(328 days)
The Vital Signs Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor. These gas sampling lines are used with GE Healthcare Compact Airway modules and CARESCAPE Respiratory modules for monitoring CO2, O2, N2O and anesthetic agents and with E-miniC for monitoring CO2.
Vital Signs Gas Sampling Lines consists of a disposable single patient use coextruded gas sampling line that is compatible with GE Healthcare Compact Airway, E-MiniC and CARESCAPE Respiratory Modules and are provided in four different lengths: 2 meters, 2.5 meters, 3 meters and 6 meters. The disposable single patient use gas sampling lines are smooth narrow diameter tubes that have standardized male luer connectors at both ends. The gas sampling line connects from a port in the breathing circuit to an expired gas monitor. The gas sampling line provides a conduit for drawing gas samples from the breathing circuit port to the gas monitor to analyze respiratory gases. These disposable single patient use gas sampling lines are used to transmit one directional flow of gas sample from the patient breathing circuit port to the gas module host device. A vacuum source and gas measurement sensors are located in the host device, which pull the gas from the breathing circuit port to the host device for gas monitoring. The gas sampling lines are accessories to the gas monitoring devices.
The provided text is a 510(k) summary for Vyaire Medical's Vital Signs™ Gas Sampling Lines. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
It does not describe a study involving a medical device that uses artificial intelligence (AI) or machine learning (ML) or a multi-reader multi-case (MRMC) study. The document focuses on the physical and performance characteristics of a gas sampling line, which is a passive medical device.
Therefore, I cannot extract the information required by your prompt, such as:
- A table of acceptance criteria and reported device performance related to AI/ML.
- Sample size used for the test set and data provenance for an AI/ML model.
- Number of experts used to establish ground truth for an AI/ML model.
- Adjudication method for an AI/ML model.
- MRMC comparative effectiveness study or effect size.
- Standalone performance of an AI/ML algorithm.
- Type of ground truth for an AI/ML model.
- Sample size for the training set of an AI/ML model.
- How ground truth for the training set of an AI/ML model was established.
The document details engineering performance tests (e.g., gauge test, separation force, leakage test, flow resistance test, biocompatibility) to show that the gas sampling lines meet specific technical standards (e.g., ISO 594-2, ISO 80601-2-55, ISO 10993 series). The "Acceptance Criteria" in the document refer to these engineering specifications, not to the performance of an AI/ML algorithm.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).