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The Venaflo Graft with Carbon is indicated for use as a subcutaneous arteriovenous conduit for blood access only.

The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.

The provided text describes a 510(k) premarket notification for the "VENAFLO™ Vascular Grafts," specifically the "Venaflo Graft with Carbon." This is a regulatory submission for a medical device and not a detailed study report describing acceptance criteria and device performance in the manner of a clinical trial or algorithm validation study.

Therefore, much of the requested information (like specific quantifiable acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance metrics, or ground truth establishment details) is not present in the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a quantitative sense.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only states "Device testing was performed on the cuffed portion of the Venaflo Graft with Carbon and compared to the results of testing performed on the Venaflo ePTFE Vascular Graft." This implies laboratory or bench testing rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable as the performance assessment appears to be based on physical device testing against recognized standards, not on expert-adjudicated clinical data.

4. Adjudication method for the test set

• Not applicable for this type of device testing.

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. This is a vascular graft, not an AI or imaging diagnostic device.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used

• The "ground truth" for this device appears to be defined by established industry standards (ANSI/AAMI VP20-1994) and FDA guidance for vascular prostheses, as well as the performance characteristics of the predicate devices. The document implies that physical/mechanical tests were conducted to demonstrate compliance with these standards and equivalence.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model.

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

• Not applicable. This is a physical medical device, not an AI model.

Summary of Device and Performance Information Provided:

• Device Name: Venaflo™ Vascular Graft (specifically Venaflo Graft with Carbon)
• Intended Use: Subcutaneous arteriovenous conduit for blood access only.
• Predicate Devices: Venaflo Vascular Graft, Venaflo ePTFE Vascular Graft, IMPRA Carboflo® Vascular Graft.
• Performance Basis: Device testing on the cuffed portion, compared to results from the Venaflo ePTFE Vascular Graft.
• Testing Standards: ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance for Vascular Graft Prostheses.
• Conclusion: The testing indicated suitability for intended use and substantial equivalence to predicate devices.

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The Venaflo Graft with Carbon is indicated for use as a subcutaneous arteriovenous conduit for blood access only.

The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.

The provided text describes a 510(k) Premarket Notification for the VENAFLO™ Vascular Grafts, specifically the Venaflo Graft with Carbon. This is a medical device submission seeking substantial equivalence to existing predicate devices. Consequently, the document does not contain information typically found in a study demonstrating how a device meets acceptance criteria through performance metrics. Instead, it focuses on demonstrating that the new device has "technological characteristics" and "performance data" that are "substantially equivalent" to predicate devices.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert ground truthing, and MRMC studies are not present in this type of regulatory submission. The goal of a 510(k) is to prove equivalence, not necessarily to perform a de novo clinical trial with new acceptance criteria.

However, I can extract the information that is available from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that testing was performed to demonstrate substantial equivalence to predicate devices, rather than against specific, quantitative acceptance criteria for superior performance.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of a clinical study with a specific sample size. The performance data refers to "device testing" performed on the cuffed portion of the Venaflo Graft with Carbon and compared to predicate devices. The nature of this testing (e.g., in vitro, animal, or limited human experience) is not detailed, nor is the number of units tested.

• Sample Size: Not specified.
• Data Provenance: Not specified, but implied to be laboratory/bench testing and potentially pre-clinical (animal) evaluation based on the industry standards cited. There is no mention of human clinical trial data or retrospective/prospective study design in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. The document describes laboratory/bench testing against established standards and comparison to predicate devices, not an expert panel adjudicating clinical outcomes or images to establish ground truth for a diagnostic device.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of an adjudication method as would be used in a clinical study involving human assessment.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices assessing human reader performance, which is not relevant to a vascular graft.

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

Not applicable. This is a physical medical device (vascular graft), not an algorithm or software requiring performance evaluation in a standalone mode.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the established performance characteristics and safety profiles of the predicate devices and compliance with recognized industry standards. This is not a "ground truth" derived from expert consensus, pathology, or outcomes data in the usual sense of a diagnostic or therapeutic clinical trial. It's about demonstrating physical and functional equivalence.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device. There is no "training set" as would be used for machine learning algorithms.

9. How the Ground Truth for the Training Set was Established:

Not applicable (see point 8).

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