(119 days)
IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows: Assists in the evaluation of coronary lesions by enabling the creation of 3D images of coronary vessel segments based on two to three 2D angiography images obtained from single plane angiography. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. Performs quantitative analysis of the left ventricle based on left ventricular angiograms. Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings Assist in device positioning by providing real time localization on predefined roadmaps. Assists in projection selection using 3D modeling based on 2D images. Performs dimensional measurements based on DICOM images. To be used in-procedure in the catheterization lab and off-line for post-procedural analysis
The IC-PRO (version 3.5, model B) system is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system improves the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning, therapeutic stage and post deployment analysis. The IC-PRO provides quantitative data and vessel measurements, left ventricular, stent dimensions, enhances visualization, localizes device on predefined roadmaps and assist in projection selection. The IC-PRO is used in patient with vascular, congenital, valvular, and myopathic heart disease and patients undergoing vascular stenting and artificial valve deployment.
The provided documentation does not contain detailed acceptance criteria or a specific study proving the device meets those criteria with statistical significance. It primarily consists of a 510(k) summary for the Paieon IC-PRO System, outlining its intended use, description, and claiming substantial equivalence to predicate devices.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "Performance Data: Testing included software validation and performance evaluation. The performance tests were made to evaluate the IC-PRO System and yield accuracy and precision results within the predetermined specifications."
However, the predetermined specifications (acceptance criteria) are not explicitly stated, nor are the specific accuracy and precision results reported in a quantifiable manner (e.g., specific percentages, ranges, or statistical measures).
Therefore, a table cannot be constructed with the information provided.
2. Sample size 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.
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 provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
The document discusses "software validation and performance evaluation" but does not mention a multi-reader multi-case (MRMC) comparative effectiveness study directly, nor does it provide any effect size for human reader improvement with or without AI assistance. The IC-PRO is described as assisting in diagnosis and analysis, implying human-in-the-loop, but no study is detailed to quantify its comparative effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not explicitly state whether a standalone performance study was conducted. Given the description of the system as providing "quantitative data and vessel measurements" and "enhances visualization," it implies that the output is intended to be used and interpreted by clinicians, suggesting a human-in-the-loop context. However, it's not definitively ruled out that some components might have been evaluated in a standalone manner without this detail being provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document. The document describes the system as "an image acquisition and processing modular software package," implying an algorithm, but details about its development and training are absent.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of what is present:
- Device: Paieon IC-PRO System (version 3.5, model B), an image acquisition and processing modular software package for cardiovascular angiography.
- Intended Use: Assists in evaluating coronary lesions (3D imaging, quantitative dimensions), quantitative analysis of the left ventricle, enhancing stent deployment visualization, device positioning, projection selection, and dimensional measurements on DICOM images. Used in-procedure and off-line.
- Performance Data Mentioned: "Testing included software validation and performance evaluation. The performance tests were made to evaluate the IC-PRO System and yield accuracy and precision results within the predetermined specifications."
- Substantial Equivalence Claim: The device is claimed to be substantially equivalent to several predicate devices (IC-PRO v3.2, Integris 3D-RA, Vitrea 2, iConnection PRO Stent Positioning System).
- Key Missing Information: All the detailed specifics requested about acceptance criteria, test set/training set sizes, data provenance, ground truth establishment, expert involvement, and study types (MRMC, standalone performance metrics) are absent from this 510(k) summary. This type of summary typically focuses on substantial equivalence rather than detailed study protocols and results.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.