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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.

Device Description

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.

AI/ML Overview

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.

Characteristic	Acceptance Criteria (Claimed Stability)	Reported Device Performance (Established Stability)
Thawed and Opened Stability	IGF-1: 15 days at 2 to 8°C
CA 125: 10 days at 2 to 8°C
All other analytes: 30 days at 2 to 8°C	IGF-1: 15 days at 2 to 8°C
CA 125: 10 days at 2 to 8°C
All other analytes: 30 days at 2 to 8°C
Thawed and Unopened Stability	IGF-I, PAP: 35 days at 2 to 8°C
Free PSA: 30 days at 2 to 8°C
CA 125: 14 days at 2 to 8°C
All other analytes: 60 days at 2 to 8°C	IGF-I, PAP: 35 days at 2 to 8°C
Free PSA: 30 days at 2 to 8°C
CA 125: 14 days at 2 to 8°C
All other analytes: 60 days at 2 to 8°C
Frozen Aliquot Stability	All analytes: 30 days at -20°C to -70°C	All analytes: 30 days at -20°C to -70°C
Shelf Life Stability	28 months at -20 to -70°C	28 months at -20 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)

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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