(62 days)
The EL-ANA Profiles™ is intended to measure autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), doublestranded DNA (dsDNA), Sm, RNP/Sm, SSA (Ro), SSB (La), Scl-70, Histones, Jo-1, Ribosomal Protein P, and Centromere. This system is intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases.
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Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the EL-ANA Profiles™ device. Unfortunately, the provided text is a 510(k) clearance letter and an "Indications For Use" statement. It does not contain the detailed information about the acceptance criteria or the study that proves the device meets those criteria.
A 510(k) clearance letter confirms that the FDA has determined the device is substantially equivalent to a predicate device, meaning it's as safe and effective. It does not typically include the full clinical study details that would outline acceptance criteria and performance data. Those details would normally be found in the 510(k) submission itself, which is a much more extensive document.
Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. I can only infer what the "acceptance criteria" were from the FDA's clearance, which is substantial equivalence to a predicate device for the stated indications for use.
Here's what I can provide based on the given information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Acceptance Criteria: Substantial equivalence to legally marketed predicate devices for the specified indications for use. This typically implies demonstrating comparable analytical performance (e.g., sensitivity, specificity, accuracy) and clinical utility to the predicate device. | The FDA determined the EL-ANA Profiles™ device is "substantially equivalent" to legally marketed predicate devices for the indications for use. This means the analytical and clinical performance of the EL-ANA Profiles™ was found to be comparable to that of the predicate devices based on the data submitted in the 510(k) application. The specific metrics of performance (e.g., sensitivity, specificity, accuracy values) are not provided in this document. The device is intended to measure autoantibodies to ssDNA, dsDNA, Sm, RNP/Sm, SSA (Ro), SSB (La), Scl-70, Histones, Jo-1, Ribosomal Protein P, and Centromere. It is intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Information Not Provided in the Text.
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)
- Information Not Provided in the Text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Information Not Provided in the Text.
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 device is an "immunological test system" for autoantibodies, not an imaging device typically analyzed by human readers in the same way. Therefore, an MRMC study as described (human readers with/without AI assistance) is not applicable to this type of device.
- Information regarding a comparative effectiveness study is not provided in the text. The 510(k) process focuses on substantial equivalence, not necessarily a comparative effectiveness study against a human standard or AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This device is an in vitro diagnostic (IVD) test. IVDs are inherently "standalone" in their analytical function; the test provides results based on the sample. The "human-in-the-loop" for this type of device is the medical professional interpreting the quantitative or qualitative results in the context of a patient's clinical presentation.
- The document does not detail the specific performance study, but IVD tests are evaluated for their analytical performance (e.g., accuracy, precision) in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For an immunological test system, the ground truth for establishing performance would typically involve:
- Clinical diagnosis: Confirmation of diseases like systemic lupus erythematosus (SLE) or related rheumatic diseases based on established diagnostic criteria (e.g., ACR criteria) and patient follow-up, which can involve expert consensus or established clinical practice.
- Reference methods/assays: Comparison against well-characterized and established assays for the same autoantibodies, often considered "gold standards" or established methods in the field.
- The specific type of ground truth used in the EL-ANA Profiles™ study is not provided in this text.
8. The sample size for the training set
- Information Not Provided in the Text. This document is about FDA clearance, not the development process. Furthermore, for a laboratory test like this, the concept of a "training set" in the machine learning sense is not generally applicable unless a computational algorithm is specifically being "trained" to interpret complex patterns, which is not indicated here for a standard immunoassay. Instead, assay parameters are optimized during development.
9. How the ground truth for the training set was established
- Information Not Provided in the Text. (See the reasoning for point 8).
In summary: The provided FDA 510(k) clearance letter confirms substantial equivalence but does not offer the granular detail of the performance study sought by your questions. This detailed information would be found in the original 510(k) submission, which is a much more extensive document.
§ 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).