(445 days)
Not Found
No
The description focuses on semi-automated, interactive tools for quantitative morphometry based on user-verified point placement and well-established guidelines, with no mention of AI, ML, or deep learning.
No.
The device is for visualization and measurement of vertebral deformities to identify patients at high risk of a future osteoporosis-related fracture, which is for diagnostic purposes, not therapeutic intervention directly.
Yes
The "Intended Use / Indications for Use" states that the device "can be interpreted by a physician to diagnose existing vertebral fractures".
Yes
The device description explicitly states "VirtuOst Vertebral Fracture Assessment (VFA) software is used to perform vertebral morphometry". It takes CT scan data as input and provides analysis and a report, indicating it is a software application processing existing medical image data. There is no mention of accompanying hardware components required for its function beyond the input CT scan.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Virtu Ost VFA's Function: Virtu Ost VFA analyzes medical images (CT scans) of the spine. It does not process biological samples from the patient. Its function is to measure anatomical features (vertebral deformities) and classify them based on established criteria.
- Input: The input is a CT scan, which is an imaging modality, not a biological sample.
- Output: The output is a report containing measurements, classifications, and risk assessments based on image analysis.
Therefore, Virtu Ost VFA falls under the category of medical image analysis software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Virtu Ost VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.
Product codes
LLZ, KGI
Device Description
VirtuOst Vertebral Fracture Assessment (VFA) software is used to perform vertebral morphometry and is an integrated component of VirtuOst (K113725). VirtuOst VFA accepts as input a sagittal section of a vertebral body, obtained from a spine-containing computed tomography (CT) scan, and provides semi-automated, interactive tools with which the user can perform six-point quantitative vertebral morphometry according to well-established guidelines. The process can be repeated for multiple vertebral bodies. For each vertebral body analyzed, the quantitative vertebral morphometry algorithm locates three points each along the superior and inferior endplate on a sagittal section through the vertebra, typically a mid-sagittal section. The user verifies or modifies point placement. Based on these six morphometry points, anterior, posterior and middle vertebral heights are measured. Percent deformities are calculated from these heights and are then compared against well-established criteria for vertebral deformities typical of osteoporosis-related vertebral fracture in order to classify types and grades of any existing osteoporosis-related fracture, from which a patient can be classified as being at high risk of a future osteoporosis-related fracture. The VFA algorithm can be applied to any complete vertebral body captured in the CT scan, and the scan can be contrast-enhanced or not. Consistent with the recommended use of the well-established fracture-classification criteria, deformity types and fracture grades and fracture-risk classifications are only reported for vertebral levels T4 through L4. A report is generated containing these results, along with images of the sagittal sections from which the measurements were acquired. A physician then interprets the report to make any medical diagnoses or treatment decisions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Spine (Lateral) T4-L4
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical study of n=40 women and men. Data source: Computed tomography scans acquired as part of standard care for 7000 women and men age 65 and older. From this resource, 716 patients had two CT exams within a 90-day period, both with at least one reconstruction with a slice thickness of 1.25mm. From those patients with potential fracture, thirty-five were consecutively selected for inclusion in the study. To ensure that the precision cohort would include patients without fracture, five more were selected from patients not flagged as having a potential fracture, for a total cohort of n=40.
Annotation Protocol: Two operators performed vertebral fracture assessment on each patient's baseline CT scan using VirtuOst VFA. All scan IDs were replaced with new IDs and scan order was randomized. After a minimum five-day wash-out period, one operator repeated the analysis of the baseline scans, and the other performed VFA of each patient's follow-up scan. Operators were blinded to each other's results as well as to their own first-pass results. Intra-operator, short-term (baseline vs. follow-up measurement by a single operator) and combined (baseline measurement by one operator vs. follow-up measurement by a second operator) precision were calculated. As a reference standard, vertebral heights were also manually measured from high resolution (0.5 mm) printouts of midsagittal sections of the L1 vertebra from each CT scan. Height ratios were calculated and fracture grades assigned using six-point morphometry methods.
Summary of Performance Studies
Study Type: Clinical Study
Sample Size: n=40 women and men
Key Metrics / Results:
Accuracy:
- Fracture determination: kappa = 0.94, 95% CI = 0.82-1.06
- Fracture grading: kappa = 0.76, 95% CI = 0.60-0.91
- No significant differences in fracture determination (p = 0.32) or fracture grades (p = 0.32).
- Mean difference in height-ratio between VirtuOst VFA and manual measurements was small (0.005 vs. 0.17-1.13).
Repeatability:
- Intra-operator fracture determination kappa: 0.94 (95% CI: 0.82-1.06)
- Intra-operator fracture grading kappa: 0.69 (95% CI: 0.52-0.87)
- Intra-operator precision of VirtuOst VFA (SDRMS= 0.018)
- Interoperator fracture determination kappa: 0.94 (95% CI: 0.82–1.06)
- Interoperator fracture grading kappa: 0.72 (95% CI: 0.55-0.89)
- Interoperator precision of height-ratios using VirtuOst VFA (SDRMS=0.023)
- Short-term fracture determination kappa: 0.88 (95% CI: 0.72-1.04)
- Short-term fracture grading kappa: 0.69 (95% CI: 0.53-0.86)
- Combined fracture determination kappa: 0.82 (95% CI: 0.62–1.02)
- Combined fracture grading kappa: 0.76 (95% CI: 0.61–0.92)
Influence of slice thickness:
- Vertebral height-ratios were smaller on average when measured from 3 mm vs. 1.25 mm CT scans (mean = 0.013, 95% CI = 0.003-0.024, p = 0.01).
- Agreement in fracture determination (kappa = 0.88, 95% CI = 0.72-1.04) and grading (kappa = 0.66, 95% CI = 0.47-0.84) were still very high between scans of different slice thickness.
- Intra-operator precision when slice thickness varied between repeat measurements (SDRMS = 0.034).
Influence of IV contrast enhancement:
- Height-ratios were larger on average when one repeat analysis was performed on an image with IV contrast enhancement (mean = 0.007; 95% CI = 0.001-0.013, p=0.02).
- Intra-operator precision when one repeat measurement was from an enhanced image (SDRMS = 0.020).
Conclusion: Virtuost VFA is highly accurate, and its precision is substantially equivalent to that of the predicate device K103475. Precision errors are small enough to have no significant effect on fracture determination or grading, and these conclusions hold for CT scan reconstruction slice thicknesses up to 3 mm with or without IV contrast enhancement.
Key Metrics
kappa, 95% CI, p-value, SDRMS, mean difference, percent deformation
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
O.N. Diagnostics, LLC. % Mr. David Kopperdahl Director, Research and Development 2150 Shattuck Ave., Suite 610 BERKELEY CA 94704
August 3, 2018
Re: K171435
Trade/Device Name: VirtuOst Vertebral Fracture Assessment Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 30, 2018 Received: August 2, 2018
Dear Mr. Kopperdahl:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171435
Device Name
VirtuOst Vertebral Fracture Assessment
Indications for Use (Describe)
Virtu Ost VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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C. 510(K) SUMMARY
| Date: | July 30, 2018 |
|---|---|
| 1) Applicant Information | |
| 510(k) Owner: | O. N. Diagnostics, LLC |
| 2150 Shattuck Ave. Suite 610 | |
| Berkeley, CA 94704 | |
| Contact Person: | David Kopperdahl |
| Director, Research and Development | |
| O. N. Diagnostics, LLC | |
| 2150 Shattuck Avenue, Suite 610 | |
| Berkeley, CA 94704 | |
| Phone 510-204-0688 | |
| Fax 510-356-4349 | |
| Establishment Reg. No.: | 3010687441 |
| 2) Device Identification | |
| Trade Name: | VirtuOst Vertebral Fracture Assessment |
| Common Name: | Vertebral Fracture Assessment |
| Regulatory Class: | II |
| Primary Classification Name: | Picture archiving and communications system |
| Primary Regulation Number: | 21 CFR 892.2050 |
| Primary Product Code: | LLZ |
| Secondary Classification Name: | Bone Densitometer |
| Secondary Regulation Number: | 21 CFR 892.1170 |
| Secondary Product Code: | KGI |
| 3) Identification of Predicate Devices | |
| K103475: | SpineAnalyzer |
| Company: | Optasia Medical |
| Primary Classification Name: | Picture archiving and communications system |
| Primary Regulation Number: | 21 CFR 892.2050 |
| Primary Product Code: | LLZ |
| K023554: | Dual-Energy Vertebral Assessment View Software Option |
| Company: | GE Lunar |
| Primary Classification Name: | Bone Densitometer |
| Primary Regulation Number: | 21 CFR 892.1170 |
| Primary Product Code: | KGI |
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4) Device Description
VirtuOst Vertebral Fracture Assessment (VFA) software is used to perform vertebral morphometry and is an integrated component of VirtuOst (K113725). VirtuOst VFA accepts as input a sagittal section of a vertebral body, obtained from a spine-containing computed tomography (CT) scan, and provides semi-automated, interactive tools with which the user can perform six-point quantitative vertebral morphometry according to well-established guidelines. The process can be repeated for multiple vertebral bodies. For each vertebral body analyzed, the quantitative vertebral morphometry algorithm locates three points each along the superior and inferior endplate on a sagittal section through the vertebra, typically a mid-sagittal section. The user verifies or modifies point placement. Based on these six morphometry points, anterior, posterior and middle vertebral heights are measured. Percent deformities are calculated from these heights and are then compared against well-established criteria for vertebral deformities typical of osteoporosis-related vertebral fracture in order to classify types and grades of any existing osteoporosis-related vertebral fracture, from which a patient can be classified as being at high risk of a future osteoporosis-related fracture. The VFA algorithm can be applied to any complete vertebral body captured in the CT scan, and the scan can be contrast-enhanced or not. Consistent with the recommended use of the well-established fracture-classification criteria, deformity types and fracture grades and fracture-risk classifications are only reported for vertebral levels T4 through L4. A report is generated containing these results, along with images of the sagittal sections from which the measurements were acquired. A physician then interprets the report to make any medical diagnoses or treatment decisions.
5) Intended Use
VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.
6) Substantial Equivalence
Summary of Technology Characteristics and Comparison with Predicate Devices
The VirtuOst VFA software application is used in bone densitometry to provide measurements of existing vertebral deformities, classifications of the type and grade of any existing fractures, and a fracture-risk classification for a future osteoporosis-related fracture; it is substantially equivalent to predicate devices K103475 and K023554. VirtuOst VFA and the predicate devices are all software applications for use in bone densitometry, are all regulated as Class II devices, and all have substantially similar intended uses: to provide measurements of vertebral deformities for a physician to use in the diagnosis of vertebral fracture and the management of osteoporosis. All three devices have the same intended patient population - those who may be at elevated risk for an osteoporosis-related fracture.
The general methodology for performing the vertebral fracture assessment is substantially the same for VirtuOst VFA and the two predicate devices can be applied to the T4 through L4 vertebral levels to measure existing vertebral deformities among any or all of those levels, and these deformities are then classified as different grades (normal, mild, moderate,
5
severe) and types of vertebral fracture (anterior wedge, biconcavity, crush), if not normal. All devices rely on the same well-established "Genant" classification scheme for typical osteoporosis-related vertebral fracture, as described in the literature. In particular, six-point morphometry is used to measure anterior, middle and posterior heights of a vertebral body; various deformity ratios are then calculated from these heights and used to estimate percent deformities; these percentages are then compared against pre-established thresholds to classify the fracture type and grade of any existing osteoporosis-related fracture. All three devices also allow the user to enter the results of a semiquantitative visual assessment of vertebral deformities. These results and select images of the bone are displayed in a medical report. A physician then interprets this information to make any medical diagnosis and treatment decision.
A side-by-side comparison of the technology characteristics of VirtuOst VFA and the predicate devices demonstrates the similarity of the devices (Table 1). These characteristics have been grouped into four main workflow steps as follows:
- Step 1 Accept an x-ray-based image of the spine as input.
- Step 2 Locate and label the vertebrae of interest.
- Step 3 Perform 6-point quantitative vertebral morphometry.
- Step 4 Generate a report.
| Table 1: Side-by-side comparison of the vertebral morphometry steps implemented by VirtuOst | |
|---|---|
| VFA and its predicates. |
| Feature | VirtuOst VFA | SpineAnalyzer | DVA |
|---|---|---|---|
| Step 1 - Accept an x-ray-based image of the spine as input. | |||
| Input Image | |||
| File Type | DICOM | DICOM or TIFF | Proprietary images |
| from Lunar scanners. | |||
| Imaging | |||
| Modality | CT | DXA and digital X-ray | DXA, SXA |
| Image format | Planar (sagittal section) | Planar (projection) | Planar (projection) |
| Step 2 - Locate and label the vertebrae of interest. | |||
| Target | |||
| Anatomy | Spine (Lateral) T4-L4 | Spine (Lateral) T4-L4 | Spine (Lateral & AP) |
| T4-L4 | |||
| Feature | VirtuOst VFA | SpineAnalyzer | DVA |
| Method for | |||
| locating | |||
| vertebra | Semi-automatic: An | ||
| active contour | |||
| segmentation routine | |||
| seeded by a user mouse | |||
| click on the vertebral | |||
| body creates a | |||
| segmentation mask of | |||
| the sagittal section. The | |||
| six points for vertebral | |||
| morphometry are | |||
| located automatically | |||
| on the edges of this | |||
| mask. Tools provided | |||
| for manual adjustment. | Semi-automatic: | ||
| 95-point segmentation | |||
| routine seeded by a | |||
| user mouse click on the | |||
| vertebral body locates | |||
| the extents of the bone. | |||
| The six points for | |||
| vertebral morphometry | |||
| are located | |||
| automatically using | |||
| this contour. Tools | |||
| provided for manual | |||
| adjustment. | Semi-automatic: | ||
| Proprietary | |||
| segmentation routine | |||
| initiated by user mouse | |||
| click in the vertebral | |||
| body. Image | |||
| processing tools | |||
| provided for manual | |||
| adjustment. | |||
| Automatic: Proprietary | |||
| routine assumes image | |||
| starts in sacrum. Image | |||
| processing tools | |||
| provided for manual | |||
| adjustment. | |||
| Label | |||
| Vertebral | |||
| Levels | Manual | Manual | Manual or Automatic |
| Step 3 - Perform 6-point quantitative vertebral morphometry. | |||
| Quantitative | |||
| Morphometry | |||
| Technique | Six-point morphometry | Six-point morphometry | Six-point morphometry |
| Vertebral | |||
| Heights | Anterior | ||
| Middle | |||
| Posterior | Anterior | ||
| Middle | |||
| Posterior | Anterior | ||
| Middle | |||
| Posterior | |||
| Deformity | |||
| Types | Wedge | ||
| Biconcavity | |||
| Crush | Wedge | ||
| Biconcavity | |||
| Crush | Wedge | ||
| Biconcavity | |||
| Crush | |||
| Deformity | |||
| Grades | Grade 0: Normal | ||
| Grade 1: Mild | |||
| Grade 2: Moderate | |||
| Grade 3: Severe | Grade 0: Normal | ||
| Grade 1: Mild | |||
| Grade 2: Moderate | |||
| Grade 3: Severe | Grade 0: Normal | ||
| Grade 1: Mild | |||
| Grade 2: Moderate | |||
| Grade 3: Severe | |||
| Percent | |||
| Deformation | Expressed as a | ||
| percentage equal to | |||
| 100*(1-ratio), e.g. a | |||
| ratio in heights of 0.75 | |||
| is reported as a 25% | |||
| deformation. | Expressed as a | ||
| percentage equal to | |||
| 100*(1-ratio), e.g. a | |||
| ratio in heights of 0.75 | |||
| is reported as a 25% | |||
| deformation. | Expressed as a | ||
| percentage equal to | |||
| 100*(ratio), e.g. a ratio | |||
| in heights of 0.75 is | |||
| reported as a 75% | |||
| deformation. | |||
| Feature | VirtuOst VFA | SpineAnalyzer | DVA |
| Fracture | |||
| Thresholds | Threshold for fracture | ||
| grade deformation | |||
| based on the percent | |||
| deformation: | |||
| Grade 0: |