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Blease Frontline Sirius Range, Anaesthesia Machines are intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anaesthetic vapour by use of a dismountable vaporizer.

The device is intended for use only by a suitably qualified physician.

The Frontline Sirius is similar to the cleared Frontline Plus anaesthesia machine and the 6200 ventilator. The size and shape of the cabinet are the different, but the pneumatic systems and ventilator are the same.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Blease Frontline Sirius Range Anaesthesia Machine, which focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance studies and acceptance criteria typically found in a clinical trial report or specific performance testing document.

Therefore, I cannot extract the requested information.

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The Blease 6200 anaesthesia ventilator is an advanced microprocessor (controller) specifically designed for controlled, pneumatically powered ventilation of adult and paediatric patients under general anaesthesia. It is designed for use with a circle type absorber and is ideally suited to both low-flow and high flow applications. It is assumed the ventilator may also be used with a Jackson-Rees/Ayres T-piece type paediatric circuit with no modification being necessary. The device is intended for use only by a suitably qualified physician.

The Blease 6200 anaesthesia ventilator is an advanced microprocessor (controller) specifically designed for controlled, pneumatically powered ventilation of adult and paediatric patients under general anaesthesia.

The provided text describes a 510(k) premarket notification for the Blease 6200 Anesthesia Ventilator II. However, it does not contain any information regarding:

• Acceptance criteria and reported device performance.
• The specifics of any study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Whether MRMC or standalone studies were conducted.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

The document is a letter from the FDA confirming the 510(k) clearance for the device and an "Intended Use Statement" for the Blease 6200 Anesthesia Ventilator. It does not delve into the technical details of the device's performance or the studies that led to its clearance beyond confirming its substantial equivalence to legally marketed predicate devices.

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The Blease Frontline Genius Range, Anaesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anaesthetic vapour by use of a dismountable vaporizer.

The device is intended for use only by a suitably qualified physician.

Not Found

This document is a 510(k) clearance letter from the FDA for an anesthesia machine (Blease Frontline Genius Range). It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance as one would typically find for a new medical device that involves complex algorithms or AI.

Therefore, I cannot provide the requested table and information as it is not present in the provided text. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance.

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