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The spirotel spirometer is intended to be used by a patient under indications For 500. The opirator epiratory therapist to test lung function in people of all the matraction of a priyation of a single-patient device only and can be used in any setting - home, factory, hospital or physician's office.

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I am sorry, but the provided text from the FDA 510(k) summary for the Spirotel, Model 29-1020, does not contain the detailed information necessary to answer the questions about acceptance criteria and the specific study proving the device meets those criteria.

The document primarily focuses on the FDA's substantial equivalence determination, the regulatory classification of the device, and general compliance requirements. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes (test set, training set), data provenance.
• Information on experts used for ground truth, adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only study.
• The type of ground truth used or how it was established for training or testing.

Therefore, I cannot generate the requested table and answer the specific study-related questions based on the input provided.

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