(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 Sm ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies Sm.
Not Found
The provided text is related to a 510(k) premarket notification for a medical device and does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and study particulars. The document primarily focuses on the FDA's decision of substantial equivalence and regulatory compliance.
However, based on the limited information, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy). It only states the Indications for Use for the device, which is:
"The Sm ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies Sm."
This describes what the device is intended to do, but not the performance thresholds it needs to meet.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not available in the provided text. The document refers to a "request for a substantially equivalent determination assuming compliance with the Current Good Manufacturing Practice requirements," but does not detail the specific clinical or analytical study that would contain this information.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not available in the provided text.
4. Adjudication Method:
This information is not available in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not available in the provided text, as this is an in vitro diagnostic device (ELISA test system), not an imaging or diagnostic device where human reader interpretation is typically involved in the same way. The device performs an "analysis of human serum," which usually implies automated or semi-automated output that does not require reader-AI comparison.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
This information is not explicitly detailed in the provided text. As an ELISA test system, its "standalone performance" would be inherent in its analytical validity (e.g., how accurately it detects Sm antibodies). The document implies that the device performs "manual or automated analysis," suggesting it can operate independently without continuous human intervention during the analysis itself, but specific performance metrics are missing.
7. Type of Ground Truth Used:
This information is not available in the provided text. For an in vitro diagnostic device detecting antibodies, the ground truth would typically be established through highly sensitive and specific reference methods, clinical diagnosis, or patient outcomes.
8. Sample Size for the Training Set:
This information is not available in the provided text.
9. How the Ground Truth for the Training Set Was Established:
This information is not available in the provided text.
Summary of Available Information:
| Feature | Information from Document |
|---|---|
| Acceptance Criteria | Not explicitly stated (only Indications for Use: "manual or automated analysis of human serum for the presence or absence of IgG antibodies Sm"). |
| Reported Device Performance | Not available. |
| Sample Size (Test Set) | Not available. |
| Data Provenance (Test Set) | Not available. |
| Number of Experts (Ground Truth - Test Set) | Not applicable/Not available (IVD device, ground truth established by analytical methods or clinical diagnosis, not typically expert panel review of images). |
| Qualifications of Experts (Ground Truth - Test Set) | Not applicable/Not available. |
| Adjudication Method (Test Set) | Not applicable/Not available. |
| MRMC Comparative Effectiveness Study | Not applicable (In Vitro Diagnostic device, not an imaging device with human AI assistance). |
| Standalone Performance Study (Algorithm Only) | Implied by "automated analysis" capability, but no performance metrics are detailed. The device itself is the "algorithm." |
| Type of Ground Truth Used | Not available (for an IVD, typically a reference method, clinical diagnosis, or pathology). |
| Sample Size (Training Set) | Not applicable/Not available (for a traditional ELISA system, there isn't a "training set" in the AI sense; instead, performance is validated through analytical and clinical studies). |
| How Ground Truth was Established (Training Set) | Not applicable/Not available. |
§ 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).