(13 days)
The Plug System S Plus is indicated for mounting Dräger-Vapor 19.1 vaporizers on Selectatec Series Mounted Manifolds.
The Plug System S Plus (Modified) is a vaporizer mounting adapter that will allow Dräger Vapor 19.n vaporizers to be mounted to Selectatec Manifolds. The Plug System S Plus (Modified) is a modification to the currently distributed Plug System S Plus (K973051).
The provided text describes a traditional medical device (vaporizer mounting adapter) rather than an AI/ML-based device. Therefore, many of the requested fields, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," “sample sized used for the test set,” “number of experts,” “adjudication method,” and “sample size for the training set,” are not applicable.
Here's the information extracted from the provided text, adapted for a traditional device context:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated Compliance) | Reported Device Performance |
|---|---|
| Compliance with ASTM Standard 1161-88, Sections 8 and 12 | The Plug System S Plus (Modified) was tested and/or analyzed to demonstrate compliance with these sections. |
| Compatibility of the mounting device with lever mechanism and vaporizer specific identification label | The device demonstrated compatibility with representative Ohmeda anesthesia machines with Selectatec Series Mounted Manifolds. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of data for an algorithm. Instead, it refers to "representative Ohmeda anesthesia machines with Selectatec Series Mounted Manifolds" for the compatibility testing. The exact number of machines or specific test cases is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This concept does not apply to the testing of this traditional device. Testing involved physical and functional verification against standards and compatibility with other hardware.
4. Adjudication method for the test set
N/A - This concept does not apply to the testing of this traditional device.
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
N/A - This is not an AI/ML device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A - This is not an AI/ML device. The device's performance is inherently "standalone" in that it performs its function without AI or human intervention in its direct operation, but it requires human users for its application.
7. The type of ground truth used
The "ground truth" for this device's performance was based on:
- Compliance with an established industry standard (ASTM Standard 1161-88, Sections 8 and 12).
- Functional compatibility with specified existing medical equipment (Dräger Vapor 19.n vaporizers and Selectatec Series Mounted Manifolds, and Ohmeda Tec 5 interlock mechanism).
8. The sample size for the training set
N/A - This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
N/A - This is not an AI/ML device.
§ 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).