(49 days)
The Diamedix Is anti-Cardiolipin Screen Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to cardiolipin in human serum as an aid in the assessment of the risk of thrombosis in patient with SLE or SLE-like disorders. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor
The Is anti-Cardiolipin Screen Test System is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative measurement of IgG, IgM and IgA antibodies to cardiolipin in human serum
Here's a breakdown of the acceptance criteria and the study details for the Is anti-Cardiolipin Screen Test System, based on the provided text:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets. Instead, the submission demonstrates the device's performance through comparison to a similar device and its clinical utility in specific patient populations. The "acceptance criteria" can be inferred as achieving satisfactory levels of agreement and correlation with established methods, along with demonstrating clinical sensitivity and specificity.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Relative Sensitivity (vs. comparable ELISA) | 82.2% (95% CI: 74.7-89.6%) |
| Relative Specificity (vs. comparable ELISA) | 100.0% (95% CI: 96.3-100.0%) |
| Overall Agreement (vs. comparable ELISA) | 91.0% (95% CI: 86.2-94.6%) |
| Clinical Specificity (Normals) | 95.3% (205/215) |
| Clinical Specificity (RPR Positive) | 66.7% (10/15) |
| Clinical Sensitivity (APS Patients) | 94.7% (54/57) |
| Clinical Sensitivity (SLE Patients) | 29.4% (10/34) |
| Clinical Sensitivity (Other Autoimmune Diseases) | 25.0% (6/24) |
| Correlation of Manual vs. Automated (MAGO Plus) | Correlation Coefficient (r) = 0.9497 (with scattergrams and regression lines showing good correlation) |
| Precision (Intra-assay and Interassay) | Reported CV% values for various serum samples and methods (manual and MAGO Plus). For example, manual interassay CV% ranged from 6.13% to 15.83%. MAGO Plus interassay CV% ranged from 16.70% to 34.51%. (No explicit acceptance criteria for CV% are given, but the data is provided to demonstrate acceptable precision for a diagnostic kit.) |
| Expected Values in Normal Population | 5.4% prevalence in a normal S. Florida blood donor population (148 tested). |
| Expected Values in Clinical Population (APS) | 94.7% positive in a clinical population with diagnosed APS (57 tested). |
2. Sample Size Used for the Test Set and Data Provenance
- Relative Sensitivity and Specificity Study:
- Sample Size: 203 frozen, retrospective sera.
- Data Provenance: Not explicitly stated, but implied to be from a general population from which frozen sera were collected.
- Clinical Sensitivity and Specificity Study:
- Sample Size: 345 frozen, retrospective, clinically characterized sera.
- Data Provenance: Not explicitly stated, but includes "Normals," "patients with diagnosed anti-phospholipid syndrome (APS)," "patients with systemic lupus erythematosus (SLE)," "patients with other autoimmune diseases," and "patients with positive RPR titers." These are clinical samples.
- Correlation of Manual and MAGO Plus results:
- Sample Size: 152 serum samples.
- Data Provenance: Not explicitly stated, but implies routine clinical samples tested by both methods.
- Precision Study:
- Sample Size: Six serum samples (two negative, four positive), tested in three separate runs, generally in triplicate per run for intra-assay, leading to 9 replicates for interassay (n=9).
- Data Provenance: Not explicitly stated.
- Expected Values Study (Normal Population):
- Sample Size: 148 S. Florida blood donors.
- Data Provenance: Prospective collection from "S. Florida blood donors."
- Expected Values Study (Clinical Population):
- Sample Size: 57 sera from patients with a diagnosis of anti-phospholipid syndrome (APS).
- Data Provenance: Retrospective, clinically characterized sera.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There is no mention of experts being used to establish a ground truth for the test sets in the traditional sense of consensus reading or clinical adjudication.
- For the "Relative Sensitivity and Specificity" study, the ground truth was established by comparison to a "commercially available ELISA kit" and further resolved by a "referee EIA method."
- For the "Clinical Sensitivity and Specificity" study, the ground truth was based on "clinically characterized sera" and "diagnosed" patient populations (APS, SLE, etc.). This implies medical diagnosis as the ground truth.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method like 2+1 or 3+1. The studies rely on comparison to existing commercial assays or established clinical diagnoses. In the "Relative Sensitivity and Specificity" study, there was "further resolution of the discordant samples" using a referee EIA method, which acts as a form of adjudication but not involving human readers/experts.
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
There was no MRMC comparative effectiveness study and no AI component mentioned in the provided text. This device is an immunoassay kit, not an AI-powered diagnostic system involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an immunoassay kit. The "standalone" performance is assessed by its analytical characteristics (sensitivity, specificity, precision, correlation to other methods) and clinical performance without human interpretation being the primary variable. The device itself generates a semi-quantitative result. The "MAGO Plus Automated EIA Processor" represents an automated, "algorithm-only" (i.e., machine-only) method for running the assay, and its correlation with manual performance was specifically studied.
7. The Type of Ground Truth Used
- Relative Sensitivity and Specificity Study: Comparison to a commercially available ELISA kit and a "referee EIA method." This is a form of reference standard comparison (another validated test).
- Clinical Sensitivity and Specificity Study: Clinical diagnosis of specific conditions (e.g., diagnosed Anti-phospholipid Syndrome (APS), Systemic Lupus Erythematosus (SLE), normal status). This is a form of outcomes data/clinical characterization.
- Expected Values Study:
- Normal population: Healthy blood donor status (absence of disease).
- Clinical population: Clinical diagnosis of Anti-phospholipid Syndrome (APS).
8. The Sample Size for the Training Set
There is no mention of a separate "training set" in the context of machine learning or AI. This is a traditional immunoassay kit. Method development and optimization would have involved internal lab work, but not a distinct "training set" as understood in AI/ML. All samples mentioned in the summaries above would typically be considered "test sets" or "validation sets" for the final device performance.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a training set in the AI/ML context, this question is not applicable. The development of the assay itself would have involved establishing the optimal conditions and reagents, but not "ground truth" for a training set in the AI sense.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).