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Prevent escape of inspiratory gases and re-breathing of expired gases while providing a means of egress for expired gases

The reusable exhalation valves are designed for use with ventilators. The exhalation valve prevents the reasured gases from escaping through the passage that will be made available to expired gases via the inflatable balloon. Also, the re-breathing of the expired gases are prevented by the balloon action.

The provided text is a 510(k) premarket notification letter from the FDA, dated August 24, 1998, regarding Exhalation Valve Models BE 30-115-B, NS 30-115-U, NS 30-115-S, and PS 54-A.

Unfortunately, this document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The letter is a regulatory approval, stating that the device is "substantially equivalent" to legally marketed predicate devices. This type of notification focuses on comparing a new device to an existing one that has already been approved, rather than presenting new performance study results against specific criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance
2. Sample size and data provenance for the test set
3. Number and qualifications of experts for ground truth
4. Adjudication method for the test set
5. MRMC comparative effectiveness study results
6. Standalone performance study
7. Type of ground truth used
8. Sample size for the training set
9. Method for establishing ground truth for the training set

The document primarily states the device's classification, applicable regulations, and the FDA's decision regarding its marketability based on substantial equivalence. It does not delve into the detailed performance data or study methodologies that would typically be associated with demonstrating acceptance criteria.

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