(75 days)
This is an in vitro diagnostic test system for thedetection and Semi-quantitation of tagsesses oblic cytoplasmic antibodies in human serum This test system is to be used as an aid in the detection of antibodies associated with autoimmune vasculitis, Wegener's granulomatosis, microscopic polyarteritis, and idiopathic crescentic glomerulonephritis.
This is an indirect fluorescent antibody test for the semi-quantitative detection of antineutrophil cytoplasmic antibody in human serum
Here's a breakdown of the acceptance criteria and study details based on the provided text, using the requested formatting:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria, but it establishes substantial equivalence by comparing the subject device's performance to a predicate device. The final reported performance after integrating a referee method is presented as the basis for this equivalence. Therefore, the "acceptance criteria" can be inferred from the reported performance that led to the FDA's substantial equivalence determination.
| Metric | Predicate Device (NOVA Lite™ ANCA) Performance | Subject Device (Immuno Concepts ANCA) Performance | Implied Acceptance Criteria (relative to predicate) |
|---|---|---|---|
| Relative sensitivity | 86.9% | 98.3% | Superior or equivalent to predicate |
| Relative specificity | 93.1% | 97.7% | Superior or equivalent to predicate |
| Overall agreement | 91.0% | 98.0% | Superior or equivalent to predicate |
2. Sample Size Used for the Test Set and Data Provenance
The study was conducted using retrospective serum samples.
- Normal Blood Donors: 497 samples (247 males, 250 females). Data provenance is not explicitly stated but implies collection from a general donor population.
- Previously ANCA-Positive Samples: 383 samples. Data provenance: Reference laboratories in the USA, the United Kingdom, and Australia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It mentions "in-house IFA assays" from reference laboratories in the USA, UK, and Australia for the previously positive samples, and the use of "referee method" (ELISA kits for MPO and PR3 antibodies) for discrepant and positive samples.
4. Adjudication Method for the Test Set
The adjudication method involved a "referee method" using ELISA kits for MPO and PR3 antibodies for samples that were:
- Positive by either the subject device or predicate device in the normal blood donor group.
- Discrepant between the subject device and the predicate device in the ANCA-positive sample group.
This can be considered a tertiary adjudication where an independent, more specific test is used to resolve discrepancies and confirm positivity/negativity. It's not a consensus method among human readers, but a higher-tier diagnostic test.
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
This information is not applicable as the device is an in vitro diagnostic test system (indirect fluorescent antibody test) for detecting antibodies in human serum, not an AI-based imaging or diagnostic aid for human readers. No human interpretation improvement with AI is mentioned or relevant to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study describes the standalone performance of the Immuno Concepts ANCA Test System directly compared to the NOVA Lite™ ANCA predicate device. This is a "device only" performance assessment where the output is directly read and compared.
7. The Type of Ground Truth Used
The ground truth was established using:
- A "referee method" based on specific antibody detection: ELISA kits for MPO (myeloperoxidase) and PR3 (proteinase 3) antibodies were used to confirm specific ANCA types in initially positive or discrepant samples. The results from these specific ELISA tests were used to reclassify samples as true positive or true negative for the final analysis.
- For the "previously determined to be positive for ANCA" samples, reference laboratory IFA assay results served as an initial ground truth, which was then further adjudicated by the ELISA referee method.
8. The Sample Size for the Training Set
The document does not mention a training set as this is an in vitro diagnostic kit, not an AI/machine learning algorithm that requires training. The provided data represents a validation/verification study.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or applicable, this question is not relevant to the provided document.
§ 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).