(75 days)
The MDI SS-A Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human SS-A in human serum. The test is intended as an aid in the diagnosis of rheumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.
The Micro Detect, Inc. SS-A reagent ( MDI SS-A Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls, Wash Buffer, Sample Diluent, Conjugate, Substrate, and Stop Solution.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MDI SS-A Test, addressing your specific questions:
Acceptance Criteria and Device Performance Study for MDI SS-A Test
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Relative Sensitivity | 100% |
| Relative Specificity | 97.2% |
| Precision (Inter-Assay) | 3.23 - 6.42 |
| Precision (Intra-Assay) | 1.73 - 5.52 |
| Stability (Shelf Life) | One year at 2-8°C |
Note: The document does not explicitly state pre-defined acceptance thresholds for sensitivity, specificity, and precision. Instead, it reports the achieved performance values, implying these met the internal or regulatory expectations for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided document does not specify the number of experts used to establish the ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The provided document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or reported in this document. The device is a diagnostic reagent, and the study focuses on its analytical performance (sensitivity, specificity, precision) rather than human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance
The device is a manual procedure using a microplate ELISA format (a reagent kit). It is not an algorithm or AI-powered device. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The reported performance metrics (sensitivity, specificity, precision) inherently reflect the standalone performance of the reagent kit when used as intended.
7. Type of Ground Truth Used
The document states that "The patient results obtained using the MDI SS-A Test is substantially equivalent to those obtained by using predicate assays." This implies that the ground truth for determining sensitivity and specificity was established by comparing the MDI SS-A Test results with results from legally marketed predicate devices. The exact nature of how those predicate devices established their ground truth (e.g., expert consensus, pathology, clinical diagnosis, or outcomes data) is not detailed for this particular study, but it relies on the established accuracy of the predicate tests.
8. Sample Size for the Training Set
The provided document does not specify a training set sample size. Given that this is a diagnostic reagent and not an AI/machine learning model, the concept of a "training set" in the context of model development is not directly applicable. The "training" in such a context would typically involve optimizing the assay's reagents and conditions, which is part of the product development process, not usually reported as a "training set" in regulatory submissions.
9. How Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" for an AI/ML model is not applicable here. The assay development process would involve optimizing parameters against known positive and negative samples, often characterized by predicate method results or clinically diagnosed patient samples. However, the document does not provide details on how the ground truth for these developmental samples (if considered a "training set") was established.
§ 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).