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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

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.

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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 and sevoflurane 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 Anesthesia 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 and sevoflurane 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, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a explicit table of acceptance criteria with specific numerical targets. Instead, it refers to compliance with voluntary standards. The "reported device performance" is essentially that it complies with these standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical or performance data with a defined sample size. The testing mentioned is "validation through testing" related to compliance with engineering standards. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a test set is not available in the provided text.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since there is no mention of a "test set" involving clinical data or expert review to establish ground truth, the number of experts and their qualifications for this purpose are not applicable and not available in the provided text. The device is a medical instrument, and its performance is evaluated against engineering standards rather than diagnostic accuracy.

4. Adjudication Method for the Test Set

As there is no mention of a "test set" requiring expert review or ground truth establishment based on clinical outcomes, an adjudication method is not applicable and not available in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No MRMC study is mentioned. This device is an anesthesia vaporizer, not an imaging or diagnostic AI requiring human interpretation. Therefore, this information is not applicable and not available.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The device is a physical medical instrument, an anesthesia vaporizer, not a software algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The performance evaluation described is for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by its compliance with internationally recognized engineering and safety standards (EN 740, ISO 5358, ASTM F1161) and its functional equivalence to a predicate device. This is a technical and engineering ground truth, not medical outcomes, pathology, or expert consensus on a diagnostic task.

8. The Sample Size for the Training Set

There is no mention of a "training set" as this device is a physical medical instrument, not a machine learning model. Therefore, this information is not applicable and not available.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the context of machine learning, the method for establishing its ground truth is not applicable and not available.

Summary of the Study:

The "study" in this context is the validation through engineering testing that demonstrates the Datex-Ohmeda Tec 7 Anesthesia Vaporizer complies with the specified voluntary standards (EN 740, ISO 5358, ASTM F1161) and is substantially equivalent to its predicate device, the Datex-Ohmeda Tec 5. This testing confirms its ability to provide metered delivery of anesthetic agents with temperature, flow, and pressure compensation, maintaining relatively constant output. The focus is on the device's technical specifications and safety profile as per established industry standards, rather than clinical trial data involving patient outcomes or expert diagnostic performance.

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