XVWeb 3D is a Picture Archiving and Communications System (PACS) that enables dental facilities to query and access digitally stored hard and soft tissue intraoral radiological images using an internet/web browser.

A web-based interface provides users the needed functionality to display patient images and studies in commercially available web browsers. Patient images/studies can be accessed by users locally within the system or across a wide-area network at distributed locations.

Acquisition can be included via integration with a DICOM-compatible Imaging and/or PACS system configured to forward images to the XVWeb 3D database. XVWeb 3D is compatible with programs that run on standard "offthe-shelf" personal computers, business computers, and servers running standard operating systems.

The system allows users to: manipulate (e.g. rotate, flip, etc.); enhance (e.g. increase brightness/contrast, gamma correction); add labels (e.g. measurements, lines, arrows, etc.), annotations to patient images/studies and other relevant operations for diagnostic purposes.

XVWeb 3D is designed for medium to large dental practices and is intended for trained dental professionals and technicians to access, manipulate, and enhance dental images for diagnostic purposes only.

Device Description

XVWeb 3D is an add-on software module for XVWeb (K132342) that enables dental practices to query and access digitally stored, 3D hard- and soft-tissue cone beam CT images using an internet/web browser. XVWeb 3D uses the web-based interface provided by XVWeb to display patient 3D images and studies.

XVWeb 3D allows users to manipulate 3D images an infinite number of ways, allowing the dental anatomy to be viewed from every possible perspective, providing the information needed to plan efficient treatments. XVWeb 3D also allows users to enhance images (e.q., increase or decrease brightness/contrast, gamma correction), and add measurement labels to 3D patient images/studies for diagnostic purposes, and view the image's DICOM information entities.

XVWeb 3D is designed for medium to large dental practices and is intended for trained dental professionals and technicians to access, manipulate, and enhance dental cone beam CT images of the teeth, jaw, and lower skull area for diagnostic purposes only. The patient population are those who have had a dental cone beam CT examination.

XVWeb 3D does not function by itself (i.e., it is not standalone software that can be launched and ran), it is integrated with XVWeb to query/access/view/ patient 3D images. XVWeb 3D is not required for XVWeb, it is an extra-cost option available to those who wish to add 3D-imaging capability to their existing XVWeb workflow. XVWeb 3D does not perform any radiographic image acquisition.

AI/ML Overview

The provided document describes the XVWeb 3D software, which is an add-on module for the XVWeb Picture Archiving and Communications System (PACS) for dental applications. It allows dental facilities to query, access, manipulate, and enhance digitally stored 3D hard and soft tissue cone beam CT images for diagnostic purposes.

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a table format. The submission focuses on demonstrating substantial equivalence to a predicate device (XVWeb, K132342) based on functional similarities and extended capabilities for 3D images.

The primary "performance" discussed relates to its functionality in viewing, manipulating, and enhancing 3D dental cone beam CT images, mirroring the capabilities of the predicate device for 2D images.

Implied Acceptance Criteria (based on device description and comparison):

Acceptance Criteria Category	Description	Reported/Implied Performance
Functional Equivalence	The device must perform the same core functions for 3D images as the predicate device (XVWeb) does for 2D images. This includes: - Querying and viewing patient images - Manipulating images (e.g., rotate, flip, view from different perspectives, zoom in/out) - Enhancing images (e.g., increase/decrease brightness/contrast, gamma correction) - Adding measurement labels - Viewing DICOM information entities - Exporting a copy of images	XVWeb 3D is described as extending the cloud capability of XVWeb to include cone beam CT datasets, applying these same characteristics to 3D images. It states, "XVWeb 3D allows users to manipulate 3D images an infinite number of ways... allowing the dental anatomy to be viewed from every possible perspective," and "allows users to enhance images (e.q., increase or decrease brightness/contrast, gamma correction), and add measurement labels to 3D patient images/studies for diagnostic purposes."
Image Processing	The device must correctly process DICOM files with rescale type HU from cone beam CT systems, converting raw images/CT frames into a web-viewable format for display. This involves: - Computing spacing between CT frames - Computing min/max pixel values - Downscaling/merging frames for web optimization - Normalizing each CT frame - Storing as JPEG files - Rendering orthogonal MPR slices (axial, sagittal, coronal), 3D volume view, and curved MPR slices (including cross-sectional slices).	The "How it works" section details a multi-step preprocessing procedure for DICOM files, including computation of frame spacing, min/max pixel values, optimization for web browser bandwidth, normalization, and storage as JPEG files. It also explicitly states that XVWeb 3D "renders the orthogonal MPR slices (the axial, sagittal, and coronal plane views) and the 3D volume view" and "renders the curved MPR slice (including cross-sectional slices)". The successful rendering of these views implies that the processing criteria are met.
Interoperability	Integration with DICOM-compatible imaging and/or PACS systems. Compatibility with standard "off-the-shelf" personal computers, business computers, and servers running standard operating systems.	"Acquisition can be included via integration with a DICOM-compatible Imaging and/or PACS system configured to forward images to the XVWeb 3D database." "XVWeb 3D is compatible with programs that run on standard 'off-the-shelf' personal computers, business computers, and servers running standard operating systems." The device explicitly uses the DICOM file format standard.
Safety and Reliability	The software should not introduce new or increased risks compared to the predicate device. The "Level of Concern" for the software is considered Moderate.	"Apteryx believes the XVWeb 3D Level of Concern to be Moderate, since a latent design flaw could result in an erroneous diagnosis that would likely lead to minor injury." This suggests that the verification and validation (V&V) testing aimed to ensure the software's safety and reliability commensurate with this level of concern. The successful 510(k) clearance implies the FDA agreed with this assessment and that the V&V was adequate.
Intended Use Adherence	The device must only be used by trained dental professionals and technicians for diagnostic purposes, specifically for enhancing and manipulating dental cone beam CT images for diagnosis.	The Indications for Use and Device Description clearly state this, e.g., "XVWeb 3D is designed for medium to large dental practices and is intended for trained dental professionals and technicians to access, manipulate, and enhance dental images for diagnostic purposes only." The study (software V&V) implicitly validates that device functionality supports this use without unintended consequences.

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

The document states, "No clinical testing was performed." Therefore, there is no mention of a specific test set of patient data, its size, or provenance. The evaluation was done through software verification and validation testing, not clinical studies with patient data.

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

Since no clinical testing or studies with patient data were performed, there was no "test set" in the sense of a dataset requiring expert ground truth establishment for diagnostic accuracy evaluation. The evaluation focused on software functionality rather than diagnostic performance against a ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring ground truth establishment or adjudication was used.

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

No MRMC study was conducted. The document explicitly states, "No clinical testing was performed." Therefore, there is no discussion of human readers improving with or without AI assistance. This device is a PACS system designed to display and manipulate images, not diagnose automatically or provide AI-assisted interpretations.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study was conducted in the sense of an algorithm making a diagnosis. The device itself is a software tool for human professionals to use for diagnostic purposes. Its "standalone" function is to correctly process, store, and display images, which was addressed through software verification and validation. It does not perform automated diagnostic algorithms.

7. Type of Ground Truth Used

No ground truth from expert consensus, pathology, or outcomes data was used for evaluating diagnostic performance, as no clinical testing was performed. The "ground truth" for the software's functionality would have been adherence to technical specifications, DICOM standards, and the correct rendering/manipulation of images as intended by the software design.

8. Sample Size for the Training Set

Not applicable. The document describes a PACS software system that displays and manipulates images, not an AI/ML model that would require a training set.

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

Not applicable, as there was no training set for an AI/ML model.

Summary

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November 30, 2018

Apteryx, Inc. Mark Gniewek Regulatory Manager 313 S. High St., Suite 200 AKRON, OH 44308

Re: K182815

Trade/Device Name: XVWeb 3D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 26, 2018 Received: October 3, 2018

Dear Mark Gniewek:

We have reviewed your 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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.'Hara For

Robert A. 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) K182815

Device Name XVWeb 3D

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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7. 510(K) SUMMARY

1. Submitter Information

Contact: Mark Gniewek, Requlatory Manager Apteryx, Inc. 313 S. High St., Suite 200 Akron, OH 44308 (330) 376-0889

Date Prepared: May 31, 2018

2. Device Name and Classification

Trade/proprietary name: XVWeb 3D Common/usual name: Classification name: Regulatory Class: .

3D imaging, analysis, and diagnostic software PACS (21 CFR 892.2050, Product Code LLZ)

3. Manufacturer Address and Registration Number

Apteryx, Inc. 313 S. High St., Suite 200 Akron, OH 44308

FDA Reqistration Number: 3007350723

4. Predicate Device Information

The predicate device is XVWeb, K132342, date of concurrence: December 20, 2013.

5. Labeling and Intended Use

Labeling

No changes to the XVWeb labeling have occurred. For those who wish to add XVWeb 3D to their existing XVWeb workflow, Apteryx simply enables the 3D imaging module on the customer's existing XVWeb site when the purchasing process is complete.

The instructions for use can be found in the product's online documentation.

Intended Use

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6. Device Description

What it is

How it works

XVWeb 3D uses the DICOM file format standard to process the raw images/CT frames that have rescale type HU (Hounsfield unit) from the cone beam CT system. These files are sent from wherever the cone beam CT examination is taking place (i.e., the doctor's office, or "client") to the XVWeb DICOM server via web service. The DICOM files contain the raw images/CT frames in the form of parallel, horizontal slices of the head, starting from the bottom and proceeding to the top (i.e., the axial plane view).

When all of the CT frames for a given patient/series are received by the XVWeb DICOM server, a separate server, referred to as the 3D server, preprocesses the axial plane CT frames. This preprocessing consists of several steps:

The spacing between each CT frame is computed ●
The minimum and maximum pixel value in all CT frames is computed ●
If necessary, frames are downscaled and/or merged to optimize them for web browser . bandwidth and throughput
Each CT frame is normalized using the minimum and maximum pixel values computed earlier
. Each CT frame is stored as a JPEG file on the customer's existing XVWeb site

When the preprocessing is complete, a user can then access the stored CT data using the XVWeb user interface in a web browser. One way the CT data will appear in the browser is as a series thumbnail image in the series bar on the left side of the XVWeb user interface. When the user clicks the CT thumbnail image, the browser begins to request the JPEG files created during the preprocessing steps. When all of the JPEG files are loaded into the browser, XVWeb 3D renders the orthogonal MPR slices (the axial, sagittal, and coronal plane views) and the 3D volume view and displays them in the XVWeb user interface. The user can then manipulate the 3D volume and slices using the controls within the XVWeb interface. XVWeb 3D also renders the

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curved MPR slice (including cross-sectional slices) and makes it available for manipulation when the Curved MPR View button is clicked and a curve is drawn in the XVWeb interface. Crosssectional slices related to the user-drawn curve are also rendered, but not until after the curve is drawn.

7. Indications for Use

Acquisition can be included via integration with a DICOM-compatible Imaging and/or PACS system configured to forward images to the XVWeb 3D database. XVWeb 3D is compatible with programs that run on standard "off-the-shelf" personal computers, business computers, and servers running standard operating systems.

The system allows users to: manipulate (e.g. rotate, flip, etc.); enhance (e.g. increase or decrease brightness/contrast, gamma correction); add labels (e.g. measurements, lines, arrows, etc.), annotations to patient images/studies and other relevant operations for diagnostic purposes.

8. Comparison

The only modification that was made to the originally-cleared device is the 3D data recognition. processing, and image manipulation capabilities within the XVWeb interface. These capabilities are contained in the add-on software module.

The XVWeb 3D module extends the cloud capability of XVWeb to include cone beam CT datasets, allowing 3D images of dental structures, soft tissues, nerve paths and bone in the human craniofacial region to be included in the XVWeb query/access/view/diagnose workflow.

Engineering drawings, schematics, etc. are not applicable to the device (figures are not pertinent to describe the differences between subject and predicate devices).

Substantial Equivalence

XVWeb 3D has the following similarities to the previously-cleared XVWeb:

. Same indicated use
Ability to query and view patient images ●
Ability to manipulate images (e.g., view from different perspectives, zoom in/out)
Ability to enhance images (e.g., increase/decrease brightness, contrast, and gamma correction)
. Ability to add measurement labels
Ability to view DICOM information entities (e.g., patient, study, series, image)
Ability to export a copy of images

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While XVWeb applied the above device characteristics to 2D images, XVWeb 3D allows these same characteristics to be applied to 3D images.

Software Verification and Validation Testing

XVWeb 3D verification and validation testing were conducted and documentation was provided, including pass/fail criteria, as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Apteryx believes the XVWeb 3D Level of Concern to be Moderate, since a latent design flaw could result in an erroneous diagnosis that would likely lead to minor injury.

Clinical Studies

No clinical testing was performed.

9. Conclusions

In summary, the XVWeb 3D module described in this submission is, in the opinion of Apteryx, substantially equivalent to the predicate device, XVWeb.

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).