Search Results

The ESTECH Aortic Easy Flow Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures reguiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours.

The Estech Aortic Easy Flow Cannula is a sterile, single-use, device. The single-lumen polymer tube incorporates wire-wrapping with multiple perforations at the distal end to provide a diffuse flow pattern. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. Each cannula is provided with a flexible obturator to assist with the placement and positioning of the cannula.

The Estech Aortic Easy Flow Cannula is a medical device intended for use in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours. The documentation provided focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device based on clinical outcomes.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or a table of performance metrics for the ESTECH Aortic Easy Flow Cannula. Instead, the core of the submission relies on demonstrating substantial equivalence to predicate devices.

The acceptance criteria implied are:

• Biocompatibility: The device must meet the criteria for biocompatibility consistent with ISO 11193.
• Labeled Performance Claims: The device must be able to meet its labeled performance claims.
• Substantial Equivalence: The device must be demonstrated to be substantially equivalent to the predicate devices in terms of intended use, technology, design, materials, manufacture, and packaging.

The reported device performance is:

Study Information

Based on the provided text, the "study" conducted is a preclinical performance data assessment and biocompatibility testing to support the claim of substantial equivalence. This is typical for a 510(k) submission where a new device is compared to existing legally marketed devices. There is no mention of a human clinical trial or a study designed to quantify device performance in terms of clinical outcomes, sensitivity, specificity, accuracy, or similar metrics typically associated with AI/diagnostic device evaluations.

Given this context, most of the requested information regarding sample size, expert involvement, and ground truth establishment (which are common for AI/diagnostic device studies) is not directly applicable or explicitly detailed in this 510(k) summary.

1. Sample size used for the test set and the data provenance: Not explicitly stated as a separate "test set" in the context of a clinical trial. The "preclinical performance data" would involve bench testing or possibly animal studies, but no specific sample sizes or data provenance (country of origin, retrospective/prospective) are detailed in this summary.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of submission is typically based on established engineering principles, regulatory standards (like ISO 11193 for biocompatibility), and comparison to the known performance characteristics of the predicate devices. Expert consensus in the context of human data interpretation (e.g., radiology reads) is not relevant here.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for establishing ground truth in human subject studies, which are not detailed here.
4. 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: Not applicable. This device is a cardiopulmonary bypass vascular cannula, not an AI-powered diagnostic tool.
5. 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.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the preclinical performance data would be derived from:
   • Regulatory Standards: ISO 11193 for biocompatibility.
   • Engineering Specifications: Performance characteristics (e.g., flow rates, pressure drops, durability) measured against design specifications and predicate device performance.
   • Predicate Device Data: Performance characteristics of the legally marketed predicate devices serving as benchmarks.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that would require a "training set."
8. How the ground truth for the training set was established: Not applicable.

Conclusion

The provided document details a 510(k) summary for a cardiopulmonary bypass vascular cannula, focusing on demonstrating substantial equivalence to predicate devices through biocompatibility testing and preclinical performance data. It does not contain the kind of detailed information about acceptance criteria, test sets, expert involvement, or ground truth establishment that would be relevant for an AI/diagnostic device performance study.

Ask a specific question about this device