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The Terumo AL8X Arterial Blood Filter for extra-corporeal service is indicated for use in all cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli, and aggregates composed of platelets, red blood cells, and other debris from the arterial line. The device may be used in procedures lasting up to 6 hours in duration.

The filter is comprised of an outer housing that contains a smaller inner housing. The outer housing is cylindrical in shape and has a slight conical-shaped lid assembly with an air vent port. The blood inlet port is positioned along the upper-side axis of the outer housing and provides the entry point for blood. The base of the housing contains the blood outlet port. The inner housing of the device contains a screen filter through which blood will pass through for filtration of particulate matter. After the blood has been filtered, it then exits the assembly via the blood outlet port. The blood-contacting surfaces of the device are coated with Terumo's polymer coating solution.

The Terumo AL8X Arterial Filter with X-Coating is a medical device intended for use in cardiopulmonary bypass procedures to remove micro-emboli (greater than 40 microns) from the arterial line. The submission K032128 establishes substantial equivalence to a predicate device, the Pall Medical AL8 Arterial Filter (K834380), rather than defining and meeting new acceptance criteria through a clinical study with a detailed ground truth establishment.

Here's an analysis based on the provided document, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific acceptance criteria with numerical thresholds. Instead, it demonstrates performance equivalence to an existing predicate device through comparative in-vitro evaluations. The primary "acceptance" is based on showing no clinically significant performance differences compared to the predicate.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify sample sizes for the in-vitro tests conducted. It generally states that "Terumo Cardiovascular Systems Corporation conducted several evaluations... to demonstrate its equivalence." The data provenance for these evaluations is described as "in-vitro performance tests," implying laboratory settings rather than human subject data. There is no information regarding the country of origin of the data or whether it was retrospective or prospective. An "in-vivo animal study (with an oxygenator device)" was mentioned for the polymer coating, but no details on size or provenance were given.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided. Since the study involved in-vitro performance evaluations and equivalence demonstration to a predicate device, the concept of "ground truth established by experts" in a clinical context (e.g., radiologists interpreting images) is not directly applicable here. The "ground truth" for the performance tests would be derived from physical measurements and established engineering/biomedical testing standards and methods.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., image reading) to resolve discrepancies in expert opinions. Given the in-vitro nature of the performance evaluations, such adjudication methods were not employed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study would involve human readers evaluating cases with and without AI assistance, which is not relevant to the evaluation of an arterial blood filter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm performance study was not done. The device is a physical medical device, not an AI algorithm. Its performance was evaluated through in-vitro tests and comparison to a predicate physical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations was based on physical and biological measurements derived from in-vitro tests, and comparison to the established performance characteristics of the predicate device. For biocompatibility, it relied on established biological standards (ISO 10993) and an in-vivo animal study. For sterilization, it was based on AAMI guidelines. There was no "expert consensus," "pathology," or "outcomes data" ground truth in the sense of a diagnostic or prognostic device study.

8. The Sample Size for the Training Set

This information is not applicable. The Terumo AL8X Arterial Filter is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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