Search Results

The Cardica® PAS-Port® Proximal Anastomosis System is intended to create the aortic anastomosis of aortic autologous vein grafts.

The Cardica® PAS-Port® Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent and reproducible anastomosis. The PAS-Port® Proximal Anastomosis System consists of a connector and a delivery system.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. This is a 510(k) summary for a medical device (PAS-Port® Proximal Anastomosis System) seeking substantial equivalence to a predicate device.

The document focuses on:

• Device identification and categorization: Trade name, common name, classification, regulation number.
• Predicate device: K081225.
• Device description: How it works for aortic vein graft anastomosis.
• Indications for Use: To create the aortic anastomosis of aortic autologous vein grafts.
• Comparison to predicate device: Stating substantial equivalence and similarity in indications for use and technological characteristics.
• Device Testing Results and Conclusion: A general statement that in vitro and in vivo testing was performed to ensure substantial equivalence, safety, and effectiveness. However, specific acceptance criteria, study designs, or actual performance metrics are not detailed.
• FDA Clearance Letter: Confirming substantial equivalence based on the provided information.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, or training set information. These details are typically part of a more extensive submission package to the FDA, not usually included in the public 510(k) summary.

Ask a specific question about this device

The PAS•Port® System is intended to create the aortic anastomosis of aortic autologous vein grafts.

The Cardica® PAS•Port® Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent and reproducible anastomosis. The PAS•Port® Proximal Anastomosis System consists of a connector and a delivery system.

The provided text is a 510(k) Premarket Notification for the Cardica® PAS•Port® Proximal Anastomosis System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets such criteria.

The document states:
"All necessary in vitro and in vivo testing has been performed on the PAS-Port™ Proximal Anastomosis System and its packaging to ensure substantial equivalence to the predicate device, and to ensure the safety and effectiveness of the device."

This statement confirms that testing was done, but it does not provide details about:

1. A table of acceptance criteria and reported device performance: No such table is present.
2. Sample size used for the test set and data provenance: Not mentioned.
3. Number of experts and their qualifications for ground truth: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is a medical device, not an AI or imaging diagnostic tool.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not applicable (not an AI/ML algorithm).
9. How ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on demonstrating "Substantial Equivalence" to a legally marketed predicate device (St. Jude Medical Aortic Connector System). This process typically involves showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, often through comparisons of materials, design, and general in vitro/in vivo testing, but it doesn't usually present detailed acceptance criteria and performance data in the way requested for an AI/ML product.

Ask a specific question about this device