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510(k) Data Aggregation
(91 days)
VUCOMP, INC.
M-Vu Breast Density is a software application intended for use with digital mammography systems. M-Vu Breast Density calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. M-Vu Breast Density provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. M-Vu Breast Density produces adjunctive information. It is not an interpretive or diagnostic aid.
M-Vu Breast Density automatically analyzes "for processing" digital mammograms and calculates the dense tissue area of each breast. The measured dense tissue area is then used to provide a Calibrated Density Category which maps the percentage of breast density to a BI-RADS category number (1 - 4).
M-Vu Breast Density is a stand-alone software application designed to interoperate with all digital radiography (DR) and computed radiography (CR) mammography systems. M-Vu Breast Density is displayed in the form of a DICOM mammography structured report or secondary capture and reports the following for output:
- Breast Area (cm2) for cach breast .
- Dense Area (cm2) for each breast .
- Percent Breast Density for each breast .
- . Breast Density Category for each case
The results of M-Vu Breast Density are designed to display on a mammography workstation, high resolution monitor. or in a printed case report. M-Vu Breast Density is designed to process approximately 60-120 cases per hour.
M-Vu Breast Density Version 1.0.0.0 has been built and tested on the M-Vu CAD Station system (K061160).
Here's an analysis of the acceptance criteria and study details for the M-Vu Breast Density device, based on the provided FDA 510(k) summary:
M-Vu® Breast Density - Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list acceptance criteria as quantitative targets for the device's performance. Instead, it describes verification and validation activities designed to demonstrate the device's functionality and alignment with known biological phenomena. The "reported device performance" is thus interpreted as the successful completion of these validation tests.
| Acceptance Criteria (Implied from Validation) | Reported Device Performance (Successful Validation) |
|---|---|
| Agreement with Expert Radiologist BI-RADS Scores: | A weighted Kappa statistic was used to compare M-Vu Breast Density's calibrated density categories with BI-RADS scores obtained from 13 expert radiologists. The study implies satisfactory agreement, as it states the comparison was performed, and the overall conclusion is that the device is "safe and effective" and "substantially equivalent." However, no specific threshold for Kappa or actual Kappa value is provided. |
| Accuracy of Fibroglandular Tissue Estimates: | M-Vu percent breast density (PBD) and breast area measurements were verified. The verification of fibroglandular area measurement was confirmed "by implication." No specific metrics or thresholds for accuracy are provided. |
| Correlation with Age-Related Density Decrease: | The device's results were compared with the expected and known decrease in breast density with age using the Spearman Rank Correlation test. This implies a significant negative correlation was observed. No specific correlation coefficient or p-value is provided. |
| Consistency between Left and Right Breast Density: | Percent Breast Density measurements from the left and right breasts of the same patient were compared using Pearson's Correlation Coefficient. This implies a high positive correlation was observed. No specific correlation coefficient or p-value is provided. |
| Consistency of PBD over Time (Up to 2 years): | Percent Breast Density measurements were made on patient images and corresponding prior images (maximum two years apart) and compared using Pearson's Correlation Coefficient. This implies a high positive correlation was observed, indicating stability of measurements over time. No specific correlation coefficient or p-value is provided. |
| Successful Clinical Network Integration: | M-Vu CAD Station (on which M-Vu Breast Density is deployed) was successfully tested for clinical network integration. This is a functional and technical acceptance, not a performance metric for density assessment. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Expert BI-RADS Comparison: Not explicitly stated. The document mentions "a set of x-ray images for which a BI-RADS scores were obtained from 13 expert radiologists," but the number of cases or images in this set is not provided.
- Sample Size for Age Correlation: Not explicitly stated. The document mentions "a data set where the women's age and results were compared," but the number of cases is not provided.
- Sample Size for Left/Right Breast Comparison: Not explicitly stated.
- Sample Size for Prior Image Comparison: Not explicitly stated.
- Data Provenance: Not specified. It is likely retrospective, given the nature of image analysis and comparison with existing data (e.g., prior images, expert BI-RADS scores). The country of origin of the data is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: 13 expert radiologists were used to provide BI-RADS scores.
- Qualifications of Experts: Stated as "expert radiologists." No specific details on their years of experience or subspecialty are provided.
4. Adjudication Method for the Test Set
For the primary comparison (BI-RADS scores), the document states that expert BI-RADS scores were "obtained from 13 expert radiologists." It does not specify an adjudication method (e.g., 2+1, 3+1, none) to establish a consensus ground truth from these 13 experts. It's possible each expert's score was treated individually, or a simple majority/median was used, but this detail is missing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document explicitly states: "This submission contains no information from clinical studies." The studies conducted are validation studies for the algorithm's performance against established measures or trends, not studies comparing human reader performance with and without AI assistance.
- Effect size of human reader improvement: Not applicable, as no MRMC study was performed.
6. Standalone Performance Study
- Was a standalone study done? Yes. All described "non-clinical performance data" are standalone studies of the M-Vu Breast Density algorithm. The device "was run over a set of x-ray images" and its outputs were then compared to various metrics (expert BI-RADS, age trends, intra-patient consistency). This demonstrates the algorithm's performance without human intervention in the density calculation process.
7. Type of Ground Truth Used
The ground truth used for the validation studies includes:
- Expert Consensus/Opinion: BI-RADS scores obtained from 13 expert radiologists.
- Known Biological/Clinical Trends: The expected decrease in breast density with age.
- Internal Consistency: Comparison of left vs. right breast density and density over time for the same patient.
No pathology or outcomes data were used as ground truth.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set of the M-Vu Breast Density algorithm.
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. Given the lack of training set details, this information is entirely absent.
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(44 days)
VUCOMP, INC.
The M-Vu™ CAD Station is intended to support the acquisition and storage of medical images for subsequent digital analysis and processing. The medical imagery can be obtained from film format (digitized by a commercial FDA-cleared medical digitizer) or digital format transmitted via a standard DICOM network interface. The CAD Station can print case information and can connect over a Local Area Network and interface with the M-Vu Viewer Station. The CAD Station is intended for use by a technician under the supervision of a medical professional.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
The M-Vu™ CAD Station is a computer-based system that supports the acquisition and storage of medical images for subsequent digital analysis and processing. The system can obtain digitized imagery from two sources: 1) digitized film images from a medical digitizer that is included as part of the system or 2) digitized images obtained from different sources and sent to the CAD Station via a DICOM network interface. The CAD Station is not intended as an archival device.
The CAD Station has several commercial components integrated together on a custom cart. The components include a 510(k)-cleared medical digitizer for scanning films, a printer for report generation, a touch screen monitor for control and displaying system status and error messages, a Windows™-OS computer for executing control software and for temporary storage of imagery and an uninterruptible power supply. The CAD Station communicates via a standard Ethernet network and can support an interface to other PACS devices through a DICOM interface. It also communicates to the M-Vu™ Viewer Station (K060451) to provide case reports including low resolution radiographic images.
The user interface to the CAD Station is via a touch screen monitor. The monitor allows control of the digitizer and provides system status information. While the system is intended to be operated in an unattended batch mode, case priorities can be manually adjusted for higher priority film or digital cases. Also, user specific configuration information and options can be accessed through an onscreen keyboard.
The printer automatically generates case reports with low resolution imagery and a printed (unique) bar code. The bar code is then used to link the case reports to the graphical imagery on the M-Vu Viewer Station.
The provided text describes the M-Vu™ CAD Station, a device intended to support the acquisition and storage of medical images. However, it explicitly states, "Discussion of Clinical Tests Performed: Not applicable." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria based on clinical performance.
The submission focuses on establishing substantial equivalence to a predicate device (Consultiva™ Case Input Station, K#031132) through non-clinical testing, particularly regarding safety and performance, including "software validation and verification testing."
Since no clinical study was performed or discussed, the following information cannot be extracted from the provided text:
- Table of acceptance criteria and reported device performance: No clinical performance data is presented.
- Sample size used for the test set and data provenance: No clinical test set.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance (algorithm only without human-in-the-loop performance): Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: No clinical training set mentioned.
- How the ground truth for the training set was established: Not applicable.
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(29 days)
VUCOMP, INC.
The M-Vu™ Viewer Station is intended to be used to display low resolution, non-diagnostic, medical images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks.
The M-Vu™ Viewer Station is a computer-based system that displays digitized. low-resolution, radiographic information. The system is typically used to support a radiologist's review of screening and/or diagnostic mammograms. The system has two main functional components: a commercially available computer with an integrated LCD display and an attached bar code reader. The computer is connected to the M-Vu™ CAD Station via an Ethernet network to download selected radiographic images and Computer-Aided Detection (CAD) results or other annotations. The Viewer Station serves no other purpose than providing convenient viewer support.
The provided 510(k) summary for the M-Vu™ Viewer Station explicitly states:
"8. Discussion of Clinical Tests Performed: Not applicable"
This means that a clinical study was not performed to prove the device meets specific acceptance criteria based on human performance or diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on non-clinical tests (software validation and verification testing) and similar intended use and characteristics.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical studies cannot be extracted from this document because such studies were not conducted for this submission.
The document indicates that the device's safety and effectiveness were supported by:
- Non-Clinical Tests: Software validation and verification testing.
- Comparison to Predicate Device: The M-Vu™ Viewer Station was found substantially equivalent to the Second Look® Viewer (K#042697) based on intended use and technological characteristics, with differences (e.g., mouse vs. touch screen, printing options) not raising new questions of safety or effectiveness.
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