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

The following analytes are listed in the package insert: B-type Natriuretic Peptide (BNP) CK-MB Isoenzyme C-Reactive Protein (CRP) Creatine Kinase (CK) D-dimer Digitoxin Homocysteine Myeloperoxidase (MPO) Myoglobin N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) Troponin I Troponin T

Liquichek Cardiac Markers Plus Control LT is prepared from human serum with added constituents of human and animal origin, stabilizers and preservatives. This product 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.

This document is a 510(k) premarket notification summary for a quality control material, not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

However, I can extract information relevant to the 'acceptance criteria' and 'study' framework as much as possible for this type of device, focusing on stability studies which are analogous to performance studies for these materials.

1. Table of Acceptance Criteria and Reported Device Performance

For a quality control material, "acceptance criteria" often refer to the established stability periods under various conditions, which are then met by "reported device performance" through stability studies.

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

• Test Set Sample Size: The document does not specify exact sample sizes for the stability studies (e.g., number of lots, replicates per time point). It mentions "replicate analyses" were used to derive mean values and ranges for value assignment and that "a representative sampling of this lot of control" was used for testing.
• Data Provenance: The studies were performed by the manufacturer, Bio-Rad Laboratories, and/or independent laboratories. The document does not specify the country of origin of the data, but the manufacturer is based in Irvine, California, USA. The studies are prospective in nature, as they are real-time and accelerated stability studies conducted on the device itself.

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

• This question is not applicable. For a quality control material, analytical values (the "ground truth" equivalent for performance testing) are established through "value assignment" processes using validated laboratory methods and instruments, not by expert consensus from individuals like radiologists. The document states: "The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents."

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical image interpretation or clinical decision-making studies, not for the analytical performance of laboratory quality control materials.

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 AI-assisted diagnostic tools that involve human interpretation of medical images or data. The device here is a quality control material intended to monitor the precision of laboratory testing procedures.

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

• This question is not applicable. This device is a quality control material, not an algorithm or AI system. Its "performance" is its stability and its ability to provide target values for laboratory instruments.

7. The Type of Ground Truth Used

• For the value assignment (which serves as the "ground truth" for expected analytic values), laboratory results from specific analytical methods and instruments are used. The document states, "The mean values and the corresponding ±3SD ranges printed in this insert were derived from replicate analyses and are specific for each lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of control." This is essentially analytical reference values established by validated laboratory testing.

8. The Sample Size for the Training Set

• This question is not applicable. This device is a quality control material and does not involve AI/ML algorithms that require training sets.

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

• This question is not applicable, as there is no training set for this device.

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Liquichek Cardiac Markers Plus Control, Cardiac Markers Plus Control LT and Cardiac Markers Plus Control LT Low are intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.

These products are prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. These controls are provided in liquid form.

The provided text is a 510(k) summary for the Liquichek™ Cardiac Markers Plus Controls. It describes a new quality control device and claims substantial equivalence to a predicate device. The document does not describe a study involving an AI/digital health device, nor does it provide acceptance criteria and performance data in the context of such a device.

Instead, the document focuses on:

• Device Identification: Product names, classification, and regulation details.
• Predicate Device: K040277, Liquichek™ Cardiac Markers Control LT.
• Device Description: Made from human serum with added constituents.
• Intended Use: Quality control serum to monitor precision of laboratory testing.
• Comparison to Predicate: Highlights new analytes (BNP, Creatine Kinase, Total, CRP) and extended open vial stability (20 days vs. 10/5 days).
• Supporting Data: Mentions stability studies for open vial (20 days at 2-8°C) and shelf life (3 years at -20°C to -70°C). These are described as "product claims" based on "stability studies" that "will be ongoing to support the shelf life."

Therefore, I cannot fulfill your request for the specific items (1-9) as they pertain to an AI/digital health device study because the provided text is for a laboratory quality control material and not a software algorithm or a device that would typically undergo such studies.

The document is a submission to the FDA seeking clearance for a new in-vitro diagnostic (IVD) quality control product, asserting its substantial equivalence to a previously cleared product. The "acceptance criteria" and "study" mentioned refer to the stability testing performed to establish shelf life and open-vial stability of the control material itself, ensuring it performs consistently over time for its intended purpose of monitoring laboratory test precision.

Here's how I can address the request based on the actual content of the document:

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

The document does not explicitly state quantitative "acceptance criteria" for the device's performance in the typical sense of sensitivity, specificity, accuracy for an AI/digital health device. Instead, it makes product claims supported by stability studies.

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 states: "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Cardiac Markers Plus Control." It also mentions "Real time studies will be ongoing to support the shelf life of this product."

• Sample Size: Not specified. (For stability studies, this usually refers to the number of control vials tested over different time points and conditions, not patient samples).
• Data Provenance: Not explicitly stated, but assumed to be internal data from Bio-Rad Laboratories (Irvine, California, USA), given they are the submitter. The studies are described as prospective in nature, especially with "real time studies... ongoing."

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. The product is a laboratory quality control material. Ground truth in this context would be the certified values of the analytes within the control material, established through rigorous manufacturing and assay procedures, not by expert consensus or interpretation of medical images/data. The "experts" would be the scientists and chemists involved in the formulation and analytical validation of the control.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data (e.g., radiology reads). This is irrelevant for a chemical quality control product.

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 for an AI/digital health device.

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

Not applicable. This is for an AI/digital health device.

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

For a quality control material, the "ground truth" (or target values) for the analytes within it are established during manufacturing and assay validation using reference methods and calibrated instruments. This is an analytical/chemical ground truth, not based on expert clinical consensus or patient outcomes.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm.

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