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For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (EDTA, citrate and heparin). The performance of the Vitros Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assays. For in vitro diagnostic use.

The Vitros Immunodiagnostic System uses luminescence as the signal in the qualitative detection of HBsAg in human plasma and serum. Coated microwells are used as the solid phase separation system. The system is compromised of three main elements: The Vitros Immunodiagnostic Products range of products, in this case Vitros Immunodiagnostic Products HBsAg Reagent Pack and Vitros Immunodiagnostic Products Calibrator; The Vitros Immunodiagnostic System- instrumentation; Common reagents used by the Vitros System in each assay, the Vitros Immunodiagnostic Products Signal Reagent and the Vitros Immunodiagnostic Products Universal Wash Reagent. The Vitros System and common reagents are dedicated specifically only for use with the Vitros Immunodiagnostic Products range of immunoassay products.

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

This 510(k) summary (K030067) is for a quality control material (HBsAg Controls), not a diagnostic device that performs detection. Therefore, the typical "acceptance criteria" and "device performance" metrics for diagnostic accuracy (like sensitivity, specificity, AUC) are not directly applicable in the same way. Instead, the "performance" here refers to the ability of the control material to reliably monitor the performance of the associated diagnostic system (Vitros ECi Immunodiagnostic System).

The primary focus of this submission is an expansion of the intended use for the controls, specifically to include the monitoring of HBsAg detection in human plasma (EDTA, citrate, and heparin) in addition to serum. The original predicate device's controls were already approved for serum.

Given this context, the "acceptance criteria" relate to demonstrating that the controls perform equivalently across different sample matrices (serum vs. various plasma types).

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific quantitative acceptance criteria (e.g., "± X% variation") are not explicitly stated in the provided document for the control material's performance across different matrices. Instead, the document describes the demonstration that "all samples (serum, EDTA, citrate or heparin) behave similarly in the assay." This implies an acceptance criterion of comparable performance, but without specific numerical thresholds.

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

• Sample Size: The document states "multiple samples collected as either whole serum or in the presence of EDTA citrate or heparin." A specific number for the test set sample size is not provided in this summary.
• Data Provenance: Not explicitly stated, but clinical laboratory in vitro diagnostic studies typically use banked or prospectively collected samples from a relevant patient population. No country of origin is mentioned. The study is described as an "assessment," suggesting it was likely a prospective or retrospective analysis of samples tested with the device.

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

This submission concerns the performance of quality control material for an HBsAg assay. The concept of "ground truth" established by experts (e.g., radiologists interpreting images) is not directly applicable here. The "truth" for the samples used in the study was determined by:

• Unspiked (negative) samples: Inherently negative for HBsAg.
• Spiked (positive) samples: Spiked with known positive HBsAg plasma, close to the weak positive detection level of the assay. This establishes their 'true positive' status for the purpose of the control's evaluation.

Therefore, no panel of independent experts was used to establish ground truth in the traditional sense for these control samples. The ground truth was defined by the sample preparation (negative or spiked positive).

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" was established by the design of the samples (unspiked negative or spiked positive), not by an expert adjudication process.

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 relevant for diagnostic devices where human readers interpret results, often with and without AI assistance (e.g., radiology AI). The Vitros HBsAg Controls are quality control materials for an automated immunoassay system, not a device requiring human interpretation in this context.

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

This question also doesn't directly apply. The "device" in question is a control material, not an algorithm, and the Vitros ECi Immunodiagnostic System itself is an automated system (algorithm-only in terms of result generation). The study described evaluated the control material's robustness across different sample matrices within the context of the automated system. It's an evaluation of the control's standalone performance in that respect, but not in the "algorithm-only vs. human-in-the-loop" sense.

7. The Type of Ground Truth Used

The ground truth used for the samples in the study was defined by the sample preparation:

• Known Negative: Unspiked samples were presumed negative.
• Known Positive (weak): Samples spiked with known HBsAg positive plasma to a level near the assay's weak positive detection threshold.

8. The Sample Size for the Training Set

• Not applicable directly. This submission is for a quality control material where performance is assessed through consistency and stability, not by training a machine learning algorithm. The "training set" concept is typically for AI/ML models.
• The quoted mean values and standard deviations for the controls are derived from "a minimum of 10 assays" in "a number of different laboratories using different reagent lots." This process, while not a "training set" in the AI sense, contributes to establishing the expected performance range of the controls.

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

Not applicable. As explained above, there is no "training set" in the context of an AI/ML model for this quality control material. The "ground truth" for the controls' expected values is established through repeated measurements (minimum of 10 assays) across various labs and reagent lots.

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