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The Hawk Anaesthesia Induction Unit is a medical device for providing continuous gas inhalation for adults and children above 5 kg body weight. It facilitates the control and administration of operator selected gas mixtures with anaesthetic agents . The anaesthetic agents are accurately dispensed by a suitable anaesthetic vaporiser, of the type specified, which may be safely and securely attached to the modular backbar.

The Hawk provides safe and accurate gas flows to maintain patient respiration during induction of anaesthesia. It is specified for use with an oxygen monitor and other suitable monitoring, these monitors are specified in the operator's manual.

The Hawk may be safely used with magnetic resonance imaging systems (MRJ) as it is MRI compatible.

The MIE Hawk Anaesthesia Induction Unit is a medical device for providing continuous gas inhalation.

I am sorry. This document does not contain the information you are requesting. This looks like an FDA clearance letter for a medical device called the "Hawk Anaesthesia Induction Unit". It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

The letter does not contain the following information:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

This type of information is typically found in a clinical study report or a technical capabilities document, not in an FDA clearance letter.

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The Vapamasta 6 Anaesthesia Vaporiser a temperature-compensated concentration-calibrated vaporiser. They are designed to introduce an accurately metered volume of vaporised anaesthetic agent into the fresh gas flow of a continuous-flow anaesthetic apparatus.

Their purpose of these devices is to vaporise an inhalable anaesthetic agent for which they have been calibrated and which is indicated on the labelling. They may be used for the induction and maintenance of a state of anaesthesia in humans during a medical procedure, usually involving a surgical operation. They may additionally be used for veterinary procedures.

The devices are calibrated for a specific anaesthetic agent and vaporisers for the following anaesthetic agents are available in the Vapamasta 6 range; Halothane, Enflurane, Isoflurane or Sevoflurane.

The Vapamasta 6 Anaesthesia Vaporiser a temperature-compensated concentration-calibrated vaporiser. They are designed to introduce an accurately metered volume of vaporised anaesthetic agent into the fresh gas flow of a continuous-flow anaesthetic apparatus.

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Vapamasta 6 Anaesthetic Vaporiser." This document indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The letter focuses on regulatory approval based on substantial equivalence, and it outlines the indications for use of the Vapamasta 6 Anaesthetic Vaporiser. It does not include the detailed performance study results that would typically address your request.

Therefore, I cannot provide the requested information based on the given text.

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