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The EMBOL-X Aortic Cannula is indicated for the perfusion of the ascending aorta during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

Device Description

The EMBOL-X® Aortic Cannula consist of a standard 3/8" ID wire reinforced tube body having a curved J-tip end and a flange for suture attachment. Attached to the side of the J-tip end is an Introducer port having a single lumen housing and a removable self-venting keyed snap-lock Obturator. The outer portion of the J-tip includes a radiused groove that accepts the complimentary radiused distal end of the provided Obturator. With the Obturator inserted, the Obturator provides a smooth, minimally disruptive fit along the J-tip's radiused groove. Removal of the Obturator from the Introducer port reveals a channel through which a physically compatible device may be introduced through the Introducer's hemostatic valve and along the groove of the J-tip. The Introducer port acts as an intravascular hemostasis conduit that can accommodate the introduction of intravascular devices with an exit diameter ranging from 12 FR to 14 FR in size. The Obturator is removed only when intravascular access with a device is necessary. The EMBOL-X Aortic Cannulas have an insertion diameter size of 24 FR. All models are a J-tip configuration whose tips are made from metal or plastic. The device is packaged sterile and non-pyrogenic, is single use only, and come with a separate optional use porous vent plug for cannula venting.

AI/ML Overview

Here's an analysis of the provided text regarding the device's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	All materials must be biocompatible.	"All materials used in the EMBOL-X Aortic Cannula are shown to be biocompatible."
Functional Performance	Joint strength, gasket seal integrity, and flow rate should be substantially equivalent or better than the predicate device(s).	"In-vitro bench test results for joint strength, gasket seal integrity, and flow rate PERFORMANCE characteristics was substantially equivalent or better than in performance to the TESTS: predicate device(s)." This statement implies that the device met this criterion by demonstrating performance either equal to or superior to the predicate devices in these specific areas.
Substantial Equivalence	The device must be substantially equivalent to legally marketed predicate devices in terms of intended use and technological characteristics.	The FDA letter (K020693) explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications of use stated in the enclosure) to legally marketed predicate devices..." The submission also states: "The EMBOL-X Aortic Cannula is technologically and substantially equivalent to the predicate devices."

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

The document explicitly mentions in-vitro bench tests. These tests are typically conducted on a controlled number of manufactured units of the device, rather than on patient data.

Sample Size for Test Set: Not specified. The document states "bench test results" which implies testing was performed on a sample of the manufactured device. The exact number of units tested for joint strength, gasket seal integrity, and flow rate is not provided.
Data Provenance: In-vitro bench testing. This means the data was generated in a laboratory setting, not from human or animal subjects. Therefore, there is no country of origin or retrospective/prospective distinction in the typical sense for clinical studies.

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

This information is not applicable in this context. The study described is in-vitro bench testing, not a clinical study involving diagnosis or interpretation by experts. Therefore, there's no "ground truth" to be established by clinical experts for these specific performance metrics. The ground truth for bench tests is typically defined by engineering specifications and physical measurements.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when multiple human readers interpret data to resolve discrepancies. For in-vitro bench testing, measurements are taken according to predefined protocols, and results are compared against engineering specifications, eliminating the need for reader adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies mentioned are in-vitro bench tests comparing the device's physical performance characteristics (joint strength, seal integrity, flow rate) to predicate devices. These are not studies involving human readers and AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device described is a medical instrument (Aortic Cannula), not a software algorithm or AI. Therefore, there are no "standalone" algorithm performance studies relevant to this submission.

7. Type of Ground Truth Used

The ground truth for the in-vitro bench tests was based on engineering specifications and physical measurements of the device's performance characteristics (joint strength, gasket seal integrity, and flow rate). The performance was then compared to the same metrics for predicate devices.

8. Sample Size for the Training Set

This information is not applicable. As this is an in-vitro bench test for a physical medical device, there is no "training set" in the context of machine learning or AI.

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

This information is not applicable. There is no training set for a physical device's in-vitro bench testing, so no ground truth was established for it in this context.

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