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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 of linearity, calibration verification and verification of reportable range for the following analyte: D-Dimer in a clinical laboratory setting by 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 liguid 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 document describes the FDA 510(k) summary for the VALIDATE® D-Dimer Calibration Verification / Linearity Test Kit (K162705). This device is an assayed quality control material, not an AI-powered diagnostic device. Therefore, the specific questions related to AI performance, such as multi-reader multi-case studies, human reader improvement with AI assistance, and AI-specific ground truth, are not directly applicable.

However, I can extract information related to the acceptance criteria and the studies performed for this device based on the provided text.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this device, a calibration verification/linearity test kit, is its ability to demonstrate linearity between specified levels and to perform consistently with a predicate device. The performance is primarily evaluated through precision/reproducibility studies and linearity testing.

Table 1: Acceptance Criteria (Implicit) and Reported Performance

Study Details:

2. Sample sizes used for the test set and the data provenance:

• Precision Study (Test Set 1):
  • Sample Size: 80 replicates per kit level (for Levels 1 through 5). Total 400 replicates (5 levels * 80 reps).
  • Methodology: 3 lots of devices, 1 lot of reagent and quality controls, tested over 20 days, 2 runs per day, 2 replicates per run.
  • Provenance: Data appears to be prospective, collected specifically for this submission. Country of origin is not explicitly stated but implied to be within the US given the submission to the FDA. The testing was done on a Stago STA-R® Evolution instrument system.
• Reproducibility Study (Test Set 2):
  • Sample Size: 75 replicates per kit level (for Levels 1 through 5). Total 375 replicates (5 levels * 75 reps).
  • Methodology: 1 lot of device, 1 lot of reagent and quality controls, tested on 3 instruments, multi-site, over 5 days, 1 run per day, 5 replicates per run.
  • Provenance: Data appears to be prospective, collected specifically for this submission. Multi-site indicates varied data sources geographically, likely within the US. The testing was done on a Stago STA® instrument system.
• Value Assignment (Levels 1 & 5) (Test Set 3):
  • Sample Size: 30 replicates for Level 1 and Level 5.
  • Methodology: Testing was performed to establish typical recovery values.
  • Provenance: Not explicitly stated, but part of the manufacturing and quality control process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable: This device is a quantitative control material for D-Dimer, not an AI or diagnostic imaging device that requires human expert interpretation for ground truth. The "ground truth" for this device's performance is its measured concentration and its linearity, verified against instrument performance and established industry standards (e.g., CLSI EP6-A).

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

• Not Applicable: As this is a quantitative control material, there is no subjective interpretation requiring adjudication by experts. The "adjudication" is based on objective statistical analysis (e.g., CV% calculation) of the measured values.

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 device is not an AI-powered diagnostic system. It is a calibration and linearity verification kit.

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

• Not Applicable: This device does not involve an algorithm being tested in a standalone capacity. Its performance is intrinsically tied to human laboratory personnel using it on an analytical instrument.

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

• The "ground truth" for this device essentially comes from:
  • Expected Quantitative Values: The known, manufactured concentrations of D-Dimer at each level (Levels 1 and 5 prepared independently, Levels 2, 3, and 4 derived from equal part dilutions).
  • Industry Standards: Adherence to guidelines like CLSI EP6-A for linearity and calibration verification.
  • Instrument Reference Standard: Traceability to the Stago LiaTest calibrator on the Stago STA-R® Evolution instrument system.

8. The sample size for the training set:

• Not Applicable in the context of machine learning model training. For a calibration verification kit, the concept of a "training set" doesn't apply in the same way. The device's characteristics are designed and controlled during manufacturing based on established analytical chemistry principles and instrument performance specifications.

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

• Not Applicable in the context of machine learning. The "ground truth" for the various levels of the calibration kit is established during its manufacturing process. Levels 1 and 5 are prepared independently by adding D-Dimer to a human plasma base matrix to target specific concentrations. Levels 2, 3, and 4 are then prepared from these by equal part dilutions according to EP6-A guidelines, ensuring a known linear relationship (equal delta) between all five levels. This forms the basis of the expected "truth" for validating linearity and calibration on user instruments.

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