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combination products, i.e. bacterial/viral filters and heat and moisture exchangers

This document is a 510(k) Summary of Safety and Effectiveness for a medical device (Gibeck Iso-Gard® HEPA Filter-HME). It provides information about the device's performance characteristics and its substantial equivalence to a predicate device.

However, the provided text does not contain the information requested for an AI/ML device study. It describes a physical medical device (a filter/heat and moisture exchanger) and its testing against physical performance criteria, not an AI algorithm.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: While there are performance metrics (bacterial/viral filtration efficiency, moisture output), these are for a physical filter, not an AI algorithm.
2. Sample size used for the test set and the data provenance: Not applicable to a physical filter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This document pertains to the regulatory submission for a physical medical device and its physical performance testing, not to an AI/ML diagnostic or prognostic device study.

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