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The STA® D-Di Calibrator kit is intended for use as a calibration plasma for D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).

The STA® D-Di Calibrator is a citrated human plasma containing D-dimer at a known level, intended for use as a calibration plasma for the assay of D-dimer antigen by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model and STA® Compact model). Each STA® D-Di Calibrator kit provides 6 x 1-ml vials of citrated human plasma in lyophilized form. The D-dimer value of each lot is indicated in the Assay Value insert supplied with each kit. The freeze-dried reagent in intact vials is stable for 24 months after the date of manufacture, when stored at 2°-8°C; the reconstituted plasma remains stable for 4 hours on board STA® analyzers.

The provided text primarily focuses on the regulatory approval of the STA® D-Di Calibrator Kit and its intended use as a calibration plasma. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics such as sensitivity, specificity, or accuracy.

The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a predicate device. This type of submission generally relies on demonstrating equivalence rather than providing detailed performance studies against specific acceptance criteria for a new device's efficacy or diagnostic accuracy.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided text only offers the following relevant details:

• Device Name: STA® D-Di Calibrator Kit
• Intended Use: To be used as a calibration plasma for the assay of D-dimer antigen by the immuno-turbidimetric method performed on STA® analyzers (STA® full-size model and STA® Compact model).
• Regulatory Status: 510(k) cleared (K964718), found substantially equivalent to predicate devices.
• Product Description: Citrated human plasma containing D-dimer at a known level, supplied in 6 x 1-ml vials in lyophilized form.
• Stability: Freeze-dried reagent is stable for 24 months at 2°-8°C. Reconstituted plasma is stable for 4 hours on board STA® analyzers.

To obtain the information requested, a detailed performance study report or design validation document would be necessary, which is not present in the provided text.

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