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The Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius Tiro can be used for spontaneous, manually assisted or automatic 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 modified Fabius GS (Fabius Tiro) is a continuous flow gas anesthesia system.

The provided document, K031400, is a 510(k) premarket notification for the Fabius Tiro Anesthesia System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific performance criteria through a detailed clinical study with acceptance criteria.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies. The content focuses on describing the device, its intended use, and the modifications from its predicate device (Fabius GS Anesthesia System) to establish substantial equivalence.

Here's why the requested information is absent based on the provided text:

• Acceptance Criteria and Device Performance: The document does not list specific measurable acceptance criteria that the Fabius Tiro had to meet. Instead, it describes modifications from a predicate device and states that "Qualification of the Fabius Tiro included a hazard analysis, system level qualification, and verification tests." However, the results or specific acceptance criteria for these tests are not detailed.
• Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance: These are elements typically found in clinical studies or performance validation studies designed to establish efficacy or diagnostic accuracy. A 510(k) submission primarily relies on demonstrating that a new device is "substantially equivalent" to an existing legally marketed device, often through engineering modifications, bench testing, and comparisons to the predicate's specifications, rather than new clinical trials with human subjects.
• Training Set Size and Ground Truth for Training Set: Since this is a hardware device (anesthesia system), it doesn't involve machine learning or AI in the sense of a "training set" for an algorithm. The software changes mentioned are purely cosmetic (changing "Fabius GS" to "Fabius Tiro").

In summary, the provided document does not contain the information necessary to complete the table and answer the specific questions about acceptance criteria and a study design as typically associated with performance validation studies for AI/ML devices or novel therapies. The FDA's letter explicitly states that they have reviewed the 510(k) and determined the device is "substantially equivalent," which is the core of this type of submission.

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