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The Sevoflurane Vaporizer SV 953 is designed for use with the Servo Ventilator 900 and for vaporizing the liquid anesthetic agent sevoflurane in conjunction with the controlled administration of anesthetic gas mixtures during surgery.

The Sevoflurane Vaporizer 953 is an anesthetic vaporizer used together with Siemens Servo Ventilator 900 in anesthetic applications. It is a modification of the Siemens Vaporizers 950/951/952. The modifications made are: At the knob a scale for Sevoflurane is added. The scale indicates concentration values from 0.2% to 8%. The knob scale, label and filling mechanism, are yellow color coded. To reach the concentration values 8% the inside diameter of a capillary tube is 0.36mm instead of 0.30mm as in the other vaporizers.

The Siemens Sevoflurane Vaporizer SV 953 is an anesthetic vaporizer that has expanded indications compared to the predicate device, the Siemens Vaporizers 950/951/952 (Halothane Vaporizer 950, Enflurane Vaporizer 951, Isoflurane Vaporizer 952). The acceptance criteria for this device are based on its equivalence to the predicate device in terms of safety and effectiveness, and its compliance with relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

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 clinical or data-driven evaluation. Instead, it refers to "all different settings of the new expanded indications" being tested. The studies described are validation tests on the device itself, rather than a study on a patient population or data set.

The data provenance is not applicable in the traditional sense of clinical data. The tests are presumably conducted internally by Siemens-Elema AB as part of their design validation process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The device validation relies on engineering and performance testing against predefined criteria and standards, not on expert adjudication of a test set in a medical imaging or diagnostic sense.

4. Adjudication method for the test set

This section is not applicable, as there is no mention of a test set requiring adjudication in the context of this device's validation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence through design and performance testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to the Sevoflurane Vaporizer SV 953, as it is a mechanical medical device, not an AI or software algorithm. Its performance is inherent to its design and functionality, which is tested directly.

7. The type of ground truth used

The "ground truth" for the device's performance is established by:

• Engineering specifications and design requirements: The device's operation must meet designed functional parameters.
• Compliance with recognized standards: ISO/DIS 8835-1.2 and ISO 5360.
• Comparison to predicate device performance: The device is deemed safe and effective if its performance is equivalent to or better than the previously approved predicate device under equivalent testing conditions.
• Pre-defined acceptance criteria: Set for the tests conducted on the device's various settings.

8. The sample size for the training set

This section is not applicable, as this is a medical device approval based on design validation and performance testing, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

This section is not applicable, as there is no training set mentioned in the context of this device's approval.

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