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The Spiral Flow Peripheral Vascular Grafts are indicated for use as vascular prostheses.

The device is intended for use in the bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee. Graft configurations are intended for use as arterial conduits for bypass, or reconstruction of peripheral arterial blood vessels.

ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation.

Vascular Flow Technologies' (VFT) Spiral Flow™ Peripheral Vascular Graft is to be used in the bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee; it has a specially designed section to induce spiral laminar flow.

The unique design feature translates Spiral Laminar Flow (SLF™) technology to the graft lumen profile. SLF™ technology is designed to propagate spiral flow though the graft and into the distal circulation.

The starting material for the VFT Spiral Flow™ Peripheral Vascular Graft is a straight tubular vascular graft made from expanded polytetrafluoroethylene (ePTFE).

The graft includes a helical overlay of polytetrafluoroethylene (PTFE) beading over most of the grafts length. This is heat set onto the external surface of the ePTFE tube. The function of the beading is to provide reinforcement for the tube.

The unique SLF™ spiral flow inducer is injection molded onto the outer surface of the straight graft. The inducer and indicator are made from ChronoFlex® C-80A; a Biodurable Medical Grade polyurethane

This document is a 510(k) Summary for a medical device modification, specifically for the Spiral Flow™ Peripheral Vascular Graft. It primarily describes the device, its intended use, and states that non-clinical tests were conducted to demonstrate substantial equivalence to a predicate device.

However, the document does not contain specific acceptance criteria, detailed study results, or the other requested information like sample sizes, expert qualifications, or details about ground truth.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states:
"The above test results confirmed the modified device met or exceeded the same specifications as that of the predicate device and is therefore substantially equivalent with respect to safety and efficacy to the predicate device"
This indicates that there were specifications (acceptance criteria) that the device had to meet, and that it did meet or exceed them, but the specific criteria and the actual performance values are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document mentions "Product Testing - Characterisation Study" and "Product Testing Flow Testing Study" but does not detail the sample sizes or data provenance.

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 applicable/provided. This document describes the modification of a physical medical device (vascular graft), not an AI-powered diagnostic device that would require human expert-established ground truth for performance evaluation in the typical sense. The testing mentioned is "non-clinical tests" like biocompatibility, characterization, and flow testing, which are laboratory/engineering tests.

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

This information is not applicable/provided for the same reasons as point 3.

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/provided. This is a physical device, not an AI system for diagnostic assistance.

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

This information is not applicable/provided as it is not an AI algorithm.

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

This information is not applicable/provided in the context of diagnostic AI. For non-clinical device testing, "ground truth" would typically refer to established scientific/engineering standards, reference measurements, or predefined physical properties that the device's performance is compared against. However, the document does not specify these details.

8. The sample size for the training set:

This information is not applicable/provided as this is not an AI/machine learning device that would require a training set.

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

This information is not applicable/provided as this is not an AI/machine learning device.

In summary:

The provided document is a 510(k) summary for a medical device (vascular graft) modification. It confirms that non-clinical testing was performed to demonstrate substantial equivalence to a predicate device. While it states that the modified device "met or exceeded the same specifications as that of the predicate device," it does not provide the specific acceptance criteria or detailed study data that would be required to complete the requested table and answer many of the specific questions about clinical study design, expert involvement, or AI performance metrics. This document focuses on regulatory approval through substantial equivalence based on engineering and material performance rather than clinical efficacy or AI performance.

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