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STA-R Evolution® Expert Series Hemostasis System is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA-R Evolution® Expert Series Hemostasis System is designed as a fully automatic system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, support for instrument maintenance, and work load optimization. The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents. The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. chronometric) measurements and photometric assays (at specific wavelengths) on plasma samples.

The provided text describes modifications to an existing device, the STA-R Evolution® Expert Series Hemostasis System, and asserts its substantial equivalence to a predicate device. However, it does not provide a specific study with acceptance criteria, reported device performance, sample sizes, expert details, or ground truth methodologies that would typically be found in a detailed validation report.

Instead, the document focuses on regulatory approval (510(k) submission) by demonstrating that the modified device has:

• The same Indications for Use.
• The same Technology.
• The same Principles of Operation.
• "Comparable Performances" to the predicate device.

The modifications are stated to "Presult in better performance" due to new hardware/mechanical components, software updates for user enhancements, data post-processing for increased reliability, and bug corrections. It also mentions a "new option of Reverse Sequence Drilling Mode (referred to as PTB)" to increase results reliability when using capped tubes.

The document explicitly states: "Nevertheless, there are no new questions regarding the Safety, Effectiveness, Technology, Principles of Operation and Performance as evidenced by Risk Assessment and Validation Studies (including all the changes mentioned above." This implies that validation studies were performed, but the details of those studies (e.g., acceptance criteria, specific performance metrics, sample sizes, ground truth) are not included in this summary.

Therefore, I cannot provide the requested table and details because the information is not present in the provided text. The document acts as a summary for a 510(k) submission, confirming the existence of validation studies without detailing their results or methodology.

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