(90 days)
Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc.
It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc.
It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling.
The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.
The Visible Patient Suite is a software device that does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software, but by radiologists, clinicians and referring physicians. A physician, provided with ample opportunity for competent human intervention, interprets images and information being displayed.
In sum, Visible Patient Suite is a software suite and includes three software components: Visible Patient Sender (VP Sender), Visible Patient Lab (VP Lab), and Visible Patient Planning (VP Planning). Visible Patient Lab is the main software component of Visible Patient Suite and includes all modules available in the software suite (except for the DICOM files anonymization module present in the Visible Patient Sender module).
Visible Patient Sender includes only modules dedicated to data management. The software is a simple tool to anonymize multidimensional digital images acquired from a variety of medical imaging modalities (DICOM images). There is no 3D data volume interpretation in this software.
Visible Patient Lab includes all Visible Patient Suite modules: data management (except for DICOM files anonymization module), data analysis and data processing. This software offers a flexible solution to help trained medical professionals with image processing knowledge (usually radiologists or radiologist technicians) in (1) the evaluation of patient's anatomy and pathology, and (2) in the creation of a 3D model of the patient's anatomy. This software proposes flexible workflow options: visualization of patient's anatomy and pathology from medical images; creation a 3D model of the patient's anatomical structures, organ segments and volumetric data; creation of an anatomical atlas (a colored image where each color represents a structure); and exports these medical data to be analyzed or reviewed later.
Visible Patient Planning includes modules dedicated to data management and data analysis, and simply contains a subset of the software modules present in Visible Patient Lab. This software offers a flexible visualization solution to help trained medical professionals (clinicians) in the evaluation of patient's anatomy and pathology to plan therapy or surgery.
Based on the provided text, the "Visible Patient Suite" is a medical imaging software that offers various tools for reading, interpreting, and treatment planning, including advanced features like organ segmentation (liver, lungs, kidneys) and vascular/airway definition.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, specificity values) for the device's performance. Instead, the performance validation is described qualitatively.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functions as intended | "In all instances, the Visible Patient Suite functioned as intended." |
| Device is safe and effective | "The Visible Patient Suite is as safe and effective as the Synapse 3D Base Tools (K120361), Synapse 3D Liver and Kidney Analysis (K142521) and Synapse 3D Lung and Abdomen Analysis (K130542)." |
| No new issues of safety or effectiveness from technological differences | "The minor technological differences between the Visible Patient Suite and its predicate devices raise no new issues of safety or effectiveness." |
| Performs similarly to predicate devices | "Performance data demonstrate that the Visible Patient Suite performs as intended and in a manner similar to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The company has verified and validated the Visible Patient Suite's moderate level of concern software." However, it does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. It states the software is "designed to be used by trained professionals (including physicians, surgeons and technicians)" and that "Diagnosis is not performed by the software, but by radiologists, clinicians and referring physicians," but this refers to the users of the software, not the experts who established the ground truth for validation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size related to human readers improving with AI vs. without AI assistance. The regulatory submission emphasizes the device's substantial equivalence to predicate devices, focusing on the software tools themselves rather than human-AI collaboration.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document implies that the software's performance was validated, but it focuses on the software as a "tool" to assist trained medical professionals. The statement "Diagnosis is not performed by the software, but by radiologists, clinicians and referring physicians" suggests that the device's intended use is not as a standalone diagnostic tool without human oversight. The provided information does not detail specific standalone performance metrics for the algorithms within the software (e.g., for segmentation accuracy in isolation).
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for validation. It mentions the creation of a "3D model of the patient's anatomical structures, organ segments and volumetric data" and an "anatomical atlas," which might imply comparisons to known anatomical references or expert-derived segmentations, but it's not explicitly defined as pathology, outcomes data, or expert consensus.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established.
Summary of what is Lacking in the Provided Text:
The provided 510(k) summary focuses primarily on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and a broad qualitative statement of performance ("functioned as intended," "as safe and effective as predicate devices"). It lacks detailed information on the specific validation study methodology, including:
- Quantitative acceptance criteria
- Test set size and provenance
- Details of ground truth establishment (number/qualifications of experts, adjudication)
- Results from specific performance metrics (e.g., accuracy, sensitivity, specificity for segmentation tasks)
- Information on training data and its ground truth.
- Any MRMC study results.
§ 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).