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An enzyme linked immunoassay (ELISA) for the detection of antinuclear and cytoplasmic antibodies in human serum to aid in the diagnosis of autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome (SS), Mixed Connective Tissue Disease (MCTD), and Scleroderma.

An enzyme linked immunoassay (ELISA)

Here's an analysis of the provided text to extract the requested information about device acceptance criteria and the study that proves the device meets those criteria:

Device Name: ImmuLisa Antinuclear Antibody Screen ELISA
Regulation Number: 21 CFR § 866.5100
Regulation Name: Antinuclear Antibody Immunological Test System
Regulatory Class: II
Product Code: LJM

Based on the provided text, the document is a 510(k) clearance letter from the FDA. This type of document declares "substantial equivalence" to a predicate device but does not typically contain the detailed acceptance criteria or the full study protocols and results. The letter mentions that the device is substantially equivalent "for the indications for use stated in the enclosure," but the enclosure itself (page 2 of the document) only lists the Indications for Use, not specific performance acceptance criteria.

Therefore, much of the requested information cannot be directly extracted from this document. However, I can infer some aspects based on the nature of a 510(k) submission for an ELISA diagnostic.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. A 510(k) clearance letter typically states the device is substantially equivalent, implying that its performance meets the standards comparable to a predicate device, but it doesn't detail the specific criteria or the results against them.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document only states the device's indications for use.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided in the document. Given that this is an ELISA diagnostic (a laboratory test that directly measures antibodies), a MRMC study, which typically involves human readers interpreting images, is unlikely to be the primary method for demonstrating effectiveness. Performance for such devices is usually assessed through analytical and clinical precision, accuracy, sensitivity, and specificity studies.

6. Standalone Performance Study

While not explicitly stated as "standalone performance study," the entire 510(k) submission for an ELISA likely includes analytical and clinical performance data for the algorithm/test itself (without human interpretation in the loop, beyond running the test and reading the quantitative results). However, the specific details of such a study are not included in this clearance letter.

7. Type of Ground Truth Used

This information is not provided in the document. For an ELISA for autoimmune diseases, ground truth would typically be established by a combination of clinical diagnosis (based on symptoms and other tests), and potentially other reference assays or biopsy/pathology for specific conditions if applicable.

8. Sample Size for the Training Set

This information is not provided in the document. Training sets are more relevant for machine learning algorithms; for a traditional ELISA, "training" isn't applicable in the same sense, though assay development and optimization phases would involve extensive testing.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document. (See point 8).

Summary of Document Contents Regarding Acceptance Criteria and Study Details:

The provided document is an FDA 510(k) clearance letter for the ImmuLisa Antinuclear Antibody Screen ELISA. It confirms the device's substantial equivalence to a predicate device for its stated Indications for Use. However, the letter does not contain the detailed acceptance criteria or the specifics of the studies (like sample sizes, ground truth establishment, expert qualifications, or detailed performance metrics) that led to this clearance. These details would typically be found in the full 510(k) submission document, which is not provided here.

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