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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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