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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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