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The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

The AF100 is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. The AF100 with Carmeda BioActive Surface (CB851) is coated with a nonleaching bioactive surface (heparin) to enhance blood compatibility and provide thromboresistant blood-contacting surfaces. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.

The provided text is a 510(k) Summary for a medical device (Affinity® AF100 Arterial Filter with Carmeda® BioActive Surface) seeking a determination of substantial equivalence to a predicate device. This type of regulatory submission in the U.S. FDA context focuses on comparing a new device to an already legally marketed one, rather than presenting a detailed study proving the new device's independent efficacy against acceptance criteria in the way clinical trials for novel devices do.

Therefore, many of the requested elements pertaining to a clinical study (like sample size for test sets and training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of document because it describes pre-clinical bench testing for substantial equivalence, not a clinical effectiveness study.

Here's a breakdown of the information that is available and a note on what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "performance tests" that were conducted to demonstrate substantial equivalence to the predicate device. However, it does not specify quantitative "acceptance criteria" for each test or detailed "reported device performance" against those criteria. It only states that these tests were conducted to "verify the performance characteristics."

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable. Performance was verified through pre-clinical bench testing, not a clinical test set with human data. The document does not specify the number of devices or trials performed for each bench test.
• Data Provenance: Not applicable, as this was pre-clinical bench testing. There is no mention of country of origin or whether it was retrospective or prospective in a clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This was pre-clinical bench testing of a physical device, not an AI/diagnostic device requiring expert ground truth for image or data interpretation.

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

• Not applicable. This was pre-clinical bench testing, not a study involving human readers or expert adjudication.

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:

• Not applicable. This device is an arterial filter for cardiopulmonary bypass, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• Not applicable. This device is a physical arterial filter, not an algorithm.

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

• For pre-clinical bench testing, "ground truth" would equate to established engineering and material science standards and measurement techniques for evaluating physical properties (e.g., pressure, filtration size, material strength). The document implies that industry standards and validated methods were used to conduct the described performance tests, but it does not detail them.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device that requires a training set.

Summary of Device Acceptance & Study:

The "acceptance criteria" for this submission are primarily demonstrating substantial equivalence to the predicate device (Affinity Arterial Filter with Carmeda® BioActive Surface (20µm) Model CB353, K001138).

The study that "proves the device meets the acceptance criteria" is a series of pre-clinical bench tests. These tests were conducted to verify that despite a change in housing material (from polycarbonate to Bisphenol A-free (BPA-free) copolyester), the new device maintains similar technological characteristics, operating principles, design features, and performance as the predicate device. The conclusion of the submission states: "Pre-clinical bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence with the predicate devices."

The FDA's letter confirms that based on the provided information, the device is deemed "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for market clearance under the 510(k) pathway.

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