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The EMBOL-X Aortic Filter is indicated for use with the EMBOL-X Aortic Cannula in cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 60 years and older undergoing first time non-emergent CABG or isolated aortic or mitral valve repair/replacement.

The EMBOL • X Aortic Filter device consists of three primary components: 1.) a distal heparin-coated mesh filter, mounted onto a flexible frame to form a filter basket for particulate emboli capture and retention; 2.) a locking cartridge housing for attachment to the EMBOL•X Aortic Cannula side port, permitting access to the aorta and to ensure correct orientation of the filter during use; and 3.) a proximal syringe-like plunger mechanism to deploy and withdraw the distal basket into and from the aorta, via the cannula, during surgery. The filter is introduced surgically into the aorta via the previously placed cannula, and particulates are captured and removed as blood passes through the filter basket. The filter may remain in situ for up to 60 minutes. The EMBOL.X Aortic Filter utilizes conventional medical grade materials and processes, and is provided packaged, labeled, and sterile, intended for single-use.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Total patients in the randomized controlled equivalency study: 1289 patients
  • Treatment arm (with EMBOL-X Aortic Filter): 645 patients
  • Control arm (standard treatment): 644 patients
• Data Provenance: Prospective, multi-center study conducted at 22 sites within the United States and Canada.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: An "independent Clinical Events Committee (CEC)" was used. The exact number of experts is not specified.
• Qualifications of Experts: The qualifications of the experts on the CEC are not specified in the provided text.

4. Adjudication Method

• Adjudication Method: "An independent Clinical Events Committee (CEC) adjudicated the major clinical endpoints and events." The specific method (e.g., 2+1, 3+1) used by the CEC for adjudication is not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, this appears to be a clinical trial comparing a device to a control group, not a study evaluating human reader performance with and without AI assistance.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as this was not an MRMC study involving AI.

6. Standalone (Algorithm Only) Performance

• Was a standalone performance study done? Not applicable. This device is a physical filter, not an algorithm, so the concept of "standalone (algorithm only)" does not apply. The effectiveness was measured by the filter's ability to capture particles and the impact on patient outcomes.

7. Type of Ground Truth Used

• Ground Truth Type:
  • For the primary safety measure (clinical events): Outcomes data adjudicated by an independent Clinical Events Committee.
  • For the primary effectiveness measure (particulate capture): Visual confirmation by light microscopy of particulate debris in the filters.

8. Sample Size for the Training Set

• The text describes a prospective clinical trial evaluating the safety and effectiveness of a physical medical device. It does not mention a "training set" in the context of machine learning or algorithms. Therefore, the concept of a training set sample size is not applicable to this device study.

9. How Ground Truth for the Training Set Was Established

• As there is no mention of a "training set" for an algorithm, this question is not applicable.

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