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510(k) Data Aggregation
(52 days)
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of circulating IgM rheumatoid factor. When used according to instructions, the kit is useful in establishing the presence of rheumatoid factor and as an aid in the diagnosis and management of rheumatic diseases.
An enzvme-linked immunosorbent assay (ELISA) designed for the detection and measurement of IgM rheumatoid factor in human serum and plasma.
The ELISA methodology is commonly used for antibody evaluations. Purified IgG has been attached to the inner surfaces of the microwell plate. During the initial incubation step, rheumatoid factor in patient serum or plasma binds specifically to the immobilized IgG and remains in place after a wash step.
A second antibody which is conjugated to horseradish peroxidase (HRP) is used to recognize the "u" chain regions of the patient's IgM rheumatoid factor remaining after the wash step. In the wells where the second antibody remains bound. the coniugated HRP catalyzes a color change in the substrate. After the reaction is stopped, the color is read in an EIA Plate reader.
Here's an analysis of the provided text, focusing on the acceptance criteria and the supporting study, structured as requested:
Acceptance Criteria and Study Details for Hemagen® Rheumatoid Factor Kit
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are largely implied by the performance metrics reported. The study aimed to demonstrate substantial equivalence to a predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (Inter-assay) | Low %CV (indicating acceptable variability between runs) | Mean %CV for IU/mL: Range from 7.2% to 11.7% (for positive samples). Mean %CV for O.D.: Range from 11.6% to 15.6%. |
| Precision (Intra-assay) | Low %CV (indicating acceptable variability within a single run) | Mean %CV for IU/mL: Range from 2.6% to 10.8% (for positive samples). Mean %CV for O.D.: Range from 2.3% to 8.4%. |
| Correlation with WHO Standard (Calibrators) | High degree of correlation with WHO International Reference Preparation | A study was conducted to demonstrate a "high degree of correlation" (specific numerical criteria not provided). |
| Relative Analytical Sensitivity | Acceptable sensitivity compared to the predicate device | 94.8% (95% CI: 87.3% to 97.9%) compared to the predicate device in the RF panels. |
| Relative Analytical Specificity | Acceptable specificity compared to the predicate device | 93.1% (95% CI: 78.0% to 98.1%) compared to the predicate device in the RF panels. |
| Performance with Normal Blood Donors | Low false positive rate compared to predicate device | In a panel of normal blood donors (N=82): 4 positives by proposed device, 4 positives by predicate, 78 negatives by both. No false positives/negatives detected by either device compared to the other. |
| Assay Performance with Serum and Plasma | Accurate estimates of IgM RF in both serum and plasma | Results indicate the kit "can provide accurate estimates of IgM rheumatoid factor in both human serum and plasma." (Specific quantitative equivalence not provided). |
| Interfering Substances (Hemoglobin) | < 20% variation in assay performance | ≤ 500 mg/dL hemoglobin concentration: No significant effect (< 20% variation). |
| Interfering Substances (Lipid) | < 20% variation in assay performance | ≤ 3000 mg/dL lipid concentration: No significant effect (< 20% variation). |
| Interfering Substances (Bilirubin) | < 20% variation in assay performance | ≤ 20 mg/dL bilirubin concentration: No significant effect (< 20% variation). |
| Prozone Effect | No unexpectedly low values with high-titered serum | Kit "gives appropriately high positive results with high-titered sera." (Specific data not provided). |
2. Sample Size Used for the Test Set and Data Provenance
- RF Panels (Comparison Testing): N = 106 serum specimens (from rheumatoid arthritis patients and apparently healthy donors).
- Normal Blood Donors (Comparison Testing): N = 82 samples.
- Serum and Plasma Comparison: N = 92 matched serum and plasma samples.
- Precision Studies: 8 different serum samples (repeated multiple times).
- Interfering Substances: Specific number of samples not stated, but "samples" were evaluated.
- Prozone: A "high-titered serum sample" was used (singular).
Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the medical device submission context, it's highly likely it was prospective testing conducted for the purpose of the submission. The "serum specimens from rheumatoid arthritis patients and normal apparently healthy donors" suggests typical clinical samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided text does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be established by comparison to the predicate device (Hemagen RF Hemagglutination Kit) and clinical classifications (rheumatoid arthritis patients and normal donors).
4. Adjudication Method for the Test Set
No adjudication method is described. The comparison is directly between the proposed device and the predicate device, seemingly on a sample-by-sample basis.
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 MRMC study was done. This document describes the performance of an in vitro diagnostic (IVD) kit, not an AI-assisted diagnostic tool that would involve human readers interpreting results. Therefore, the concept of "human readers improve with AI" is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this entire study describes the standalone performance of the Hemagen® Rheumatoid Factor Kit (an ELISA assay). It is an algorithm-only (in the sense of a defined chemical/enzymatic process with a quantitative output read by a machine) performance without human interpretation or intervention in the diagnostic process itself. The interpretation of the optical density into IU/mL and its classification as positive/negative based on a cutoff is inherent to the kit's design.
7. The Type of Ground Truth Used
The primary ground truth used for performance evaluation (specifically sensitivity and specificity) is the predicate device (Hemagen RF Hemagglutination Kit). Additionally, for the comparison testing, samples were drawn from "rheumatoid arthritis patients" and "normal apparently healthy donors," implying a clinical diagnosis (outcomes data) based on established medical criteria as a secondary ground truth, against which both the proposed and predicate device were compared.
8. The Sample Size for the Training Set
No training set is mentioned in the document. This is an IVD kit describing analytical performance, not a machine learning model that would typically have a distinct training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning model is described.
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