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The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.
Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules.
Not all features are available for all patient types or product configurations.
The CARESCAPE R860 ventilator 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 CARESCAPE R860 is a flexible, adaptable, intuitive critical care ventilator. Touchscreen capability allows the user to quickly and easily access patient information and procedures. A wide selection of performance options gives the user full control of the system configuration. The CARESCAPE R860 features patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.
The CARESCAPE R860 is designed to provide mechanical ventilation for adult, pediatric and neonatal patient types weighing 0.25 kg and above, and having degrees of pulmonary impairment varying from minor to severe.
The CARESCAPE R860 introduces a new user interface with touch screen capabilities. Icons represent configurable views of past (historical trends), present (patient status), and possible future patient needs through clinical decision support, including Spontaneous Breathing Trial to evaluate a patient's ability to breath spontaneously for a limited, specified duration of time.
This ventilator comes with standard ventilation modes as well as purchasable ventilation modes and clinical decision support features.
Standard ventilation modes:

• A/C VC (Assist Control Volume Control) .
• A/C PC (Assist Control Pressure Control) .
• A/C PRVC (Assist Control Pressure Regulated Volume Control)
• SIMV VC (Synchronized Intermittent Mandatory Ventilation Volume Control) ●
• SIMV PC (Synchronized Intermittent Mandatory Ventilation Pressure Control)
• CPAP/PS (Continuous Positive Airway Pressure/Pressure Support)
• SBT (Spontaneous Breathing Trial) .
  Purchasable ventilation modes:
• . nCPAP (nasal Continuous Positive Airway Pressure)
• . SIMV PRVC (Synchronized Intermittent Mandatory Ventilation Pressure Regulated Volume Control)
• . BiLevel
• . BiLevel VG (BiLevel airway pressure ventilation Volume Guaranteed)
• VS (Volume Support) ●
• NIV (Non-Invasive Ventilation) .
• . APRV (Airway Pressure Release Ventilation)
  Additional features:
• . FRC (Functional Residual Capacity)
• . SpiroDynamics
  The CARESCAPE R860 is based on the Engström Carestation feature set and contains similar performance characteristics to the Engström family of ventilators.
  The CARESCAPE R860 is a microprocessor-based, pneumatically controlled, data driven ventilator which includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb nebulizer control board. The ventilator consists of two main components: the display and the ventilator unit. The display allows the user to interface with the system through a resistive touch screen and Trim Knob with keys. The CARESCAPE R860 also includes an optional module bay which allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.
  The user interface for control of nebulization is provided via the ventilator display unit. The standard nebulizer board is provided with the CARESCAPE R860. Users have the option to configure the system to use an external pneumatic nebulizer in place of the standard nebulizer.
  Optional accessories common to the CARESCAPE R860 and the predicate Engström family of ventilators include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets. Additional optional accessories include airway modules, intratracheal pressure sensor, auxiliary electrical outlets, adjustable mounting rail, nebulizer and components, and module bay.
  The optional medical air compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air supply. The compressor is installed in the base of the ventilator cart. The compressor is powered from AC mains only. A source of compressed oxygen is required to be connected to ventilator equipped with the optional compressor. The use of an integrated air compressor was first cleared on the predicate Engström Carestation and Engström Pro in K050597.
  Optional functionality 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, E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (K051092), E-MiniC module (K052582), or E-sCO, E-sCOV, E-sCAiO, E-sCAiOV (K123195) which are physically integrated into the CARESCAPE R860, receive electronic power from the CARESCAPE R860 and communicate measured values to the CARESCAPE R860 for display on the system display unit.

This document, a 510(k) Pre-market Notification, describes the CARESCAPE R860 ventilator and asserts its substantial equivalence to a predicate device, the Engström Carestation.

Based on the provided text, the CARESCAPE R860 device is a ventilator, not an AI/ML powered device designed to meet specific performance criteria based on an AI model's output. Therefore, many of the requested criteria regarding AI model evaluation (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or type of ground truth) are not applicable (N/A) in this context.

The document primarily focuses on demonstrating the device's adherence to regulatory standards and its functional equivalence to a previously cleared device through non-clinical testing.

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1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a ventilator and not an AI/ML diagnostic or predictive device, the "acceptance criteria" are related to compliance with medical device standards and functional equivalence to a predicate, rather than specific performance metrics like sensitivity or specificity for an AI model.

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: N/A (No specific "test set" in the context of AI/ML evaluation is mentioned. The testing involved functional verification and validation of a medical device against engineering specifications and regulatory standards.)
• Data Provenance: N/A (The testing performed is non-clinical, involving the device itself rather than patient data.)

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)

• Number of Experts: N/A
• Qualifications of Experts: N/A
  • Explanation: Ground truth in this context refers to the correct functioning of the ventilator according to engineering specifications and regulatory standards. This is typically established through engineering and quality assurance processes, not by expert medical review of output data.

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

• Adjudication Method: N/A

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

• MRMC Study Done: No.
• Effect Size: N/A
  • Explanation: This is not an AI-assisted diagnostic device, so MRMC studies are not relevant.

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

• Standalone Performance: N/A
  • Explanation: This device is a ventilator, performing mechanical functions. While it has software, it's not an AI algorithm in the sense of making diagnostic or treatment recommendations that would have a standalone performance evaluated against a ground truth. Its "performance" is its ability to deliver ventilation parameters accurately and safely.

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

• Type of Ground Truth: Engineering specifications, regulatory standards (e.g., ISO 80601-2-12 for medical ventilators), and performance characteristics of the predicate device (Engström Carestation). The "ground truth" is the established correct mechanical and software operation within specified tolerances.

8. The sample size for the training set

• Sample Size for Training Set: N/A (No AI model training involved.)

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

• How Ground Truth Established: N/A (No AI model training involved.)

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

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

Not all features are available with all patient populations.

The Engström Carestation is not a pulmonary function calculation device.

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

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

Both the GE Datex-Ohmeda Engström Carestation and Engström Pro are designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. Optional Neonatal capabilities allow the Engström Carestation and Engström Pro to be used with patients weighing 0.25 kg and above.

The modes of ventilation currently available include:

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

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

The ventilator consists of two main components: a display and a ventilator unit. The display allows the user to interface with the system and control settings through use of soft keys on the display, a com wheel, and a resistive touch screen. The Engström Carestation also includes a module bay that allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.

The user interface for control of nebulization is provided via the ventilator display unit. The standard nebulizer board is provided with both the Engström Carestation and Engström Pro variants. Users have the option to configure the system to use an external pneumatic nebulizer in place of the standard nebulizer.

The optional medical air compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air supply. The compressor is installed in the base of the ventilator cart. The compressor is powered from AC mains only. A source of compressed oxygen is required to be connected to Engström Carestation/Engström Pro equipped with the optional compressor. The use of an integrated air compressor was first cleared in K050597.

Optional accessories common to both Engström Carestation and Engström Pro include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets, and a data capture accessory. Additional optional accessories specific to the Engström Carestation include airway modules, intratracheal pressure sensor, auxiliary electrical outlets, and module bay. Optional functionality specific to the Engström Carestation includes integrated respiratory gas monitoring, capabilities to measure SpiroDynamics via a GE supplied intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash In/Wash Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda Gas Modules, M-C. M-COV. M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, rev 3.2 software and higher (K001814), E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (K051092), or M-Mini-CO2 Module (K023454) or E-MiniC module (K052582) which are physically integrated into the Engström Carestation, receive electronic power from the Engström Carestation and communicate measured values to the Engström Carestation for display on the system display unit.

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

The provided document describes nonclinical testing only.

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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