(35 days)
The Cardica® C-Port® xA Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
The Cardica C-Port xA Anastomosis System is a sterile, single use device for creation of a reliably patent end-to-side anastomosis between a conduit and a small vessel. The product consists of accessories to assist in the conduit loading and a device that completes the anastomosis with stainless steel clips. Once the conduit has been loaded onto the device and the device positioned against the target vessel, the anastomosis is created by pushing the actuation button.
The provided text is a 510(k) summary for the Cardica® C-Port® xA Anastomosis System. It is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a study with an AI component. Therefore, much of the requested information about AI model performance and study details is not present.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify quantitative acceptance criteria or provide detailed performance metrics like sensitivity, specificity, accuracy, or F1-score for the device itself. Instead, the submission states that "All necessary verification testing has been performed on the C-Port xA Anastomosis System with the modified clip to assure substantial equivalence to the predicate device and to assure the safety and effectiveness of the device."
The focus is on demonstrating that the modified device is as safe and effective as the predicate device (Cardica® C-Port® xA Anastomosis System, K053524). This is a common approach for 510(k) submissions where a modification to an already cleared device is being presented.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (K053524) in terms of: | The Cardica C-Port xA Anastomosis System with the modified clip has been |
| - Indications for Use | shown to be substantially equivalent to the currently marketed predicate |
| - Scientific technology | device. |
| - Operation principles | |
| - Basic device design and size | |
| - Materials | |
| - Shelf life | |
| - Packaging and sterilization materials and processes | |
| Safety and effectiveness | Verification testing performed to assure safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for any specific test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective). The testing mentioned is "verification testing" to assure substantial equivalence, rather than a clinical trial with a defined test set for performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore not present. The device is a surgical instrument (anastomosis system) and not an AI or diagnostic device that requires expert-established ground truth for image or data interpretation. The "ground truth" for a device like this would relate to its mechanical performance, biocompatibility, and ability to create a functional anastomosis, which would be assessed through engineering tests, animal studies, or potentially human clinical data (though not detailed here).
4. Adjudication Method for the Test Set
This information is not applicable and therefore not present, as there is no diagnostic output that requires adjudication.
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
There is no mention of an MRMC study, AI, or human readers. The device is a surgical instrument.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a manual surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
The concept of "ground truth" as it applies to an AI or diagnostic device (e.g., pathology, outcomes data) is not directly applicable here. For this surgical device, the "ground truth" would be related to its engineering specifications, successful creation of an anastomosis, and patient outcomes related to the surgical procedure, as determined through various verification and potentially pre-clinical/clinical tests. The document broadly states "All necessary verification testing has been performed," without detailing the specific "ground truth" for each test.
8. The Sample Size for the Training Set
This is not applicable since the device is not an AI system that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as above.
In summary, this 510(k) submission is for a modification to a mechanical surgical device and primarily focuses on demonstrating substantial equivalence to a predicate device through verification testing. It does not involve AI, image analysis, or diagnostic capabilities, and therefore, most of the requested information regarding AI model performance, expert ground truth, and study designs for such applications is absent.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.