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The Aalto Scientific Micro Hematocrit Control are human blood based solutions intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for hematocrit.

The Aalto Scientific Micro Hematocrit Controls are prepared using human blood and chemicals, including less than 0.1% sodium azide as preservative. The Aalto Scientific Micro Hematocrit Controls are for in vitro diagnostic use only. The human components used in the manufacture of the product have been tested and found to be non reactive by FDA approved methods for HIV 1/2, HbsAg HCV and HTLV 1/2.

This document is a 510(k) summary for the Aalto MicroHematocrit Control, a device used to monitor the precision of laboratory testing procedures for hematocrit. It claims substantial equivalence to STI Hematachek Separation Technology. This submission does not contain a study with acceptance criteria for device performance.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone performance results.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document focuses on describing the device, its intended use, and its technological characteristics compared to a predicate device, as required for a 510(k) submission seeking substantial equivalence, rather than presenting a performance study with detailed acceptance criteria and results.

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