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CardNav, an image acquisition and processing modular software package, is indicated for use as follows: Assist in projection selection using 3D modeling based on 2D images. Perform quantitative analysis on coronary veins based on fluoroscopy images. Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy. Perform motion analysis on coronary veins based on fluoroscopy images. To be used in cardiac procedures and off-line for post-procedural analysis.

CardNav (version 1.0) is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. It enhances the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning and therapeutic staging. This data is obtained without altering the basic angiography procedure.

The provided text is a 510(k) summary for the CardNav device, and it states that the device is "substantially equivalent" to predicate devices. However, the document does not contain an acceptance criteria table or specific quantitative performance metrics for the device. It generally mentions "in-house software verification testing, on-site system evaluation, bench testing using phantoms and retrospective clinical data, and animal study comparing device results with a sonomicrometry measurement method." It concludes that "The results of the testing indicate that CardNav 1.0 performs as intended and is safe for its intended use."

Therefore, I cannot populate the table with specific acceptance criteria and reported device performance from the provided text.

Based on the provided text, here's what I can extract regarding the study and ground truth:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The 510(k) summary states that "The results of the testing indicate that CardNav 1.0 performs as intended and is safe for its intended use" but does not offer specific quantitative acceptance criteria or corresponding performance statistics.

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

   • Test set sample size: Not specified.
   • Data provenance: The document mentions "retrospective clinical data" and an "animal study." No specific countries of origin are provided for the clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.

4. Adjudication method for the test set: Not specified.

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: An MRMC comparative effectiveness study is not mentioned in the document. The focus of the 510(k) is on the device's performance as intended and its substantial equivalence to predicate devices, not on human reader improvement with AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The studies mentioned (in-house software verification, on-site system evaluation, bench testing, animal study) refer to the device's performance. While "without human-in-the-loop" is not explicitly stated, "algorithm only" performance is implied in these types of tests for a software device. The clinical use cases describe the software assisting in various tasks, indicating a human-in-the-loop scenario for its intended use, but the underlying performance of the algorithms themselves would be evaluated in standalone settings.

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

   • For the animal study, the ground truth was a "sonomicrometry measurement method."
   • For the "retrospective clinical data," the type of ground truth is not explicitly stated, but it would typically involve clinical assessments or established diagnostic methods.

8. The sample size for the training set: Not specified. The document relates to a 510(k) submission, which typically focuses on validation data rather than training data for AI/ML models.

9. How the ground truth for the training set was established: Not specified, as training set details are not provided.

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

• Assists in projection selection using 3D modeling based on 2D images
• Performs dimensional measurements based on DICOM images.
• Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy.
  The system is to be used in-procedure and off-line for post-procedural analysis.

The C-THV (version 4.6) system is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system enhances the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning, therapeutic staging and post deployment analysis. The C-THV provides quantitative data of vessel and localizes device on predefined roadmaps. The C-THV is intended to be used in patients with vascular, congenital, valvular, and myopathic heart disease as well as with patients undergoing artificial valve deployment. The C-THV package includes and elaborates on previously developed, 510(k) cleared, and marketed modules of IC-PRO (version 3.5, model B) system. It comprised of the following modules:

1. Optimal Projection
2. Dimensional Measurements
3. Virtual Valve
4. Positioning

Here's a breakdown of the acceptance criteria and the study information based on the provided text, where available:

1. A table of acceptance criteria and the reported device performance

The provided 510(k) summary does not explicitly list "acceptance criteria" with numerical targets. Instead, it states that "Performance tests have yielded accuracy and precision results within the predetermined specifications." This implies that the device met internal specifications defined by the manufacturer, but these specific criteria are not detailed in the public summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set, nor does it provide information about the data provenance (country of origin, retrospective/prospective).

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 available in the provided text.

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

This information is not available in the provided text.

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 does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any information on the effect size of human readers improving with AI assistance. The C-THV system is described as an "image acquisition and processing modular software package" that "assists" in various tasks, implying a tool for human use rather than an AI-driven autonomous system.

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

The provided text focuses on the device's role in assisting in diagnosis, procedure planning, and measurements, implying human interaction. It does not indicate that a standalone (algorithm only) performance study was conducted.

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

The document states that "Performance tests have yielded accuracy and precision results within the predetermined specifications," but it does not specify how this ground truth was established (e.g., expert consensus, pathology, other validated methods). The nature of the device (angiography analysis for dimensional measurements and positioning) suggests that ground truth would likely involve highly accurate measurements or expert consensus based on established medical imaging practices.

8. The sample size for the training set

This information is not available in the provided text.

9. How the ground truth for the training set was established

This information is not available in the provided text.

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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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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
• To be used in-procedure in the catheterization lab and off-line for postprocedural analysis

The IC-PRO 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 and post deployment analysis. IC-PRO enhances visualization and provides quantitative data of vessel, left ventricular and stent dimensions.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IC-PRO System, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria (e.g., "accuracy greater than X%", "precision within Y mm"). Instead, it describes performance in general terms relative to validation and predicate devices.

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

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

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified (e.g., 2+1, 3+1, none). The document only mentions "performance evaluation."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: Not explicitly mentioned as a comparative effectiveness study with human readers. The wording "comparable to results obtained by the marketed predicate devices" suggests a comparison, but it doesn't specify if human readers were part of an MRMC study comparing AI-assisted vs. non-AI-assisted performance.
• Effect Size: Not provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• The document implies that "performance testing was performed to evaluate the IC-PRO System" and produced "accuracy and precision results." This suggests a standalone evaluation of the algorithm's output (e.g., derived measurements) against a ground truth, rather than being solely a human-in-the-loop study. However, it doesn't definitively exclude human interaction during the acquisition or initial parameter setting that might influence the reported performance.

7. The Type of Ground Truth Used

• The document does not explicitly state the specific type of ground truth used (e.g., expert consensus, pathology, phantom measurements, or another form of reference standard). It mentions comparison to "predetermined specifications" and "marketed predicate devices," which implies that the ground truth would have been established measurements for the same anatomical structures.

8. The Sample Size for the Training Set

• The document does not mention a training set or its sample size. This is common for older 510(k)s, especially for systems that might not rely on machine learning in the modern sense (e.g., rule-based algorithms, advanced image processing) for their primary function, or if the training data details were not deemed essential for the summary.

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

• Since a training set is not mentioned, the method for establishing its ground truth is also not provided.

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The CardiOp-B System is a software system that 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. CardiOp-B provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. CardiOp-B can also perform quantitative analysis of the left ventricle based on left ventricular angiograms. CardiOp-B is intended for use in real-time in the catheterization lab and off-line for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel.

The CardiOp-B System is an image acquisition and processing software system designed as an add-on to conventional X-ray angiography systems. The CardiOp-B system improves the output of coronary angiography by presenting a three-dimensional reconstruction of the stenosed vessel as well as quantitative cross-section information. The LVA (Left Ventricular Analysis) package is an addition to the CardiOp-B System which is the subject of this Traditional 510(K).

1. Acceptance Criteria and Reported Device Performance

The CardiOp-B System, as described in the 510(k) summary, includes an LVA (Left Ventricular Analysis) package. The performance data section states: "Performance testing was performed to evaluate the modifications to the CardiOp-B system and produced accuracy and precision results within the predetermined specifications and comparable to results obtained by the marketed predicate devices."

While specific numerical acceptance criteria for the LVA package are not explicitly provided in the excerpt, the general criteria are implied to be accuracy and precision results within predetermined specifications and comparable to results obtained by predicate devices.

2. Sample Size and Data Provenance for Test Set

The provided text does not specify the sample size used for the test set. It also does not explicitly state the country of origin of the data or whether the data was retrospective or prospective.

3. Number and Qualifications of Experts for Ground Truth

The provided text does not specify the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The provided text does not describe any adjudication method used for the test set.

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

The provided text does not mention whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it provide an effect size for human reader improvement with or without AI assistance.

6. Standalone Performance Study

The information indicates that the CardiOp-B System is a "software system that assists in the evaluation of coronary lesions" and "provides quantitative information." While it performs quantitative analysis, the context suggests it's an assistive tool for clinicians, meaning a standalone (algorithm only) performance study might not be directly applicable in the same way as a diagnostic device replacing human interpretation. However, the performance testing described would assess the algorithm's standalone capabilities in terms of accuracy and precision of its measurements, but it's not explicitly framed as a standalone diagnostic performance study.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated. Given the device provides "quantitative information regarding the calculated dimensions of arterial segments based on the 3D image" and "quantitative analysis of the left ventricle based on left ventricular angiograms," the ground truth would likely involve highly accurate measurements from a gold standard method, potentially direct measurements from high-resolution imaging or another validated quantitative angiography method.

8. Sample Size for the Training Set

The provided text does not specify the sample size for the training set.

9. How Ground Truth for the Training Set was Established

The provided text does not specify how the ground truth for the training set was established.

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The CardiOp-B System is a software system that 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. CardiOp-B provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. CardiOp-B is intended for use in real-time in the catheterization lab and off-line for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel.

The CardiOp-B System is an image acquisition and processing software system designed as an add-on to conventional X-ray angiography systems. The CardiOp-B system improves the output of coronary angiography by presenting a three-dimensional reconstruction of the stenosed vessel as well as quantitative cross-section information. The modifications to the CardiOp-B System which are the subject of this Special 510(K) include: Bifurcation and side-branch analysis

The Paieon CardiOp-B System, a 3D Vessel Analysis System, received 510(k) clearance (K072591) based on its substantial equivalence to predicate devices. The system is designed to create 3D images of coronary vessel segments from 2D angiography images and provide quantitative information about arterial dimensions.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria or a detailed performance table from a clinical study. Instead, it mentions that "Applicable performance testing was performed to evaluate the modifications to the CardiOp-B system," which included "software validation and phantom performance evaluation." The "test results were found to be acceptable as required by the respective test plans and protocols, demonstrating that the modified device performs according to its specifications." Without specific criteria, it's impossible to populate a table with acceptance criteria and their corresponding reported values.

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

The document mentions "phantom performance evaluation." This suggests that the test set likely consisted of images from phantoms (simulated anatomical structures), rather than human patient data. No specific sample size is provided for this phantom test set. Data provenance is not explicitly stated beyond "phantom performance evaluation," which implies controlled, synthetic data rather than retrospective or prospective human clinical data. The country of origin for the data is not specified.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. Given that the testing involved "phantom performance evaluation," the ground truth likely came from the known, precisely manufactured dimensions of the phantoms, rather than expert consensus on medical images.

4. Adjudication Method for the Test Set:

No adjudication method is described. For phantom studies, adjudication by human experts is typically not necessary as the "ground truth" is inherent in the design specifications of the phantom.

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

No MRMC comparative effectiveness study is mentioned, nor is there any information about the effect size of human readers improving with or without AI assistance. The study described focuses on the device's inherent performance rather than its impact on human reader performance.

6. Standalone Performance Study (Algorithm Only):

Yes, a standalone performance evaluation was conducted. The document states, "Applicable performance testing was performed to evaluate the modifications to the CardiOp-B system. Testing included software validation and phantom performance evaluation." This indicates that the device's algorithms were tested independently, likely by comparing its measurements against the known dimensions of the phantoms.

7. Type of Ground Truth Used:

The ground truth used was based on the known dimensions of phantoms. The phrase "phantom performance evaluation" strongly suggests that precisely engineered phantoms were used, where the true dimensions of the vessels/stenoses are known by design.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size of a training set. This suggests that the device's underlying algorithms may not have been developed using a supervised learning approach requiring a labeled training set, or that information was not deemed necessary for a Special 510(k) submission focused on modifications.

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

As no training set is mentioned, information on how its ground truth was established is not provided.

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The CardiOp-B System is a software system that 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 Segments based on CardiOp-B provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. CardiOp-B is intended for use in real-time in the catheterization lab and offline for post-procedural analysis. It is intended for use by clinicians, technicians and research personnel

The CardiOp-B System is an image acquisition and processing software system designed as an add-on to conventional X-ray angiography systems. The CardiOp-B system presents a three-dimensional reconstruction of the stenosed vessel as well as quantitative cross-section information. The system includes a software package that runs on off-the-shelf hardware. CardiOp-B's features and benefits include 3D reconstruction, real-time and quantitative measurements.

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

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state quantitative acceptance criteria in the typical sense (e.g., "accuracy > X%"). Instead, the performance data describes the results in relation to pre-determined specifications and comparison to a predicate device.

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

• Test Set Sample Size: Not explicitly stated for either the phantom or clinical image validation.
• Data Provenance:
  • Phantoms: The study used "phantoms," which are engineered objects designed to mimic biological structures for testing purposes. Their origin is not specified but is typically controlled laboratory settings.
  • Clinical Images: "Clinical images" were used. The country of origin is not specified, and it's not explicitly stated whether the data was retrospective or prospective. Given the context of a 510(k) summary from 2003, it's more common for such data to be retrospective, but this is an inference.

3. 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.

4. Adjudication method for the test set:

• Adjudication Method: Not specified. The document primarily refers to "comparison to those achieved with currently marketed QCA systems" for phantoms and "correlation... between the systems" for clinical images. This implies a comparative analysis rather than an explicit expert adjudication process against a distinct ground truth for the device's measurements.

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:

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not described or indicated. The CardiOp-B system's evaluation was primarily focused on its own performance against phantoms and correlation with a predicate device, not on how it augmented human performance.

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

• Standalone Performance: Yes, the described performance data appears to be for the standalone (algorithm-only) performance of the CardiOp-B System. The system "provides quantitative information," "analyzes 2-3 angiography images," and "creates a 3D image as well as quantitative data." The evaluation compares the system's output directly to phantom specifications and the predicate device's output.

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

• For Phantom Data: The ground truth was based on the known, engineered dimensions of the phantoms, which serve as a gold standard for accuracy and precision measurements in a controlled environment.
• For Clinical Data: The "ground truth" was effectively established by the measurements from the predicate QCA-CMS system. The study sought to demonstrate correlation with this established device, implying the predicate device's measurements served as a reference for comparison, rather than an independent "expert consensus" or "pathology" ground truth for the clinical cases themselves.

8. The sample size for the training set:

• Training Set Sample Size: Not specified. The document focuses exclusively on performance data and validation, with no mention of training data or how the model was developed (e.g., machine learning approaches).

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

• Training Set Ground Truth: Not specified, as there is no information provided about a training set or its ground truth.

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