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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 Engstrom Carestation is designed to provide mechanical ventilation for adults and pediatric patients 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 Engstrom Carestation includes integrated Oxygen, FiO2, airway pressure, spirometry and volume monitoring gas monitoring capabilities via nebulizer. Options include integrating modules listed in the product labeling.

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 Engstrom Carestation is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, Spirometry and volume monitoring and optional Datex-Ohmeda patient monitoring modules.

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

The ventilator consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to access and control settings. The ventilator unit controls pneumatic gas flow to and from the patient. The module bay allows integration of various Datex-Ohmeda patient monitoring modules with the ventilator.

Optional accessories include a trolley/cart, airway modules, module bay, support arm, mounting brackets, and auxiliary electrical outlets.

This document is a 510(k) summary for the GE Datex-Ohmeda Engstrom Carestation, a continuous ventilator. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a new, novel AI/software medical device might.

Therefore, many of the requested categories for AI/software device evaluation (like sample sizes for test/training sets, expert qualifications, adjudication, MRMC studies, standalone performance, and detailed ground truth establishment methods) are not applicable or explicitly not found in this type of submission.

The "acceptance criteria" for this conventional device are primarily based on complying with recognized voluntary standards and demonstrating performance comparable to existing, legally marketed predicate devices.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

1. UL 2601 General requirements for Medical Electrical Equipment
2. ASTM F1100 Particular Requirements for Critical Care Ventilators
3. EN/IEC 60601-1: General requirements for Medical Electrical Equipment
4. EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility
5. EN 475 Electrically Generated Alarm Signals
6. CGA V-1 ad ISO 5145 Medical Gas Cylinders Threaded Cylinders
7. EN 980 Graphical Symbols
8. EN/IEC 60601-2-12, Medical Electrical Equipment -- Critical Care Ventilators |
   | Intended Use: Mechanical ventilation for patients weighting 5kg and above with varying degrees of pulmonary impairment. | The device provides mechanical ventilation in various modes (VCV, PCV, PCV-VG, SIMV-VC, SIMV-PC, Bi-level, CPAP/PSV, Apnea backup) for the described patient population. |

Study Details (Based on available information in a 510(k) for a conventional medical device)

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

   • N/A (Not Applicable): This document does not describe a "test set" in the context of an AI/software performance study. The evaluation for substantial equivalence relies on design validation and compliance with recognized standards, often involving engineering testing, bench testing, and sometimes animal or human factors testing, but not typically a "test set" of patient data for performance metrics like sensitivity/specificity.

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

   • N/A (Not Applicable): As there is no "test set" of patient data in the AI/software sense, there are no experts establishing ground truth for such a set based on this submission. The "ground truth" for a conventional ventilator often relates to its ability to accurately deliver set parameters, respond to patient needs, and ensure patient safety, which is assessed through engineering and clinical validation testing, not expert consensus on diagnostic images or similar.

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

   • N/A (Not Applicable): Not relevant for this type of device submission.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, not applicable: The GE Datex-Ohmeda Engstrom Carestation is a conventional ventilator, not an AI-assisted diagnostic or therapeutic device that involves "human readers." Therefore, an MRMC study is not relevant.

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

   • N/A (Not Applicable): This is a hardware medical device with integrated software for control; it's not an algorithm that operates in a "standalone" fashion to perform a diagnostic or interventional task independent of the physical device or a human operator. The device's performance is inherently tied to its function as a ventilator.

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

   • The "ground truth" for this device's performance is based on engineering specifications, established physiological principles, and compliance with performance standards. For example, ground truth for delivered oxygen concentration would be verified against calibrated measurement devices, or ground truth for pressure delivery would be against known pressure sensors. The submission states "rigorous testing" was performed, which implies verification against known accurate measurements and validated methods.

7. The sample size for the training set:

   • N/A (Not Applicable): This file describes a conventional hardware-based medical device. It does not refer to machine learning model development and therefore does not have a "training set" in that context.

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

   • N/A (Not Applicable): See point 7.

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