(31 days)
VasQ is intended for use as an external support for upper extremity arteriovenous fistulas created for vascular access by means of vascular surgery.
VasQ is designed for use as an external support for upper extremity arteriovenous fistulas created for vascular access by means of vascular surgery. The design of the device is intended to promote outward remodeling of the AVF vein and ultimate usability of the fistula by aiding in the maintenance of optimal hemodynamic flow profile and relieving excessive mechanical stress at the anastomotic connection. Implantation of the device does not interfere with the standard surgical techniques required to create the AVF (i.e. dissection, mobilization and suturing the anastomosis).
The provided text is a 510(k) summary for the VasQ device, an extravascular support for arteriovenous fistulas. It describes the device, its intended use, technological characteristics, and a comparison to a predicate device to demonstrate substantial equivalence.
However, the document explicitly does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in terms of AI/algorithm performance. The "Performance Data" section solely refers to design verification tests (Biocompatibility, Device integrity, Kink, Crush, corrosion) related to the physical changes in the device (braiding contractor and manufacturing changes for the braid component), and a risk analysis (FMECA).
The request asks for information related to:
- Acceptance criteria and reported device performance (table format): Not available in the document.
- Sample size and data provenance for a test set: Not applicable as no AI/algorithm performance study is described.
- Number and qualifications of experts for ground truth: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study and effect size: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
Therefore, based solely on the provided text, I cannot fulfill the request as it pertains to AI/algorithm performance criteria or associated studies. The document only covers the substantial equivalence of a physical medical device (VasQ) to its predicate, focusing on physical and material properties, not an AI or software component requiring the detailed performance metrics outlined in the prompt.
N/A