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The indication for Flow-c/Flow-e Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

The indication for the Flow-i/Flow-c/Flow-e Anesthesia system is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

Flow-i, Flow-c and Flow-e Anesthesia systems within the Flow Anesthesia family 4.7 are high-performance Anesthesia systems designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult.

Flow Anesthesia family is a software-controlled semi-closed system for inhalation Anesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide).

The Flow-i/-c/-e 4.7 consists of a core, where gases are mixed and administered, and a User Interface where the settings are made and ventilation and anesthesia are monitored.

The Flow-i/-c/-e 4.7 is based on the cleared predicate device FLOW-i 4.2 (K160665) with some improvements.

The provided text is a 510(k) Summary for an anesthesia system. It outlines the device description, indications for use, comparison to a predicate device, and non-clinical testing. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets those criteria for an AI/algorithm-based device.

This document describes a medical device (anesthesia system) which is hardware and software controlled, but there is no mention of an AI/algorithm that performs diagnostic or prognostic functions, or that assists human readers in an interpretive task. The "MAC Brain" mentioned is a display indicator based on a calculated MAC value, not an AI model requiring a separate validation study with human experts, MRMC studies, or specific performance metrics like sensitivity/specificity against ground truth.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance for an AI/algorithm.
2. Sample size used for the test set and data provenance for an AI/algorithm.
3. Number of experts and their qualifications for establishing ground truth for an AI/algorithm.
4. Adjudication method for an AI/algorithm's test set.
5. MRMC comparative effectiveness study results for AI assistance.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for an AI/algorithm.
8. Training set sample size for an AI algorithm.
9. How ground truth for the training set was established for an AI algorithm.

The document focuses on demonstrating substantial equivalence of an anesthesia machine to a predicate device, based on changes that "do not affect the overall performance or technology of the device" or "raise different questions about safety and effectiveness." The testing mentioned (Software: Code review, Static code analysis, System testing; Performance: System testing, Regression, Free User testing, Waveform testing, Comparative testing for MAC Brain, Comparative testing for Recruitment Maneuver) is typical for hardware and software validation of a medical device, not specifically for an AI/ML algorithm requiring clinical performance studies against human experts or a gold standard.

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