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The Fabius GS/Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius GS/Fabius Tiro can be used for spontaneous, manually assisted, automatic, pressure support, or synchronized mandatory intermittent ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.

The Fabius GS/Fabius Tiro is a continuous flow gas anesthesia system.

The provided document is a 510(k) summary for the Fabius GS/Fabius Tiro Anesthesia System, specifically for a software modification to include Synchronized Intermittent Mandatory Ventilation with Pressure Support (SIMV/PS) as an optional ventilation mode.

Based on the content, here's an analysis of the acceptance criteria and study information:

Description of Acceptance Criteria and Reported Device Performance

The document describes the addition of SIMV/PS mode to the existing Fabius GS/Fabius Tiro Anesthesia System. The acceptance criteria are implicitly based on demonstrating substantial equivalence to existing predicate devices (Evita 4 Ventilator K961687 and 7900 Ventilator K023366) with SIMV with Pressure Support ventilation modes. The substantial equivalence is claimed based on functional similarities and that the device "meets" these similarities.

Study Details:

This document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study on the device's performance against specific acceptance criteria. Therefore, many of the requested details typically found in the clinical study report are not explicitly present.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of this 510(k) submission. No patient-level test set data is mentioned for performance evaluation in the conventional sense. The "test set" here refers to the parameters and functionalities that were verified against the predicate devices.
   • Data Provenance: Not specified. The submission relies on a comparison of technical specifications and features with previously cleared predicate devices.

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

   • Not applicable as this is a comparison against predicate devices' functionalities, not a diagnostic or clinical performance study requiring expert ground truth establishment. The "ground truth" for substantial equivalence is the functionality of the predicate devices.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. There's no clinical data adjudication described in this type of submission.

4. 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 MRMC study was conducted. This device is an anesthesia system, not an AI-powered diagnostic tool for human readers.

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

   • No standalone algorithm performance study was described. The submission focuses on the integration of a new ventilation mode (software change) into an existing, cleared anesthesia system. Performance claims are based on similarity to predicate devices already cleared for use.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this submission is the established functionality and regulatory clearance of the predicate devices (Evita 4 Ventilator and 7900 Ventilator) regarding their SIMV with Pressure Support ventilation modes. The new device's SIMV/PS mode is deemed substantially equivalent based on matching these functionalities and parameters.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI algorithm in the sense that it requires a training set of data. The "training set" would implicitly be the established engineering and design principles used to develop the software, which are not quantified in terms of sample size here.

8. How the ground truth for the training set was established:

   • Not applicable for the same reasons as above. The "ground truth" for the development of the SIMV/PS mode would stem from medical knowledge of ventilation, engineering specifications, and the functionality observed in the predicate devices.

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