(46 days)
The MDI Sm Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human Sm in human serum. The test is intended as an aid in the diagnosis of theumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.
The Micro Detect, Inc. Sm reagent ( MDI Sm 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 to extract the requested information about the device's acceptance criteria and the study proving it:
Device: MDI Sm Test
1. Table of acceptance criteria and reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Relative Sensitivity | 100% |
| Relative Specificity | 100% |
| Precision (Inter-assay %CV) | 3.7 - 7.07 |
| Precision (Intra-assay %CV) | 1.06 - 7.3 |
| Stability | One year at 2-8°C (predicted) |
Note: The document states that the stability of one year at 2-8°C was predicted from stress condition studies, and real-time stability had only been monitored for two weeks at 2-8°C. This suggests that the one-year stability criterion was based on accelerated testing, with ongoing real-time monitoring.
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions the use of "human serum."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.
4. Adjudication method for the test set
The document does not specify any adjudication method for the 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
No. The MDI Sm Test is described as a "manual procedure" using a micro plate ELISA format. It is an in vitro diagnostic (IVD) device designed for semi-quantitative determination of IgG antibodies, not an AI-powered diagnostic system involving human readers interpreting images or data for improvement with AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in the context of an IVD device, the performance metrics (sensitivity, specificity, precision, stability) are indicative of the standalone performance of the device itself (the reagents and protocol). There is no "human-in-the-loop" component in the device's performance evaluation as described, beyond the standard laboratory technician performing the manual procedure as instructed. The performance values reported are for the device's ability to detect antibodies independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth was established by comparison to results obtained from predicate assays. It states: "The patient results obtained using the MDI Sm Test is substantially equivalent to those obtained by using predicate assays: Relative Sensitivity: 100% Relative Specificity: 100 %". This suggests that the "true" positive or negative status for Sm antibodies was determined by these established predicate assays.
8. The sample size for the training set
The document does not mention a "training set" as would be used for machine learning. This is an IVD device, and its development would typically involve optimization and validation studies, rather than machine learning training.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of machine learning, this question is not applicable. For conventional IVD development, ground truth for developmental and validation samples would likely be established using reference methods, defined clinical criteria, or established predicate devices.
§ 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).