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The GE Datex-Ohmeda Centiva/5 Critical Care Ventilator is designed as a critical care ventilator for adult to pediatrics. It provides volume, bi-level and pressure support ventilation (PSV), Continuous Positive Airway Pressure (CPAP) and PSV with apnea backup ventilation modes. It incorporates monitoring of the volume, peak pressure, PEEP, rate and FIO2.

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 Centiva/5 is a flexible, intuitive and simple to operate critical care ventilator. It offers a configurable and compact design and is equipped with a RS-232 serial data interface to enable communication with Clinical Information Management Systems.

The GE Datex-Ohmeda Centiva/5 is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, flow and volume monitoring. The Centiva/5 is equipped with a pneumatic outlet capable of driving standard pneumatic drug nebulizers.

The ventilator consists of two main components: a display or control panel and a ventilator unit. The display allows the user to interact with the system and set parameters. The ventilator unit controls and provides pneumatic gas flow to and from the patient.

Optional accessories include a trolley/cart, support arm, optional humidifier and an external battery unit.

This is a 510(k) premarket notification for a medical device (GE Datex-Ohmeda Centiva/5 Ventilator), not a study evaluating the performance of an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not applicable.

Here's an explanation based on the provided document:

Regarding the GE Datex-Ohmeda Centiva/5 Ventilator:

This document is a 510(k) summary, which demonstrates substantial equivalence to predicate devices, not a performance study as typically understood for AI/ML devices. The "performance" here refers to meeting established safety and effectiveness standards for ventilators.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria (Voluntary Standards)	Reported Device Performance (Compliance)
   UL 2601 General requirements for Medical Electrical Equipment	The device underwent "rigorous testing that, in part, supports the compliance" to this standard.
   ASTM F1100 Particular Requirements for Critical Care Ventilators	The device underwent "rigorous testing that, in part, supports the compliance" to this standard.
   EN/IEC 60601-1: General requirements for Medical Electrical Equipment	The device underwent "rigorous testing that, in part, supports the compliance" to this standard.
   EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility	The device underwent "rigorous testing that, in part, supports the compliance" to this standard.
   EN 475 Electrically Generated Alarm Signals	The device underwent "rigorous testing that, in part, supports the compliance" to this standard.
   CGA V-1 and ISO 5145 Medical Gas Cylinders Threaded Cylinders	The device underwent "rigorous testing that, in part, supports the compliance" to this standard.
   EN 980 Graphical Symbols	The device underwent "rigorous testing that, in part, supports the compliance" to this standard.
   EN/IEC 60601-2-12, Medical Electrical Equipment Critical Care Ventilators	The device underwent "rigorous testing that, in part, supports the compliance" to this standard.

   Note: The document states that the device's substantial equivalence to predicate devices was confirmed through "rigorous testing" which supports compliance with the listed voluntary standards. Specific performance metrics (e.g., accuracy of flow, pressure, volume delivery) are not detailed in this summary document, as they would be part of the full 510(k) submission.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study involving a test dataset for algorithm evaluation. Compliance is assessed against engineering and medical device standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, is not relevant here. The "truth" is whether the device meets the specified engineering and performance standards for a ventilator.

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 not an AI-assisted device.

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

7. The type of ground truth used: For this type of device, the "ground truth" would be established engineering specifications, safety standards, and performance test results that demonstrate the device operates as intended and meets regulatory requirements for mechanical ventilation. It's not "expert consensus, pathology, or outcomes data" in the AI/ML sense.

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.

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