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PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multi exam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow, which is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.

PET VCAR (Volume Computer Assisted Reading) is a PET/CT post processing software package which can be used by the trained clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user defined threshold settings. Bookmarks are any highlighted item including 2D or 3D region of interests and their associated measurements and annotations on the images. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multi exam comparison. It is designed to measure PET Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow. Bookmark propagating is the feature that allows all bookmarks from the baseline exam of the patient to be automatically populated to subsequent exams of the same patient to facilitate the analysis of changes between the exams. PET VCAR offers a tool called Summary Table that compiles and manages all the analytical information in an organized and interactive design. The Summary Table is synchronized with the image display layouts offering quick measurement / image visual validation. PET VCAR's workflow is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure, or function.

Acceptance Criteria and Study for PET VCAR

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set. It mentions "bench testing" to evaluate the automatic reference region VOI placement algorithm and "verification on the AW VolumeShare workstation and AW Server platforms" for overall software performance. The data provenance (e.g., country of origin, retrospective/prospective) is not specified.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

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

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through software verification and bench testing, rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted in the form of "bench testing" to evaluate the "automatic reference region VOI placement algorithm." The document states that "the algorithm passed the defined acceptance criteria." Additionally, the overall software performance was verified on "AW VolumeShare workstation and AW Server platforms."

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated. Given the nature of the device (assistive software for image analysis) and the testing described (bench testing for an algorithm, software verification), it likely involved:

• Bench testing for the VOI algorithm: Comparison against a pre-defined "correct" placement based on established anatomical landmarks or manual expert placement.
• Overall software performance: Verification against expected output and functionality, implying internal reference data or pre-defined outcomes for various operations.

8. Sample Size for the Training Set

The document does not provide information about a training set since the study described is focused on verification and validation of the device's performance against pre-defined criteria, rather than training a new algorithm or AI model from scratch.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for the studies described, the method for establishing its ground truth is not applicable or provided in the document.

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PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. The PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined threshold settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multiexam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow. PET VCAR offers a tool called Interactive Data Analysis (IDA) spreadsheet that compiles and manages all the analytical information in an organized and interactive design. The IDA is synchronized with the image display layouts offering quick measurement / image visual validation. PET VCAR's workflow is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.

PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. The PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined threshold settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multiexam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow. PET VCAR offers a tool called Interactive Data Analysis (IDA) spreadsheet that compiles and manages all the analytical information in an organized and interactive design. The IDA is synchronized with the image display layouts offering quick measurement / image visual validation. PET VCAR's workflow is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.

The GE PET VCAR has to ensure relations with the following external systems:
Data Import: Image, exam and patient data can be imported in accordance with the DICOM Standard.
Data Export: Finding, exam and patient information can be exported in the Secondary Capture format of the DICOM standard that enables its storage on PACS systems. Finding, exam and patient information can be exported in the Structured Report format of the DICOM standard that enables its display with DICOM SR compatible viewers. Finding, exam and patient information can be exported in standard formats like HTML, XML, PDF, CSV, that enables its display with viewers compatible with the mentioned formats.
Configuration Requirements: PET VCAR is compatible with Advantage Windows Workstation™ 4.4 or higher

This submission is a 510(k) summary for GE Healthcare's PET VCAR, focusing on its substantial equivalence to previously marketed devices. The document does not contain acceptance criteria or a study that extensively describes device performance against such criteria. The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with predefined acceptance criteria as might be seen for novel devices requiring PMA.

Therefore, many of the requested details about acceptance criteria, specific performance studies, sample sizes, ground truth establishment, and MRMC studies are not present in the provided text.

Based on the available text, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define acceptance criteria in terms of numerical performance thresholds (e.g., sensitivity, specificity, accuracy, or quantitative measurement error) that the PET VCAR device needed to meet. Instead, the "performance" discussed is related to its functional capabilities and equivalence to predicate devices.

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

• Not provided in the document. The 510(k) summary focuses on substantial equivalence based on technical characteristics and intended use, rather than a detailed performance study with a specific test set.

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

• Not provided in the document. Since no explicit test set or ground truth establishment is detailed for clinical performance, this information is absent.

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

• Not provided in the document. No adjudication method is mentioned as a dedicated performance study 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:

• No, an MRMC comparative effectiveness study was not explicitly mentioned or detailed. The device's role is described as "assist in diagnosis" and "improving analysis and workflow," but no quantitative measure of human reader improvement with the AI assistance is provided. The 510(k) submission does not include data on the effectiveness of human readers with AI versus without AI assistance.

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

• No, a standalone performance study was not explicitly mentioned or detailed. The device is described as a "software package which can be used by the clinician to assist," indicating a human-in-the-loop design. It explicitly states, "PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function." This confirms it's not a standalone diagnostic device.

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

• Not provided in the document. As 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 provided in the document. The document does not discuss the training of the software's algorithms, and therefore, no training set size is mentioned.

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

• Not provided in the document. Similar to point 8, this information is absent from the 510(k) summary.

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