(39 days)
Dentrix Ascend Imaging is a web-based Dental Picture Archiving and Communications Systems (PACS), i.e. dental imaging software, that enables dental care facilities to acquire, process, edit, and enhance dental images.
Dentrix Ascend Imaging provides a web-based interface for image acquisition and management of images which are used in the field of Dentistry and when operated by dental professionals who are responsible for providing dental care.
Images can be acquired from dental image acquisition devices and/or consumer imaging devices such as color digital cameras. Previously acquired images or volumes can be selected for upload directly from the user's computer.
Supported images include intraoral dental x-rays/volumes and intraoral and extraoral color images produced by intraoral video or consumer digital cameras.
Dentrix Ascend Imaging is used for diagnostic purposes in the field of dentistry. Dentrix Ascend Imaging is not intended for diagnostic use on a mobile display.
Images can be edited/enhanced (e.g. zoomed, contrast adjusted, rotated, rotated, filtered, etc...) as well as exported to standard image file formats.
Dentrix Ascend Imaging is web-based dental image software that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images canbe annotated and tagged and are available for use. Dentrix Ascend Imaging can be accessed by the user via an internet connection and does not require traditional s oftware installation on the user's computer.
Dentrix Ascend Imaging operates from within the Google brand ChromeWeb Browser version 39.x and higher on supported Windows and Mac Operating Systems and from within the Apple brand Safari Web Browser 8.x on Apple IOS iPad devices. Dentrix Ascend Imaging requires a minimum 17" monitor for viewing images upon a Windows or MAC PC, and operates upon an iPad device with minimum 1024 X768 resolution. The iPad device can be used for non-diagnostic purposes only.
The provided document is a 510(k) premarket notification for a medical device called Dentrix Ascend Imaging, a web-based Picture Archiving and Communications System (PACS) for dental imaging. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data to prove novel safety and effectiveness.
Therefore, the document does not contain the detailed information typically found in a study demonstrating acceptance criteria for a new device's performance, especially not in a clinical context.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly define "acceptance criteria" in a quantitative, measurable sense for the device's diagnostic performance (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, it establishes substantial equivalence by comparing its features and functions to the predicate device.
The table below summarizes the comparison between the proposed device (Dentrix Ascend Imaging) and the predicate device (Curve Image) as presented in the document, which serves as the basis for demonstrating equivalence and, implicitly, meeting "acceptance" in the context of a 510(k).
Table: Comparison of Dentrix Ascend Imaging to Predicate Device
| Feature/Characteristic | Predicate Device: Curve Image (K112974) | Proposed Device: Dentrix Ascend Imaging (K151438) | Equivalence Assessment / Reported Performance |
|---|---|---|---|
| Intended Use | Internet-based, image management software (PACS) for dental offices to keep hard and soft tissue charts in digital images. | Web-based Dental PACS, i.e., dental imaging software, that enables dental care facilities to acquire, process, edit, and enhance dental images. | "Virtually identical" |
| Indications for Use | For diagnostic use, acquisition, editing, and storage of digital images. | For diagnostic purposes in the field of dentistry; acquisition, processing, editing, and enhancement of dental images. | "Virtually identical" |
| Environment of Use | Dental Offices | Dental Offices | Identical |
| Host Platform | Web-based Software Application | Web-based Software Application | Identical |
| Technical Characteristics | - Web-based application and interface |
- Secure data transmission (HTTPS)
- Database Management and Storage
- Secure server and Infrastructure | - Web-based application and interface
- Secure data transmission (HTTPS)
- Database Management and Storage
- Secure server and Infrastructure | Identical |
| Key Functionality (Examples) | - Browsing images by date/source - Viewing an image
- Uploading image file
- Acquiring image from web camera/TWAIN/standard dental devices
- Copying/Saving/Annotating modified images
- Zooming, Inverting colors, Rotating, Flipping, Adjusting Brightness/Contrast
- Lossless Image Compression
- Zoom depth: absolute 1x, Fit, Relative
- Crop Image | - Browsing images by date/source
- Viewing an image
- Uploading image file
- Acquiring image from web camera/TWAIN/standard dental devices
- Exporting/Saving/Annotating modified images
- Zooming, Inverting, Rotating, Flipping, Adjusting Brightness/Contrast
- Lossless Image Compression
- Zoom depth: absolute 1x, Fit, Relative
- Spotlight Image
- Density Measurement | "Substantially all of the features and functionality." Dentrix Ascend Imaging has additional features like "Spotlight Image" and "Density Measurement" and some minor differences (e.g., "Exporting an Image" vs "Copying an Image"). |
| Non-Clinical Performance Testing | Not detailed for predicate, but assumed similar. | "Series of non-clinical performance tests were performed." These tests "demonstrated that Dentrix Ascend Imaging is safe and effective for its intended use and its indications of use." | Passed internal validation and verification testing for reliable post-processing and display of images. |
| Clinical Performance Testing | Not applicable / Not mentioned. | None performed or required. | Not required for substantial equivalence in this context. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Absent. The document refers to "non-clinical performance testing" and "validation and verification testing" but does not detail the sample sizes, type of data (e.g., number of images, patient cases), or data provenance used for these internal tests. These tests are presumably internal development and verification tests rather than external clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Absent. Since no clinical performance testing or diagnostic accuracy study is presented, the concept of "ground truth" established by experts for a test set is not applicable in this 510(k) submission. The non-clinical tests would have validated software functions against engineering specifications, not clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Absent. As no clinical study involving expert interpretation is detailed, adjudication methods are not discussed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Absent. No MRMC or comparative effectiveness study involving human readers or AI assistance (as a diagnostic aid) was performed or mentioned. Dentrix Ascend Imaging is described as a PACS system, primarily for image acquisition, management, and post-processing, not an AI-powered diagnostic tool that assists human readers in lesion detection or diagnosis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Absent. This device is a PACS for managing and displaying images under human professional operation, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Absent. As detailed in points 2 and 3, no clinical ground truth (expert consensus, pathology, outcomes) was established or used for performance testing. The "ground truth" for the non-clinical tests would have been the functional specifications of the software.
8. The sample size for the training set
- Absent. This device is a PACS, not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
- Absent. This is not an AI/ML device and therefore does not have a training set or associated ground truth.
Conclusion on "Study":
The "study" referenced in the document is a "Summary of Non-Clinical Performance Testing," which involved "positive and negative testing against the device requirements and human factors" and "validation and verification testing." This is typical for demonstrating substantial equivalence for a PACS system, focusing on functional performance, cybersecurity, and adherence to recognized standards (ISO 14971:2007 for Risk Management, IEC 62304:2012 for Software Life Cycle Processes). It explicitly states that "No clinical performance testing has been included in this submission" and that such testing was "neither required nor performed" based on the hazard analysis and device classification. Therefore, the document does not contain the kind of detailed clinical study information often associated with proving acceptance criteria for diagnostic accuracy or safety in many other types of medical devices.
§ 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).