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The REAADS von Willebrand Factor Activity Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of von Willebrand Factor Activity (vWF:Act) in citrated human plasma.

The REAADS von Willebrand Factor Activity Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate formal, similar to the predicate device. Diluted patient plasma is incubated in the wells, allowing any available antigen to bind to the monoclonal antibody on the microwell surface. The plates are washed to remove unbound proteins or other plasma molecules. Bound antigen is quantitated using horseradish peroxidase (HRP) conjugated anti-human von Willebrand Factor antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in optical density (O.D.) units with a spectrophotometer at 450mm. Patient von Willebrand Factor Activity in relative percent concentration is determined against a curve made from the reference plasma provided with the kit. The total incubation time (at room temperature) of the assay is 40 minutes.

The provided text describes a 510(k) submission for the REAADS von Willebrand Factor Activity Test Kit. This is an in vitro diagnostic (IVD) device, not an AI/ML medical device. Therefore, many of the requested categories (e.g., sample size for the test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not directly applicable or reported in the context of an IVD submission.

However, I can extract the information that is available and relevant to an IVD device's acceptance criteria and study.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For IVDs, "acceptance criteria" are typically related to the analytical performance (e.g., correlation, precision, linearity) compared to a predicate device. The primary "performance" reported here is the correlation with the predicate device.

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

• Sample Size: 262 clinical samples.
• Data Provenance: Not explicitly stated, but derived from "clinical samples," implying human blood plasma samples. The predicate device's manufacturer is based in Dundee, Scotland, but it's not stated if samples were from there or elsewhere. The study is retrospective in the sense that the samples were analyzed and compared, but not a prospective interventional trial.

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

• This concept is not directly applicable to an IVD like this. The "ground truth" for an IVD determining a quantitative activity level is typically the result from a reference method or, in this case, the predicate device, which is considered a legally marketed standard. There are no "experts" in the sense of medical professionals interpreting images or clinical data to establish a ground truth diagnosis for this type of quantitative assay.

4. Adjudication Method for the Test Set

• Not applicable. This is a quantitative assay comparison, not an interpretation task requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study is not relevant for this type of quantitative IVD comparison.

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

• This concept is not applicable. The device itself is an assay kit. Its "performance" is its analytical output, which is quantitative. It operates in a laboratory setting.

7. The Type of Ground Truth Used

• The "ground truth" or reference standard for comparison in this study was the predicate device's measurements (Shield von Willebrand Factor Activity Kit, K000398). The study aimed to demonstrate substantial equivalence by correlating results from the new device with the predicate.

8. The Sample Size for the Training Set

• Not applicable as this is an assay kit, not an AI/ML model that requires a training set. The "development" would involve optimizing assay reagents and conditions, not training a statistical model on data.

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

• Not applicable; see point 8.

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