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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.

Not Found

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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Plateletworks (K990398) is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures as measured by a change in platelet count due to activation of functional platelets. It may be used at the point-of-care on the Ichor or Coulter hematology analyzers as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.

Automated Platelet Aggregation System

I am sorry, but there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) clearance letter from the FDA for the Plateletworks® device, indicating substantial equivalence to a predicate device and outlining regulatory information. It does not contain details about specific performance studies or acceptance criteria.

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Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood accermination on ong cardiac interventional procedures as measured by a change in platelet count due to activation of functional It may be used at the point-of-care on the Ichor platelets. hematology analyzer as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Collagen for Plateletworks™" device. It outlines the FDA's determination of substantial equivalence and regulatory class for the device. However, it does not contain any information about acceptance criteria, study details, performance data, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related questions you've asked.

The document is a regulatory approval letter, not a scientific study report or clinical trial summary. It refers to an "enclosure" for indications for use, but the enclosure itself (which starts on page 2 of the provided text) only describes the intended use of the device, not its performance metrics or how those metrics were validated.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not present.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not present (the device is an "Automated Platelet Aggregation System," implying an automated measurement, but no performance study details are given).
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The document mainly states that the device is deemed "substantially equivalent" to legally marketed predicate devices, meaning its safety and effectiveness are considered comparable based on the information submitted in the 510(k) application. The specifics of the studies proving this equivalence are not included in this letter.

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Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures as measured by a change in platelet count due to activation of functional platelets. It may be used at the point-of-care on the Ichor hematology analyzer as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.

Plateletworks is a unitized screening assay for determining platelet aggregation in a whole blood sample using the Ichor hematology analyzer. The Plateletworks methodology is an adaptation of platelet aggregometry that is extremely simple, and quick to perform (results are available in about five minutes). This method involves using the Ichor hematology analyzer (based on electronic impedance principles) to measure total platelet count in a whole blood sample and then to redetermine the number of platelets in a second sample that has been exposed to a known platelet agonist. The agonist will stimulate those platelets which are functional to aggregate into clumps, and they will not be counted as platelets in the second sample. The difference in platelet counts between samples one and two provides a direct measurement of platelet aggregation and is reported as percent aggregation as per the following equation: Baseline Platelet Count - Agonist Platelet Count x 100 = % Aggregation Baseline Platelet Count

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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