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Liquid Assayed Multiqual 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.

Liquid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added.

The provided documentation describes the Liquid Assayed Multiqual device, a quality control serum. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes for test/training sets, expert involvement, or adjudication methods in the way typically expected for a diagnostic or AI-driven device.

This document is a Summary of Safety and Effectiveness (part of a 510(k) submission) for a quality control material. Its primary purpose is to establish substantial equivalence to a predicate device, not to present a detailed performance study with discrete acceptance criteria for a diagnostic tool.

Therefore, many of the requested items cannot be extracted from this document. Here's a breakdown of what can be inferred or directly stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit "acceptance criteria" are stated in the document in terms of performance metrics (e.g., sensitivity, specificity, accuracy, precision ranges for analytes). The document focuses on demonstrating that the new device is substantially equivalent to a predicate by having similar intended use, form, matrix, storage conditions, and open vial claims, with the primary difference being the addition of Lactic Acid as an analyte.

The "performance" reported is primarily related to stability:

Explanation: The "acceptance criteria" here are implied by the stability claims made for the device. The study demonstrating these is referred to generally as "Stability studies."

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

• Sample Size (Test Set): Not specified. The document refers to "Stability studies" but does not detail the number of samples or batches used for these studies.
• Data Provenance: Not specified. The country of origin for the data or whether it was retrospective or prospective is not mentioned.

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

Not applicable. This is a quality control material, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for a quality control material is its chemical stability and stated analyte values, which are determined through laboratory testing procedures, not expert consensus.

4. Adjudication method for the test set

Not applicable. See point 3.

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 not an AI-driven or diagnostic device that involves human readers or AI assistance.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for a quality control device like this would be the analytically determined values and stability characteristics of the biochemical components within the control material, established through validated laboratory methods. It's based on chemical and physical testing rather than clinical outcomes or expert interpretation of images/data.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

Not applicable. See point 8.

Summary of the Study:

The document states that "Stability studies have been performed to determine the open vial stability and shelf life for the Liquid Assayed Multiqual." These studies resulted in the product claims listed under section 7.0 and 7.1, 7.2, and 7.3. The type of study conducted was a stability study to determine how long the control material retains its specified characteristics under various conditions (open vial, thawed and unopened, and frozen shelf life). All supporting data is stated to be "retained on file at Bio-Rad Laboratories."

Without access to those detailed studies, further specifics on methodology, sample sizes, or exact performance data beyond the claims made cannot be provided from this public summary.

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Liquid Assayed Multiqual® Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.

Liquid Assayed Multiqual® Control is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin) chemicals, drugs, preservatives and stabilizers have been added. The control is provided in liquid form for convenience.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Bio-Rad Laboratories Liquid Assayed Multiqual Control:

This document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results for novel device functions. Therefore, much of the requested information regarding detailed study design (like sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not explicitly available in this summary. The provided text primarily discusses stability studies to support product claims.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the stability claims for the control material. The reported device performance is presented as the stability duration for various storage conditions.

Regarding the Study Information:

Since this is a 510(k) summary for a control material, the "study" referred to is primarily stability testing rather than a clinical effectiveness study. The intent is to demonstrate that the control material maintains its integrity and stability under specified conditions for its intended use, which is "to monitor the precision of laboratory testing procedures."

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 specified in the provided summary.
• Data Provenance: Not specified in the provided summary. "Real time studies will be ongoing to support the shelf life of this product" suggests a prospective component, but the summary primarily describes historical data that has already been collected. The studies were performed by Bio-Rad Laboratories, located in Irvine, California, USA, so presumably the data originates there.

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" for stability is typically determined by analytical testing methods and comparison to initial formulated values, not expert consensus as in a diagnostic imaging study.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. Stability studies rely on laboratory measurements and statistical analysis, not expert 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

• MRMC Study: No, this is not applicable. This device is a liquid assayed control material, not an AI or diagnostic imaging device.

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

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

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

• Type of Ground Truth: For stability studies of control materials, the "ground truth" is typically the initial analytical values of the components within the control at the time of manufacture, and then subsequent measurements are compared against these initial values to determine if they remain within acceptable ranges over time and under various storage conditions. This is based on analytical testing and established analytical methods, not expert consensus or pathology.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI or machine learning device. The studies are related to the stability of the manufactured product.

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

• Ground Truth for Training Set: Not applicable.

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