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AESKULISA ENA 6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and purified native human snRNP/Sm, Sm and SS-A 60 kDa.

The assay is a tool in the diagnosis of certain systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.

solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and purified native human snRNP/Sm, Sm and SS-A 60 kDa.

This document, a 510(k) premarket notification, does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria in the format requested.

The provided text is an FDA clearance letter for a device named "AESKULISA ENA6 S". It confirms that the device is substantially equivalent to legally marketed predicate devices. While it mentions the "Indications For Use" for the device, it does not include the specific study design, performance metrics, or acceptance criteria that would typically be found in a detailed study report or clinical trial summary.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, you would need to refer to the full 510(k) submission document or related study reports, which are not included here.

Here's a breakdown of why each point cannot be addressed with the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The letter only states the device is "substantially equivalent."
2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an in-vitro diagnostic immunoassay, not an AI-based imaging device with human readers. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: As above, this is an immunoassay, not an algorithm, so this concept is not applicable.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned. Immunoassays typically don't have "training sets" in the AI sense; instead, they have validation studies.
9. How the ground truth for the training set was established: Not mentioned, and as above, the concept of a "training set" with ground truth in this context is generally not applicable.

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