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For use with pulmonary function testing (PFT) equipment only. To filter air between the patient's exhaled air and the testing equipment. Single patient use, single session, and disposable. Maximum duration of use is 24 hrs.

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This document is a 510(k) premarket notification for spirometry filters and does not contain information on acceptance criteria or studies proving device performance against such criteria in the way typically expected for an AI/ML medical device.

The FDA 510(k) clearance letter (K111587) for "Alerkan Spirometry Filters - Models 9502, 9503, 9504, and 9505" indicates that the device is substantially equivalent to legally marketed predicate devices. This type of clearance primarily focuses on demonstrating that the new device is as safe and effective as devices already on the market, rather than requiring extensive clinical trials with specific performance criteria against a ground truth as would be expected for a novel diagnostic algorithm.

Therefore, most of the requested information (items 1 through 9) is not applicable to this document. The document describes the device's intended use and compatibility with various PFT equipment but does not define specific performance metrics for the filters themselves (e.g., filtration efficiency at certain pore sizes, pressure drop, etc.) nor does it present a study to demonstrate such performance.

Explanation for non-applicability of requested information:

1. A table of acceptance criteria and the reported device performance: Not present. This document is a 510(k) clearance, which confirms substantial equivalence to predicate devices, not performance against novel acceptance criteria.
2. Sample size used for the test set and the data provenance: Not applicable. No test set for algorithm performance is discussed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a diagnostic output is relevant here.
4. Adjudication method: Not applicable. No diagnostic outputs requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML device, nor a diagnostic device requiring human interpretation of results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical filter, not an algorithm.
7. The type of ground truth used: Not applicable. No ground truth is established for assessing diagnostic performance.
8. The sample size for the training set: Not applicable. No algorithm training.
9. How the ground truth for the training set was established: Not applicable. No algorithm training.

The document essentially provides information about the administrative clearance of physical spirometry filters, including their models, intended use, compatibility, and environment of use for pulmonary function testing. It does not provide the kind of performance data and study details requested in your prompt, which are typically associated with the evaluation of diagnostic algorithms or imaging devices.

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