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The intended use of the Alpha Micron®-20/40 Microaggregate Filter is for filtering microaggregate debris from plasma derivative products to prevent pulmonary embolization.

The Alpha Micron®-20/40 Microaggregate Filter is a filter used for the filtration of microaggregate debris from plasma derivative products in order to aid in the prevention of pulmonary embolization. The device is designed to be utilized in either of two applications; by syringe, or by administration set. The syringe is inserted into the exposed inlet of the filter while the spike end is inserted into the bottle (or bag) of the plasma derivative. The blood plasma derivative is aspirated through the filter into the syringe resulting in filtration. The administration set is placed into the exposed inlet of the filter while the spike end is attached to an infusion set. The plasma derivative is drawn through the filter during administration resulting in filtration.

The provided text is a 510(k) summary for a medical device (Alpha Micron®-20/40 Microaggregate Filter) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/ML devices or diagnostic accuracy studies.

The document describes the device, its intended use, and claims substantial equivalence to previously marketed devices. Substantial equivalence for this type of device typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device. This is often achieved through comparison of materials, design, manufacturing processes, and performance specifications rather than a clinical study with acceptance criteria in the context of diagnostic accuracy.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because it describes a hardware microaggregate filter, not a device requiring such detailed performance evaluation.

The provided text does not contain the information requested for the following reasons:

• Type of Device: The device described is a physical "Microaggregate Filter" for blood products, not a diagnostic or AI/ML-driven device that would typically involve acceptance criteria and studies related to diagnostic accuracy, such as those involving radiologists or pathology.
• Study Design: The document outlines the device's description, intended use, and claim of "substantial equivalence" to predicate devices. Substantial equivalence for this type of device is usually demonstrated through comparative technical specifications and performance data (e.g., flow rate, filtration efficiency) rather than clinical studies with "ground truth" established by experts in the diagnostic sense.
• Missing Information: There is no mention of acceptance criteria formulated as performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or details about training sets.

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