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Liquichek Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Liquichek Immunology Control is prepared from defibrinated human plasma with added serum proteins, preservatives and stabilizers. The control is provided in liquid form for convenience. Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.

Here's an analysis of the provided 510(k) summary for the Liquichek Immunology Control, structured according to your request:

Acceptance Criteria and Device Performance

This 510(k) summary describes a quality control material, not a diagnostic device that performs interpretations. Therefore, the "device performance" relates to its stability and ability to maintain its intended properties over time, rather than diagnostic accuracy metrics like sensitivity or specificity.

Table 1: Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "Acceptance Criteria were met to support the product claims as follows." This confirms that the reported performance meets the established acceptance criteria for stability.

Study Details

Given that the device is a quality control material and not an AI-powered diagnostic tool, many of the requested study details (e.g., sample size for test set, experts for ground truth, MRMC study, standalone performance) are not applicable or relevant in the traditional sense. The studies performed focused on product stability.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify an exact "sample size" in terms of number of patient samples, as this is a quality control material. Instead, it refers to "a representative sampling of this lot of product" used for value assignment and stability studies.
• Data Provenance: The studies were conducted by "the manufacturer and/or independent laboratories." No specific country of origin is mentioned for the data, but the manufacturer (Bio-Rad Laboratories) is based in Irvine, California, USA. The stability studies were prospective in nature, as they tracked the product's performance over time.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. For a quality control material, "ground truth" refers to the expected values and stability characteristics. These are established through scientific testing and adherence to manufacturing specifications, rather than expert interpretation of a diagnostic outcome. The "value assignment" process involves replicate analyses by the manufacturer and/or independent laboratories using manufacturer-supported reagents.

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

• Not Applicable. Adjudication methods are typically used in studies involving human interpretation or uncertain diagnostic outcomes. For stability testing of a QC material, the "ground truth" (stability profile) is determined by objective laboratory measurements against set specifications, not by expert consensus or adjudication.

5. 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

• Not Applicable. This is a quality control material, not an AI diagnostic device, so MRMC studies are irrelevant.

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

• Not Applicable. The device is a physical quality control material, not an algorithm.

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

• For stability studies: The "ground truth" is defined by pre-established scientific and manufacturing specifications for acceptable analyte concentration ranges and stability profiles over time and under various storage conditions. The studies verified that the material's measured analyte levels and other characteristics remained within these specified ranges throughout the claimed stability periods.
• For value assignment: The ground truth consists of "mean values and the corresponding ±3SD ranges printed in the instructions for use," derived from "replicate analyses" using manufacturer-supported reagents.

8. The sample size for the training set

• Not Applicable. This is a quality control material; it does not involve AI or machine learning algorithms that require a "training set."

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.

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