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VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.

The VIOLA is a sterile, single-use device designed to maintain hemostasis and facilitate the completion of multiple proximal anastomoses during a coronary artery bypass grafting procedure, without application of an aortic clamp. The VIOLA system can be used to create up to 4 anastomoses within the same patient.

This modified version of VIOLA includes an ergonomic handle with operating button and a straight distal end.

The VIOLA is comprised of:

1. A concentric 4 mm aortic punch with a detachable handle.
2. A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle.
3. A silicone boundary marker stencil for marking the maximal suture line around the aortic incision.

The steps to create a sealed anastomosis hole that enables the surgeon to perform a clampless anastomosis include (1) the creation of a small "needle hole" (performed in the center of the boundary marker), (2) insertion and deployment of the sealing element, (3) creation of an anastomosis hole using the VIOLA's punch, and (4) performing the anastomosis.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) summary for a medical device called "VIOLA" and it focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions performance data in the form of "risk analysis," "bond strength testing," and "simulated use testing" that "passed successfully all acceptance criteria," but it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Details about experts for ground truth or adjudication methods.
• Information on multi-reader multi-case studies or effect sizes.
• Details on standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set or its ground truth establishment.

The document primarily states that the modified device's technological characteristics are similar to the predicate and that performance data demonstrates it is as safe and effective.

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VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.

The VIOLA is a sterile, single-use device designed to maintain hemostasis and facilitate the completion of multiple proximal anastomoses during a coronary artery bypass grafting procedure, without application of an aortic clamp. The VIOLA system can be used to create up to 4 anastomoses within the same patient.

The VIOLA is comprised of:

• 1. A concentric 4 mm aortic punch with a detachable handle.
• 2. A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle.
• 3. A silicone boundary marker stencil for marking the maximal suture line around the aortic incision.

The steps to create a sealed anastomosis hole that enables the surgeon to perform a clampless anastomosis include (1) the creation of a small "needle hole" (performed in the center of the boundary marker), (2) insertion and deployment of the sealing element, (3) creation of an anastomosis hole using the VIOLA's punch, and (4) performing the anastomosis.

The provided text is a 510(k) summary for the Vascular Graft Solutions, Ltd.'s VIOLA device. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the way typically expected for a detailed performance study with quantifiable metrics and a test set.

The "Performance Data" section lists several types of validation and testing conducted, but these are general categories of testing (e.g., sterilization validation, biocompatibility, design verification, animal testing) rather than a study designed to evaluate performance against specific, pre-defined acceptance criteria for the device's clinical function in humans.

Therefore, many of the requested fields cannot be filled based on the provided document.

Here's a breakdown of what can and cannot be extracted:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the document. The document lists types of performance data (e.g., "Bond Strength Testing," "Sealing Element Crush Resistance Testing"), but it does not provide specific acceptance criterion values (e.g., "Bond strength must be > X N") nor the reported performance values that demonstrate these criteria were met.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified in terms of a clinical or ex-vivo performance test set with a defined sample size for statistical analysis against acceptance criteria. The document mentions "Animal testing," but does not detail the number of animals or the specific test set size derived from this.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): The animal study was conducted in compliance with Good Laboratory Practice (GLP) requirements (21 CFR 58), but the country of origin is not specified. It would be considered prospective for the animal study.

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 information is not present. The document does not describe a clinical or ex-vivo human-based study where experts would establish ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not present.

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:

This information is not applicable/present. The device is a "Vascular Clamp" and a "clampless proximal anastomosis sealing system," not an AI-assisted diagnostic or imaging interpretation tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable/present. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the "Animal testing," the ground truth would likely involve direct assessment of surgical outcomes (e.g., hemostasis, anastomosis integrity, tissue reaction) by veterinary or surgical experts following the procedure, possibly supplemented with histopathology. The document doesn't specify the exact type of ground truth.

8. The sample size for the training set:

This information is not applicable/present. The device is a physical medical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable/present.

Summary of available information regarding performance:

The document states that the following performance data was generated:

• Sterilization Validation per ISO 11135-1:2014 and ISO 10993-7:2008.
• Packaging validation for sterile barrier and labeling after transit simulation and accelerated aging.
• Biocompatibility testing (material mediated pyrogenicity, cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, partial thromboplastin time, SC5b-9 complement activation, hemolysis, and thrombogenicity) in accordance with ISO 10993-1.
• Design verification testing including Bond Strength Testing, Sealing Element Crush Resistance Testing, Punch Performance Testing, Simulated Use Testing, and Corrosion Resistance Testing.
• Animal testing to evaluate the safety, performance, and usability of the device conducted in compliance with Good Laboratory Practice (GLP) requirements (21 CFR 58).

These tests are generally required for medical device clearance to demonstrate functionality, safety, and manufacturing quality, often against internal specifications or industry standards. However, the document does not present them as a study with specific acceptance criteria and detailed quantitative results for clinical or user-related performance, nor does it define a "test set" in the context of clinical evaluation. The conclusion is based on substantial equivalence, which primarily relies on comparing the device's characteristics to a legally marketed predicate device and demonstrating that any differences do not raise new questions of safety or effectiveness.

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