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The BeadXpress® System is an in vitro diagnostic device intended for the simultaneous detection of multiple analytes in a DNA sample utilizing VeraCode holographic microbead technology. The BeadXpress System consists of the BeadXpress Reader and VeraScan software.

The BeadXpress® System is an open platform fluidic microbead reader which includes a dual-color laser detection system that enables optical scanning of multiplexed assays developed using the VeraCode digital microbead technology and VeraScan 2.0 software. The instrument performs a routine set of operating steps: Reader Initialization, Fluidic Initialization, Scanning, Data Consolidation and Flushing. Hardware is contained within a single instrument housing. The system consists of four sub-systems (fluidics, opto-mechanical, motion and electrical) that interact with each other to provide the desired results. The fluidic system consists of the parts that move fluids and beads through the system as well as the key groove plate upon which the beads lay to be scanned. The optomechanical system contains the two lasers and all the optical components that are involved with the optical alignment and delivery of the beams to the beads and collection of the signals generated. This motion system contains all the hardware that is involved with the physical movement of the internal parts of the reader and utilizes four major axes to control the movement and spacial orientation of the specific sub-systems. The electrical system contains all the electronic components that are responsible for control of the individual components and system overall.

The VeraScan software is installed on a PC directly connected to the BeadXpress Reader. It is used for operating the BeadXpress Reader and through the use of software modules, analyzing the scan results and genotype calls.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

The provided document describes the Illumina, Inc. BeadXpress Reader System with VeraScan Software (v. 2.0.17.0). However, the document does not contain specific acceptance criteria or the study that directly proves the device meets those criteria for the BeadXpress Reader System itself.

Instead, the document consistently refers to the clearance of a separate assay (K093129), the "VeraCode® Genotyping Test for Factor V and Factor II," for which the BeadXpress System is intended to be used. The performance characteristics of the system (accuracy, precision, linearity, carryover, interfering substances) are stated to have been assessed during the clearance of that assay.

Therefore, I cannot provide the complete requested information for the BeadXpress Reader System itself based on this document alone, as the performance evaluation is explicitly tied to a different, separately cleared assay.

However, I can extract what is implied about the acceptance criteria and the study structure from the provided text, while making it clear that specific numbers are missing.

Implied Acceptance Criteria and Reported Device Performance (Table)

Since the document states that "Accuracy," "Precision/Reproducibility," "Linearity," and "Carryover" were "assessed during the clearance of the assay (K093129)," this implies general expectations for these performance metrics. The specific quantitative acceptance criteria or reported performance values for the BeadXpress system itself are not provided in this document.

Detailed Study Information (Based on implications and absence of data)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified in this document for the BeadXpress Reader System itself. The performance assessment refers to "clearance of the assay (K093129)," which would have its own test set.
   • Data Provenance: Not specified in this document. Given it's an FDA 510(k) submission, it would likely involve controlled laboratory studies, but specific country of origin or whether it's retrospective/prospective is not mentioned for the system's performance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/not specified for the BeadXpress Reader System's performance validation in this document. The "ground truth" would be related to the genetic mutations detected by Assay K093129, and the establishment of that ground truth (e.g., through Sanger sequencing or other gold standard methods) is not detailed here.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/not specified. Clinical adjudication methods are typically for subjective interpretations (e.g., imaging), which is not the primary function of this instrument. For a genotyping system, "ground truth" is typically established by definitive molecular methods, not expert human adjudication of the instrument's output in the same way.

4. 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:

   • No. This is an instrument and software system for automated genotyping, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study related to human reading improvement with AI assistance is not relevant and was not performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. The "VeraScan software" with the "Genotyping (GT) Module" "analyzes scan data to call genotypes." This describes a standalone algorithmic performance. The document states: "Once analysis is completed, the software displays data results and graphical visualizations to help the user interpret run success." The system's primary function is automated detection and calling. The "performance characteristics" (accuracy, precision, etc.) of the system would be assessed in this standalone mode through the assay's validation (K093129).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For genotyping, the ground truth would typically be established by a gold-standard molecular method (e.g., Sanger sequencing, another validated genotyping method, or verified reference materials). This document does not explicitly state the ground truth method used for the assay (K093129) to which the system's performance is tied.

7. The sample size for the training set:

   • Not specified. The document does not describe a machine learning model developed with a training set for the BeadXpress Reader itself. The "Genotyping (GT) Module" configures run settings and calls genotypes "by using a process flow that associates fluorescence data in each color channel with calling thresholds supplied by the kit manifest." This implies a rule-based or threshold-based algorithm, rather than a machine learning model that undergoes a training phase with a specific dataset.

8. How the ground truth for the training set was established:

   • Not applicable, as no machine learning training set is described for the system. The "kit manifest" provides the "calling thresholds," which represent the established parameters for interpreting the fluorescence data for specific assays.

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