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510(k) Data Aggregation
(34 days)
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
The Stellar Bio Systems' Indirect Fluorescence Assay (IFA) for IgG Antinuclear Antibody (ANA) HEp2 is intended for the qualitative and semi-quantitative detection of IgG (Immunoglobulin G) antinuclear antibodies in human serum. Detection of ANA in humans can be used as an aid in the diagnosis of autoimmune connective tissue diseases.
The ANA IgG IFA is an Indirect Fluorescence Assay (IFA) for the detection of IgG antibodies to ANA antigens in human serum.
Here's a breakdown of the acceptance criteria and the study details for the Stellar Bio Systems' Indirect Fluorescence Assay for Anti-Nuclear Antibodies (ANA) IgG Antibody, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The device's performance was evaluated relative to a commercially available ANA IFA kit. The acceptance criteria are implicitly defined by the reported performance metrics, which demonstrate the device's ability to provide comparable results to an existing device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Stellar ANA IFA Kit) |
|---|---|---|
| Relative Sensitivity | ~93.5% (referencing alternate IFA) | 93.5% (95% CI: 87.0% - 97.3%) |
| Relative Specificity | ~97.8% (referencing alternate IFA) | 97.8% (95% CI: 92.2% - 99.7%) |
| Relative Agreement | ~95.4% (referencing alternate IFA) | 95.4% (95% CI: 91.5% - 97.9%) |
| Titer Agreement (Identical) | N/A (reported for 25 positive sera) | 12/25 sera had identical titers |
| Titer Agreement (± 1 dilution) | N/A (reported for 25 positive sera) | 11/25 sera were within ± one, two-fold dilution |
| Titer Agreement (± 2 dilutions) | N/A (reported for 25 positive sera) | 2/25 sera were within ± two, two-fold dilutions |
| Reproducibility | N/A (reported for 4 sera) | 35/36 endpoint titers identical, 1/36 within ± one dilution |
Study Details
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: 199 sera (100 from patients diagnosed with SLE, 99 from normals).
- Data Provenance: The samples were "frozen retrospective sera." The "99 sera were from normals with various ages, gender, and geographical areas." This suggests the data is retrospective and likely from mixed geographical origins, though specific countries are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the summary. The study used a "commercially available ANA IFA" as the comparator (or "alternate IFA") to establish "relative" truth, but it does not specify how the initial diagnosis of SLE or the determination of "normals" was made, nor the involvement of experts in establishing the reference standard.
4. Adjudication method for the test set:
- This information is not provided. The comparison was made against an "Alternate IFA," but the specifics of how discrepancies between the new device and the alternate were handled (if at all) are not detailed.
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:
- A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, and the device is not an AI-assisted device. It is a laboratory assay (Indirect Fluorescence Assay) for detecting antibodies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is an in-vitro diagnostic assay, not an algorithm or software. Its performance is inherent to the chemical and biological reactions involved in the test. Therefore, the concept of "standalone (algorithm only)" is not applicable. The reported performance is the standalone performance of the assay itself.
7. The type of ground truth used:
- The "ground truth" for this study was relative to another commercially available ANA IFA. The summary explicitly states: "Please be advised that 'relative' refers to the comparison of this assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease."
- For the SLE patients, their diagnosis (described as "patients diagnosed with SLE") served as an initial categorization, but the comparator IFA was the reference standard against which the new device was measured for "relative" performance.
8. The sample size for the training set:
- This information is not applicable/provided. This device is a manual laboratory assay, not a machine learning model that requires a "training set" in the computational sense. The described evaluations are performance studies.
9. How the ground truth for the training set was established:
- This information is not applicable as there is no training set in the context of this type of device.
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