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Plateletworks Arachidonic Acid (PW-ACA) is an in vitro diagnostic screening test on whole blood for the qualitative determination of platelet inhibition by aspirin which inhibit arachidonic acid induced platelet aggregation. The change in platelet count due to activation and aqqreqation of functional platelets is measured using an electronic impedance-base cell counter.

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This is an FDA Premarket Notification (510(k)) letter for the Plateletworks Arachidonic Acid device. This document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a 510(k) summary. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device and can proceed to market.

Therefore, many of the requested details cannot be extracted from the provided text.

Based on the provided text, the following can be inferred or stated:

• Device Name: Plateletworks Arachidonic Acid (PW-ACA)
• Intended Use: An in vitro diagnostic screening test on whole blood for the qualitative determination of platelet inhibition by aspirin which inhibit arachidonic acid induced platelet aggregation. The change in platelet count due to activation and aggregation of functional platelets is measured using an electronic impedance-based cell counter.

Here's what cannot be found in the provided text:

• Acceptance criteria and reported device performance table
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• Whether a standalone (algorithm only) performance study was done
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

To obtain these details, one would typically need to refer to the 510(k) summary document, which is a public summary of the information provided in the 510(k) submission, including performance data and a discussion of substantial equivalence.

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