(54 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 ANA Screen ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies to a variety of nuclear antigens such as those directed against double stranded DNA, Jo-1. Sm. Sm/RNP. SSA. SSB. and Scl-70. The test system is also capable of detecting ANA demonstrating the centromere, nucleolar, peripheral and spindle IFA patterns.
Not Found
I am unable to provide the specific details of the acceptance criteria and study that proves the device meets the acceptance criteria based on the provided document. The document is a 510(k) clearance letter for the "Aptus (Automated) Application for the ANA Screen ELISA Test System" and an "Indications for Use" statement.
While it confirms the device's clearance and its intended use, it does not contain the detailed data, study designs, or acceptance criteria that would typically be found in a submission summary, clinical study report, or a more comprehensive technical document.
The document states that the FDA has "reviewed your Section 510(k) notification of intent to market the device" and "determined the device is substantially equivalent...". This determination is based on the information provided by the manufacturer in their 510(k) submission, which would have included data to support the claims of substantial equivalence. However, that underlying data and the specific acceptance criteria are not present in these pages.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not provided.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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: Not mentioned. The device is referred to as an "Automated Application" for an ELISA test system, which generally implies a lab-based assay, not necessarily an AI-assisted diagnostic imaging or interpretation tool for human readers in the way an MRMC study would typically assess.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "automated" aspect suggests standalone performance, but specific study details are not provided.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, the provided document is a regulatory approval letter and indications for use, not a detailed technical report that describes the performance study.
§ 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).