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The GE Datex-Ohmeda 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 Carestation and Engström Pro expand the patient range to 0.25 kg.

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. 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 Carestation and Engström Pro are flexible, and intuitive, critical care ventilators. A wide selection of performance options gives the user full control of the system configuration. The Engström Carestation and Engström Pro feature patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.

Both the GE Datex-Ohmeda 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 allow the Engström Carestation and Engström Pro to be used with patients weighing 0.25 kg and above.

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 Support Ventilation (CPAP/PSV)
9. Apnea backup (available in SIMV-VC, SIMV-PC, SIMV-PCVG/BiLevel-VG, BiLevel, CPAP/PSV, and VG-PS)
10. Non-invasive ventilation (NIV), not available in neonatal mode
11. Infant Nasal CPAP (nCPAP), only available in neonatal mode
12. Volume Guarantee. Pressure Support (VG-PS), only available in neonatal mode

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 through use of soft keys on the display, a com wheel, and a resistive touch screen. The Engström 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 standard nebulizer board is provided with both the Engström Carestation and Engström Pro variants. Users have the option to configure the system to use an external pneumatic nebulizer in place of the standard nebulizer.

The optional medical air compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air 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 Engström Carestation/Engström Pro equipped with the optional compressor. The use of an integrated air compressor was first cleared in K050597.

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. 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 Engström Carestation includes 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 In/Wash Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda Gas Modules, M-C. M-COV. M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, rev 3.2 software and higher (K001814), E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (K051092), or M-Mini-CO2 Module (K023454) or E-MiniC module (K052582) which are physically integrated into the Engström Carestation, receive electronic power from the Engström Carestation and communicate measured values to the Engström Carestation for display on the system display unit.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Datex-Ohmeda Engström Carestation and Engström Pro ventilators.

This 510(k) submission (K140575) is primarily for the addition of an alternate integrated air compressor (EVair) to the existing GE Datex-Ohmeda Engström Carestation and Engström Pro ventilators, which were previously cleared under K111116. The submission states "There have been no changes to the intended use or fundamental scientific technology." and "The addition of the alternate compressor, EVair, does not affect the safe or effective use of the ventilator as the compressor interfaces with the ventilator in the same manner, and performs in an equivalent manner. There is no change to the Engstrom performance as a result of this change." Consequently, the acceptance criteria and studies focus specifically on the new compressor and its functional equivalence, rather than a broad re-evaluation of the entire ventilator system.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) (adding an alternate component), the acceptance criteria are framed around functional equivalence and safety of the new EVair compressor compared to the predicate EVair03.

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

The provided document describes nonclinical testing only.

• Sample Size: The document does not specify a quantitative "sample size" in terms of units tested for the compressor, nor does it refer to patient data. Testing appears to be on developmental units of the EVair compressor integrated with the Engström ventilators.
• Data Provenance: The testing was "nonclinical," meaning it did not involve human patients. It was conducted by the manufacturer, Datex-Ohmeda, Inc. (GE Healthcare). There is no mention of country of origin for specific test data, but the company is based in Madison, WI, USA. The testing is prospective in the sense that it evaluates a newly designed component (EVair compressor) before its market release.

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

• The concept of "ground truth established by experts" is not directly applicable here as this is a nonclinical engineering and functional equivalence study for a medical device component.
• The ground truth for this type of evaluation is typically defined by engineering specifications, regulatory standards (e.g., ISO, IEC for medical electrical equipment), and the performance characteristics of the legally marketed predicate device.
• The "experts" involved would be the manufacturer's engineers, quality assurance personnel, and regulatory specialists who designed, tested, and evaluated the device against these objective criteria. Their qualifications would stem from their professional expertise in medical device development, testing, and regulatory requirements.

4. Adjudication Method for the Test Set

• Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers (e.g., radiologists interpreting images) where consensus or a tie-breaking mechanism is needed to establish a "true" label.
• This submission describes nonclinical engineering testing. Therefore, such adjudication methods are not applicable. The results of the tests (e.g., pressure measurements, acoustic levels, vibration, thermal performance, software function) are objective, quantitative data compared against predefined specifications and predicate performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done.
• MRMC studies are clinical studies designed to evaluate the diagnostic performance of human readers, often comparing performance with and without an AI-assisted device.
• This 510(k) submission is for an alternate component (air compressor) of a ventilator, not a diagnostic AI device. The submission explicitly states: "The modifications made to the Engström ventilator did not require clinical testing."

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

• This question is framed for AI/algorithm-based devices. The Engström Carestation and Engström Pro are physical medical devices (ventilators) with microprocessor control, not standalone AI algorithms.
• The "standalone performance" of the EVair compressor itself was evaluated during its design and verification to meet engineering specifications (acoustics, vibration, thermal dissipation) and then its integrated performance with the ventilator system was verified. This can be considered the equivalent of a "standalone" functional test for the component.

7. The Type of Ground Truth Used

• For this nonclinical submission, the ground truth is based on:
  • Engineering Specifications: Detailed technical requirements for component performance (e.g., pressure ranges, flow rates, alarm thresholds, acoustic limits, vibration levels, thermal profiles).
  • Regulatory Standards: Compliance with relevant national and international standards for medical devices, particularly continuous ventilators (e.g., 21 CFR 868.5895, ISO, IEC standards).
  • Predicate Device Performance: The demonstrated safe and effective performance of the previously cleared predicate device (Engstrom Ventilator K111116 and its EVair03 compressor). The new EVair compressor was evaluated against the functional performance of the EVair03.

8. The Sample Size for the Training Set

• This question is relevant for machine learning or AI models.
• Not applicable. This submission is for a physical medical device and its component, not an AI model requiring a training set.

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

• Not applicable, as there is no training set for an AI model in this submission.

Ask a specific question about this device

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 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 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 (available in SIMV-VC, SIMV-PC, SIMV-PCVG/BiLevel-VG, BiLevel, CPAP/PSV, and VG-PS)
10. Non-invasive ventilation (NIV), not available in neonatal mode
11. Infant Nasal CPAP (nCPAP), only available in neonatal mode
12. Volume Guarantee, Pressure Support (VG-PS), only available in neonatal mode

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 through use of soft keys on the display, a com wheel, and a resistive touch screen. 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 Engström Carestation and Engström 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 Engström Carestation or Engström 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 Engström 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 Engström Carestation includes 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 In/Wash Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda Gas Modules, M-C, M-CO, M-COV, M-COV, M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, rev 3.2 software and higher (K001814), E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (K051092), or M-Mini-CO2 Module (K023454) or E-MiniC module (K052582) which are physically integrated into the Engström Carestation, receive electronic power from the Engstrom Carestation and communicate measured values to the Engström Carestation for display on the system display unit.

The provided text describes a 510(k) premarket notification for the GE Datex-Ohmeda Engström Ventilator family (Engström Carestation and Engström Pro). This submission is for an updated version of an existing device, primarily involving software changes.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly provide a table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity) for the device's functions. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and verification.

However, the general acceptance criteria for this type of submission are implied through the testing methods described:

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "Testing on unit level," "Integration testing," "Performance Testing (Verification)," and "Safety Testing (Verification)" but does not specify the number of devices or scenarios used for these tests.
• Data Provenance: The testing appears to be conducted in-house by GE Healthcare/Datex-Ohmeda Inc. as part of their development and verification process. The data is retrospective in the sense that it's based on internal testing conducted on the device prior to submission, rather than prospective clinical trials. There is no mention of data origin by country.

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

Not applicable. This submission is for a ventilator, and the testing described is primarily engineering verification and validation against technical specifications and predicate device performance. It does not involve interpretation of medical images or diagnostic outputs that would require clinical expert "ground truth" establishment in the way a diagnostic AI device would. "Simulated Use/User Requirements Testing (Validation)" was performed, implying user involvement, but the number and qualifications of these users/experts are not specified, nor is their role in establishing a "ground truth" defined in the typical diagnostic context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the testing is against technical specifications and predicate device performance, not against expert-adjudicated ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was done. The text explicitly states: "The modifications made to the Engstrom ventilator did not require clinical testing."

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

The device itself is a standalone medical device (a ventilator), not an algorithm intended for diagnostic interpretation. The software updates were evaluated for their standalone functionality as part of the ventilator system. The non-clinical tests verified and validated the "safety and functionality" of the ventilator with the software changes.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is its adherence to:

• Technical Specifications: The device's design specifications for ventilation parameters, safety features, alarm conditions, etc.
• Predicate Device Performance: The established safety and effectiveness of the previously cleared Engstrom Ventilator (K093886) and Hamilton G5 Ventilator (K070513).
• Applicable Standards: Compliance with relevant medical device standards (e.g., electrical safety, electromagnetic compatibility).

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device (ventilator) with software updates, not an AI/ML algorithm that requires a "training set" in the machine learning sense. The software updates were based on "customer feedback" and "minor changes to bring the product in line with current specifications," but this is not equivalent to a supervised learning training process.

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

Not applicable, as there was no AI/ML training set in the context described by the question.

Ask a specific question about this device

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.

Ask a specific question about this device

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 the Engstrom Family expand the patient range to 0.5 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 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 (Engstrom Carestation and Engstrom 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 Engstrom Pro is a defeatured variant of the Engström Carestation.

Both the GE Datex-Ohmeda Engstrom 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 on Engström Family expand its patient range to 0.5 kg.

The modes of ventilation are available include:

• . Volume Controlled (VCV)
• Pressure Controlled (PCV) .
• . Pressure Controlled, Volume Guaranteed (PCV-VG)
• Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC) ●
• . Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC)
• . Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee (SIMV-PCVG),
• . Bi-level Airway Pressure Ventilation
• Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV)
• . Apnea backup (active in Bi-level and CPAP/PSV)
• . Non-invasive ventilation (NIV), note that NIV is not available in neonatal mode
• . Neonatal Nasal CPAP (nCPAP).

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 nebulizer.

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 Engström Carestation and Engström Pro.

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

Optional accessories common to both Engstrom Carestation and Engstrom Pro include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets, and auxiliary electrical outlets. 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. All alarm functions and reactions to failure of the compressed gas supply, are provided by the Engstrom Carestation or Engstrom Pro as cleared in K041775. 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/Engstrom Pro equipped with the optional compressor.

Additional optional accessories specific to the Engstrom Carestation include airway modules, intratracheal pressue sensor, and module bay. Optional functionality specific to the Engstrom Carestation include neonatal use, 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 In/Wash Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-C, M-CO, M-COV, M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, (rev 3.2 software and higher) K# 001814) or Mini-CO2 Module (K023454) which are physically integrated into the Engstrom Carestation, receive electronic power from the Engstrom Carestation and communicate measured values to the Engstrom Carestation for display on the system display unit.

Enstrom Pro is a defeatured variant of the Engstrom Carestation. It uses the same hardware and software as the Engstrom Carestation, with the following differences:

• . FRC and Spirodynamics are not available
• Monitoring module is not available .
• . Cart outlets are not available
• . A new cart is provided
• . Aesthetic differentiation

The provided text is a 510(k) Premarket Notification summary for the Engström Ventilator. It describes hardware and software updates to an existing ventilator (Engström Carestation) and introduces a "defeatured variant" (Engström Pro).

Crucially, this document states: "The modifications made to the Engstrom ventilator did not require clinical testing." This means there is no "study that proves the device meets the acceptance criteria" in terms of clinical performance.

Therefore, I cannot provide details on clinical acceptance criteria or studies as the submission itself indicates none were performed or required for the modifications.

However, I can extract information related to non-clinical testing and regulatory compliance, which served as the basis for substantial equivalence for this device.

Here's a breakdown of what the document does provide:

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

   Acceptance Criteria (Non-Clinical/Regulatory Compliance)	Reported Device Performance
   UL 2601 General requirements for Medical Electrical Equipment	Verification of compliance made
   EN/IEC 60601-1: General requirements for Medical Electrical Equipment	Verification of compliance made
   EN/IEC 60601-1-2: 2001 Medical Electrical Equipment Electromagnetic Compatibility	Verification of compliance made
   EN 475 Electrically Generated Alarm Signals	Verification of compliance made
   CGA V-1 ad ISO 5145 Medical Gas Cylinders Threaded Cylinders	Verification of compliance made
   EN 980 Graphical Symbols	Verification of compliance made
   EN/IEC 60601-2-12, Medical Electrical Equipment Critical Care Ventilators	Verification of compliance made
   Software Validation	Thoroughly tested through validation
   Verification of Specifications	Thoroughly tested through verification

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

   • Sample Size for Test Set: Not applicable as no clinical testing was performed. The non-clinical testing involved verification against engineering specifications and international standards, which would typically involve testing of device prototypes or production units, not patient data.
   • Data Provenance: Not applicable for clinical data. The testing was non-clinical, likely performed internally by the manufacturer during design verification and validation.

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. Ground truth, in a clinical sense, was not established as there was no clinical testing. For non-clinical specification verification, the "ground truth" would be the engineering design specifications and the requirements of the standards themselves, verified by engineers and quality personnel.

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

   • Not applicable. There was no clinical test set requiring adjudication.

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 a ventilator device, not an AI diagnostic or assistance tool for human "readers." The modifications were to ventilation modes and hardware variants for an established device type.

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

   • Not applicable as this is a medical device (ventilator), not an algorithm or AI system in the typical sense. Its performance is inherent to its mechanical and software operation.

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

   • For the non-clinical testing, the "ground truth" was compliance with established engineering specifications and international safety and performance standards for medical electrical equipment and critical care ventilators.

8. The sample size for the training set:

   • Not applicable. As no clinical testing was done, there was no clinical training set. For software development and verification, there would have been internal testing and validation processes, but these don't typically involve "training sets" in the machine learning sense.

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

   • Not applicable.

In summary, the 510(k) submission for the Engström Ventilator relies on non-clinical verification and validation against established engineering specifications and international standards to demonstrate substantial equivalence to predicate devices. It explicitly states that clinical testing was not required for the modifications made.

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