Intended use
What APEC Vox QCA is for, and what it must not be used for.
This page states the intended purpose of APEC Vox QCA and the limits on its use.
Current version and intended future product
Research and validation platform
APEC Vox QCA is currently a research and validation platform, used under a research-use agreement. It is not a certified medical device, it has no diagnostic function, and its output must not be relied on in the care of a patient.
A clinical QCA tool
APEC is developing APEC Vox QCA towards a clinical quantitative coronary angiography tool. It will be offered for clinical use only once its validation is complete and the required regulatory approval is in place.
Scope
- Product
- APEC Vox QCA.
- Status
- Research and validation platform. Not a certified medical device.
- Purpose
- Assistance and observation, in a research setting.
- Intended user
- A clinician or researcher already competent in coronary angiography.
- Contact
- [email protected]
What it does, and what it is not for
What it does
APEC Vox QCA measures coronary dimensions from angiographic images. It segments the vessel and the stenosis on a frame and measures the vessel edge to edge along its centreline.
- Proximal diameter, minimum lumen diameter, distal diameter, lesion length and %stenosis, along a centreline traced between two operator clicks.
- Millimetres where the study carries C-arm geometry or the operator calibrates on the catheter. Pixels otherwise, labelled as pixels.
- A record, on every measurement, of how that measurement was produced — including which rule fired and where the scale came from.
- Export of the session as a table, with the masks alongside it.
What it is not for
APEC Vox QCA has no diagnostic function. Nothing it produces is a clinical finding, and no output of it is intended to be relied on in the care of a patient.
- Diagnosis, or grading a lesion for a clinical report.
- Selecting, sizing or positioning a device.
- Choosing, planning or reviewing treatment.
- Triage, screening, or any decision about a patient's care.
- Any use in which a number it produces is acted on.
A pilot site uses APEC Vox QCA alongside its normal workflow, not in place of any part of it. Taking part does not mean changing how anyone is treated.
Who it is for
The intended user is a clinician or researcher who is already competent in coronary angiography and able to judge, from the image, whether a measurement is plausible. APEC Vox QCA does not supply that judgement and does not replace it.
The software shows the frame it measured, the centreline it traced, the wall it found and the diameter along the vessel, and it records which rule produced each number. That is so the user can check the measurement, not so the measurement can be taken on trust. Where the user's reading of the angiogram and the software disagree, the user is right by default and the result should be flagged.
APEC Vox QCA is not for use by anyone not qualified to interpret a coronary angiogram.
Reporting a problem
A wrong result is useful to us. Flag it from inside the application: one click sends the result to the study team, with no patient details attached. Flagging results that look wrong is part of what a pilot site is asked to do.
Anything that cannot go through the application — a question about this statement, a concern about how the software is being used at a site, or a request to withdraw a flagged result — goes to [email protected].