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The REAADS Monoclonal Free Protein S Antigen Test Kit is an in vitro diagnostic assay for the quantitative determination of Free Protein S levels in human citrated plasma (as a percent of normal concentration) by enzyme-linked immunosorbant assay (ELISA). The REAADS Monoclonal Free Protein S Antigen Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS Monoclonal Free Protein S Antigen Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. A capture monoclonal antibody specific for human Free Protein S is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available Free Protein S to bind to the anti-human Free Protein S monoclonal antibody on the microwell surface. The plates are washed to remove unbound proteins or other plasma molecules. Bound Free Protein S is quantitated using horseradish peroxidase (HRP) conjugated anti-human Protein S detection polyclonal antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2,O.) is added to develop a colored reaction. The intensity of the color is measured in optical density (O.D.) units with a spectrophotometer at 450nm. Free Protein S relative percent concentrations in patient plasma are determined against a curve prepared from the reference plasma provided with the kit. Patient ODs are used to determine Free Protein S antigen levels in relative percent concentrations from a reference curve. The reference curve is produced by testing multiple dilutions of an assayed reference plasma supplied with the kit.

This document describes the REAADS Monoclonal Free Protein S Antigen Test Kit, an in vitro diagnostic assay, and its comparison to a predicate device, the REAADS Protein S Antigen Test Kit (PEG Method).

Here's an analysis based on the provided text, addressing your points:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document mentions "all plasma samples, including the suspected deficient samples" were used for the correlation study. However, the exact number of samples is not specified in the provided text.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It mentions "patient plasma" and "clinical samples," suggesting human samples were used in a clinical study context, but further details are absent.

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

• This information is not provided in the document. The comparison is made between the new device and a predicate device (the PEG Method), implying the predicate device's results serve as a reference, but there's no mention of expert-established ground truth for the test set.

4. Adjudication Method for the Test Set

• This information is not provided in the document. The study compares the new device's results to the predicate device's results, but there's no mention of an adjudication process involving multiple readers or experts for this comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (ELISA test kit), not an imaging or diagnostic AI requiring human interpretation, so MRMC is not applicable in this context. The study compares two test kits.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, in a sense. The REAADS Monoclonal Free Protein S Antigen Test Kit is an ELISA-based assay that provides quantitative results. Its performance is evaluated intrinsically through its chemical reactions and detection, not through human interpretation of an algorithm's output. Therefore, the reported performance (correlation with the predicate device) represents the standalone performance of the test kit itself.

7. The Type of Ground Truth Used

• The "ground truth" for the comparative study was the results obtained from the legally marketed predicate device, the REAADS Protein S Antigen Test Kit (PEG Method). This acts as the comparative standard to establish equivalence.

8. The Sample Size for the Training Set

• This information is not applicable/provided. ELISA kits do not typically have a "training set" in the same way machine learning algorithms do. The kit is developed based on established biochemical principles and validated against known samples and existing methods. The "reference plasma provided with the kit" is used to create a reference curve for each run, but this is part of the assay's operational procedure, not a training set for an algorithm.

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

• This information is not applicable/provided for the reasons stated above (not a machine learning algorithm). The "ground truth" in the context of the kit's operation would be the known concentrations of Protein S in the reference plasma (assayed reference plasma) provided with the kit, which is used to generate the standard curve. The establishment of this reference plasma's "ground truth" is not detailed here but would typically involve highly controlled and verified methods.

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