(115 days)
The VASORING* VRC Vascular Ring Connector is indicated for use as a connector for attaching a vascular graft to native tissue where conditions preclude a conventional end-to-end sutured anastomosis.
The vascular ring connector is made of biocompatible titanium alloy. Placed in the vascular prosthesis to form a Graft-Connector Unit, it can be used as an intraluminal graft. The braided ligature tape (Ethicon® Nylon Tape) is for tying the ring connector from outside of the blood vessel to provide sutureless anastomosis that is time-saving. There are two grooves on the outer surface of the connector: the narrow groove is for suture fixation between the connector and the vascular prosthesis; and the wider groove is for ligature fixation between the connector and the blood vessel. The titanium alloy allows the ring connector to be of thin-wall design which gives larger inner diameter while maintaining adequate mechanical strength at the anastomotic sites.
The provided text describes a pre-market notification (510(k) submission) for the VASORING* VRC Vascular Ring Connector. It details the device, its intended use, and the performance summaries provided to the FDA to establish substantial equivalence to predicate devices.
However, the document does not describe specific acceptance criteria in a quantitative manner nor does it provide detailed descriptions of the studies that would typically prove a device meets such criteria. Instead, it offers a high-level summary of tests performed and their general satisfactory outcomes.
Therefore, for aspects of your request that require specific numerical acceptance criteria or detailed study methodologies (like sample sizes, ground truth establishment for training, or MRMC study details), the information is not present in the provided text.
Below is the information that can be extracted or reasonably inferred from the given document, along with an explanation of what is not available.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated/Inferred) | Reported Device Performance |
|---|---|
| Functional/Performance Requirements: Device must meet all functional and performance requirements for its intended use as a vascular ring connector. | "Bench testing was performed to ensure that VASORING* VRC will meet all functional and performance requirements for its intended use. All bench tests... demonstrated satisfactory performance." |
| Material Biocompatibility: Material must be biocompatible according to international standards. | "The titanium alloy connector was also tested for material biocompatibility per ISO 10993 guidelines... biocompatibility tests... demonstrated satisfactory performance." |
| Thrombogenicity: Device must not induce significant or adverse thrombogenic phenomena. | "Two pre-clinical animal studies were performed to investigate the thrombogenicity phenomena; a 4-hours study to assess immediate impact of using the VRC for anastomoses, and the other was a 20-week observation of the test animals... thrombogenicity studies demonstrated satisfactory performance." |
| Equivalence to Predicate Device: The device should be substantially equivalent to legally marketed predicate devices for its intended use. | "The VASORING* VRC Vascular Ring Connector is identical to the Meadox Intra-Aortic Graft polyester connector with respect to intended use." (This is a claim made for substantial equivalence, not a direct performance metric). The FDA determined the device is "substantially equivalent" for the stated indications for use. |
Missing Information: The document does not provide specific quantitative thresholds or definitions for "satisfactory performance" for any of the criteria (e.g., maximum allowable thrombus formation, specific tensile strength values for the connector, etc.).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified. The document mentions "two pre-clinical animal studies" but does not give the number of animals used.
- Data Provenance:
- Country of Origin: The submitting company (SUNWEI TECH Co. Ltd.) is based in Taipei, TAIWAN. While bench and animal studies likely occurred in Taiwan or a contracted facility, the specific location of the studies is not stated.
- Retrospective or Prospective: The animal studies were prospective ("a 4-hours study" and "a 20-week observation"). Bench testing would also be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable in the context of this device and report. The device is a physical medical implant (a vascular connector). Its performance is assessed through bench tests and animal studies, not through interpretation of medical images or data by human experts for "ground truth" as relevant to AI/diagnostic studies. The "ground truth" for these tests would be objective measurements (e.g., blood flow, thrombus formation, material integrity) rather than expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human readers/experts in studies involving subjective interpretations (e.g., radiology for AI model ground truth). The performance of this vascular connector is assessed through objective, empirical tests in a lab and animal setting.
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
- No, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for diagnostic medical devices or AI-assisted diagnostic tools where human interpretation is a key component. The VASORING* VRC is a vascular connector, a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical vascular connector, not an algorithm or AI system. Its performance is inherent to the device itself and its interaction with biological systems, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For bench testing: The ground truth would be objective physical and mechanical measurements (e.g., tensile strength, flow rate, pressure resistance, dimensions) against predefined engineering specifications.
- For biocompatibility testing: The ground truth would be laboratory test results against ISO 10993 cytotoxicity, sensitization, irritation, genotoxicity, etc., standards.
- For thrombogenicity studies (animal studies): The ground truth would be histopathological examination, physiological measurements (e.g., blood flow), and visual assessment of thrombus formation in the animal models.
8. The sample size for the training set
- This question is not applicable as there is no "training set" in the context of this device. A training set is used for machine learning models. This device's performance is established through traditional engineering and biological testing, not by training an algorithm.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as point 8.
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”