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The Varelisa ß2-Glycoprotein I IgM Antibodies EIA kit is designed for the semiquantitative and qualitative determination of ß2-glycoprotein I IgM antibodies in serum or plasma.

The presence of ß2-glycoprotein I antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of thrombotic disorders related to the primary Antiphospholipid Syndrome or occurring secondary to systemic lupus erythematosus (SLE) or other autoimmune diseases.

The Varelisa B2-Glycoprotein I IgM Antibodies Assay is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of B2-glycoprotein I IgM antibodies in serum or plasma.

The test kit contains microplate strips coated with human purified ß2glycoprotein I, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, buffered diluent and wash buffer.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria (e.g., sensitivity, specificity thresholds) for the Varelisa® B2-Glycoprotein I IgM Antibodies device. Instead, the study aims to demonstrate substantial equivalence to a predicate device, the INOVA QUANTA Lite™ ß2 GPI IgM. The reported performance is based on qualitative comparisons and the conclusion of substantial equivalence.

• results obtained within a comparison study analyzing positive, equivocal and negative sera.
• results obtained for externally defined Calibrators.
• results obtained for samples from apparently healthy subjects (normal population)."** |
  | Effectiveness with serum samples | Implied to be effective as it's a common sample type for this assay type and compared to a predicate using serum. |
  | Effectiveness with plasma samples | "Corresponding performance data underline the effectiveness of the assay with plasma as sample." |
  | Performance as expected from medical literature | "The data show that the assay performs as expected from the medical literature." |
  | Comparability of evaluation methods (OD-cutoff vs. decision point) | "Corresponding performance data show the comparability of the results." |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The exact numerical sample size for the test set (comparison study analyzing positive, equivocal, and negative sera; externally defined calibrators; normal population) is not specified in the provided text.
• Data Provenance: The text does not specify the country of origin of the data. It mentions "externally defined Calibrators" and "samples from apparently healthy subjects (normal population)". It is implied to be a retrospective study as it's a comparison study to a predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the text. The study focuses on demonstrating comparability between two assay kits, rather than establishing a gold standard diagnosis by human experts for the test set itself. The "ground truth" for the samples would have been their established status as positive, negative, or equivocal for the autoantibody.

4. Adjudication Method for the Test Set

This information is not provided in the text. Given it's a serological assay comparison, expert adjudication in the typical sense (e.g., for imaging interpretation) is unlikely to be the primary method for test set ground truth. The initial classification of samples (positive, negative, equivocal) would have been based on established laboratory methods or clinical diagnoses.

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 performed. This type of study is more common for diagnostic imaging AI devices where human interpretation is a key component. The Varelisa® B2-Glycoprotein I IgM Antibodies device is an in-vitro diagnostic (IVD) assay kit for laboratory use, not an AI-powered diagnostic tool for human reader improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was effectively done. The device itself is an in-vitro diagnostic assay that provides a result (semiquantitative or qualitative determination of antibodies) without direct human interpretation in the sense of an "algorithm only". The comparison study assesses the performance of this standalone assay against a predicate standalone assay. The results are based on the assay's output (e.g., optical density, antibody units), not on a human's interpretation of those results.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

The ground truth for the comparison study would likely have been established by:

• Clinical Diagnosis / Established Patient Status: Samples categorized as "positive, equivocal, and negative sera" would have their status determined by established clinical diagnoses of thrombotic disorders, SLE, or other autoimmune diseases, in conjunction with other laboratory findings.
• Reference Method Results: For the "externally defined Calibrators," their true value would be established by a reference method or traceable standard.
• Healthy Population Screening: "Samples from apparently healthy subjects (normal population)" would be considered negative by definition for the condition.

The text does not explicitly state "pathology" or "outcomes data" as the direct ground truth, but clinical diagnosis often relies on these.

8. The Sample Size for the Training Set

This information is not applicable / not provided for this type of medical device submission. The Varelisa® B2-Glycoprotein I IgM Antibodies is a chemical reagent-based assay kit, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The device's performance characteristics are established through analytical and clinical validation studies, not an algorithmic training process.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable / not provided as there is no "training set" for this type of device.

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