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The Aerogen USB Controller System includes the Aeroneb® Professional and Aeroneb® Solo Nebulizers, which are intended to aerosolize physician-prescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment.

The Aeroneb® Professional Nebulizer is intended for multiple patient use in hospital environment and single patient use in home environment. Aeroneb® Solo Nebulizer is for single patient use. Both nebulizers are for pediatric (29 days or older) and adult patients.

The Aerogen USB Controller System includes the previously cleared Aeroneb® Professional and Solo Nebulizers. The Aerogen USB Controller is an alternative controller to the existing Aeroneb® Pro and Aeroneb® Pro-X Controllers. The power source for the Aerogen USB Controller is the Aerogen USB AC/DC Adapter.

The Aerogen USB Controller System utilises the following components:

• Aeroneb® Pro or Solo Nebulizers
• Aerogen USB Controller
• T-Piece
• AC/DC Adapter and Clips

The Aerogen USB Controller can be used to power the Aeroneb® Pro and Solo nebulizers in both the hospital and homecare environments. For homecare use, it is operated on vent only.

The Aerogen USB Controller provides two modes of operation; a 30 minute and a 6 hour nebulization cycle. The particular mode to be used depends on the accompanying nebulizer. The Aeroneb Pro® nebulizer can be used in the 30 minute intermittent mode only, whereas the Aeroneb® Solo nebulizer can be used in both the 30 minute intermittent and 6 hour modes.

The medical device in question is the Aerogen USB Controller System, which comprises the Aerogen USB Controller and the existing Aeroneb® Professional and Aeroneb® Solo Nebulizers. The study described focuses on demonstrating the substantial equivalence of the new Aerogen USB Controller to previously cleared controllers for the nebulizers.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample size for the cascade impaction testing, nor does it detail the provenance of the data in terms of country of origin or whether it was retrospective or prospective. It mentions "cascade impaction testing was performed: using an Aeroneb Pro nebulizer and an Aeroneb Solo nebulizer with a USB Controller and one drug - Salbutamol Sulphate (Albuterol)." This suggests a controlled laboratory test setup rather than clinical data from human subjects.

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

This information is not provided in the document. The "ground truth" for the performance testing (specifically MMAD) was laboratory measurement using an 8-stage Andersen Cascade Impactor (ACI) against a predefined specification range. This is an objective measurement rather than expert consensus on subjective data.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As noted above, the primary performance criteria (MMAD) were determined through objective laboratory measurement using a device (8-stage Andersen Cascade Impactor), not through expert review 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

An MRMC comparative effectiveness study was not performed. This device is a nebulizer controller, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

A standalone performance evaluation was performed for the device's functional characteristics. The cascade impaction testing (MMAD droplet size and other aerosol characteristics) evaluated the nebulizer's performance with the new USB controller in a laboratory setting, independent of human interaction beyond operating the device for the test. The electrical safety and EMC testing were also standalone assessments of the device's compliance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the primary performance characteristic (MMAD Droplet Size) was based on objective laboratory measurements using an 8-stage Andersen Cascade Impactor against a pre-defined and scientifically accepted specification range (1 to 5 µm). For electrical safety and EMC, the ground truth was compliance with recognized international standards. For software, it was adherence to FDA guidance and a consensus standard (IEC 62304:2006).

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The Aerogen USB Controller System is a hardware device with associated software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software" section refers to a Level of Concern Assessment and Safety Classification, meaning the software development followed established, verified engineering practices, not a machine learning training paradigm.

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

This information is not provided and is not applicable as there was no AI/ML training set. The "ground truth" for the software's safety and level of concern was established by adherence to FDA guidance (2005 FDA Guidance) and an international consensus standard (IEC 62304:2006) for software development in medical devices.

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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 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.

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The Helontix Vent is designed to deliver helium/oxygen mixtures to spontaneously breathing patients via a facemask with or without pressure support. The system is designed for facility use and should only be used under the orders of a clinician.

The Helontix Vent delivery system is not intended as a life support device and is not intended for intubated patients.

The Helontix vent is a stand alone assembly to deliver heliox or oxygen. To accomplish this, the Helontix vent consists of a device with a built in battery and a trollev with mounted oxygen and Heliox gas cylinders. When connected to O2 and Heliox (79%He, 21%O2) the Helontix vent delivers a mixture of oxygen and helium in the required fraction to the patient who can breathe over a mask that is connected to the device via a hose system. The Helontix vent interacts with the user via a user interface, i.e. a display, diodes, speaker, several keys and a control wheel. The device informs the user on the screen about set values, monitored values, alarms, ventilation modes and the navigation through the menus while the user can choose the ventilation mode, set values, silence alarms and navigate through menus by using keys and control wheel. The Helontix vent is device designed for Non-invasive Positive Pressure Ventilations (NPPV) for spontaneous breathing patients. The inspiration flow can be either triggered by the patient with a surplus support of pressure (pressure support mode, PSM, 3-30mbar@peak flow 160SLPM) or alternatively a constant flow from 5-60 SLPM without a pressure support (constant flow mode, CFM) can be selected. The breathing circuit, mask and filter used are purchased previously cleared devices.

The provided text describes a 510(k) premarket notification for the Linde Gas Therapeutics Helontix Vent, a device designed to deliver helium/oxygen mixtures to spontaneously breathing patients. The document focuses on establishing substantial equivalence to predicate devices and adherence to regulatory standards, rather than presenting a detailed clinical study with specific acceptance criteria and outcome data in the format requested.

Therefore, the following information can be extracted about the device's validation, but will not fully align with the requested structure of a study proving a device meets acceptance criteria derived from a clinical trial, as that type of study is not described:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the listed voluntary standards and the assertion of "positive results from extensive testing" demonstrating substantial equivalence. The document does not provide a table with specific, measurable performance metrics and corresponding acceptance thresholds for clinical efficacy, nor does it present quantitative results from a specific clinical study for the Helontix Vent. Instead, it refers to regulatory and engineering standards.

2. Sample size used for the test set and the data provenance:
The document does not describe a clinical study or a test set of patient data. The "extensive testing" mentioned refers to engineering and software validation, not a clinical trial with human subjects. Thus, information on sample size and data provenance (country, retrospective/prospective) for a clinical test set is not provided.

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 test set with expert-established ground truth is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set requiring adjudication is described.

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. The device is a ventilator for heliox delivery, not an AI-powered diagnostic or reader-assistance tool. No MRMC study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device for gas delivery, not an algorithm. Performance assessment would involve engineering and physical testing, not algorithm-only performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context refers to compliance with established engineering standards, software requirements, and safety regulations. These are verified through various physical and software tests, rather than human expert consensus on clinical data or pathology.

8. The sample size for the training set:
Not applicable as no machine learning algorithm with a training set is described.

9. How the ground truth for the training set was established:
Not applicable as no machine learning algorithm with a training set is described.

Summary of Study (Based on Provided Text):

The "study" described in the 510(k) summary is primarily a premarket notification to demonstrate substantial equivalence to legally marketed predicate devices and compliance with relevant voluntary standards and regulatory requirements. It is a technical and regulatory validation process, not a clinical study designed to prove device efficacy through patient outcomes or expert reads.

The document states:

• "Positive results from extensive testing demonstrate that the Linde Helontix Vent is substantially equivalent to the predicate devices."
• "EMC, Electrical, Environmental and full performance testing is also provided in support of the submission."
• "The submissions contains full software information regarding the Level of Concern Analysis, Risk Analysis, Software Development, Software Requirements and Design, Verification and Validation testing, and Traceability."

These statements indicate that the device underwent various forms of engineering, software, and performance testing to ensure it met safety requirements and functioned as intended within the parameters of the industry standards listed. The "ground truth" for these tests would be the specifications and requirements defined by those standards and the device's design documentation. No clinical trial with patient-specific outcome data, expert reviews, or AI performance metrics is mentioned or detailed.

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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 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.

Ask a specific question about this device

The GE Datex-Ohmeda Engström Carestation is 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 the patient range to 0.5 kg. The modes of ventilation 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) .

The GE Datex-Ohmeda Engström Carestation is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulzier. Options include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, an integrated air compressor, 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 Engström Ventilator (EV) is a flexible, adaptable, and intuitive critical care ventilator. 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 GE Datex-Ohmeda Engström Carestation is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulzier. Options include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, an integrated air compressor, 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.

The ventilator consists of three main components: a display, a ventilator unit, and an optional module bay. 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 module bay allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.

Additional optional accessories include a trolley/cart, compressor, airway modules, module bay, support arm, humidifier and water trap mounting brackets, and auxiliary electrical outlets. The user interface for control of nebulization is provided via the ventilator display unit. The Aerogen Aeroneb Pro Nebulizer (K021175) is provided standard with the unit.

This document is a 510(k) summary for the GE Datex-Ohmeda Engstrom Carestation, a continuous ventilator. The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way medical device effectiveness studies for AI/software devices typically do.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices and compliance with voluntary standards for medical electrical equipment.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth type and training set details) are not applicable or not provided in this type of regulatory submission for a physical medical device like a ventilator.

Here's a breakdown based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy) or a comparative performance study against a defined benchmark. Instead, the "acceptance criteria" for a traditional device like this ventilator are implicitly met by:

• Substantial Equivalence: The primary "acceptance" is that the device is substantially equivalent to legally marketed predicate devices.
• Compliance with Voluntary Standards: The device's design and testing demonstrate compliance with recognized industry standards.

• GE Datex-Ohmeda Engstrom Carestation (K051895, K060862)
• Drager Evita XL (K051623)
• Drager Babylog 8000 Plus (K974176)
• Siemens Servo-I (K041111223) |
  | Compliance with Applicable Voluntary Standards | The device was designed to comply with applicable portions of:
• UL 2601 (General requirements for Medical Electrical Equipment)
• ASTM F1100 (Particular Requirements for Critical Care Ventilators)
• EN/IEC 60601-1 (General requirements for Medical Electrical Equipment)
• EN/IEC 60601-1-2 (Medical Electrical Equipment Electromagnetic Compatibility)
• EN 475 (Electrically Generated Alarm Signals)
• CGA V-1 ad ISO 5145 (Medical Gas Cylinders Threaded Cylinders)
• EN 980 (Graphical Symbols)
• EN/IEC 60601-2-12 (Medical Electrical Equipment Critical Care Ventilators) |
  | Safety and Effectiveness for Intended Use | Provides mechanical ventilation for adults and pediatrics (5kg and above, optionally 0.5kg for neonates) with varying degrees of pulmonary impairment. |
  | Performance of Integrated Components and Optional Accessories | Includes integrated FiO2, airway pressure, spirometry, volume monitoring, Aerogen Aeroneb Pro nebulizer. Options for integrated respiratory gas monitoring (via Datex-Ohmeda M-Gas Module/Mini-CO2 Module), integrated air compressor, SpiroDynamics measurement, and FRC calculation. |

Study Proving Device Meets Acceptance Criteria:

The document states: "The GE Datex-Ohmeda Engström Carestation has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Engström Carestation to the standards listed above."

This "rigorous testing" would likely include:

• Bench testing: To verify technical specifications and performance against design requirements and standards (e.g., airflow accuracy, pressure control, alarm functionality).
• Electrical safety and EMC testing: To comply with UL 2601, EN/IEC 60601-1, and EN/IEC 60601-1-2.
• Software verification and validation: To ensure the microprocessor-based control system functions as intended.
• Materials compatibility testing: For components in contact with gases or patients.

However, the specific details regarding the methodology, results, or quantitative metrics of these internal validation tests are not disclosed in this 510(k) summary. These details would be contained within the full 510(k) submission, which is not publicly available.

Due to the nature of this submission (a 510(k) for a physical ventilator, not an AI/software device), the following items are largely not applicable or not provided in this public summary:

2. Sample size used for the test set and the data provenance: Not applicable in the context of device performance claims made via standards compliance and substantial equivalence to predicate devices. Testing would involve engineering validation and verification, not a clinical "test set" in the sense of patient data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a ventilator's physical performance is primarily against engineering specifications and industry standards, not expert clinical interpretation of data.

4. Adjudication method for the test set: Not applicable.

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 is for a physical ventilator, not an AI-assisted diagnostic or therapeutic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical ventilator.

7. The type of ground truth used: For a physical device, the "ground truth" would be established by:
* Engineering specifications and design requirements: Ventilator output (pressure, volume, flow) measured against intended values.
* Reference standards and calibrated equipment: For measuring performance parameters.
* Physiological models: For testing performance under simulated patient conditions.
* Clinical consensus on safety parameters: Ensuring the device operates within safe physiological ranges.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The GE Datex-Ohmeda Engström Carestation is designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. The modes of ventilation 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) .
• Bi-level Airway Pressure Ventilation t
• Constant Positive Airway Pressure Support Ventilation (CPAP/PSV) .
• Apnea backup (active in Bi-level and CPAP/PSV) .

The GE Datex-Ohmeda Engström Carestation is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulzier. Options include intecrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, an integrated air compressor, 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.

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 Engström Ventilator (EV) is a flexible, adaptable, and intuitive critical care ventilator. 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 GE Datex-Ohmeda Engstrom Carestation is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulzier. Options include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, capabilities to measure spirodynamics in patients using sized 6.5 tracheal tubes and larger, measurement of functional residual capacity and an integrated air compressor.

The ventilator consists of three main components: a display, a ventilator unit, and an optional module bay. 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 module bay allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.

Additional optional accessories include a trolley/cart, compressor, airway module bay, support arm, humidifier and water trap mounting brackets, and auxiliary electrical outlets. The user interface for control of nebulization is provided via the ventilator display unit. The Aerogen Aeroneb Pro Nebulizer (K021175) is provided standard with the unit.

Here's an analysis of the provided text regarding the GE Datex-Ohmeda Engstrom Carestation:

Important Note: The provided document is a 510(k) summary and FDA clearance letter. It mainly focuses on establishing substantial equivalence to a previously cleared device, not on presenting novel clinical study results with acceptance criteria in the way you might expect for a new, non-substantially equivalent device or a software as a medical device (SaMD). Therefore, many of your requested items, particularly those related to detailed study methodologies, sample sizes for training/test sets, expert ground truth, and comparative effectiveness, are not explicitly present or applicable in this type of submission.

The "study that proves the device meets the acceptance criteria" in this context refers to the rigorous testing mentioned to support compliance with voluntary standards, which is a key part of demonstrating substantial equivalence for hardware devices like ventilators. It's not a clinical trial comparing performance against a clinical endpoint for a diagnostic device.

Here's the breakdown of the information requested, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The 510(k) summary states "rigorous testing," which would typically involve engineering and performance testing on the device itself, but specific sample sizes of devices or test conditions are not detailed. This is a hardware device, not a diagnostic algorithm; thus, "test set" in the common AI/ML sense doesn't apply directly.
• Data Provenance: Not applicable in the traditional sense for a hardware ventilator. The testing would be conducted in a laboratory or simulated environment, not on a "data set" originating from patients in a specific country. This is a device performance summary, not a data-driven algorithm performance summary.

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

• Not applicable/Not specified. For a hardware ventilator, "ground truth" is typically established by physical measurements, engineering specifications, and established medical standards for ventilator performance, rather than expert consensus on a dataset. Clinical experts would define the requirements but not typically establish "ground truth" for the device's technical performance in a test set.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human-AI studies or for complex diagnostic assessments. For a ventilator's performance testing, the "adjudication" is generally based on objective measurements meeting predetermined engineering specifications and regulatory standards.

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

• No. An MRMC study is relevant for diagnostic imaging or other human-in-the-loop AI/ML applications where human readers' performance is being evaluated with and without AI assistance. This document describes a mechanical ventilator (hardware), not a diagnostic AI system, so such a study would not apply.
• Effect Size of Human Readers Improve with AI vs without AI: Not applicable for this device.

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

• Not applicable in the typical AI/ML sense. While the ventilator itself operates "standalone" in its mechanical functions, the concept of a "standalone algorithm" performance study refers to the isolated performance of a diagnostic or predictive algorithm. The ventilator's performance is intrinsically linked to its hardware and software working together to deliver ventilation. The document states it's a "microprocessor based, electronically controlled, pneumatically driven ventilator," implying algorithms control its function, but their "standalone performance" isn't evaluated separately from the device as a whole.

7. The Type of Ground Truth Used

• Engineering Specifications and Voluntary Standards: The primary "ground truth" for a device like this would be established by objective, measurable engineering specifications (e.g., accuracy of delivered tidal volume, pressure control, alarm threshold accuracy) and compliance with the listed voluntary standards (UL, ASTM, EN/IEC). These standards define acceptable performance ranges and safety requirements.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This is a hardware device being cleared via substantial equivalence, not an AI/ML algorithm requiring a training set in the conventional sense. The "training" of the device refers to its design, development, and testing against pre-defined specifications and standards.

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

• Not applicable/Not specified. As above, the concept of a "training set" ground truth doesn't directly apply here. The "ground truth" for the device's inherent design and functionality would be based on established principles of respiratory physiology, mechanical engineering, electrical engineering, and medical device safety standards.

Ask a specific question about this device

The GE Datex-Ohmeda Engstrom Carestation is designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. 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) .
• Bi-level Airway Pressure Ventilation ●
• Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV) .
• Apnea backup (active in Bi-level and CPAP/PSV) .

The Engström Ventilator (EV) is a flexible, adaptable, and intuitive critical care ventilator. 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 GE Datex-Ohmeda Engstrom Carestation is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulzier. Options include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling and an integrated air compressor.

The ventilator consists of three main components: a display, a ventilator unit, and an optional module bay. 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 module bay allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Note: The document provided is a 510(k) summary for a medical device (ventilator). These summaries often focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the manner one might find for a novel diagnostic algorithm. Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, etc.) are not typically found or disclosed in this type of regulatory filing for this class of device. The "studies" for this device often refer to engineering tests and compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. For this type of device, "testing" primarily refers to engineering verification and validation against performance specifications and recognized standards, not necessarily a "test set" of patient data in the way one would analyze an AI algorithm.
• Data Provenance: Not applicable in the context of clinical patient data. The "study" refers to engineering and quality assurance testing.

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

• Not specified or applicable. The ground truth for a ventilator's performance is typically established by metrological standards, engineering specifications, and functional testing, not by expert clinician consensus on a dataset.

4. Adjudication method for the test set

• Not specified or applicable. Adjudication methods are typically used for subjective clinical interpretations, which is not the primary assessment method for a ventilator's functional performance in this context.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers (e.g., radiologists, pathologists). The GE Datex-Ohmeda Engstrom Carestation is a standalone mechanical ventilator; it does not involve human "readers" interpreting output with or without AI assistance in this manner.

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

• Yes, in essence. The "performance" of the ventilator is "standalone" in that its operation (controlling gases, delivering breaths, monitoring) is independent of human interpretation in the way an AI algorithm might be. The device's integrated measurement capabilities (FiO2, airway pressure, spirometry, volume monitoring) perform their functions autonomously. However, this is not a standalone "algorithm" in the context of an AI-driven diagnostic. It is the core function of the device itself.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by:
  • Engineering specifications and design requirements: Ensuring the device can deliver specified volumes, pressures, and modes of ventilation accurately.
  • Compliance with recognized voluntary standards: (e.g., UL 2601, ASTM F1100, EN/IEC 60601 series). These standards define acceptable performance characteristics and safety criteria.
  • Functional tests and calibration: Verifying that components and the overall system operate within specified tolerances.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm trained on a dataset. Its design and validation rely on engineering principles, component testing, and system-level functional verification.

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

• Not applicable, as there is no "training set" in the context of an AI algorithm.

Ask a specific question about this device

The GE Datex-Ohmeda Engstrom Carestation is designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. 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) ◆
• Bi-level Airway Pressure Ventilation .
• Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV) .
• Apnea backup (active in Bi-level and CPAP/PSV) .

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

The Engström Ventilator (EV) is a flexible, adaptable, and intuitive critical care ventilator. 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 vertilation, and the capability of interfacing with central information management systems.

The GE Datex-Ohmeda Engstrom Carestation is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulzier. Options include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling and an integrated air compressor.

The ventilator consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows nower, nebulization, and pneumatic gas flow to and from the vehinder ann some bay allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.

Additional optional accessories include a trolley/cart, compressor, airway modules, module bay, Additional optional water trap mounting brackets, and auxiliary electrical outlets. Support ann, mamamor and watcher is provided via the ventilator display unit. The rne ason internate for Nebulizer (K021175) is provided standard with the unit.

The provided text describes a 510(k) submission for the "GE Datex-Ohmeda Engstrom Carestation," a continuous ventilator. This document explicitly states that the device has been validated through "rigorous testing that, in part, supports the compliance" of the device to several voluntary standards.

However, the provided text does not contain specific acceptance criteria or detailed results of a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, or accuracy related to disease detection or diagnosis.

Instead, this document is a regulatory submission demonstrating substantial equivalence to a predicate device and compliance with applicable safety and performance standards for a medical ventilator. The "acceptance criteria" here are compliance with these regulatory and voluntary standards, and the "study" is the rigorous testing mentioned, but the specifics are not detailed in the provided text.

Therefore, I cannot fill out the detailed table and answer the specific questions about sample size, expert ground truth, MRMC studies, or standalone performance as they relate to performance metrics typically expected for AI/diagnostic devices. The information provided is for a traditional medical device (ventilator).

Here's what I can extract from the provided text based on the general nature of the request:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the specific questions that relate to AI/Diagnostic studies, the document does not provide the necessary information:

2. Sample sized used for the test set and the data provenance: Not applicable/Provided. This document is for a physical medical device (ventilator), not a diagnostic algorithm. The "testing" refers to verification and validation against engineering specifications and regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Provided. Ground truth, in the context of this device, relates to its ability to meet performance specifications (e.g., deliver set volumes/pressures, maintain alarms accurately), which would be assessed by engineers and testing personnel against pre-defined engineering requirements and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Provided. This is not a study requiring adjudication of diagnostic outputs.

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 a ventilator, not an AI or diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a ventilator, not an algorithm being assessed in standalone mode.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for a ventilator's performance would be its adherence to established engineering specifications and physiological parameters (e.g., accuracy of delivered tidal volume, pressure control, alarm functionality) as measured by calibrated equipment and verified against relevant standards (e.g., ISO, ASTM, IEC). The specifics are not detailed here.

8. The sample size for the training set: Not applicable/Provided. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable/Provided.

In summary: The provided document is a 510(k) summary for a ventilator, focusing on its substantial equivalence to predicate devices and compliance with safety and performance standards. It does not contain the detailed study information typically found for AI or diagnostic devices, which is what the individual questions are tailored for. The "acceptance criteria" are the regulatory and voluntary standards, and the "study" is the internal "rigorous testing" conducted by the manufacturer to demonstrate compliance, the specifics of which are not disclosed in this summary document.

Ask a specific question about this device

The GE Datex-Ohmeda Aptaér Heliox delivery system is designed to deliver heliox from a source gas cylinder to spontaneously breathing patients via a facemask using pressure support. A built-in nebulizer, the Aerogen Aeroneb Pro (K021175) is provided for adding nebulized medication to the delivered heliox. The system is designed for facility use and should only be used under the orders of a clinician. The Aptaér Heliox Delivery System is not intended as a life support device and is not intended for intubated patients.

The GE Datex-Ohmeda Aptaér Heliox delivery system is designed to deliver heliox from a source gas cylinder to spontaneously breathing patients via a facemask using pressure support. A built-in nebulizer, the Aerogen Aeroneb Pro (K021175) is provided for adding nebulized medication to the delivered heliox. The system is designed for facility use and should only be used under the orders of a clinician. The Aptaér Heliox Delivery System is not intended as a life support device and is not intended for intubated patients.

The provided document is a 510(k) summary for the GE Datex-Ohmeda Aptaér Heliox Delivery System. This type of regulatory document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of the device's performance against specific acceptance criteria in a clinical or AI context.

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, detailed study design, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily focuses on:

• Identifying the device and its regulatory classification.
• Stating its intended use (delivering heliox to spontaneously breathing patients via a facemask).
• Claiming substantial equivalence to two predicate devices (Viasys Avea Ventilator and Puritan Bennett 7200 Series Ventilator).
• Listing voluntary standards the device was designed to comply with (e.g., UL 2601, ASTM F100, EN/IEC 60601-1).
• Stating that the device has been "validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Aptaér Heliox Delivery System to the standards listed above."

This statement about "rigorous testing" is a general claim of validation for a medical device's physical and functional aspects, not an AI or algorithm performance study with specific metrics as requested.

Ask a specific question about this device