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The GE Datex-Ohmeda Engström family of ventilators (Engström Carestation and Engström Pro) are designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. Optional Neonatal capabilities on Engström family expand the patient range to 0.25 kg.

The GE Datex-Ohmeda Engström family of ventilators are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry and volume monitoring. Options include an Aerogen Aeroneb nebulizer, data capture accessory and an integrated air compressor. Options available on Engström Carestation only include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, capabilities to measure SpiroDynamics via an intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash In/Wash Out method.

Not all features are available with all patient populations.

The Engström Carestation is not a pulmonary function calculation device.

The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

The GE Datex-Ohmeda Engström family of ventilators (Engström Carestation and Engström Pro) are flexible, adaptable, and intuitive critical care ventilators. A wide selection of performance options gives the user full control of the system configuration. The Engström Carestation is a complete system featuring patient monitoring, patient ventilation, and the capability of interfacing with central information management systems. The Engström Pro is a defeatured variant of the Engström Carestation.

Both the GE Datex-Ohmeda Engström Carestation and Engstrom Pro are designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. Optional Neonatal capabilities expand its patient range to 0.25 kg.

The modes of ventilation currently available include:

1. Volume Controlled (VCV)
2. Pressure Controlled (PCV)
3. Pressure Controlled, Volume Guaranteed (PCV-VG)
4. Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC)
5. Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC)
6. Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee (SIMV-PCVG)
7. Bi-level Airway Pressure Ventilation
8. Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV)
9. Apnea backup (active in Bi-level and CPAP/PSV)
10. Non-invasive ventilation (NIV), note that NIV is not available in neonatal mode
11. Infant Nasal CPAP (nCPAP)
12. Volume Guarantee, Pressure Support (VG-PS)

The GE Datex-Ohmeda Engström Carestation and Engström Pro are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulizer control board.

The ventilator consists of two main components: a display and a ventilator unit. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The Engstrom Carestation also includes a module bay that allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.

The user interface for control of nebulization is provided via the ventilator display unit. The Aerogen Aeroneb Pro Nebulizer board (K021175) is provided standard with the unit. Nebulizers are options for both the Engstrom Carestation and Engstrom Pro. Users have the option to configure the system to use an external pneumatic nebulizer in place of the Aerogen.

Optional accessories common to both Engström Carestation and Engström Pro include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets, and a data capture accessory. The GE Datex-Ohmeda EV Air Compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air supply. The compressor has no alarm functions. The Engstrom Carestation or Engstrom Pro provides all alarm functions and reactions to a failure of the compressed gas supply. The compressor is installed in the base of the ventilator cart. The compressor is powered from AC mains only. A source of compressed oxygen is required to be connected to Engstrom Carestation/Engström Pro equipped with the optional compressor. The compressor was cleared in K041775.

Additional optional accessories specific to the Engström Carestation include airway modules, intratracheal pressure sensor, auxiliary electrical outlets, and module bay. Optional functionality specific to the Engstrom Carestation include integrated respiratory gas monitoring, capabilities to measure SpiroDynamics via a GE supplied intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-C, M-COV, M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, rev 3.2 software and higher, (K001814) or Mini-CO2 Module (K023454) which are physically integrated into the Engstrom Carestation, receive electronic power from the Engström Carestation and communicate measured values to the Engström Carestation for display on the system display unit.

This document is a 510(k) premarket notification for the GE Datex-Ohmeda Engström Ventilator, seeking substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical data.

Specifically, the document states:

• "The modifications made to the Engstrom ventilator did not require clinical testing."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such clinical study data or acceptance criteria related to a performance study are present in the provided text. The submission focuses on verification of specifications, validation (including software validation), electrical safety, and electromagnetic compatibility testing, rather than a clinical performance study with defined acceptance criteria for AI or a detailed comparison of device performance against a benchmark.

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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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