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The Immuno Concepts IgG Anti-nDNA Fluorescent Test System is for in vitro diagnostic use for the qualitative detection and semi-quantitation of anti-nDNA antibodies of the IgG class in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence Semiautomated Microscope. The Immuno Concepts IgG Anti-IDNA Fluorescent Test System is to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software.

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The provided text is a 510(k) premarket notification clearance letter from the FDA for the "Immuno Concepts IgG Anti-nDNA Fluorescent Test System" and the "Image Navigator® Fluorescence Semiautomated Microscope." It details the device's indications for use and general regulatory information but does not contain the specific acceptance criteria, study details, or performance data that would allow for a complete answer to your request.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. To find the detailed study information, one would typically need to review the full 510(k) summary or the pivotal study report submitted by the manufacturer to the FDA, which is not included in this clearance letter.

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INTENDED USE: This is an indirect Fluorescent antibody test for the qualitative and semi-quantitative detection of IgG autoantibodies in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence SemiAutomated Microscope. This test system is to be used as an aid in the detection of anti-mitochondrial (AMA), antiparietal cell (APCA), and anti-smooth muscle (ASMA) autoantibodies associated with Type 1 Autoimmune Hepatitis, Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software.

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This FDA 510(k) clearance letter for K180202, the HISTOFLUOR RODENT LKS FLUORESCENT ANTIBODY TEST SYSTEM Image Navigator by Immuno Concepts, provides information about its intended use but does not include a detailed description of the acceptance criteria or a study proving that the device meets those criteria, nor does it provide specifics about the test set, ground truth, or training set parameters.

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. The "Indications for Use" section describes what the device is intended for (qualitative and semi-quantitative detection of certain autoantibodies) and how it's to be used (manual fluorescent microscopy or with the Image Navigator® Fluorescence Semi-Automated Microscope, with a trained operator confirming results).

Therefore, based solely on the provided text, I cannot complete the requested table and detailed study information. The details about the performance study, acceptance criteria, sample sizes, expert qualifications, and ground truth methodologies would typically be found in the 510(k) submission document itself, which is a much larger and more technical document than this clearance letter.

Here's what can be inferred or stated from the provided text, along with the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Information that cannot be determined from the provided FDA clearance letter:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be determined from the provided text. The clearance letter does not include details on the study design, sample sizes, or data origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Cannot be determined from the provided text. The letter states that a "trained operator must confirm results generated with the Image Navigator® semi-automated device and software," implying human oversight, but it does not specify the number or qualifications of experts for establishing ground truth during the validation studies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Cannot be determined from the provided text. No information on adjudication methods is present.

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

• Cannot be determined from the provided text. The letter does not explicitly mention an MRMC study or quantify human performance improvement with AI assistance. It indicates the device can be used with a semi-automated microscope and software, but the impact on human readers is not detailed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Implied not standalone by "A trained operator must confirm results." The text states, "A trained operator must confirm results generated with the Image Navigator® semi-automated device and software." This indicates that the device is intended for use with human-in-the-loop and not as a fully standalone diagnostic tool for final results. Whether a standalone performance evaluation was conducted internally for algorithm development is not stated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Cannot be determined from the provided text. While the device aids in detecting autoantibodies associated with specific conditions (Type 1 Autoimmune Hepatitis, Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis) "in conjunction with other laboratory and clinical findings," the specific method for establishing ground truth in the device's validation studies is not described.

8. The sample size for the training set

• Cannot be determined from the provided text. Information about the training set size is not included in this document.

9. How the ground truth for the training set was established

• Cannot be determined from the provided text. No details are provided regarding the establishment of ground truth for any training data used for the device's algorithm.

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Instrument: The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital indirect immunofluorescent slides. The Image Navigator can only be used with cleared or approved Immuno Concepts in vitro diagnostic assays that are indicated for use on the microscope. All suggested results generated by the Image Navigator software must be confirmed by trained laboratory personnel.

Assay: This is an indirect fluorescent antibody test for the semi-quantitative detection of IgG antinuclear antibody (ANA) in human serum by manual fluorescent microscopy or with the Image Navigator Fluorescence Semi-Automated Microscope. This test system uses transfected HEp-2000® cells, which allow specific identification of autoantibodies to the SSA/Ro antigen. Autoantibodies to SSA/Ro may show a distinctive staining pattern on the transfected cells. When this pattern is present, it is considered to be confirmatory evidence that anti-SSA/Ro antibodies are present. Absence of this distinctive pattern does not rule out the possible presence of anti-SSA/Ro antibodies. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator semi-automated device and software.

The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital indirect immunofluorescent slides.

The provided document serves as an FDA 510(k) clearance letter for the HEp-2000® Fluorescent ANA/Ro Test System; Image Navigator by Immuno Concepts. While it outlines the device's indications for use and classification, it does not include detailed information regarding acceptance criteria, study design, specific performance metrics, or ground truth establishment.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is an administrative clearance, not a scientific study report.

To answer your request, a different type of document, such as a summary of safety and effectiveness (SSED) from the FDA or the original submission's performance data, would be needed.

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