(50 days)
The presence of autoantibodies to a number of nuclear constituents has proven to be useful in the diagnosis of various connective tissue diseases. Although the exact etiology of autoimmune diseases is unknown, and the specific role played by autoantibodies in the onset of various autoimmune connective tissue diseases is obscure, the association and frequency of detection of these antibodies may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases.
The dsDNA ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies dsDNA.
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This is an FDA Premarket Notification (510(k)) K983422 for the Zeus Scientific, Inc. Aptus (Automated) Application for the dsDNA Test System.
Based on the provided text, it is not possible to fully answer all aspects of your request as the document is a regulatory approval letter and does not contain detailed study information. However, I can extract what is available and indicate what information is missing.
Here's a breakdown of the available information and missing details:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The letter is an FDA approval for marketing based on substantial equivalence, but it does not detail specific acceptance criteria for a study or numerical performance results.
2. Sample size used for the test set and the data provenance
This information is not present in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not present in the provided document.
4. Adjudication method for the test set
This information is not present in the provided document.
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 information is not present in the provided document. The device is for "manual or automated analysis of human serum for the presence or absence of IgG antibodies dsDNA," suggesting an in-vitro diagnostic, not an imaging device typically associated with MRMC studies or human reader improvement with AI assistance in the way you've described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is named "Aptus (Automated) Application for the dsDNA ELISA Test System" and states it is intended for "manual or automated analysis." This implies that a standalone, automated performance was considered or is an intended use, but the document does not provide details of such a study.
7. The type of ground truth used
This information is not explicitly stated in the provided document. For a dsDNA ELISA test, the ground truth would typically be established by a reference method or clinical diagnosis of autoimmune disease (e.g., systemic lupus erythematosus), but the document does not specify.
8. The sample size for the training set
This information is not present in the provided document.
9. How the ground truth for the training set was established
This information is not present in the provided document.
Summary of what is known from the document:
- Device Name: Aptus (Automated) Application for the dsDNA ELISA Test System
- Intended Use: The dsDNA ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies to dsDNA. It is used in the diagnostic work-up of patients with suspected connective tissue diseases, as the presence of autoantibodies to nuclear constituents has proven useful in diagnosing various connective tissue diseases.
- Regulatory Status: Substantially equivalent to legally marketed predicate devices, classified as Class II, Product Code LRM.
- Type of Device: In-vitro diagnostic device.
To obtain the detailed study information you're asking for, you would typically need to review the 510(k) submission document itself, which would contain the preclinical and clinical study reports. The provided text is only the FDA's decision letter.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).