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IL Test™ von Willebrand Factor is an in vitro diagnostic automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (vWF:Ag) in human citrated plasma on IL Coagulation Systems. When a plasma containing vWF:Ag is mixed with the Latex Reagent and the Reaction Buffer, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of vWF:Ag in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates (turbidimetric immunoassay).

IL Test™ von Willebrand Factor is an in vitro diagnostic automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (vWF.Ag) in human citrated plasma on IL Coagulation Systems. When a plasma containing vWF:Ag is mixed with the Latex Reagent and the Reaction Buffer, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of vWF:Ag in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates (turbidimetric immunoassay).

Acceptance Criteria and Device Performance Study for IL Test™ von Willebrand Factor

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values for the slope and correlation coefficient. Instead, it presents the performance of the device and claims substantial equivalence to the predicate device. For the purpose of this response, we will consider the strong correlation and near-unity slopes observed as the de facto "met" criteria for substantial equivalence in this context. Similarly, for precision, while no explicit criteria are given, the achieved %CV values are presented as satisfactory.

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

• Sample Size for Test Set: 120 citrated plasma samples.
• Data Provenance: The document does not explicitly state the country of origin. It is a submission to the U.S. FDA, indicating the study was likely conducted to support a U.S. market application. The study type is retrospective, as it involves evaluating existing plasma samples with vWF:Ag levels ranging from 0.3% to 634.3%.

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

This device is an in vitro diagnostic (IVD) assay for quantitative determination of a biomarker (vWF:Ag). The "ground truth" for such assays is typically established by comparative analysis against a legally marketed predicate device using clinical samples, rather than expert interpretation of images or clinical assessments by a panel of experts. Therefore, the concept of "number of experts" and "qualifications of those experts" as applied to medical imaging interpretation or clinical diagnosis does not directly apply here. The "ground truth" for the test set is derived from the measurements obtained by the predicate device (Asserachrom® vWF).

4. Adjudication Method for the Test Set

Not applicable. As explained above, this is an IVD assay where "ground truth" is established by comparison to a predicate device, not by expert consensus or adjudication. The comparison involves quantitative measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for medical imaging devices where human readers interpret cases, and the AI's effect on reader performance is evaluated. The IL Test™ von Willebrand Factor is an automated in vitro diagnostic assay.

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

Yes, a standalone performance study was done. The performance data presented in the summary, including method comparison and precision, represents the automated performance of the IL Test™ von Willebrand Factor device without human intervention beyond sample loading and running the assay according to manufacturer instructions. The results are generated directly by the "IL Coagulation Systems" (ACL Futura and ACL 6000) using the IL Test™ reagent.

7. The Type of Ground Truth Used

The type of ground truth used is comparison to a legally marketed predicate device. The vWF:Ag levels measured by the predicate device (Asserachrom® vWF) on the 120 plasma samples served as the reference for evaluating the performance of the IL Test™ von Willebrand Factor.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" for the IL Test™ von Willebrand Factor. This is typical for traditional IVD assays, which are developed through chemical and assay formulation, optimization, and validation against established methods and clinical samples, rather than through machine learning model training on large datasets in the same way an AI-driven imaging device would. The performance data presented is for validation, not training.

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

Not applicable, as no training set is described for this type of IVD assay. The development process would have involved establishing analytical performance characteristics and clinical utility through iterative experimental work and comparison to existing methods, but not in the framework of a "training set" with expert-established ground truth in the AI sense.

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