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The AFFINITY® 38 µ Arterial Filter with Trillium™ Biopassive Surface is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.

The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is a single use device designed to filter microemboli from the blood in the extracorporeal circuits during cardiopulmonary bypass surgery. The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is coated with a non-leaching biopassive surface.

This K013084 submission for the AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is a "SPECIAL 510(k)" for a modification to an existing device (AFFINITY® 38 µ Arterial Blood Filter, K952532) by adding a Trillium™ Biopassive Surface coating. The submission primarily relies on demonstrating substantial equivalence to predicate devices, rather than conducting a de novo effectiveness study with defined acceptance criteria and associated performance results in tables.

Therefore, many of the requested sections below cannot be fully populated as the provided document does not contain such detailed effectiveness study information. The focus is on the technological characteristics comparison and biocompatibility/in vitro bench testing to show that the new coating does not significantly affect safety and effectiveness compared to the predicate devices.

Here's the information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the format of a table for an effectiveness study. Instead, it states that "biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the AFFINITY® 38 // Arterial Blood Filter with Trillium™ did not significantly affect safety and effectiveness."

The tests performed were:

• Coating Characteristics
• Physical Characteristics
• Performance Characteristics

The overall "performance" is implicitly deemed acceptable as it allows for substantial equivalence. The document doesn't provide specific numerical targets or results for these characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any test sets or the provenance of the data (country of origin, retrospective/prospective). The studies mentioned are "biocompatibility and in vitro bench testing," which typically involve laboratory tests rather than human subject data in the way clinical studies do.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. The evaluation of material characteristics and in-vitro performance generally relies on scientific and engineering testing, not expert consensus for ground truth on a test set in the clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the document. Adjudication methods are typically relevant for clinical studies involving reader interpretation, which is not what was performed for this device modification.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is an arterial blood filter, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is an arterial blood filter, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission is based on scientific and engineering standards and tests for material properties, biocompatibility, and filter performance (e.g., flow rates, filtration efficiency – though not detailed in the summary). It's essentially an engineering and laboratory-based ground truth, comparing the modified device's characteristics to those of the predicate devices and accepted material standards.

8. The sample size for the training set

This is not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. This device is not an AI/ML algorithm that requires a training set.

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