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The Capiox® Bubble Trap with X-coating " is a device intended to facilitate air bubble removal from the blood flowing through a cardiopulmonary bypass circuit for up to 6 hours.

The Capiox® Bubble Trap with X-coating is comprised of a single outer housing with no inner housing. This outer housing is cylindrical in shape and has a slight conical-shaped lid assembly affixed to the upper area of the cylinder. The lid assembly has an air vent (purge) port on the top outer surface to facilitate air removal during use. The blood inlet port is positioned along the upper-side_axis_of_the_cylinder_housing_and_allows_for the entry of blood ... The base_of_the housing contains the blood outlet port. The cylinder housing contains a screen filter assembly through which blood will pass through for filtration of air bubbles. After the blood has been filtered, it then exits the assembly via the blood outlet port.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria:

Acceptance Criteria and Device Performance Study for Capiox® Bubble Trap with X-coating™

The provided document describes the Terumo Capiox® Bubble Trap with X-coating™ and its performance evaluation for substantial equivalence to a predicate device. The core of the performance evaluation is a comparison study.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets. Instead, it demonstrates "functional equivalence" and "substantial equivalence" to a predicate device, the non-coated BT15 Bubble Trap. Therefore, the "acceptance criteria" are implicitly that the new device performs comparably to the predicate device in the listed performance evaluations. The "reported device performance" refers to the demonstration of this equivalence.

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

The document does not explicitly state the numerical sample sizes for each in-vitro performance evaluation. It only mentions that "the following tests were performed."

• Sample Size: Not explicitly stated for the in-vitro tests.

• Data Provenance: The in-vitro performance evaluations were conducted by "Terumo Corporation, in conjunction with Terumo Cardiovascular Systems Corporation," implying an internal, retrospective (for the purpose of this submission, though the tests themselves would have been prospective investigations) study. No country of origin for the direct test data is specified beyond the Terumo entities.

  An in-vivo animal study was conducted by Terumo Cardiovascular Systems and Sierra Biomedical Laboratories in 1999 to evaluate the X-Coating material itself. This study would be considered retrospective for the current submission.

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

This type of information is not provided in the document. The studies described are primarily in-vitro lab tests and material evaluations, not clinical studies requiring expert ground truth for interpretation of patient data.

4. Adjudication Method (for the test set)

This information is not applicable or not provided. The studies are in-vitro performance evaluations demonstrating equivalence to a predicate, not clinical studies requiring adjudication of medical diagnoses.

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

No, an MRMC comparative effectiveness study was not mentioned. The studies described are in-vitro performance evaluations and an in-vivo animal study for material safety, not studies involving human readers or comparative effectiveness in a clinical setting.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical medical device (bubble trap), not an algorithm or software. The "standalone" performance in this context would be the in-vitro functional performance tests, which were indeed conducted without human intervention in the function of the device itself during the test.

7. The Type of Ground Truth Used

For the in-vitro performance evaluations (Air Removal Efficiency, Hemolytic Effect, Pressure Drop, Mechanical Integrity/Leakage, Prime Volume), the "ground truth" is defined by objective, measurable physical and chemical properties and engineering specifications. The performance of the new device is compared directly against the established performance of the predicate device.

For the X-Coating material's safety, the "ground truth" was established by in-vivo animal study outcomes, specifically looking for "adverse conditions."

8. The Sample Size for the Training Set

This information is not applicable or not provided. The Capiox® Bubble Trap with X-coating™ is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for such a device would be its design, manufacturing processes, and material selection based on established engineering principles and prior device knowledge.

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

This information is not applicable as there is no "training set" in the context of AI/ML for this physical device. The "ground truth" for its development and design would have been established through a combination of engineering principles, material science knowledge, regulatory standards, and performance data from previous device generations (like the predicate device).

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