(16 days)
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
| Acceptance Criteria Category | Specific Criteria (Based on described standards) | Reported Device Performance |
|---|---|---|
| Regulatory Compliance | Substantial Equivalence to predicate devices (K041775, K023354) | Deemed Substantially Equivalent by FDA (K050597) |
| Prescription Use (21 CFR 801 Subpart D) | Indicated for Prescription Use | |
| Voluntary Standards Compliance | UL 2601 General requirements for Medical Electrical Equipment | Device designed to comply with applicable portions. |
| ASTM F1100 Particular Requirements for Critical Care Ventilators | Device designed to comply with applicable portions. | |
| EN/IEC 60601-1: General requirements for Medical Electrical Equipment | Device designed to comply with applicable portions. | |
| EN/IEC 60601-1-2: 2001 Medical Electrical Equipment Electromagnetic Compatibility | Device designed to comply with applicable portions. | |
| EN 475 Electrically Generated Alarm Signals | Device designed to comply with applicable portions. | |
| CGA V-1 ad ISO 5145 Medical Gas Cylinders Threaded Cylinders | Device designed to comply with applicable portions. | |
| EN 980 Graphical Symbols | Device designed to comply with applicable portions. | |
| EN/IEC 60601-2-12, Medical Electrical Equipment Critical Care Ventilators | Device designed to comply with applicable portions. | |
| Intended Use | Provide mechanical ventilation for adults and pediatrics weighing 5kg and above. | Device design includes various ventilation modes for this population. |
| Provide integrated FiO2, airway pressure, spirometry and volume monitoring. | Device includes these integrated monitoring capabilities. | |
| Incorporate Aerogen Aeroneb Pro nebulizer. | Device includes this nebulizer. | |
| Optional integrated respiratory gas monitoring. | Available via Datex-Ohmeda M-Gas Modules and Mini-CO2 Module. | |
| Optional integrated air compressor. | Available accessory for breathable compressed air supply. | |
| Designed for facility use, including within-facility transport, under clinician orders. | Stated in Indications for Use. |
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.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).