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The VITROS Immunodiagnostic Products Anti-HBs Controls are intended for use in monitoring the performance of the VITROS Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to Hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack on the VITROS Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays.

For in vitro diagnostic use.

The VITROS Immunodiagnostic Products Anti-HBs Controls are comprised of three levels of controls in separate vials:

Control 1 (Negative)
Anti-HBs negative plasma obtained from donors who were tested individually and found to be negative for hepatitis B surface antigen, and for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (enzyme immunoassays, EIA).

Control 2 (Positive)
Anti-HBs negative plasma spiked with anti-HBs positive plasma to give a nominal VITROS Anti-HBs result of 25.00 mIU/mL. The positive plasma was obtained from donors who were tested individually and found to be negative for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (EIA).

Control 3 (Positive)
Anti-HBs negative plasma spiked with anti-HBs positive plasma to give a nominal VITROS Anti-HBs result of 380 mIU/mL. The positive plasma was obtained from donors who were tested individually and found to be negative for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (EIA).

All controls contain antimicrobial agent and are freeze-dried.

The controls are assigned values from a minimum of 10 assays. The standard deviation is that which would be anticipated for single determinations of each control in a number of different laboratories using different reagent batches.

This document describes the VITROS Immunodiagnostic Products Anti-HBs Controls, which are quality control materials used to monitor the performance of the VITROS Immunodiagnostic System for quantitative determination of anti-HBs in human serum.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not specify explicit acceptance criteria (e.g., precision limits, accuracy targets) for the device performance study. Instead, it describes how the control values are established and states that the new device is substantially equivalent to a predicate device based on their characteristics.

The "reported device performance" in this context refers to how the control values are assigned and their intended use, rather than specific performance metrics like sensitivity or specificity for a diagnostic test.

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

The document does not describe a specific "test set" in the context of evaluating the device's diagnostic accuracy. The study described is for establishing the values of the control materials themselves.

• Sample Size for Controls Value Assignment: "The controls are assigned values from a minimum of 10 assays." This refers to the number of assays performed to determine the mean and standard deviation for each control lot.
• Data Provenance: The plasma for the controls is obtained from human donors. The document does not specify the country of origin. It indicates that the plasma sources were tested using FDA-approved methods. The study described is retrospective in the sense that the plasma is collected and then prepared into controls, followed by value assignment.

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

This information is not applicable to the type of device and study described. This is a quality control material, not a diagnostic test that requires expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable to the type of device and study described, as there is no diagnostic test performance being adjudicated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted and is not relevant for this type of quality control device.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study, as typically understood for diagnostic algorithms, was not conducted and is not relevant for this type of quality control device. The "performance" described is the process of assigning values to the control materials, which are then used to monitor the performance of an immunodiagnostic system.

7. Type of Ground Truth Used

The "ground truth" for the control materials is established through:

• Reference Method/Assay: For the positive controls (Control 2 and 3), anti-HBs negative plasma was "spiked with anti-HBs positive plasma to give a nominal VITROS Anti-HBs result of 25.00 mIU/mL" and "380 mIU/mL" respectively. This indicates a target concentration.
• Assay-derived Values: The final assigned values (mean and standard deviation) for each control are derived from "a minimum of 10 assays" performed on the VITROS Immunodiagnostic System. So, the ground truth for the value itself is derived from the performance of the system it's designed to control, rather than an independent external gold standard in the typical sense of a diagnostic test.
• Donor Screening: For safety, the plasma used was screened for HIV 1+2 and HCV using FDA-approved EIA methods.

8. Sample Size for the Training Set

The document describes the process for establishing the values of the controls, not a machine learning algorithm with a training set. As such, there is no "training set" in the context of AI/ML. The "minimum of 10 assays" mentioned in #2 is for value assignment, not model training.

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

As there is no training set for an AI/ML algorithm, this question is not applicable. The ground truth for the control values themselves, as described in #7, is based on a combination of spiking to achieve nominal concentrations and empirical determination through multiple assays on the target instrument.

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