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The Polytech filter is a disposable, single-patient session filter for spirometric and pulmonary function testing. The Polytech filter is designed to reduce cross contamination in pulmonary function equipment. The filter is to be used with children and adult subjects, but it is not indicated for use with neonatal subjects. It is to be used under the direction of a physician.

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This document is a 510(k) summary for the Polytech Pulmonary Function Filter, a disposable filter for spirometric and pulmonary function testing. As such, it does not contain the detailed information required to answer your specific questions about acceptance criteria and study particulars for a device using an AI algorithm.

The questions you've asked are typically relevant for AI/ML-based medical devices that require extensive validation studies to demonstrate their performance against defined acceptance criteria. This document is for a physical, disposable filter, not an AI diagnostic or predictive tool.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and the reported device performance: This document does not define performance metrics in terms of sensitivity, specificity, accuracy, etc., as would be expected for an AI algorithm. Its performance relates to its physical function as a filter.
• Sample size used for the test set and the data provenance: Not applicable to a physical filter.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone performance was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

This document indicates that the device is a "Polytech Pulmonary Function Filter" and that it is "designed to reduce cross-contamination in pulmonary function equipment." The FDA deemed it "substantially equivalent" to legally marketed predicate devices. This equivalence is typically based on comparing the new device's technological characteristics and performance to those of a legally marketed predicate device, ensuring it's as safe and effective. The performance of such a filter would be assessed based on its filtration efficiency (e.g., bacterial/viral filtration efficiency), pressure drop, and absence of shedding, rather than diagnostic precision metrics.

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