(111 days)
The Workspace is intended for use in conjunction with 3TP's proprietary post processing pharmacokinetic analysis software (FDA 510(k) number: K03150) to provide additional mathematical and/or statistical information specific to a particular region within a 3TP color-coded image. The Workspace does not change the original 3TP Software algorithm or the image series produced by the 3TP The Workspace supports the analysis and presentation of datasets algorithm. generated by 3TP Software algorithm and incorporates the following functions: Pixel of Interest curve (POI), Region of Interest curve (ROI), Report Card, Volume Calculation, 3TP Histogram, and 3-D visualization of 3TP data series.
3TP Workspace is intended to be used as post processing software designed to receive 3TP specific series and provide additional tools to analyze those 3TP series. 3TP itself, supports the evaluation of dynamic MR data gathered during the injection of a bolus of contrast media. The resulting time course information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images.
The provided text does not contain detailed acceptance criteria or a study that proves the device meets specific performance metrics in the way modern regulatory submissions typically do for medical device software. This document is a 510(k) premarket notification for a Picture Archiving and Communications System (PACS) component called "Workspace," which aids in post-processing pharmacokinetic analysis software.
The document primarily focuses on establishing substantial equivalence to predicate devices and describing the device's intended use and functions, rather than presenting a performance study with quantitative acceptance criteria.
However, based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Verification: The Workspace will successfully integrate with 3TP's proprietary post-processing pharmacokinetic analysis software (K03150) and perform its stated functions. | The device's various functions (POI, ROI curves, Report Card, Volume Calculation, Statistical Analysis, 3-D Visualization) are described as tools that support the analysis and presentation of data generated by the 3TP Software algorithm. The document states it will "successfully complete integration testing and verification." |
| Safety: The use of 3TP Workspace will not result in any additional hazards compared to predicate devices. | The document explicitly states: "The use of the 3TP Workspace does not result in any additional hazards, compared to the other post-processing software packages... The 3TP Workspace does not include any new indications for use nor does the use of this device result in any new potential hazards." |
| Effectiveness (in terms of aiding diagnosis): The Workspace will assist users (radiologists) in evaluating data and aiding diagnosis by providing mathematical and statistical information. | The "Indications for Use" and "Summary of Information Respecting Safety and Effectiveness" sections describe how the functions (e.g., Report Card, Statistical Analysis) "assist the user by providing number based data... in order to further aid in his diagnosis" and "assists the radiologist in determining the degree of heterogeneity or homogeneity." |
| Software Validation: The software will be successfully validated prior to market release. | "the software beta testing will be successfully completed validating the 3TP Workspace prior to market release." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a quantitative sample size for a test set, nor does it mention data provenance (e.g., country of origin, retrospective/prospective). The "Performance Testing" section states: "The 3TP Workspace will successfully complete integration testing and verification prior to beta validation and the software beta testing will be successfully completed validating the 3TP Workspace prior to market release." This implies testing was primarily focused on software functionality and integration, rather than a clinical performance study using a specific dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The validation mentioned is for software functionality.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set and associated adjudication method are described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The document does not describe any comparative effectiveness study (with or without AI assistance) involving human readers.
6. Standalone Performance Study
No standalone (algorithm only) performance study with quantitative metrics (e.g., sensitivity, specificity) is described. The "Workspace" device is explicitly stated to be "intended for use in conjunction with 3TP's proprietary post processing pharmacokinetic analysis software (FDA 510(k) number: K03150)" and does not perform diagnostic tasks independently. Its functions are tools for post-processing and analysis of data generated by another algorithm.
7. Type of Ground Truth Used
Not applicable. The document does not describe a clinical performance study that would require a "ground truth" (e.g., pathology, outcomes data). The validation mentioned is for software functionality and integration.
8. Sample Size for the Training Set
Not applicable. The "Workspace" device is a post-processing analysis tool, not an AI/ML algorithm that requires a training set in the conventional sense. It processes data generated by another algorithm (K03150).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for this device.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).