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INVIA's Corridor4DM v2010 application is intended to provide processing quantification, and multidimensional review of the biodistribution of radionuclides in the body using planar and tomographic images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion tomographic images. Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the corònary arteries, a risk factor for coronary artery disease. Co-registration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.

Corridor4DM v2010 is a comprehensive application designed to process, review, and quantitatively analyze nuclear medicine, PET, and CT patient studies. The application provides tools to process, quantify, and display static, dynamic, gated planar,- standard ungated ECT images, ECG gated ECT images, and dynamic ECT images. ECT data is displayed on both a slice-by-slice basis and as 3-dimensional surface- rendered images in many user selectable formats. All of the image formats can be viewed as a single dataset or as a comparison of related datasets. Among several optional display screens are sideby-side displays optimized for the review of uncorrected and attenuation corrected cardiac images. . Corridor4DM v2010 algorithmically determines and displays the left ventricular endocardial and epicardial surfaces. These surfaces provide quantitative assessments of cardiac functions. Corridor-4DM v2010 includes the ability to save and export diagnostic findings in a variety of formats. The application generates DICOM multi-frame (MFSC) and secondary screen captures (SSC) in addition to producing static (JPEG, TIFF) and dynamic (AVI) image files.

The provided text is a 510(k) summary for the Corridor4DM v2010 device and does not contain detailed information about specific acceptance criteria, a comprehensive study proving adherence to such criteria, or performance metrics. It focuses on demonstrating substantial equivalence to predicate devices.

Therefore, most of the requested information cannot be extracted directly from the provided document.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be answered from the provided text. The document states that "Corridor4DM v2010 validation testing showed no new issues of safety and effectiveness when compared to predicate devices," but it does not specify what those validation tests were, what acceptance criteria were set, or the quantitative performance results.

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

• Cannot be answered from the provided text. The document does not mention any specific test set sample sizes or data provenance for any validation study.

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)

• Cannot be answered from the provided text. There is no information about expert involvement in establishing ground truth for any test set.

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

• Cannot be answered from the provided text. No adjudication method is described.

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

• Cannot be answered from the provided text. The document describes the device as a "comprehensive application designed to process, review, and quantitatively analyze nuclear medicine, PET, and CT patient studies." It also states "The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual assessment." This suggests it's an aid, but no MRMC comparative effectiveness study or improvement effect size for human readers with and without AI assistance is mentioned.

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

• Cannot be answered from the provided text directly in terms of a standalone performance study. The document implies that the device performs algorithmic determinations (e.g., "algorithmically determines and displays the left ventricular endocardial and epicardial surfaces"). However, it's explicitly stated that the "Clinician retains the ultimate responsibility," indicating it's not a standalone diagnostic device. No specific standalone performance study metrics are provided.

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

• Cannot be answered from the provided text. The document does not specify how ground truth was established for any validation or testing performed.

8. The sample size for the training set

• Cannot be answered from the provided text. There is no mention of a training set or its size.

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

• Cannot be answered from the provided text. As no training set is mentioned, naturally, how its ground truth was established is also not provided.

Summary of what is present:

• Intended Use: To provide processing, quantification, and multidimensional review of biodistribution of radionuclides using planar and tomographic images, perform quantitative measurements of tracer uptake, aid in myocardial perfusion image interpretation, and offer optional cardiac CT interpretation and calcium quantification.
• Safety and Effectiveness Assessment: Assessed via a Risk Management Plan in accordance with ISO 14971.
• Conclusion: The device is deemed substantially equivalent to predicate devices based on intended usage, technology comparison, and system performance, with validation testing showing "no new issues of safety and effectiveness."
• Device Functionality: Algorithmically determines and displays left ventricular endocardial and epicardial surfaces, provides quantitative assessments of cardiac function, and generates various image formats and dynamic files.

To obtain the detailed information requested, one would need to refer to more comprehensive documentation related to the device's validation and verification testing, which is typically part of the full 510(k) submission but not fully included in the public-facing summary.

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Invia's Corridor4DM application is intended to provide processing, quantification, and multidimensional review of reconstructed cardiac emission tomographic studies (SPECT and PET). Cardiac CT interpretation and calcium quantification are optional features that are integrated into Corridor4DM (SPECT-CT and PET-CT). The calcium-scoring package is a non-invasive diagnostic tool that can be used to evaluate the calcified plaques in the coronary arteries, a risk factor for coronary artery disease. Calcium scoring may be used to monitor the progression overtime of the amount or volume of calcium in the coronary arteries, which may be related to the prognosis of a cardiac attack. Coregistration or fusion of volumetric data (ECT and/or CT) is provided as a quality control for the identification of structures where correlative spatial information is necessary for a diagnostic interpretation.

Corridor4DM is a comprehensive cardiac emission computed tomographic (ECT) application designed to review and quantitatively analyze cardiac ECT (SPECT and PET) nuclear medicine patient studies. The application provides tools for processing and displaying standard ungated and ECG gated cardiac ECT images on both a slice-by-slice basis and as a 3-dimensional surface rendered images in many user selectable formats. Additionally, it provides quantitative assessments of heart function by computing and displaying left ventricular chamber volumes, ejection fraction and transient ischemic dilation (TID) values and provides an assessment of the data set(s) in comparison to a similar patient population with a low likelihood of cardiac disease. The application provides a number of different single or multi-dimensional display(s) to allow the users to select those that best fit their needs. Cardiac CT interpretation and cardiac calcium quantification are optional features that are integrated into Corridor4DM.

This 510(k) summary for the Corridor4DM device does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technology comparison, and general system performance, rather than providing specific performance metrics, acceptance criteria, or a detailed study design with statistical evidence.

However, I can extract the information that is present and highlight what is missing.

Missing Information Disclaimer

The provided 510(k) summary does not include:

• A table of specific acceptance criteria.
• Quantitative reported device performance metrics against those criteria.
• Details on the sample size used for any test set or the data provenance.
• The number or qualifications of experts used to establish ground truth for a test set.
• Any adjudication method.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used for a test set (e.g., pathology, outcomes data).
• The sample size for a training set.
• How ground truth for a training set was established.

Information Extracted from the Provided 510(k) Summary:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or reported device performance data against such criteria are provided in this 510(k) summary.

The comparison table provided focuses on features and functionalities to demonstrate substantial equivalence, not performance metrics.

Note: The "Reported Device Performance" in this context refers to the affirmation of the presence or absence of a feature, rather than quantitative performance metrics like sensitivity, specificity, accuracy, or statistical equivalency. The submission argues for substantial equivalence based on having similar functionalities as the predicate devices.

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

Not specified in the provided 510(k) summary. The document does not describe a clinical performance study with a specific test set. The comparison is based on functional equivalence to predicate devices.

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

Not applicable/specified. A formal test set with expert-established ground truth is not detailed in this 510(k) summary.

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

Not applicable/specified. An adjudication method for a test set is not described.

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

Not applicable/specified. This 510(k) summary does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is a "processing, quantification, and multidimensional review" application, not explicitly an AI-assisted diagnostic tool in the typical sense for MRMC studies as of this submission date (2008). The focus is on providing tools for quantification and review.

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

Not applicable/specified. No standalone performance study details are provided. The device is described as an application with processing, quantification, and review tools, implying human interaction.

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

Not applicable/specified. Since no specific performance study with a test set is detailed, the type of ground truth used is not mentioned.

8. The sample size for the training set

Not specified. The document does not describe an AI/machine learning model development process with a training set.

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

Not applicable/specified. As no training set is described, the method for establishing its ground truth is also not.

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