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The intended use of the device is to aid in the detection of pulmonary nodules (2-30 mm in diameter) in adults (22 years of age and older) on chest radiographs. The device is intended to be used as a concurrent reader. The device is not intended to be used for diagnosis. The device is intended to be used in the radiology department.

The device is a software device that uses artificial intelligence to analyze chest radiographs. The device is intended to be used as a concurrent reader to aid in the detection of pulmonary nodules. The device is not intended to be used for diagnosis. The device is intended to be used in the radiology department.

Please provide the input text you are referring to as "{0}", "{1}", and "{2}". I need this information to describe the acceptance criteria and the study that proves the device meets them.

Once you provide the input, I will be able to construct a comprehensive response including:

1. A table comparing acceptance criteria with reported device performance.
2. Details on sample size, data provenance, and study design (retrospective/prospective).
3. Information on the number and qualifications of experts used for ground truth establishment.
4. Description of the adjudication method employed for the test set.
5. Whether an MRMC study was conducted and its findings regarding AI assistance.
6. Confirmation of standalone algorithm performance evaluation.
7. The type of ground truth utilized (e.g., expert consensus, pathology, outcomes).
8. The sample size of the training set.
9. The methodology for establishing ground truth within the training set.

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