(7 days)
The Datex-Ohmeda D-Tec is an electronic vaporizer which delivers the anesthetic agent desflurane. It heats desflurane to maintain temperature and vapor pressure for consistent output. For added convenience and safety, the vaporizer has an LED display which indicates vaporizer status - no output, low agent, warm-up, operational and alarm battery low. The D-Tec attaches to the Dragerwerk interlocking manifold which allows the user to change vaporizer arrangement from case to case or move vaporizers from suite to suite without the need for tools.
The Datex-OhmedaD-Tec anesthesia vaporzier is device that delivers physician selected concentrations of desflurane anesthetic agent to a flow of medical gases through an anesthesia machine, and to the patient. The spacing of the port valves, helps ensure that the Datex-Ohmeda D-Tec anesthesia vaporizer can only be mounted on Dragerwerk anesthesia systems with a Dragerwerk interlocking manifold.
This document is a 510(k) summary for the Datex-Ohmeda D-Tec Anesthesia Vaporizer. It outlines the safety and effectiveness of the device by establishing substantial equivalence to previously marketed devices and compliance with voluntary standards.
Here's the breakdown of the requested information based on the provided text, noting that much of the information typically found in acceptance criteria studies for AI/software devices (like sample sizes, ground truth establishment, MRMC studies) is not applicable to a hardware device like an anesthesia vaporizer:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Voluntary Standards) | Reported Device Performance |
|---|---|
| EN 740 Anesthetic Work Stations | Complies |
| EN 60601-1, ISO 601-1: 1988 Medical Electrical Equipment | Complies |
| EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatability | Complies |
| ISO 5358 Anesthetic Gas Machines | Complies |
| ASTM F1161 Specifications for Anesthetic Gas Machines | Complies |
Explanation: The document states that "The Datex-Ohmeda D-Tec anesthesia vaporizer was designed to comply with the applicable portions of the following voluntary standards" and "The Datex-Ohmeda D-Tec anesthesia vaporizer has been validated through rigorous testing that, in part, support the compliance of the Datex-Ohmeda D-Tec anesthesia vaporizer to the above mentioned standards." This implies that meeting these standards serves as the acceptance criteria and the rigorous testing demonstrated compliance.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as this is a hardware medical device (anesthesia vaporizer), not a software or AI-based device that relies on a "test set" of data in the same way. The testing would be laboratory-based and engineering validation, not data-driven.
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)
This information is not applicable. Ground truth, in the context of expert consensus, is typically for diagnostic imaging or similar scenarios where human interpretation is a primary component. For an anesthesia vaporizer, "ground truth" would be the device's physical performance against established engineering and medical device standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as #2 and #3.
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
This information is not applicable as this is a hardware device. MRMC studies are used to evaluate the impact of AI on human reader performance, which isn't relevant for an anesthesia vaporizer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a hardware device. "Standalone" performance as an algorithm is not a concept for an anesthesia vaporizer. Its "performance" is its ability to deliver anesthetic agent as specified, which is evaluated through engineering tests, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be established by the voluntary standards themselves (EN 740, EN 60601-1, etc.) and validated through engineering and laboratory testing. The device's performance (e.g., accuracy of anesthetic agent delivery, temperature control, safety features) is measured against the specifications and requirements outlined in these standards.
8. The sample size for the training set
This information is not applicable as this is a hardware device and does not involve training data for an algorithm.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as #8.
§ 868.5880 Anesthetic vaporizer.
(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).