(44 days)
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.
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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:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not present.
- 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).
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- 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.
§ 864.5700 Automated platelet aggregation system.
(a)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.(b)
Classification. Class II (performance standards).