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The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of IgM antibody to Hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (heparin, EDTA or citrate). For in vitro diagnostic use.

The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are comprised of two levels of controls in separate vials: Control 1 (Negative) and Control 2 (Positive). Control 1 is normal human plasma obtained from donors tested 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 is normal human plasma spiked with anti-HBc IgM positive plasma, obtained from donors tested negative for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (EIA). Both controls contain antimicrobial agent and are freeze-dried. The controls are assigned values from a minimum of 10 assays.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vitros Immunodiagnostic Products Anti-HBc IgM Controls:

The provided document is a 510(k) summary for a Quality Control Material (Assayed and Unassayed), not a diagnostic device that performs a diagnosis or screening. Therefore, some of the requested information (like multi-reader multi-case studies, effect size, standalone performance, and extensive ground truth details for a training set of an AI model) are not applicable to this type of medical device submission.

The "acceptance criteria" for a control material like this are primarily related to its performance in monitoring a diagnostic system, rather than diagnostic accuracy itself. The study described focuses on demonstrating substantial equivalence to a predicate device and showing the control material behaves as expected.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes the formulation and intended use of the controls, and states they are "substantially equivalent" to a predicate, rather than providing explicit numeric acceptance criteria and detailed performance results from a specific study. The acceptance criteria for the control material itself would typically involve its stability, consistency, and ability to produce expected results (e.g., positive control yields a positive result, negative control yields a negative result) when run on the target diagnostic system.

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of diagnostic accuracy for a patient population. For controls, the "testing" involves verifying the control's properties. The document mentions "a minimum of 10 assays" used to assign values to the controls, implying that each control level (positive and negative) was run at least 10 times to establish its expected range/value.
• Data Provenance: The plasma components for the controls are described as "Normal human plasma obtained from donors."
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not specified, but given the nature of control material manufacturing, it would be a controlled, prospective process of sourcing, processing, and testing materials.

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

This information is not applicable in the context of an AI device's performance study. For this control material:

• The "ground truth" for the individual components of the controls (e.g., negative for certain markers, positive for anti-HBc IgM) was established by using "FDA approved methods (enzyme immunoassays, EIA)".
• There were no "experts" in the sense of radiologists or clinical specialists interpreting images or complex patient data to establish ground truth for the control material itself. The determination of negativity or positivity of the source plasma was based on standard laboratory test results.

4. Adjudication Method for the Test Set

Not applicable. There was no complex subjective assessment of patient data requiring adjudication. The assessment of the source plasma was based on objective laboratory test results.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that an AI algorithm assists human readers in interpreting (e.g., medical images). The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are quality control materials, not diagnostic algorithms, and therefore do not involve human readers interpreting patient cases with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This device is a quality control material, not an algorithm. Its "performance" is its ability to consistently provide a known positive or negative signal on a specific diagnostic system (the Vitros ECi Immunodiagnostic System), allowing laboratories to monitor the system's performance.

7. The Type of Ground Truth Used

• For the source material (plasma) used to create the controls: Laboratory test results using "FDA approved methods (enzyme immunoassays, EIA)" to determine the presence or absence of specific markers (e.g., hepatitis B surface antigen, antibodies to HIV 1+2, HCV, and anti-HBc IgM).
• For the control material itself: Its "ground truth" is its assigned value/category (positive or negative) established through a minimum of 10 assays, which then serves as a known standard for verifying the performance of the Vitros ECi system.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and does not have a "training set" in the conventional sense.

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

Not applicable. (See point 8).

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