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Mission CliniCheck Controls is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha Hydroxybutyrate Dehydrogenase (a-HBDH), Amylase, Apolipoprotein A-1, Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 Complement C4 Complement, Calcium, Carbon Dioxide (CO2), Chloride, Cholesterol (Total), HDL- Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine, Gamma Glutamyltransferase (GGT), Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron, Iron Binding Capacity, Total (TIBC), Iron Binding Capacity, Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total, T Free, T4 Total, Thyroid Stimulating Hormone (TSH), Transferrin, Triglycerides, Urea, Urea Nitrogen, and Uric Acid on instruments listed in the expected values chart.

Mission CliniCheck Assayed Chemistry Control is a human serum based product containing constituents of purified biochemicals (tissue extracts of human and animal origin) chemicals, preservatives and stabilizers. Two levels of Control are provided in a lyophilized form. Each level is packaged into a glass amber bottle containing 5mL of product. The product is packaged in single level boxes (12 x 5mL) or multiple level boxes (6 x 2 x 5mL) and stored at 2 - 8°C. All human source material was tested and found negative by FDA approved methods for HBsAG, HCV, and HIV-1/2.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

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

The provided text does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, precision limits) for the Mission CliniCheck Assayed Chemistry Control. Instead, the "performance" described relates to stability and shelf-life, demonstrating that the control material maintains its characteristics over time.

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 specify a "test set" in the context of typical AI algorithm validation. The tests conducted were related to stability studies for the control material itself. Therefore, the sample size would refer to the number of control units tested for stability, but this information is not provided.

The provenance of this data is internal to the manufacturer, Diamond Diagnostics, Inc., as they conducted these tests to support their product claims. The studies appear to be prospective in nature, as they involve testing the product over time under various conditions (accelerated, refrigerated, frozen) to determine its stability. No information regarding country of origin for the data is provided beyond the applicant's address in Holliston, MA, USA.

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 question is not applicable to the type of device being described. The Mission CliniCheck Assayed Chemistry Control is a quality control material, not a diagnostic device requiring expert interpretation of results to establish "ground truth." Its "truth" is its certified analyte concentrations.

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

Not applicable. This device does not involve human interpretation or adjudication in the way an AI diagnostic tool would.

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 and not an AI-assisted diagnostic device that would involve human readers.

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.

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

The "ground truth" for this device would be the certified values of the analytes within the control material. These values are established through rigorous analytical testing using reference methods and/or expert laboratories to define the expected concentration ranges for each analyte. The document doesn't detail this process, but it is standard for assayed quality control materials.

8. The sample size for the training set

Not applicable. This device is a quality control material, not a machine learning model, so there is no training set.

9. 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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