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The FastPack® Control Kit is an assayed quality control for the verification of the accuracy and precision of the FastPack® and FastPack® IP Systems when used for the quantitative determination of the analytes listed in the package insert. The following analytes are included in the package insert:

• Free Thyroxine (FT4)
• Human Chorionic Gonadotropin (hCG)
• Testosterone
• Total Prostate Specific Antigen (tPSA)
• Thyroid Stimulating Hormone (TSH)

FastPack® Control Kit is prepared in a synthetic matrix containing chemicals, preservatives, and stabilizers with added analyte constituents of human and synthesized origin. The control is provided in liquid form for convenience.

This document describes a K123725 FastPack® Control Kit, which is a quality control material used to verify the accuracy and precision of immunoassay systems (FastPack® and FastPack® IP Systems). As such, the "acceptance criteria" and "device performance" in this context refer to the stability and value assignment of the control material, not a diagnostic or AI algorithm's performance on patient data.

Here's an analysis of the provided information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are related to its stability and the accurate assignment of analyte values.

2. Sample Size and Data Provenance (for test set)

This device is a quality control material, not a diagnostic device that processes patient data. Therefore, the concept of a "test set" in the context of patient data, country of origin, or retrospective/prospective data is not applicable here.

The "test set" for this device would be the samples of the control material itself that are used for the value assignment and stability studies.

• Sample Size for Value Assignment: For each analyte and each of the two control levels, 36 determinations were performed (6 FastPack® analyzers * 3 reagent lots * 2 calibrations = 36 determinations).
• Data Provenance: Not applicable in the sense of patient data. The data originates from the internal testing conducted by Qualigen, Inc., presumably at their facility in Carlsbad, CA, as part of their manufacturing and quality control process. The studies are prospective for the purpose of validating the control material.

3. Number of Experts and Qualifications for Ground Truth (for test set)

Again, this is a quality control material. "Ground truth" for this device is based on analytical measurement results from calibrated instruments and established statistical methods, not expert human interpretation of clinical data. Therefore, experts in the sense of radiologists or clinicians are not involved in establishing the "ground truth" for the performance of the control material itself. The "experts" would be the scientific and technical personnel (e.g., analytical chemists, quality control specialists) at Qualigen, Inc. who perform these measurements and statistical analyses. Their qualifications are inherent in their roles within a medical device manufacturer.

4. Adjudication Method (for test set)

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to conflicts in human expert interpretations of clinical data. The value assignment and stability studies for a control material rely on direct analytical measurements and statistical calculations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is designed to assess and compare the performance of human readers, often with and without AI assistance, on diagnostic tasks (cases). This is not relevant to a quality control material.

6. Standalone (Algorithm Only) Performance Study

No. This device is an assayed quality control material, not an algorithm. Its "performance" is its ability to provide stable and accurately assigned values, which is assessed through analytical testing, not by an algorithm's output.

7. Type of Ground Truth Used

The ground truth used for this device is based on analytical measurements and statistical calculations from repeated testing on multiple instruments and reagent lots. It involves:

• Quantitative measurements of analyte concentrations using the FastPack® and FastPack® IP Systems.
• Statistical analysis to determine means, standard deviations, and coefficients of variation.
• Defined ranges (e.g., mean ± 3SD) for each analyte and level.

8. Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning algorithms. This device is a biochemical control material, not an AI model. Therefore, there is no "training set" in the conventional sense. The "training" here would refer to the process of manufacturing and calibrating the control material itself, and the data generated during the value assignment process serves to characterize each manufactured lot.

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

As noted above, there is no "training set" for an algorithm. The "ground truth" for the control material's characteristics (its assigned values and stability) is established through rigorous analytical testing and statistical analysis by the manufacturer, as described in section 3 ("Value Assignment of Analytes") of the 510(k) summary. This process quantifies the target values and acceptable ranges for each analyte within the control kit.

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