacity.

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

Not applicable for clinical ground truth. The "ground truth" in this context would be defined by engineering specifications and standards against which the device's functional performance was verified.

8. The sample size for the training set:

Not applicable as no machine learning model was developed or trained for this submission in a way that would involve a "training set" of clinical data.

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

Not applicable for the same reasons as above.

Summary of Non-Clinical Testing and "Acceptance Criteria" for this submission:

The document outlines a series of non-clinical tests and standards compliance achieved by the Aespire View (version 7). These form the basis for its "acceptance" and determination of substantial equivalence.

In conclusion, this FDA 510(k) submission for the Aespire View anesthesia system did not involve a clinical study or generate clinical performance data against acceptance criteria, as the modifications were deemed to not require clinical testing to establish substantial equivalence. The "study" that proves the device meets (non-clinical) acceptance criteria involved extensive engineering verification and validation, along with adherence to recognized international standards.

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The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.

The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The systems are to be used only by trained and qualified medical professionals.

The Aespire 7900 and Aespire View supply set flows of medical gases to the breathing system. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. They are available in trolley and pendant models, with two or three gases, two vaporizer positions and up to three cylinder connections. All models connect to oxygen and can additionally connect with up to two optional gases (air, N2O). The Aespire systems accept Tec 4. Tec 5. Tec 6. Tec 6+ and Tec 7 vaporizers on a Selectatec manifold. Safety features are designed to decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures. The Aespire View product provides optional electronic Total Fresh Gas Flow (TFS) monitoring. The Aespire View also features a color display, while the Aespire 7900 uses a monochromatic display.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in this family of Anesthesia Systems. 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 Support Ventilation (SIMV/PSV) Mode, Pressure Support with Apnea Backup.(PSVPro) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control (SIMV-PC) Mode (Optional), and Pressure Control Ventilation – Volume Guaranteed (PCV-VG) mode (Optional on Aespire View variant only).

This document describes a 510(k) premarket notification for a medical device. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria in a clinical setting.

Therefore, many of the requested items related to clinical studies, such as sample size, ground truth establishment, expert qualifications, and comparative effectiveness studies (MRMC), are not applicable or not provided in this type of submission.

Here's an analysis of the provided text based on your request, highlighting what information is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical clinical or standalone performance study. Instead, it focuses on verifying specifications and safety against existing standards and the predicate device.

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

This information is not provided. The submission focuses on verification testing (engineering/bench testing) of the updated circuit board and overall system against specifications, not a clinical "test set" in the context of diagnostic or AI performance.

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

Not applicable. There is no mention of a "test set" requiring expert ground truth in the context of clinical performance evaluation for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a "test set" requiring expert-based ground truth adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The modification to the family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator did not require clinical testing." This indicates no clinical study comparing human readers (or human readers with AI assistance) was performed.

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

This is not applicable in the context of this device. The changes were to an internal electronic sensor interface circuit board within an anesthesia system, not a diagnostic algorithm. The "performance testing (Verification)" and "safety testing (Verification)" would be akin to standalone engineering tests to ensure the updated component functions correctly and safely within the system, but not "algorithm only without human-in-the-loop performance" in the sense of an AI/diagnostic device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering specifications, safety standards, and validated performance characteristics of the device and its components, verified through various engineering and quality assurance measures (e.g., risk analysis, design reviews, environmental testing, electromagnetic compatibility testing). There is no "clinical ground truth" (like pathology or outcomes data) mentioned because no clinical study was performed.

8. The Sample Size for the Training Set

Not applicable. This device is an anesthesia system with an updated circuit board, not an AI or machine learning algorithm that requires a "training set."

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

Not applicable, as there is no "training set" for this device.

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The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation. The devices are not suitable for use in a MRI environment.

The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The systems are to be used only by trained and qualified medical professionals.

The Aespire 7900 and Aespire View supply set flows of medical gases to the breathing system. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. They are available in trolley and pendant models, with two or three gases, two vaporizer positions and up to three cylinder connections. All models connect to oxygen and can additionally connect with up to two optional gases (air, N2O). The Aespire systems accept Tec 4, Tec 5, Tec 6, Tec 6+ and Tec 7 vaporizers on a Selectatec manifold. Safety features are designed to decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures. The Aespire View family member provides optional electronic Total Fresh Gas Flow (TFS) monitoring. The Aespire View also features a color display, while the Aespire 7900 uses a monochromatic display.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in this family of Anesthesia Systems. 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 Support Ventilation (SIMV/PSV) Mode, Pressure Support with Apnea Backup (PSVPro) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control (SIMV-PC) Mode (Optional), and Pressure Control Ventilation - Volume Guaranteed (PCV-VG) mode (Optional on Aespire View variant only),

This document is a 510(k) summary for the GE Datex-Ohmeda Aespire Anesthesia System, specifically introducing the Aespire View variant. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials or acceptance criteria for a new device type. As such, much of the requested information regarding acceptance criteria, study details, and expert involvement is not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or reported device performance in the way typically associated with a new algorithm or diagnostic device. Instead, it states that the device was thoroughly tested through verification of specifications and validation. The performance is generally implied by the claim of substantial equivalence to predicate devices (K050626 and K090233), meaning it is expected to perform comparably.

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

The document does not specify a separate "test set" in the context of clinical performance evaluation. The "testing" mentioned refers to nonclinical verification and validation. Therefore, sample size and data provenance for a clinical test set are not applicable here.

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

This information is not present as there was no clinical study described that involved establishing a ground truth by experts from a test set.

4. Adjudication Method:

This information is not present as there was no clinical study described that would require an adjudication method.

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

The document explicitly states: "The modifications to the family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator did not require clinical testing." Therefore, an MRMC comparative effectiveness study was not done.

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

This concept is not applicable to an anesthesia system. The Aespire Anesthesia System is a medical device operated by trained professionals, not a standalone algorithm. The document describes non-clinical testing for the device's functionality.

7. Type of Ground Truth Used:

The document does not describe any clinical ground truth (e.g., pathology, outcomes data) for performance evaluation, as no clinical testing was deemed necessary for the modifications. The "ground truth" for the device's functionality would be its adherence to engineering specifications and safety standards through nonclinical testing.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable here as this is a hardware/software medical device, not a machine learning algorithm being trained on data in the traditional sense. The software validation is mentioned, but "training set" doesn't fit the context.

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

This question is not applicable for the reasons stated above.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The document highlights that the GE Datex-Ohmeda Aespire View Anesthesia System underwent "thoroughly tested through verification of specifications and validation, including software validation." Additionally, biocompatibility testing was conducted for the total flow sensor module, and electrical safety and electromagnetic compatibility testing were completed.

The conclusion is that based on these nonclinical tests and the comparison to legally marketed predicate devices, there are "no new questions of safety and effectiveness for the introduction of the Aespire View". This indicates that the device met its internal design and safety specifications, and its performance was considered to be equivalent to existing, cleared devices. This represents a substantial equivalence claim under 510(k) regulations, rather than a de novo clinical study proving novel acceptance criteria.

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