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The IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform is an in vitro diagnostic test system for the qualitative detection of the IgA and IgM classes of Rheumatoid Factors, and the IgG class of anti-cyclic citrullinated peptide antibodies (CCPproprietary third generation equivalent formulation) in human serum specimens.

The IgX PLEXTM Rheumatoid Arthritis Qualitative Assay is intended for use in clinical laboratories as an aid in the diagnosis of Rheumatoid Arthritis in conjunction with other laboratory and clinical findings, and requires the SQiDworks™ Diagnostics Platform.

The device consists of the IgX PLEX™ Rheumatoid Arthritis Qualitative Assay (RL1 kit) and the SQiDworks™ Diagnostics Platform (the Platform); the Platform incorporates the SQiDworks™ Integrated Software (the Software). The Platform is a multiplex immunoassay instrument that fully automates the process of a specific IgX PLEX™ Assay from serum transfer to reporting of all assay markers for each individual patient sample. Once the assay's biochemical reactions have completed, the instrument automatically performs a multi-color fluorescent scan of each well in the microarray, analyzes the data, and generates a report containing qualitative results for all assay markers. The SQiDworks Diagnostics Platform also includes numerous internal quality checks and user safety features with fail-safe and interlock mechanisms.

The instrument integrates an automated pipetting station, a fluorescent scanner, washing and drying stations, and other ancillary hardware components using dedicated instrument control. In addition, the software provides scheduling, self-verification, data acquisition, data management, analysis algorithms and reporting software.

Results for each patient sample from the IgX PLEXIM Rheumatoid Arthritis Qualitative Assay and the SQiDworks™ Diagnostics Platform are obtained simultaneously for cach of the three assay markers: RF IgM, RF IgA and CCP IgG using the results from one well containing one aliquot of the patient's serum. Results are reported independently.

The IgX PLEXIM Rheumatoid Arthritis Qualitative Assay (RL1) kit consists of two boxes (with different temperature requirements) of components as described below.

The provided document describes the IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform. Here's a breakdown of the acceptance criteria and study details based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance characteristics from nonclinical (in-house) studies. It describes ranges for reproducibility, clinical sensitivity, clinical specificity, and overall agreement with predicate devices rather than pre-defined acceptance criteria with specific thresholds. It implies these ranges demonstrate the safety and effectiveness for intended use.

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

The document mentions "A series of nonclinical (in-house) studies were conducted," but it does not specify the sample size for the test set used in these studies. The data provenance is stated as "in-house" studies, implying it was conducted by the manufacturer, SQI Diagnostics Systems, Inc., which is based in Toronto, Ontario, Canada. It does not explicitly state whether the studies were retrospective or prospective.

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

The document states that "clinical diagnosis (RA or non-RA, including normals) was used as the reference result" for clinical sensitivity and specificity. However, it does not specify the number or qualifications of experts who established this clinical diagnosis (ground truth). It also does not mention if experts were used for interpreting the device's results in the study.

4. Adjudication Method for the Test Set:

The document does not provide information on any adjudication method used for the test set, or for establishing the clinical diagnosis that served as ground truth.

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 device is an in vitro diagnostic test system that automates the process from serum transfer to reporting of assay markers. It does not involve human "readers" in the context of interpreting images or complex data that would typically necessitate an MRMC comparative effectiveness study with AI assistance. Therefore, no MRMC comparative effectiveness study involving human readers with and without AI assistance was done.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the studies described are for the "IgX PLEX™ Rheumatoid Arthritis Qualitative Assay and SQiDworks™ Diagnostics Platform." The platform "fully automates the process... from serum transfer to reporting of all assay markers." The performance characteristics described (reproducibility, clinical sensitivity, specificity, agreement) refer to the performance of this automated system, i.e., the algorithm/device primarily in a standalone capacity. While the intended use requires it in conjunction with other laboratory and clinical findings, the reported performance metrics are for the device's direct output.

7. The Type of Ground Truth Used:

For clinical sensitivity and specificity, the ground truth was clinical diagnosis (RA or non-RA, including normals). For the study assessing overall agreement, the predicate test systems (Quanta LITE™ RF IgA ELISA, Quanta LITE™ RF IgM ELISA, and Quanta LITE™ CCP3 IgG ELISA) served as the reference for comparison.

8. The Sample Size for the Training Set:

The document does not provide information on the sample size used for any training set. Given the nature of a multiplex immunoassay instrument and assay, "training set" might refer to data used for establishing assay parameters, cutoff values, or calibration curves rather than machine learning model training in the typical sense. However, no specifics are provided.

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

The document does not mention a distinct "training set" or how its ground truth would have been established. It only discusses the ground truth for the clinical validation referenced in the performance characteristics section. For calibrators, it mentions they are "eight dilutions of a sample derived from human sera containing an appropriate representation of each of the analytes to be reported" and that "The assay standards (secondary standards) for RF (IgA and IgM) are traceable to the WHO/First British Standard 64/2 (primary standards)." For CCP IgG, it states "results are internally calculated in U/mL and are comparable to other assays on the market." This suggests a process of using established standards and internal calculations to define quantitative values, which are then converted to qualitative results based on assay-specific cutoff values.

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