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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

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An assayed quality control serum to monitor the precision of laboratory teating procedures for analytes 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.

Here's a breakdown of the acceptance criteria and study information for the Liquichek™ Cardiac Markers Control LT device, based on the provided text:

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

The provided document describes a quality control material, not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy for diagnosing a condition. Therefore, the "acceptance criteria" are related to the stability and integrity of the control material itself, rather than diagnostic performance.

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

The document does not explicitly state the "sample size" in terms of a number of patient samples, as this is a control material. Instead, stability studies were performed. The sample size for these studies is not specified (e.g., how many vials were tested, how many replicates).

• Data Provenance: Not specified, but likely Bio-Rad Laboratories' internal testing, which is based in Irvine, California, USA.
• Retrospective or Prospective: The stability studies described are prospective in nature ("Real time studies will be ongoing to support the shelf life of this product").

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 is not applicable to a quality control material. The "ground truth" for a control material is its expected concentration values for various analytes, which are established by the manufacturer through rigorous analytical methods using reference materials and internal standards. Experts are not typically involved in establishing the "ground truth" of a control material in the same way they would for a diagnostic test interpreting patient data.

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

Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretations for diagnostic studies. For a quality control material, the performance is measured against established analytical stability criteria.

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-powered diagnostic device, and thus no human reader studies are relevant.

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

Not applicable, as this is not an algorithm or AI device. It's a laboratory reagent.

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

For a quality control material, the "ground truth" for stability studies is based on:

• Reference analytical methods: Ensuring the analytes remain within specified concentration ranges over time under various storage conditions.
• Manufacturer's specifications: The established target ranges and acceptable variations for each analyte within the control material.
• Stability testing protocols: Standardized procedures to assess degradation or changes in analyte concentration.

8. The sample size for the training set

Not applicable, as this is not a machine learning or AI device that requires a training set.

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

Not applicable.

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Liquichek Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory's specific cardiac marker procedures.

Liquichek Cardiac Markers Control LT is prepared from human serum with added constituents of human and non-human origin. The control is provided in liquid form for convenience.

The provided document is a 510(k) summary for the Bio-Rad Liquichek Cardiac Markers Control LT. It is a submission to the FDA for a quality control material used in laboratories to monitor cardiac marker procedures. The document establishes substantial equivalence to a previously marketed device (Liquichek Cardiac Markers Control K961828) rather than detailing a study proving performance against acceptance criteria for a new device.

Therefore, many of the requested details about acceptance criteria, study performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or available within this type of regulatory submission for a quality control material.

However, I can extract the relevant information based on the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance:

For a quality control material like this, the "acceptance criteria" and "reported device performance" are typically related to demonstrating that the new device has "substantially equivalent" characteristics to a predicate device. The document explicitly provides a comparison table against the predicate device.

Rationale for "Acceptance Criteria" here: In the context of a 510(k) for a quality control material, the acceptance criteria for a new device are primarily its ability to match the essential characteristics and performance of a legally marketed predicate device, demonstrating that it is "substantially equivalent." The key difference noted (Troponin I targeted at lower levels) is considered acceptable as it still serves the intended purpose of a control, just at a different target level. The FDA's approval letter confirms their determination of substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. For a quality control material intended to monitor laboratory precision, testing would typically involve evaluating the stability, homogeneity, and analyte values across multiple lots and over time, compared to established reference methods or predicate controls. The document does not provide details on the specific sample sizes used for such internal characterization studies.
• Data Provenance: Not specified in terms of country of origin. The submission is made by Bio-Rad Laboratories, located in Irvine, California, USA. The studies would have been conducted internally by Bio-Rad. It is an internal characterization study for the control material itself, rather than a clinical study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. For a quality control material, the "ground truth" (i.e., the assigned values for analytes) is established through rigorous analytical testing using reference methods and comprehensive characterization studies performed by qualified laboratory personnel at the manufacturer's facility, not by external experts or adjudication panels in the way a diagnostic algorithm might be evaluated.
• Qualifications of Experts: Not applicable in the context of an adjudication panel. The analyses would be performed by qualified laboratory scientists and technicians.

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

• Adjudication Method: Not applicable. Adjudication methods like 2+1 are used in clinical studies where expert consensus is needed to establish a "ground truth" for diagnostic outcomes. For a quality control material, the "true" values are determined by analytical methods, not by expert consensus.

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:

• MRMC Study: No. This is a quality control material, not an AI-powered diagnostic device. Therefore, no MRMC comparative effectiveness study was performed, and the concept of "human readers improving with AI" does not apply.

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

• Standalone Performance: Not applicable. This is a physical quality control material, not an algorithm or software device.

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

• Type of Ground Truth: For a quality control material, the "ground truth" refers to the target or assigned values for each analyte within the control. This is established through analytical testing using validated reference methods and internal laboratory characterization studies, including repeat measurements on multiple instruments, potentially against reference materials, and stability studies. It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is a quality control material, not a machine learning algorithm that requires a training set. The values and characteristics of the control are determined through laboratory characterization, not by training an AI model.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device type.

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