Search Results
Found 2 results
510(k) Data Aggregation
(56 days)
Visible Patient, SAS
Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning for both pediatric and adult patients. 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 Ul to segment anatomical structures, which are visible in the image data (bones, organs, vascular/ainway 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.
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).
a) Visible Patient Sender
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 imaqinq modalities (DICOM images). There is no 3D data volume interpretation in this software.
b) Visible Patient Lab
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.
c) Visible Patient Planning
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.
The provided text does not contain detailed acceptance criteria and the comprehensive study results to populate all the requested information for acceptance criteria and device performance. The document is a 510(k) clearance letter and a summary, which typically focuses on substantial equivalence rather than a full performance study report.
However, based on the available information, here's what can be extracted:
Acceptance Criteria and Device Performance (Limited Information Available)
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments from Document |
|---|---|---|---|
| Volume Computation Accuracy | Implied: Accurate computation of volumes. | Tested on phantom data. | "For the volume computation and distance measurement, all tests were performed on phantom data with pre-established physical characteristics (specific measures and volumes)." |
| Distance Measurement Accuracy | Implied: Accurate measurement of distances. | Tested on phantom data. | "For the volume computation and distance measurement, all tests were performed on phantom data with pre-established physical characteristics (specific measures and volumes)." |
| Software Functionality | All functionalities perform as intended. | All functionalities tested during development. | "All functionalities were tested during the test phase of the development. Each feature can be used for pediatric or adult patients." |
| Segmentation Accuracy (Organ segments: liver, lungs, kidneys) | Implied: Accurate detection and labeling of specified organ segments. | Performance implied through design and functionality description. Specific metrics not provided. | "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." |
Study Details from the Document:
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "phantom data with pre-established physical characteristics" for volume and distance measurements, and "all functionalities were tested." The exact number of phantom images or real patient cases used for testing is not detailed.
- Data Provenance: Phantom data (for volume/distance). No specific country of origin for any clinical data is mentioned, nor is it specified if the testing was retrospective or prospective. The document states a "literature study was conducted to support device performance" during validation, suggesting external data may have been referenced, but details are absent.
-
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):
- This information is not provided in the document.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
-
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:
- It is highly unlikely an MRMC study was done or reported here. The device is described as "Medical Image Management and Processing System" with tools for reading, interpreting, and treatment planning, along with segmentation and labeling. It explicitly states it is not for primary diagnostic interpretation of mammography images and is "intended to assist the clinician who is solely responsible for making all final patient management decisions." There is no mention of an AI-assistance study or any effect size on human reader improvement. The focus is on the device's capability to perform its specified image processing functions.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The description of testing on "phantom data with pre-established physical characteristics" for volume and distance computation suggests a form of standalone performance evaluation against a known ground truth. However, specific standalone performance metrics (e.g., precision, recall, Dice score for segmentation) are not reported beyond the general statement that "all functionalities were tested."
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For volume computation and distance measurement, the ground truth was "pre-established physical characteristics" of phantom data.
- For other segmentation and labeling functionalities, the type of ground truth used for testing is not explicitly stated. It can be inferred that it would likely involve expert-derived annotations if real patient data was used, but this is not confirmed.
-
The sample size for the training set:
- This information is not provided as this document focuses on validation/testing.
-
How the ground truth for the training set was established:
- This information is not provided as this document focuses on validation/testing.
Ask a specific question about this device
(90 days)
VISIBLE PATIENT, SAS
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.
Ask a specific question about this device
Page 1 of 1