(86 days)
The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. It is available in halothane, isoflurane, sevoflurane and enflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent that it is designed for. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.
The Datex-Ohmeda Tec 7 vaporizer is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. It is available in halothane, sevoflurane and enflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent that it is designed for. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.
Here's an analysis of the provided text to fulfill your request.
Based on the provided documents, there is no specific study described that proves the device meets particular acceptance criteria in the format you've requested.
The documents are a 510(k) Summary of Safety and Effectiveness and an FDA clearance letter for the Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer. These types of documents assert substantial equivalence to previously cleared devices rather than providing detailed clinical or performance studies with acceptance criteria in the way you might find for novel AI/ML medical devices.
Instead, the submission relies on:
- Substantial Equivalence: The key argument is that the Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer is substantially equivalent to existing Datex-Ohmeda Tec 7 (isoflurane, halothane, sevoflurane) and Datex-Ohmeda Tec 5 Anesthesia Vaporizers.
- Compliance with Voluntary Standards: The device was designed to comply with applicable portions of EN 740, ISO 5358, and ASTM F1161.
- Engineering Tests/Validation: The document states, "The Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizers have been validated through testing that, in part, support the compliance of the current and predicate device to the above mentioned standards." However, it does not detail these tests, their acceptance criteria, or their results.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, expert adjudication, or MRMC studies for a performance study.
Here's how I would answer your request based on the lack of this specific information in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from a detailed performance study) | Reported Device Performance (from a detailed performance study) |
|---|---|
| Not specified in the provided documents. | Not specified in the provided documents. |
| The submission asserts substantial equivalence to predicate devices and compliance with voluntary standards (EN 740, ISO 5358, ASTM F1161). It mentions "testing that... support the compliance," but detailed criteria and results are not provided. | The device is described as designed for "metered delivery of specific inhalation anesthetic agents," and is "temperature, flow and pressure compensated so that its output remains relatively constant." No quantitative performance metrics from specific tests are given. |
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/Not specified. The provided document does not describe a test set or data provenance in the context of a performance study for this device. The submission focuses on substantial equivalence and compliance with engineering standards.
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/Not specified. This pertains to clinical or diagnostic performance studies, which are not detailed in the provided documents.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. This information is relevant for studies involving human interpretation or expert consensus on ground truth, which is not 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
- No. The device described is an anesthesia vaporizer, a hardware medical device, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified. This is a hardware device; the concept of a standalone "algorithm only" performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not specified. For a hardware device like an anesthesia vaporizer, "ground truth" typically refers to engineering specifications, calibrated measurements, and adherence to safety and performance standards, rather than clinical outcomes or diagnostic interpretations. The document refers to compliance with voluntary standards (EN 740, ISO 5358, ASTM F1161).
8. The sample size for the training set
- Not applicable/Not specified. This concerns AI/ML devices, not a hardware device like an anesthesia vaporizer.
9. How the ground truth for the training set was established
- Not applicable/Not specified. This concerns AI/ML devices, not a hardware device like an anesthesia vaporizer.
§ 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).