(27 days)
The Datex-Ohmeda S/5™ Compact Airway Module, E-CAiOVX family is intended to be used TIE Datex-Ohmeda 07-5 - Oct plant in monitors for monitoring respiratory, ventilatory and gas exchange parameters of hospitalized patients.
The Datex-Ohmeda S/5™ Compact Airway Module, E-CAiOVX family is indicated for The Date.x-Onlineda 075 - Comparation (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas luchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Cxchange status (Oxygon Octountiples, EE). Gas exchange status monitoring is not indicated in the Quottent RQ, and Energy Expendhadevice is indicated for use by qualified medical personnel only.
The Datex-Ohmeda S/5™ Compact Airway Module, E-CAiOVX is a double-width plug-in parameter module for monitoring respiratory (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate), ventilatory (airway pressure, volume and flow) and gas exchange parameters (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). The E-CAiOVX is a Compact Airway measuring module for a modular monitoring system.
The E-CAiOVX module consists of:
- AOVA infrared measuring sensor for measuring CO2, N2O and anaesthetic agents
- Paramagnetic O2 sensor .
- Side-Stream Spirometry measurement .
- Gas Exchange measurement
- Halothane, Sevoflurane, Isoflurane and Desflurane).
The provided text describes a 510(k) premarket notification for a medical device, the Datex-Ohmeda S/5™ Compact Airway Module (model family E-CAiOVX). This is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to prove the device meets specific acceptance criteria based on performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and sample sizes for training and test sets are not explicitly present in this type of regulatory document. The document focuses on demonstrating that the new device is fundamentally the same as a previously approved device.
Here's an attempt to answer the questions based on the provided text, noting where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it asserts that "The Customer and parameter specifications are the same, except for one minor modification" as compared to the predicate device. This implies that the acceptance criteria are essentially those already established for the predicate device, and the new device meets them by virtue of being substantially equivalent.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes a 510(k) submission which relies on demonstrating substantial equivalence to a predicate device, rather than a clinical trial with a test set of data. The "nonclinical testing" mentioned refers to verification and validation of specifications, not typically a "test set" in the context of AI/ML performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As this is not a study involving expert-established ground truth for a test set, this information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is mentioned.
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 device described is an airway gas and spirometry monitoring module, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance evaluation of the device's measurement capabilities. The document states "The Datex-Ohmeda S/5TM Compact Airway Module... have been assessed against... thoroughly tested through validation and verification of specifications." This implies standalone testing was performed to ensure the device meets its specified performance parameters. However, specific results of this standalone performance are not detailed in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "nonclinical testing" (verification and validation), the "ground truth" would be established by reference standards or highly accurate measurement techniques for the various physiological parameters (CO2, O2, anesthetic agents, pressure, volume, flow, etc.) the device is designed to measure. This is inherent in the "validation and verification of specifications" against recognized standards (e.g., ISO, ASTM).
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that would have a "training set" in the conventional sense. The software enhancements are described as "mostly improvements simplifying manufacturing and tests during manufacturing," implying maintenance and optimization rather than a machine learning training process.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/ML model.
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).