(279 days)
The indication for FLOW-i 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 is a high-performance anesthesia system 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-i is a software-controlled circle system for inhalation anesthesia (Sevoflurane, Desflurane, Isoflurane and/or nitrous oxide). The most important features that enhance FLOW-i performance compared with a traditional anesthesia system are: o a ventilator whose functionality is based on ICU-ventilator technology, the volume reflector technology, o the electronically controlled injector vaporizers and o o the ergonomic design.
The provided text describes a 510(k) premarket notification for the MAQUET FLOW-i Anesthesia System. It outlines the device's description, intended use, and a comparison to predicate devices, but it does not contain information about specific acceptance criteria, study details, or performance metrics in a quantifiable sense typically found in clinical studies or performance validation reports.
Therefore, many of the requested fields cannot be filled from the given text.
Here's an attempt to answer based on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
The document mentions "Performance testing has resulted in data that demonstrates that FLOW-i Anaesthesia System performs within its specifications and within the acceptable limits of the applied performance standards." However, it does not provide specific acceptance criteria values or detailed reported performance data.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific Values Not Provided in Text | Specific Values Not Provided in Text |
| (e.g., Accuracy of gas flow within X%) | (e.g., Gas flow accuracy observed Y%) |
| (e.g., Concentration stability within Z%) | (e.g., Concentration stability observed W%) |
| Performs within its specifications | Performs within its specifications |
| Performs within acceptable limits of applied performance standards | Performs within acceptable limits of applied performance standards |
2. Sample size used for the test set and the data provenance
The document doesn't explicitly mention "test set" in the context of human studies for performance. The non-clinical testing refers to:
- Sample Size: Not specified.
- Data Provenance: Not applicable as these are non-clinical technical tests, not patient data studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This information would typically be relevant for studies involving human interpretation or clinical evaluations, which are not detailed in this non-clinical testing summary.
4. Adjudication method for the test set
Not applicable. As there's no mention of a human-involved test set requiring ground truth establishment, no adjudication method is described.
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. The FLOW-i Anesthesia System is described as a medical device for administering anesthesia, not an AI-assisted diagnostic or interpretive tool that would involve human "readers" or an MRMC study in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes "Non-clinical Testing and Performance" which includes verification of operating data and accuracy of measurements, software validation, electrical and mechanical safety, etc. These are standalone evaluations of the device's components and system without explicit human intervention during the performance measurement itself, fitting a broad interpretation of "standalone performance." However, it's not an "algorithm only" performance in the sense of AI.
7. The type of ground truth used
For the non-clinical testing mentioned:
- Ground Truth: Engineering specifications, regulatory standards, physical measurements, and expected operational parameters. For instance, for "Verification of Operating Data and Accuracy of Measurements," the ground truth would be the known input values and expected output values based on established physics and engineering principles.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that would typically have a "training set" in the conventional sense. The device's functionality is based on established engineering principles and software logic, not on learning from a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).