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VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit solutions are assayed quality control materials intended for in vitro diagnostic use in the quantitative determination verification verification and verification of reportable range for the following analyte: D-Dimer in a clinical laboratory personnel. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.

Each VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit contains one analyte set of D-Dimer in a human plasma base matrix. The kit includes a set containing five liquid levels, 3.0 mL each. The set is provided to establish the relationship between theoretical and actual performance of the included analyte D-Dimer. Material of human origin used in the manufacture of this test kit was tested at the donor level using FDA approved methods and was found to be non-reactive for HBsAG and to antibodies to HCV and HIV-1/2.

The provided text describes a 510(k) premarket notification for an in vitro diagnostic device, the VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit. This document does not pertain to an AI/ML medical device, but rather to a quality control material used for calibrating laboratory instruments.

Therefore, many of the requested criteria for describing an AI/ML device's acceptance criteria and study proving its performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this document.

However, I can extract information related to the device's performance validation as presented in the document:

Acceptance Criteria and Device Performance (for a Calibration Verification/Linearity Test Kit - Not an AI/ML Device)

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance in terms of precision/reproducibility and linearity, rather than typical AI metrics like sensitivity, specificity, or AUC. The "acceptance criteria" are implied by the statements that "All levels of the VALIDATE® D-Dimer kit met the CV% acceptance criteria on the Siemens CS-2500 instrument system." and that linearity testing was carried out. Specific numerical acceptance criteria for CV% are not explicitly stated in the provided text.

2. Sample Size Used for the Test Set and Data Provenance

• Precision/Reproducibility Study:

  • Sample Size (Replicates): 80 replicates per kit level for precision study; 75 replicates per kit level for reproducibility study.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be from internal lab testing ("on the Siemens Sysmex CS-2500 instrument system" at "multi-site" for reproducibility). The studies are prospective in nature, as they involve active testing of the device.

• Linearity Study:

  • Sample Size: Not explicitly stated in terms of number of runs or replicates, beyond "Linearity testing was carried out."
  • Data Provenance: Internal lab testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This is a quality control material for an in vitro diagnostic test, not an AI/ML device that requires human expert annotation for ground truth. The "ground truth" (or target values) for this device is based on its intended concentration levels (Levels 1 through 5) and the expected linear relationship between them.

4. Adjudication Method for the Test Set

• Not applicable. No human interpretation or qualitative assessment requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is relevant for AI/ML devices that assist human readers in image interpretation or similar tasks. This device is a quantitative control material.

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

• Not applicable. This is a physical kit used to verify instrument performance, not a standalone algorithm. Its "performance" is its ability to reproducibly produce expected values and demonstrate linearity when run on an instrument.

7. The Type of Ground Truth Used

• Internal Reference Standard / Expected Values: The "ground truth" for this device revolves around the predetermined concentrations of D-Dimer in each level (1-5) and their designed linear relationship.
  • Level 1 and 5 are prepared independently with D-Dimer added to a human plasma base.
  • Levels 2, 3, and 4 are subsequently prepared from Levels 1 and 5 by equal part dilutions following CLSI EP6-A guidelines.
  • "Typical recovery values" are established by testing 30 replicates of Levels 1 and 5.
  • The device is traceable to the instrument's (Siemens Sysmex CS-2500) calibrator curve (Innovance® reagent calibrator).

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML model that undergoes "training" in the computational sense. Its formulation and design are based on established laboratory quality control guidelines (e.g., CLSI EP6-A).

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

• Not applicable. See point 8. The "ground truth" for the development of the kit (i.e., establishing the target values and linearity across levels) is described by:
  • Independent preparation of Levels 1 and 5.
  • Subsequent preparation of Levels 2, 3, and 4 via equal part dilutions from Levels 1 and 5.
  • Determination of "typical value ranges" and "typical recovery values" for Levels 1 and 5 through 30 replicates of testing.
  • Adherence to CLSI EP6-A guidelines for linearity.

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