Search Results

The EndoDirect arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The cannula is intended to deliver oxygenated blood for cardiopulmonary bypass for a duration of less than 6 hours. The EndoDirect arterial cannula also allows the hemostatic introduction and removal of vascular catheters such as the Port Access EndoClamp aortic catheter. The EndoDirect arterial cannula is intended for introduction and use through a thoracic trocar or incision.

The AutoIncisor Introducer is intended for use with Port Access arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta.

Edwards EndoDirect arterial cannula is a flexible plastic tube intended to provide a means of safely delivering oxygenated blood for cardiopulmonary bypass procedures and allows for the hemostatic introduction and removal of vascular catheters.

The EndoDirect arterial cannula has the following features: a beveled tip with an end hole, side perfusion holes, and a stabilizer ring for suture and tourniquet, a wirewound shaft for flexibility and kink resistance, a barbed connection site with 3/8 in. acceptance, a hemostasis valve, and a mark indicating tip orientation. A lubricious coating is applied to the surface of the cannula body to facilitate ease of insertion and retraction of the EndoClamp aortic catheter.

The provided text describes a 510(k) submission for the Edwards Lifesciences EndoDirect Arterial Cannula. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, study design elements (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance), and training set details are not applicable or not provided in a 510(k) summary for a device like an arterial cannula.

Here's an explanation based on the provided document:

1. A table of acceptance criteria and the reported device performance

• Not Applicable in this context. For a 510(k) submission of a device like an arterial cannula, the "acceptance criteria" are related to demonstrating substantial equivalence to a predicate device, not necessarily meeting a predefined set of performance thresholds in a clinical study with specific sensitivity/specificity metrics.

• The document states: "The functional data indicate that the proposed device performs in a substantially equivalent manner when compared with the predicate device."

  Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
  Intended Use: Comparable	"comparable to the predicate device in intended use and other labeling"
  Fundamental Scientific Technology: Comparable	"comparable... fundamental scientific technology"
  Material Type: Comparable	"comparable... material type"
  Principles of Operation: Comparable	"comparable... principles of operation"
  Functional Performance: Substantially Equivalent	"The functional data indicate that the proposed device performs in a substantially equivalent manner when compared with the predicate device."

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

• Not Provided / Not Applicable in this context. The 510(k) summary does not describe a clinical "test set" in the way one would for an AI/diagnostic device. The "functional data" mentioned is likely from bench testing (e.g., flow rates, pressure resistance, kink resistance, material compatibility, etc.) rather than a clinical trial with human subjects. The details of such functional testing (sample size, specific test protocols, etc.) are typically submitted as part of the full 510(k) but are not included in the public summary.

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)

• Not Applicable. As there's no clinical test set with a "ground truth" to establish in the context of an AI/diagnostic device, this information is not provided.

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

• Not Applicable. No clinical test set requiring adjudication is described.

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

• No. This is a medical device (arterial cannula), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant and was not conducted.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable in the AI/diagnostic sense. For a physical device, the "truth" is typically defined by engineering specifications, material properties, and performance metrics measured through bench testing. The substantial equivalence argument relies on comparing these aspects to a legally marketed predicate device.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."

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

• Not Applicable. As there is no training set, this information is not relevant.

In summary: The provided document is a 510(k) summary for a physical medical device (an arterial cannula). The primary goal of this submission is to demonstrate substantial equivalence to an existing predicate device, not to prove performance against specific acceptance criteria in a clinical study for a diagnostic algorithm. Therefore, many of the detailed questions related to AI/diagnostic device evaluation do not apply. The "study" mentioned is the "Functional/Safety Testing" which concluded that the proposed device performs in a "substantially equivalent manner when compared with the predicate device."

Ask a specific question about this device