(198 days)
The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments. For in vitro diagnostic use.
The Axis-Shield Anti-CCP device contains the following components: a microtitre plate with 8 x 12-well breakapart strips coated with purified synthetic cyclic citrullinated peptide, in a resealable foil pack with desiccant; ready to use calibrators (diluent with or without IqG antibodies against CCP2); positive and negative assay controls (human plasma with or without IgG antibodies against CCP); ready-to-use reference control; goat anti-human IgG horseradish peroxidase conjugate: TMB substrate; sample diluent (5x) wash buffer (10x); ready-to-use stop solution.
Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the supporting study:
The provided text describes a 510(k) submission for the Axis-Shield Anti-CCP device, claiming substantial equivalence to the DIASTAT™ Anti-CCP Assay. The primary study presented is a method comparison and concordance analysis between the two devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds (e.g., "concordance must be >95%"). Instead, it presents the achieved performance and implies that this level of performance was considered "substantially equivalent" to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance (Axis-Shield Anti-CCP vs. DIASTAT™ Anti-CCP) |
|---|---|
| Concordance | 99% concordance for all samples tested (n=514) |
| Clinical Differentiation | Comparable with respect to cut-off and clinical differentiation, as indicated by ROC curve analysis: |
- Axis-Shield anti-CCP AUC: 0.910 (95% CI: 0.881 to 0.940)
- DIASTAT™ anti-CCP AUC: 0.903 (95% CI: 0.871 to 0.934) (using suggested cut-off of 5.0 U/mL) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 514 samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, demographics of participants). The document only mentions using "human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate)." It's a clinical performance study comparing two assays, implying human samples. The study appears to be retrospective as it involves running existing banked samples on both devices for comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth in this study is based on the results of the predicate device (DIASTAT™ Anti-CCP Assay). This is a comparison study, not a study aiming to establish the accuracy against a gold standard for Rheumatoid Arthritis diagnosis directly. Therefore, there were no human experts establishing a separate ground truth for the test set beyond the predicate device's results.
4. Adjudication Method for the Test Set
The concept of an adjudication method (like 2+1 or 3+1) is typically relevant when establishing a ground truth based on multiple expert opinions. Since the ground truth for comparison was the predicate device's results, no expert adjudication method was used for the test set. The devices were likely run independently and their results compared.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (ELISA assay), not an imaging-based AI system that requires human interpretation. Therefore, there is no "human readers improve with AI vs. without AI assistance" effect size to report.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the study primarily demonstrates the standalone performance of the Axis-Shield Anti-CCP device by comparing its output (antibody levels) directly to the predicate device's output. ELISA assays are inherently standalone tests; human involvement is in performing the lab procedure, not in interpreting the raw results in a way that would classify it as "human-in-the-loop" for the algorithm itself.
7. The Type of Ground Truth Used
The "ground truth" for the comparison study was the results obtained from the legally marketed predicate device (DIASTAT™ Anti-CCP Assay). While the intended use notes the test is an "aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information," the study itself does not directly use a definitive RA diagnosis (e.g., pathology, long-term outcomes, or consensus clinical diagnosis) as its ground truth for evaluation. Instead, it assumes the predicate's results are acceptable and compares the new device's results to them.
8. The Sample Size for the Training Set
The document does not provide information on a training set for the Axis-Shield Anti-CCP device. ELISA assays are typically developed through biochemical optimization and validation, not through machine learning training on a 'training set' in the conventional AI sense. The "clinical performance" study described is a validation or test set study for the finished device.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of an algorithm requiring ground truth, this information is not applicable and not provided in the document.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).