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The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579) to perform quantitative determinations of D-dimer antigen levels in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.

The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers to perform quantitative assays of D-dimer antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with specific mouse anti-human D-dimer monoclonal antibodies.

Each STA®-Liatest® D-Di test kit provides: 6 x 5-ml vials of ready-for-use Tris buffer and 6 x 6-ml vials of a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.

Reagents in intact vials remain stable for 18 months after the date of manufacture, when stored at 2°-8°C. After opening of the vials, kit reagents (with STA®-Reducers and perforated caps installed on the vials) are stable for 15 days on board STA® analyzers.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. Instead, it describes a 510(k) premarket notification for a medical device, the STA®-Liatest® D-Di Test Kit, which indicates it has been found "substantially equivalent" to a predicate device. This substantial equivalence determination generally means that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.

Here's a breakdown of the requested information based on the provided text, and where the information is not available:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not specified.
• Data provenance: Not specified.

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)

• Not applicable/Not specified. The substantial equivalence claim is made against a predicate device, not by establishing ground truth based on expert consensus for the new device's performance.

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

• Not applicable/Not specified. The document does not describe a test set or an adjudication process for such a set.

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

• No. This device is an in-vitro diagnostic test kit (an immuno-turbidimetric method), not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study.

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

• Not applicable. This is an automated laboratory test kit; its performance is inherently "standalone" in the sense that the analyzer performs the measurement. However, it's not an "algorithm only" in the context of AI.

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

• The ground truth for chemical assays like D-dimer is typically established through reference methods or validated standards. The document states the new device is "substantially equivalent" to the ASSERACHROM® D-Di kit, which is a "microtiter ELISA-based procedure." This implies the predicate device's established performance serves as the benchmark. The inherent ground truth for D-dimer measurements relates to the actual concentration of D-dimer antigen in the plasma, which would be determined by a highly accurate and precise analytical method. The document does not specify details on how the accuracy of either device was independently validated against a gold standard.

8. The sample size for the training set

• Not applicable/Not specified. This device is a reagent kit and analyzer system, not a machine learning algorithm that requires a "training set" in the conventional sense of AI development.

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

• Not applicable/Not specified. As mentioned above, there is no "training set" in the context of an AI algorithm for this device.

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