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The Flosense is intended to be used as a disposable pneumotach for Puritan-Bennett spirometers which currently use the Puritan Bennett FS200 Flow Sensor.

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This is a traditional 510(k) clearance letter for a medical device (Flosense, Model 29-8010) and does not contain the detailed information about acceptance criteria and a study design that you've requested. These sections are typically found in the 510(k) submission itself or in a summary document (like a 510(k) summary or a clinical study report), not in the FDA's clearance letter. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

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

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