(11 days)
AESKULISA®dsDNA-G is a solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. The assay is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
solid phase enzyme immunoassay with human recombinant doublestranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum.
This FDA 510(k) clearance letter for the AESKULISA dsDNA G device does not contain the detailed study information needed to fully address your request regarding acceptance criteria and device performance. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.
However, based on the information provided, I can infer some points and explicitly state what is not present in this document:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision). The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a predicate device, and while performance data is submitted, it is not typically detailed in the clearance letter itself.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document does not provide any information about the sample size used for the test set, data provenance (country of origin), or whether the study was retrospective or prospective.
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):
This document does not provide information on the number or qualifications of experts used to establish ground truth for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This document does not provide any information about an adjudication method for a test set.
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:
The device described, AESKULISA dsDNA G, is an "immunoassay" for the quantitative and qualitative detection of IgG antibodies. This is a laboratory diagnostic test and is not an AI-assisted diagnostic device that would involve human readers or MRMC studies. Therefore, this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a laboratory immunoassay, not an algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable here. Its performance is inherent to the assay's biochemical reactions and detection method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
While not explicitly stated in this document, for an immunoassay like AESKULISA dsDNA G, the "ground truth" for the presence or absence of IgG antibodies against dsDNA would typically be established by:
- Clinical diagnosis of Systemic Lupus Erythematosus (SLE) confirmed by established criteria (e.g., ACR or SLICC criteria), which often includes a combination of clinical findings, other serological tests, and sometimes biopsy results.
- Reference laboratory methods for dsDNA antibody testing, which might involve other established immunoassays or IFA techniques where the "positive" or "negative" status is determined by expert interpretation and standard cut-offs.
The document only states the assay "is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings." This implies the "ground truth" for SLE diagnosis is complex and multi-faceted, not solely dependent on this one test.
8. The sample size for the training set:
This document does not provide information on the sample size for a training set. As an immunoassay, the concept of a "training set" in the context of machine learning (where this term is often used) doesn't directly apply. However, during the development of an immunoassay, there would be extensive testing on various patient cohorts to establish cut-offs, demonstrate linearity, precision, and agreement with predicate devices. These cohorts would serve a similar purpose to a training set in informing the assay's parameters.
9. How the ground truth for the training set was established:
This document does not provide information on how any ground truth for a "training set" was established. (See explanation for point 8).
Summary of what can be extracted from the document:
- Device Name: AESKULISA dsDNA G
- Indication for Use: Quantitative and qualitative detection of IgG antibodies against dsDNA in human serum as a tool in the diagnosis of systemic lupus erythematosus (SLE), to be used in conjunction with other serological tests and clinical findings.
- Regulatory Class: Class II
- Product Code: LSW
- Regulation Name: Antinuclear antibody immunological test system (21 CFR 866.5100)
- Type of Device: Solid phase enzyme immunoassay (ELISA) using human recombinant double-stranded DNA (dsDNA).
- Clearance Type: 510(k) substantial equivalence.
To obtain the detailed study information regarding acceptance criteria, performance metrics, sample sizes, and ground truth establishment, one would typically need to consult the full 510(k) submission available from the FDA, or the device's Instructions for Use (IFU) document, which often summarizes the performance characteristics from the validation studies.
§ 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).