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Liquichek Tumor Marker 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 Tumor Marker Control is prepared from human source material with added constituents of human and animal origin, chemicals, stabilizers and preservatives. The control is provided in liquid form for convenience.

This document is a 510(k) Summary for a quality control material, not a medical device that would typically undergo a study with acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" here refer to the stability claims of the control material, and the "study" is the stability testing performed.

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

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

For a quality control material, "acceptance criteria" are typically related to its stability and ability to maintain its assigned values over specific storage conditions and timeframes. The performance is the duration for which these conditions are met.

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 a "sample size for the test set" in the context of clinical performance or diagnostic accuracy. Instead, it refers to stability studies. The details for these studies are:

• Sample Size: Not specified in terms of number of runs or batches, but implies "a representative sampling of this lot of product" was used for value assignment and stability testing.
• Data Provenance: The studies were performed internally by Bio-Rad Laboratories and/or "independent laboratories." The country of origin is not specified, but Bio-Rad Laboratories is based in California, USA.
• Retrospective or Prospective: These would be prospective studies, as they involve testing the product over time under various storage conditions.

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 as the device is a quality control material and not a diagnostic device requiring expert interpretation of results to establish "ground truth" for a test set. The "ground truth" for this device relates to the assigned quantitative values of the analytes within the control material, which are established through a process called "Value Assignment."

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

This is not applicable for a quality control material. Value assignment and stability testing are typically performed through replicate analyses and statistical methods, not through 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

This is not applicable. The device is a quality control material, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

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

This is not applicable. The device itself is a material, not an algorithm. Its "performance" is its stability and the reproducibility of its assigned values when tested by laboratory instruments.

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

For a quality control material, the "ground truth" refers to the established, target values of the analytes within the control. This is established through:

• Value Assignment: "The mean values and corresponding ±3SD ranges in the Assignment of Values Data Charts were derived from replicate analyses and are specific for this lot of product. Data from Unity™ Interlaboratory Program are included in the determination of some ranges." This indicates a process involving extensive laboratory testing and potentially interlaboratory comparisons to determine accurate and precise target values.

8. The sample size for the training set

This is not applicable. This device is a quality control material, not an algorithm that requires a "training set."

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

This is not applicable, as there is no "training set" for this type of device.

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Liquichek Tumor Marker 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 Tumor Marker Control, a trilevel liquid control is prepared from human source material with added constituents of human and animal origin, stabilizers and preservatives.

Here's a summary of the acceptance criteria and the study details for the Liquichek Tumor Marker Control, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "replicate analyses" and "a representative sampling of this lot of product" for value assignment, but no specific number of samples or details on provenance beyond the manufacturer and/or independent laboratories. The document indicates the human source material used to manufacture the control was tested by FDA accepted methods and found non-reactive for specific viruses.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device. The study is for stability claims of a quality control material, not for diagnostic accuracy requiring expert consensus on clinical cases. Ground truth for control materials is typically established through precise analytical methods and value assignment processes.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This study does not involve adjudication of expert readings or clinical interpretations.

4. 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 stability study for a quality control material, not an AI-powered diagnostic device or a comparative effectiveness study involving human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a control material, not an algorithm.

6. The type of ground truth used:

   • Value Assignment: The mean values and ±3SD ranges printed in the product insert were derived from replicate analyses using manufacturer supported reagents and a representative sampling of the product. These values serve as the established "truth" for monitoring precision.
   • Stability Studies: For stability, the ground truth is the initial established value of the control material, against which subsequent measurements over time (under various conditions) are compared to ensure they remain within acceptable ranges. The acceptance criteria themselves define the acceptable deviation from this established truth.

7. The sample size for the training set: Not applicable. This device is a quality control material and does not involve artificial intelligence or machine learning that requires a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

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

Liquichek Tumor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. This control is substantially equivalent to the following quality control material that is currently in the market: Lyphochek Tumor Markers Control Bio-Rad Laboratories Irvine, California 92618 510 (k) Number: K011579. The new device is in liquid form with a matrix of human and animal serum albumin, contains preservatives, has Level 1, 2 and 3, and has different storage and open vial claims compared to the predicate device. It also contains claims for a different set of analytes.

This document is a 510(k) premarket notification for the Bio-Rad Laboratories Liquichek Tumor Markers Control. The purpose of a 510(k) is to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study" described here are focused on establishing substantial equivalence rather than traditional performance metrics like sensitivity, specificity, or AUC as might be seen for a diagnostic or AI device.

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

The core "acceptance criteria" for a 510(k) in this context is demonstrating substantial equivalence to a predicate device. This is achieved by comparing characteristics and showing that any differences do not raise new questions of safety or effectiveness. The "reported device performance" primarily refers to stability studies supporting the product claims.

• Form: Liquid (new) vs. Lyophilized (predicate)
• Matrix: Human and animal serum albumin (new) vs. Human serum (predicate)
• Levels: Level 1, 2, and 3 (new) vs. Level 1 and 2 (predicate)
• Preservatives: Contains preservatives (new) vs. Does not contain preservatives (predicate)
• Storage (Unopened): -20°C to -70°C, until expiration date (new) vs. 2°C to 8°C, until expiration date (predicate)
• Open Vial Claim / After reconstitution: All analytes 30 days at 2-8°C (exception: IGF-1 15 days) (new) vs. All analytes 14 days at 2-8°C (various exceptions) (predicate)
• After reconstituting and freezing: No claims (new) vs. 30 days at -10 to -20°C (predicate)
• Analytes: Some differences in the specific list of claimed analytes (new device contains claims for some analytes not in predicate and vice versa). |
  | Stability: Support claims for shelf life and open vial stability with relevant studies. | Stability Studies Performed:
• Open Vial Stability: All analytes stable for 30 days at 2-8℃, except IGF-1 (15 days).
• Shelf Life: 2 Years at -20°C to -70°C. |

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

This document is for a quality control material and does not involve a "test set" in the sense of clinical samples for a diagnostic or AI device. The "study" mentioned refers to stability studies of the control material itself.

• Sample size for stability studies: Not explicitly stated in this summary. It mentions "Stability studies have been performed," implying internal testing of the control material batches.
• Data provenance: Not explicitly stated, but it's internal Bio-Rad Laboratories data. Given the address, it's likely originating from Irvine, California, USA.
• Retrospective or prospective: Stability studies are inherently prospective, following the material over time under defined conditions.

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. This is a quality control material, not a diagnostic device requiring expert interpretation of clinical data to establish a ground truth. The "ground truth" for a QC material is its established analyte concentrations and stability profiles.

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

Not applicable. There is no clinical test set requiring adjudication in this submission.

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-assisted diagnostic device.

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

Not applicable. This is a quality control material, not an algorithm/AI device.

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

For a quality control material, the "ground truth" is established through:

• Assigned Values/Target Concentrations: These are determined by the manufacturer through rigorous analytical testing using reference methods and/or highly characterized calibrators.
• Stability Profiles: Determined by real-time and accelerated stability studies under various storage and usage conditions, measuring changes in analyte concentrations over time.

8. The sample size for the training set

Not applicable. This is a quality control material, not an AI device trained on a dataset.

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

Not applicable. No training set for an AI/algorithm is involved.

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