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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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IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows:

1. 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.
2. Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
3. Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
4. Assist in device positioning by providing real time localization on predefined roadmaps.
5. To be used in-procedure in the catheterization lab and off-line for post-procedural analysis

The IC-PRO (version 3.2) 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. IC-PRO (version 3.2) provides quantitative data of vessel, left ventricular and stent dimensions enhances visualization and localizes device on predefined roadmaps.

Here's an analysis of the acceptance criteria and study information for the IC-PRO System based on the provided text:

Acceptance Criteria and Device Performance

The provided 510(k) summary states that "Performance Data: The performance tests were made to evaluate the IC-PRO System and yield accuracy and precision results within the predetermined specifications with compare to results obtained by the marketed predicate devices."

However, the specific "predetermined specifications" (i.e., the acceptance criteria with numerical targets) and the corresponding "accuracy and precision results" for the IC-PRO System are not explicitly detailed or quantified in the provided text. The document only generically states that the system's performance was acceptable when compared to predicate devices.

Therefore, the table below reflects what can be inferred rather than explicitly stated.

Study Information

Based on the provided text, the available study information is as follows:

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified, but given the submitter's address (Israel), it's possible that data originated from Israel or other international sites. It is also not specified whether the data was retrospective or prospective.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified.

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

   • Not specified. The document only mentions "Performance Data: The performance tests were made to evaluate the IC-PRO System and yield accuracy and precision results within the predetermined specifications with compare to results obtained by the marketed predicate devices." There is no mention of an adjudication process for a test set.

4. 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, an MRMC comparative effectiveness study was not mentioned. The study described focuses on comparing the device's performance to predicate devices, not on how human readers perform with or without the device's assistance.

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

   • Yes, implicitly. The statement "The performance tests were made to evaluate the IC-PRO System and yield accuracy and precision results within the predetermined specifications with compare to results obtained by the marketed predicate devices" suggests a standalone evaluation of the software's output against a reference (likely the predicate devices' output or a clinical standard). There is no mention of a human-in-the-loop component in this performance testing.

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

   • The "ground truth" for the performance evaluation appears to be the results obtained by the marketed predicate devices. The exact nature of how this "ground truth" was established for the predicate devices, or if there was an independent clinical standard used as the ultimate ground truth, is not detailed.

7. The sample size for the training set:

   • Not specified. (The document focuses on performance evaluation rather than development details like training sets).

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

   • Not specified, as the training set details are not provided.

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