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Liquichek™ Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.

Liquichek™ Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.

The document describes the device, Liquichek™ Cardiac Markers Control LT, as an assayed quality control serum. The "acceptance criteria" in this context refers to the stability of the analytes within the control serum under specified storage conditions, which determines its shelf life and open-vial stability. The study conducted to "prove the device meets the acceptance criteria" is a series of stability studies.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

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: Not explicitly stated. The document mentions "All supporting data is retained on file at Bio-Rad Laboratories," but does not provide details on the number of samples or batches tested for the stability studies.
• Data Provenance: The studies were conducted by Bio-Rad Laboratories (Irvine, California, USA). They are described as "stability studies" and "real time studies," suggesting a prospective nature for the shelf-life evaluation.

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)

This type of information is not applicable to this device and study. The device is a quality control material intended to monitor the precision of laboratory procedures. The "ground truth" for its performance is determined by established analytical methods for measuring the stability of the cardiac markers within the control, not by expert interpretation.

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

This is not applicable to this type of device and study. Adjudication methods typically apply to studies where human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For a quality control material, performance is measured against pre-defined analytical specifications.

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

This is not applicable to this device. An MRMC study is relevant for diagnostic devices that involve human interpretation and potentially AI assistance. The Liquichek™ Cardiac Markers Control LT is a quality control material, not a diagnostic or AI-assisted diagnostic device.

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

This is not applicable to this device. This concept relates to the performance of an AI algorithm without human intervention, which is not relevant for a quality control material.

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

The "ground truth" for this device's performance is based on the analytical stability of the cardiac markers and other constituents within the control material over time, under specified storage conditions. This is determined through quantitative chemical and biochemical assays, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable to this device. The Liquichek™ Cardiac Markers Control LT is a chemical control product, not an AI or machine learning algorithm that requires a training set.

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

This is not applicable to this device for the reasons stated in point 8.

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