(62 days)
The EMBOL-X Access Device / Aortic Cannula is indicated for the perfusion of the ascending aorta during short-term (≤ 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
The Edwards Lifesciences EMBOL-X Access Device / Aortic Cannulae are polymeric tubes intended to provide a means of returning oxygenated blood from the oxygenator to the patient during cardiopulmonary bypass procedures. A port is included for optional insertion of the EMBOL-X filter device. The cannulae are available in three configurations. Variants include one code with an open tip and two codes with an alternate tip hole configuration. Cannulae bodies are reinforced by means of a stainless steel wire entirely encapsulated within the wall of the cannula to minimize the potential for cannula kinking. The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
The provided document describes a 510(k) premarket notification for the Edwards Lifesciences® EMBOL-X® Access Device / Aortic Cannula. This is a medical device and the study described is a functional/safety test, not typically a diagnostic algorithm requiring multi-reader, multi-case studies or large expert ground-truthing efforts as one would expect for AI/ML devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Pre-established) | Reported Device Performance |
|---|---|
| Cannula / Tip Bending: No defects after manipulation | Met pre-established acceptance criteria |
| Static Pressure (6 hrs): No defects after exposure to static air pressure and manipulation | Met pre-established acceptance criteria |
| Dynamic Pressure (6 hrs): No defects after exposure to dynamic water flow and manipulation | Met pre-established acceptance criteria |
| Tip/Cannula Bond Strength: Adherence to tensile test requirements | Met pre-established acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each functional test.
The data provenance is also not explicitly stated beyond the fact that these are functional tests performed to evaluate the physical components of the device. It's implicitly prospective, as these are tests conducted on the newly manufactured device variants. Country of origin not specified for the tests themselves, but the manufacturer is Edwards Lifesciences® LLC (USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is not applicable to the functional performance tests described. Ground truth for these tests is based on objective physical measurements and visual inspections against defined engineering specifications, not expert interpretation of complex data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided and is generally not applicable to the functional performance testing of a physical medical device like a cannula. Adjudication methods are typically relevant for studies involving subjective human interpretation, such as image-based diagnostics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic algorithms or systems where human readers interpret medical data (e.g., images) and their performance is being compared with and without AI assistance. The EMBOL-X Access Device / Aortic Cannula is a physical medical device, not a diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is not an algorithm. The "standalone" performance here refers to the device's functional performance on its own, which is described by the "Functional/Safety Testing."
7. The Type of Ground Truth Used
The ground truth used for these functional/safety tests is based on engineering specifications and objective physical measurements/inspections. For example, a bond strength test would have a pre-defined minimum tensile strength (a factual, measurable criterion). Inspections for defects would be against defined visual or tactile standards.
8. The Sample Size for the Training Set
This document describes a premarket notification for a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of an AI/ML algorithm. The device's design and manufacturing rely on established engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI/ML algorithm, this question is not applicable. The functional performance of the device is assessed against predetermined engineering and safety standards, which are derived from industry best practices, regulatory requirements, and the device's intended use.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).