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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.

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.

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):

• 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.

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XVWeb 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 database. XVWeb 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.

XVWeb 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.

XVWeb is a web-based dental picture archiving and communications system that provides a dental facility the ability to access their patient radiological image library over the internet. It is designed for deployment in medium to large dental facilities with multiple viewing stations and/or across remote sites using standard TCP/IP network infrastructures. The system uses a web-based interface that allows users to display patient images and studies in commercially available web browsers such as Internet Explorer, Mozilla, Firefox, or Google Chrome.

XVWeb includes features for dental practices to: manipulate, enhance, add lahels, annotations to patient images/studies, and other relevant operations for diagnostic purposes. XVWeb includes image acquisition capabilities via integration with DICOM-compatible imaging systems that facilitate the production of original images. All images available for viewing in XVWeb have been received from DICOM compliant modalities or systems.

Here's an analysis of the acceptance criteria and study information for the XVWeb device, based on the provided text:

Preamble: It's important to note that the provided text is a 510(k) Premarket Notification summary for a Picture Archiving and Communications System (PACS) named XVWeb. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, rather than to prove safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described herein are primarily focused on demonstrating that XVWeb performs comparably to its predicates and meets general safety and performance standards for a medical device of its type, rather than an AI-specific performance study. The document does not describe an AI system, but rather a PACS.

Acceptance Criteria and Reported Device Performance

Given that XVWeb is a PACS and not an AI-driven diagnostic device, the "acceptance criteria" are related to its functional equivalence, technical characteristics, and safety compared to predicate PACS systems. The reported device performance is inherently its functionality mirroring or improving upon its predicates without raising new safety or effectiveness concerns.

Table 1: Acceptance Criteria and Reported Device Performance for XVWeb

• View various image types
• Manipulate images (rotate, flip, zoom)
• Enhance images (brightness, contrast, gamma)
• Add labels/annotations/measurements
• DICOM compatibility
• Secure data transmission (HTTPS) | XVWeb provides all core features present in the predicate devices and several expanded features, without altering intended use or raising new safety/effectiveness questions. |
  | Safety | No new types of safety questions raised compared to predicates. | Non-Clinical Testing performed, including Device Hazard Analysis. No new safety questions identified. |
  | Effectiveness | No new types of effectiveness questions raised compared to predicates. | Non-Clinical Testing performed, including Module Testing, System Verification and Validation Testing. Effectiveness is considered equivalent to predicates. |
  | Non-Clinical Testing | Pass stress testing in a simulated environment; successful module, system verification, and validation testing. | Performed and passed: Device Hazard Analysis, Module Testing, System Verification and Validation Testing. |

Study Details

The provided document describes a 510(k) Premarket Notification for a Picture Archiving and Communications System (PACS), not an AI-driven device. Therefore, the "study" is a demonstration of substantial equivalence to predicate devices through a comparison of intended use, technological characteristics, and performance, rather than a clinical study evaluating an AI algorithm's diagnostic performance.

1. Sample Size Used for the Test Set and Data Provenance:
* Test Set Sample Size: Not explicitly applicable in the context of an AI-driven device performance study. The "test set" here refers to the system itself being evaluated against a set of functional and performance requirements and compared to predicate devices. No specific "test set" of patient images or clinical cases with ground truth is mentioned for quantitative performance metrics.
* Data Provenance: Not applicable as there is no specific dataset of patient images being "tested" in the manner of an AI algorithm evaluation. The system handles "patient radiological image library over the internet," implying it would handle data from various dental imaging systems.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
* Not applicable. There is no mention of experts establishing a "ground truth" for a specific test set of images for diagnostic accuracy, as this is a PACS system and not a diagnostic AI algorithm. The ground truth for functional equivalence relies on regulatory standards and the established performance of the predicate PACS devices.

3. Adjudication Method for the Test Set:
* Not applicable as there is no test set of images requiring expert adjudication for ground truth.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
* No. The document explicitly states "Clinical trials have been performed side-by-side with current systems to ensure proper performance of the software" (Section IX). However, this is presented in the context of performance assurance for a PACS, not a comparative effectiveness study with human readers for diagnostic accuracy improved by an AI. There is no mention of human readers or an AI component to improve diagnosis.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
* Not applicable. XVWeb is a PACS, an infrastructure for viewing and managing images, not a standalone diagnostic algorithm.

6. The Type of Ground Truth Used:
* The "ground truth" for this 510(k) is the established functionality, safety, and effectiveness of the predicate PACS devices (Curve Image 2.0 and Centricity PACS Web Diagnostic). The claim is substantial equivalence to these devices, meaning XVWeb performs its intended functions similarly and safely. The "ground truth" is therefore regulatory precedent and comparative functional analysis, not specific pathology, expert consensus on images, or outcomes data.

7. The Sample Size for the Training Set:
* Not applicable. As a PACS, XVWeb is a software system for image management and viewing; it is not described as utilizing machine learning or AI that would require a "training set" of data.

8. How the Ground Truth for the Training Set Was Established:
* Not applicable, as there is no training set for a machine learning model described.

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