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The Fabius MRI is indicated as a continuous flow anaesthesia system. The Fabius MRI may be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anaesthetic vapor, and monitoring of oxygen concentration, breathing pressure and respiratory volume.

The Fabius MRI is indicated for use in MRI scanner rooms with 1.5 and 3.0 tesla magnets at a location of 40 m tesla (400 gauss) or less.

The Fabius MRI is a continuous flow anesthesia system usable in an MRI environment.

Fabius MRI is equipped with a compact breathing system, providing fresh gas decoupling, PEEP, and pressure limitation.

The following ventilation options are available:

• Volume Controlled Ventilation
• Pressure Controlled Ventilation
• Pressure Support (Optional)
• SIMV/PS (Optional)
• Manual Ventilation
• Spontaneous Breathing

Fabius MRI is equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2),

The provided text is a 510(k) summary for the Fabius MRI device, an anesthesia gas machine. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance results, sample sizes for testing, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone performance studies.

Instead, the document focuses on:

• Device Identification: Applicant/Manufacturer name, contact, device name (Fabius MRI), common name (Gas-machine, anesthesia), classification details, and date of submission.
• Device Description: Fabius MRI is a continuous flow anesthesia system usable in MRI environments (1.5 and 3 Tesla magnets, < 40 millitesta/400 gauss location). It supports various ventilation options and monitors airway pressure, volume, and inspired oxygen concentration.
• Intended Use: For use in MRI environments and standard ORs, induction and recovery rooms, with specified magnet strengths and gauss limitations.
• Predicate Devices: Fabius GS (K042419) and GE Datex Ohmeda Aestiva /5 MRI (K050055).
• Substantial Equivalence Justification: The Fabius MRI is a modified Fabius GS with MRI-specific adaptations and is similar to the Aestiva/5MRI in MRI environment compatibility and gauss-limit alarms.
• Qualification: Mentions a risk management report, system-level qualification, and verification testing according to applicable standards and in an MRI environment.
• FDA Clearance Letter: Confirms the device's substantial equivalence and clearance for marketing.

Since the original document does not contain the requested information about acceptance criteria or study details, I cannot fill in the table or provide answers to the specific questions regarding performance studies.

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