(196 days)
The Aortic Connector System is intended to create the aortic anastomosis of aortic autologous vein grafts.
The Aortic Connector 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 Symmetry Aortic Connector System consists of a self expanding implantable connector and delivery system.
Here's a breakdown of the acceptance criteria and study information for the Aortic Connector System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Performance equivalent to standard suture anastomoses | Mechanical, In Vitro, and animal testing demonstrates that the performance of the Aortic Connector System is equivalent to standard suture anastomoses. |
| Secure, patent, and reproducible anastomosis | Not explicitly stated as a separate acceptance criterion, but implied as a design goal the device aims to achieve, as it "replaces sutures to create a secure, patent, and reproducible anastomosis." The testing demonstrating equivalence to sutures would implicitly cover this. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the mechanical, in vitro, or animal testing.
- Test Set Sample Size: Not specified.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the context of a 510(k) submission in the US, it's highly likely the testing was conducted in the US and involved a mix of in vitro (laboratory), mechanical (simulated conditions), and in vivo (animal) studies. The type of testing suggests it was prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of human experts to establish ground truth for the device's performance. The testing described focuses on objective mechanical and biological endpoints rather than expert-derived assessments.
4. Adjudication Method for the Test Set
Not applicable, as expert adjudication is not mentioned in the testing described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study compares the device's performance to "standard suture anastomoses" through mechanical, in vitro, and animal testing, not against human readers' performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the testing described is effectively "standalone" in the sense that it evaluates the device's inherent mechanical and biological performance without human intervention in the loop for assessment. The "device" in this context is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the study was established through objective measurements and observations from mechanical, in vitro, and animal testing, comparing the Aortic Connector System's performance to "standard suture anastomoses." This would include metrics such as:
- Mechanical strength/integrity (e.g., burst pressure, tensile strength of the anastomosis)
- Patency (e.g., flow characteristics in in vitro models or animal studies)
- Biocompatibility and tissue response in animal models
- Reproducibility of the anastomosis
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here, as this device is a physical medical implant and delivery system, not an artificial intelligence/machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.