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To aid in the diagnosis of systemic lupus erythematosus and related conditions.

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I am sorry, but the provided text does not contain the detailed information necessary to answer the request about acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a diagnostic device, which confirms substantial equivalence but does not describe the specific performance studies, sample sizes, ground truth establishment, or expert qualifications that would typically be detailed in a submission summary or a scientific publication.

Therefore, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance. (Note: This is an in-vitro diagnostic, not an AI-based imaging device, so this question is likely not applicable)
6. If a standalone (algorithm only) performance study was done. (Note: This is an in-vitro diagnostic, not an AI-based algorithm, so this question is likely not applicable)
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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