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VelocityAIS (VelocityAI) is a stand-alone software product that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. VelocityAIS (VelocityAI) is not intended for mammography diagnosis.

Version 2.0 of VelocityAIS, also marketed as VelocityAI with this version, is a stand-alone software product that provides medical image processing designed to facilitate the oncology or other clinical specialty work flow by allowing the comparison of medical imaging data from different modalities, points in time, and/or scanning protocols. The product provides users with the means to display, co-register and fuse medical images from multiple modalities including PET, SPECT, CT, and MR, draw Regions of Interest (ROI), calculate, and report relative differences in pixel intensities, Standardized Uptake Value (SUV) or other values within those regions, and import and export results to and from commercially available radiation treatment planning systems and PACS devices. Version 2.0 of the product contains the additional features of: Automated deformable registration. Anatomical atlas based segmentation tools. Operating systems compatibility with MicroSoft Windows XP Home and Professional (Service Pack 2), MicroSoft Vista Home and Professional, Linux (CentOS) and MacOSX (Leopard). VelocityAIS (VelocityAI) is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.

The provided document is a 510(k) Pre-Market Notification Summary for the VelocityAIS (also "VelocityAI") software, version 2.0. This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific clinical study with granular performance metrics and acceptance criteria for a novel device function.

Here's a breakdown of the requested information based on the provided text, and explicit statements about what is not available in this document:

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

Explanation: The document states that the software "meets its functional specifications and performance requirements" but does not provide a table of quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, processing speed) or specific numerical performance results. The core of this 510(k) is about demonstrating substantial equivalence to existing predicate devices, implying that its performance is equivalent or better without introducing new safety/effectiveness concerns.

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

• Sample Size for Test Set: Not mentioned in the provided text.
• Data Provenance: Not mentioned in the provided text. The document describes the software's capabilities with "medical imaging data from multiple DICOM conformant imaging modality sources" but does not specify the origin or nature of the data used for verification/validation.
• Retrospective/Prospective: Not mentioned in the provided text.

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)

• Not mentioned in the provided text. The document focuses on software functionality and comparison to predicate devices, not on the details of a clinical reader study or the establishment of ground truth by experts.

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

• Not mentioned 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

• Not mentioned in the provided text. This 510(k) summary does not describe an MRMC comparative effectiveness study or the impact of AI assistance on human readers. The device is described as "medical image processing designed to facilitate the oncology or other clinical specialty work flow" and providing "a means for comparison of medical imaging data," but it doesn't quantify improvements in human reader performance.

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

• The document describes the device as a "stand-alone software product" that provides image processing capabilities, implying its functionality without direct human intervention in its core processing. However, it's an "aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties," meaning human experts interpret the output.
• Performance of the algorithm only (e.g., specific metrics for deformable registration or segmentation accuracy): Not explicitly detailed in the provided text. The claim is general: "verified and validated that the VelocityAIS (VelocityAI) software meets its functional specifications and performance requirements."

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

• Not mentioned in the provided text.

8. The sample size for the training set

• Not mentioned in the provided text. The document does not describe the training of any AI/ML models, though it mentions "Automated deformable registration" and "Anatomical atlas based segmentation tools" which could imply the use of such models.

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

• Not mentioned in the provided text.

In summary, the provided 510(k) document is a regulatory submission focused on substantial equivalence. It confirms that the manufacturer verified and validated the software's functional specifications and performance requirements. However, it does not contain the detailed clinical study information (e.g., specific acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness study results) that is typically found in a clinical validation report for a device with advanced diagnostic capabilities. This type of information is often provided in more detailed validation reports or during later clinical trials, which are not part of this initial 510(k) summary for a "Picture Archiving and Communication System (Medical Imaging Software)" with image processing features.

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