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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the VirtuOst Vertebral Fracture Assessment device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in percentages or thresholds in a dedicated section. However, it implicitly uses agreement and precision metrics compared to manual measurements and a predicate device as evidence of acceptable performance for market clearance.

Acceptance Criteria (Implied)	VirtuOst VFA Reported Performance
Accuracy for fracture determination (vs. manual)	kappa = 0.94 (95% CI = 0.82-1.06)
Accuracy for fracture grading (Grades 0-3 vs. manual)	kappa = 0.76 (95% CI = 0.60-0.91)
Mean difference in height-ratio (VirtuOst VFA vs. manual)	0.005 (small compared to range 0.17-1.13)
No significant difference in fracture determination (vs. manual)	p = 0.32
No significant difference in fracture grades (vs. manual)	p = 0.32
Intra-operator precision (SDRMS)	0.018 (similar to predicate K103475: 0.021-0.039)
Interoperator precision (SDRMS)	0.023 (similar to predicate K103475: 0.025-0.048)
Agreement in fracture determination (1.25mm vs 3mm slice)	kappa = 0.88 (95% CI = 0.72-1.04)
Agreement in fracture grading (1.25mm vs 3mm slice)	kappa = 0.66 (95% CI = 0.47-0.84)
Intra-operator precision (variable slice thickness)	SDRMS = 0.034 (within range of predicate K103475 at constant slice thickness)
Intra-operator precision (one enhanced image)	SDRMS = 0.020 (similar to unenhanced images)
Mean difference in height-ratio (unenhanced vs. enhanced)	0.007 (small compared to range in height-ratios)

Summary of Device Performance: The study concludes that VirtuOst VFA is highly accurate, and its precision is substantially equivalent to that of the predicate device. Precision errors are small and do not significantly affect fracture determination or grading, even with varying CT slice thicknesses (up to 3mm) and the use of IV contrast enhancement.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: n=40 women and men (35 with potential fractures, 5 without).
Data Provenance:
- Country of Origin: Not explicitly stated, but the study used "computed tomography scans acquired as part of standard care for 7000 women and men age 65 and older."
- Retrospective or Prospective: The selection of patients from an existing database of 7000 CT scans, where scans were within a 90-day period (implying existing sets of scans), indicates a retrospective study design for data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not explicitly stated. The text mentions "vertebral heights were also manually measured from high resolution (0.5 mm) printouts of midsagittal sections of the L1 vertebra from each CT scan." It does not specify who performed these manual measurements or their qualifications. It simply refers to these "manual measurements" as the reference standard.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly described. The manual measurements are presented as a reference standard, but the process by which multiple experts might have agreed upon these measurements (e.g., 2+1, 3+1) is not detailed. The study mentions two operators performing VFA, but this is for repeatability analysis of the device, not for establishing ground truth directly.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done?: No. The study conducted was primarily a precision and accuracy study, comparing the device's measurements against manual measurements and assessing intra- and inter-operator variability. It did not involve comparing human readers' diagnostic performance with AI assistance versus without AI assistance.
Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as no MRMC comparative effectiveness study was performed in this manner.

6. Standalone Performance Study

Was a standalone study done?: Yes. The study investigated the "Accuracy of VirtuOst VFA relative to the manual measurements" and its repeatability (intra-operator, interoperator, short-term, combined precision), as well as the impact of slice thickness and contrast enhancement on the device's performance. This directly assesses the algorithm's performance independent of real-time human interpretation loop changes in diagnostic workflow.

7. Type of Ground Truth Used

Ground Truth Type: "Manual measurements" of vertebral heights from high-resolution printouts of midsagittal sections using six-point morphometry methods. This constitutes an expert-derived or reference standard measurement based on established definitions of vertebral fracture. The specific "experts" who performed these manual measurements are not explicitly qualified in the text.

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document focuses on the validation study and does not provide details about the training data used to develop the VirtuOst VFA algorithm.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not specified in the provided text.

Summary

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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

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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)

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, LLC2150 Shattuck Ave. Suite 610Berkeley, CA 94704
Contact Person:	David KopperdahlDirector, Research and DevelopmentO. N. Diagnostics, LLC2150 Shattuck Avenue, Suite 610Berkeley, CA 94704Phone 510-204-0688Fax 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

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,

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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 ImageFile Type	DICOM	DICOM or TIFF	Proprietary imagesfrom Lunar scanners.
ImagingModality	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.
TargetAnatomy	Spine (Lateral) T4-L4	Spine (Lateral) T4-L4	Spine (Lateral & AP)T4-L4
Feature	VirtuOst VFA	SpineAnalyzer	DVA
Method forlocatingvertebra	Semi-automatic: Anactive contoursegmentation routineseeded by a user mouseclick on the vertebralbody creates asegmentation mask ofthe sagittal section. Thesix points for vertebralmorphometry arelocated automaticallyon the edges of thismask. Tools providedfor manual adjustment.	Semi-automatic:95-point segmentationroutine seeded by auser mouse click on thevertebral body locatesthe extents of the bone.The six points forvertebral morphometryare locatedautomatically usingthis contour. Toolsprovided for manualadjustment.	Semi-automatic:Proprietarysegmentation routineinitiated by user mouseclick in the vertebralbody. Imageprocessing toolsprovided for manualadjustment.Automatic: Proprietaryroutine assumes imagestarts in sacrum. Imageprocessing toolsprovided for manualadjustment.
LabelVertebralLevels	Manual	Manual	Manual or Automatic
Step 3 - Perform 6-point quantitative vertebral morphometry.
QuantitativeMorphometryTechnique	Six-point morphometry	Six-point morphometry	Six-point morphometry
VertebralHeights	AnteriorMiddlePosterior	AnteriorMiddlePosterior	AnteriorMiddlePosterior
DeformityTypes	WedgeBiconcavityCrush	WedgeBiconcavityCrush	WedgeBiconcavityCrush
DeformityGrades	Grade 0: NormalGrade 1: MildGrade 2: ModerateGrade 3: Severe	Grade 0: NormalGrade 1: MildGrade 2: ModerateGrade 3: Severe	Grade 0: NormalGrade 1: MildGrade 2: ModerateGrade 3: Severe
PercentDeformation	Expressed as apercentage equal to100*(1-ratio), e.g. aratio in heights of 0.75is reported as a 25%deformation.	Expressed as apercentage equal to100*(1-ratio), e.g. aratio in heights of 0.75is reported as a 25%deformation.	Expressed as apercentage equal to100*(ratio), e.g. a ratioin heights of 0.75 isreported as a 75%deformation.
Feature	VirtuOst VFA	SpineAnalyzer	DVA
FractureThresholds	Threshold for fracturegrade deformationbased on the percentdeformation:Grade 0: <20%Grade 1: ≥20 to <25%Grade 2: ≥25 to <40%Grade 3: ≥40%	Threshold for fracturegrade deformationbased on the percentdeformation:Grade 0: <20%Grade 1: ≥20 to <25%Grade 2: ≥25 to <40%Grade 3: ≥40%	Threshold on thepercent deformation asnumber of standarddeviations belownormal:Grade 0: <2 SDGrade 1: <3 SDGrade 2: <4 SDGrade 3: ≥4 SDPercentage-basedthresholds can also beinput by user.
Genant Semi-quantitativeAssessment	Performed manually byuser.	Performed manually byuser.	Performed manually byuser.
Step 4 - Generate a report.
MorphometryResults	Percent deformationDeformity typesDeformity grades	Percent deformationDeformity typesDeformity grades	Percent deformationDeformity typesDeformity grades
	If semiquantitativeanalysis performed,both quantitative andsemiquantitativemorphometry resultsare reported.	If semiquantitativeanalysis performed,both quantitative andsemiquantitativemorphometry resultsare reported.	If semiquantitativeanalysis performed,results replacequantitativemorphometry results.
Images	Lateral view of thesagittal section of thevertebral body.	Lateral projection ofthe vertebral body.	Lateral projection ofthe vertebral body.AP projection if APdeformities assessed.
ImageAnnotation	Vertebral level labelsand the sixmorphometry points.	Vertebral level labelsand the sixmorphometry points.	Vertebral outlines andlevel labels and the sixmorphometry points.
Feature	VirtuOst VFA	SpineAnalyzer	DVA
Interpretation	Space available on report for clinician's narrative.Automatic fracture determination included on report. The Instructions for Use indicate that this is morphometry-based and not intended to replace “clinical judgment.”	Space available on report for clinician's narrative.Automatic fracture determination included on report. The Instructions for Use indicate that this is morphometry-based and not intended to replace “clinical judgment.”	Space available on report for clinician's narrative.

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Summary of Clinical and Non-Clinical Performance Data

A clinical study of n=40 women and men was conducted to measure the repeatability and precision of VirtuOst VFA measurements. We used computed tomography scans acquired as part of standard care for 7000 women and men age 65 and older. From this resource, we found 716 patients who had two CT exams within a 90-day period, both with at least one reconstruction with a slice thickness of 1.25mm. A lateral projection of each CT image was then viewed in order to qualitatively identify candidate scans with spine fractures. 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, we also selected five more from patients not flagged as having a potential fracture, for a total cohort of n=40.

Two operators performed vertebral fracture assessment on each patient's baseline CT scan using VirtuOst VFA. We then replaced all scan IDs with new IDs and randomized the scan order. 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. From these data, 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 as described above. By these measurements, twenty-eight patients had a vertebral fracture at L1.

To address the influence of slice thickness on VirtuOst VFA results, we resampled the 40 baseline CT scans to a slice thickness value of 3 mm using trilinear interpolation. The VFA analysis was then repeated after a five-day wash-out period blinded to the data from the 1.25 mm analyses. The resampling method was tested on an independent set of 30 CT scans for which 1 mm and 3 mm primary reconstructions were made from a single acquisition. Vertebral height ratios were not

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significantly different when measured using the 3 mm primary reconstruction compared to using a 3 mm image resampled from the 1 mm reconstruction (p=0.27).

Accuracy of VirtuOst VFA relative to the manual measurements was quantified by the mean difference in vertebral height ratios and by Cohen's kappa for repeatability for a binary no-fracture (Grade 0) versus fracture (Grades 1-3) determination, and for fracture grading on a scale of 0-3. Repeatability of VirtuOst VFA was quantified by kappa for fracture determination and grading, and precision in the vertebral height-ratios on which fracture grades are based was characterized by the root mean square standard deviation in the differences of repeat measurement pairs (SDRMS). Agreement in fracture determination and grading, and differences in vertebral height ratios when using 1.25 mm versus 3 mm CT scan reconstructions were also quantified by these same statistics.

With respect to accuracy, VirtuOst VFA and the manual measurements agreed well for both fracture determination (kappa = 0.94, 95% CI = 0.82-1.06) and grading (kappa = 0.76, 95% CI = 0.60-0.91). There were no significant differences in fracture determination (p = 0.32) or fracture grades (p = 0.32), and the mean difference in the height-ratio between VirtuOst VFA and manual measurements was small compared to the range in height ratios (0.005 vs. 0.17-1.13).

Repeatability of VirtuOst VFA was very good for both fracture determination and fracture grading (Table 2). Intra-operator precision of VirtuOst VFA (SDRMS= 0.018) was similar to that of predicate device K103475 (SDRMS= 0.021-0.039). Interoperator precision of height-ratios using VirtuOst VFA (SDRMS=0.023) was also similar to that of the predicate (SDRMS = 0.025-0.048).

	Intra-operator	Interoperator	Short-term	Combined
Fracture Determination: no-fracture (Grade 0) vs. fracture (Grades 1–3)
kappa	0.94	0.94	0.88	0.82
95% CI	0.82-1.06	0.82–1.06	0.72-1.04	0.62–1.02
p-value	0.32	0.32	1.00	0.56
Fracture Grading (Grades 0-3)
kappa	0.69	0.72	0.69	0.76
95% CI	0.52-0.87	0.55-0.89	0.53-0.86	0.61–0.92
p-value	0.96	0.57	0.32	0.63

Table 2: Repeatability for fracture determination and fracture grades. Results are for intra-operator, interoperator, short-term and combined precision.

kappa = Cohen's kappa for repeatability; 95% CI = 95% confidence intervals; P-values from Bowker's test

Vertebral height-ratios were smaller on average when measured from 3 mm compared to 1.25 mm slice thickness CT scans (mean = 0.013, 95% CI = 0.003-0.024, p = 0.01), but again the difference was small compared to the range in height-ratios. 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 the scans of different slice thickness; and intra-operator precision when slice thickness varied between repeat measurements (SDRMS = 0.034) was still within the range reported by predicate device K103475 when slice thickness was constant.

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When one of the repeat analyses was performed on an image with IV contrast enhancement, the height-ratios were larger on average (mean = 0.007; 95% CI = 0.001-0.013, p=0.02). Again the difference was small compared to the range in height-ratios; and intra-operator precision when one repeat measurement was from an enhanced image (SDRMS = 0.020) was similar to precision when both measurements were from unenhanced images.

These data demonstrate that Virtuost VFA is highly accurate and indicate that the precision of VirtuOst VFA is substantially equivalent to that of the precision errors are small enough to have no significant effect on fracture determination or grading; and that these conclusion hold for CT scan reconstruction slice thicknesses up to 3 mm with or without IV contrast enhancement.

7) Conclusion

O.N. Diagnostics believes that VirtuOst is substantially equivalent to the predicate devices on the basis of intended use, technological characteristics and the performance data presented.

Regulation Number and Section

§ 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).