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The Allura 3D-RA Rel. 6 is intended to assist physicians in analyzing two dimensional X-ray images by creating three dimensional views from sets of two dimensional images created during rotational angiographic runs. The Allura 3D-RA Rel. 6 is intended to assist in the diagnosis and treatment of endovascular diseases, for example, stenosis, aneurysms, and arteriovenous malformations. The Allura 3D-RA Rel.6 also supports measurement of lesion dimensions and anatomical distances.

The 3D Roadmap Rel. 1 is an extension of Allura 3D-RA, which provides image guidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering.

The MR-CT Roadmap Rel. 1 is an extension of Allura 3D-RA, which provides image guidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering.

The device description of the 3D Interventional Tools software medical devices that are subject of this 510(k) submission are as follows:

Allura 3D-RA Rel. 6 software medical device (Allura 3D-RA Rel. 6)
The Allura 3D-RA Rel. 6 is a software product (Interventional Tool) intended to provide high-speed and high resolution 3D visualization of vessels and bones anatomy. Allura 3D-RA is intended to be used in combination with an Allura X-ray system.

The Allura 3D-RA Rel. 6 generates a 3D reconstruction from 2D X-ray images to visualize vascular anatomy, and helps to identify vascular pathologies from a single contrast-enhanced rotational angiogram. It can be used during anv angiography procedure and can cover any anatomical area including cerebral, abdominal, and peripheral. It also allows for 3D visualization of the spine.

3D Roadmap Rel. 1 software medical device (3D Roadmap Rel. 1)
The 3D Roadmap Rel. 1 is a software product intended (Interventional Tool) to assist the physician during complex interventions by providing live 3D image guidance for navigating endovascular devices through vascular structures anywhere in the body. 3D Roadmap is intended to be used in combination with an Allura X-ray system.

The 3D Roadmap Rel. 1 overlays live 2D fluoroscopic images on a 3D reconstruction of the vessel tree processed by Allura 3D-RA Rel. 6 and therefore, assist the physician in catheter maneuvering. It can be used during any endovascular intervention and can cover any anatomy, including cerebral, abdominal, and peripheral vasculature.

MR-CT Roadmap Rel. 1 software medical device (MR-CT Roadmap Rel. 1)
The MR-CT Roadmap Rel.1 is a software product intended to provide live 3D image guidance for navigating endovascular devices through vascular structures anywhere in the body, reusing segmented MRA or CTA data that has been acquired previously. The MR-CT Roadmap Rel.1 is intended to be used in combination with an Allura X-ray system.

The MR-CT Roadmap Rel.1 overlays live 2D fluoroscopic images on a previously acquired MRA or CTA volume, which is registered by the Allura 3D-RA Rel. 6 with the X-ray system using a rotational scan and therefore, assist the physician in catheter maneuvering. It can be used during any endovascular intervention and can cover any anatomy, including for example cerebral, abdominal, and peripheral vasculature.

The 3D Interventional Tools software medical devices (Allura 3D-RA Rel. 6, 3D Roadmap Rel. 1, and MR-CT Roadmap Rel. 1) underwent verification and validation testing to ensure compliance with intended use, claims, requirement specifications, and risk management requirements.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • The study was a retrospective validation study performed on 3DRA clinical datasets with aneurysms. The exact number of datasets is not specified beyond "clinical datasets." The provenance (country of origin) of the data is not mentioned.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Three experts were used to validate the performance of the aneurysm tool.
   • One of the experts was an interventional neuro radiologist. The qualifications of the other two experts are not explicitly stated.

3. Adjudication method for the test set:

   • The adjudication method is not explicitly described beyond stating that the performance was "validated by three experts."

4. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • No MRMC comparative effectiveness study is mentioned, or any effect size of human readers improving with or without AI assistance. The study focuses on the standalone performance of the aneurysm tool.

5. Standalone (algorithm only) performance:

   • Yes, a standalone performance study was done for the aneurysm tool. The reported success rate of segmentation (73%) is the algorithm's performance.

6. Type of ground truth used:

   • The ground truth was established by three experts, with one being an interventional neuro radiologist, based on 3DRA clinical datasets. This suggests an expert consensus/interpretation of the clinical data.

7. Sample size for the training set:

   • The document does not specify the sample size used for the training set.

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

   • The document does not specify how the ground truth for the training set was established. It only discusses the validation study and its ground truth.

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The indications for use statement for the proposed Interventional Workspot software medical device, as presented in the IFU, are as follows:

The Interventional Workspot has the following medical purpose:

• import, export, and store digital clinical images.
• manage the patient information associated with those images.

The Interventional Workspot software medical device is a software platform for hosting the aforementioned currently marketed and predicate software medical devices. It provides the same functionalities (for example, import, export, and data handling) that are required by the aforementioned currently marketed and predicate software medical devices to support the physician with performing interventional procedures.

The interventional workspot is a software platform to host Interventional Tools. It provides common functionalities (e.g. import / export and data handling functions) that are required by the Interventional Tools to support the physician with performing the interventional procedure.

This 510(k) summary describes Philips Interventional Workspot, a software platform intended to host other interventional tools, providing functionalities such as import, export, and data handling of digital clinical images and patient information.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It indicates that the device underwent non-clinical verification and validation tests.

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

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is "non-clinical verification and validation tests," implying software-based evaluations rather than studies involving patient data. Therefore, details regarding test set sample size and data provenance (country of origin, retrospective/prospective) are not provided and do not appear to be relevant to the type of testing performed for this device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. As the testing was non-clinical verification and validation of software functionalities, there was no "ground truth" related to medical diagnoses or human interpretation that would require expert adjudication.

4. Adjudication Method

Not applicable. No expert adjudication process is described for non-clinical software testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe a multi-reader, multi-case comparative effectiveness study involving human readers or the effect size of AI assistance. This device is a software platform, not an AI-powered diagnostic tool, so such a study would not typically be conducted.

6. Standalone (Algorithm Only) Performance Study

Yes, in the sense that the "Summary of testing" details non-clinical verification and validation tests indicating the algorithm/software's standalone performance in meeting its functional requirements and regulatory standards. However, it's not a standalone clinical performance study as might be conducted for a diagnostic algorithm. The statement "The results of these tests demonstrate that Interventional Workspot met the acceptance criteria" refers to the software's performance in isolation from clinical application.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical verification and validation tests would be the pre-defined requirement specifications and expected behavior of the software functionalities (e.g., successful import/export, correct data handling, DICOM compliance). It does not involve expert consensus, pathology, or outcomes data, as these are related to clinical efficacy or diagnostic accuracy, which are not the focus of this device's testing.

8. Sample Size for the Training Set

Not applicable. This device is described as a software platform providing functionalities like import, export, and data handling. It is not an AI/ML algorithm that requires a "training set" of data in the conventional sense to learn patterns or make predictions. Its development would involve software engineering and testing against functional specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of software platform. The "ground truth" for its development and testing would be derived from its design specifications and compliance with relevant industry standards (e.g., DICOM for image handling).

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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.

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