(57 days)
SOTA Cloud Imaging is indicated for use as a clinical software application that receives images and data from Clio or Clio Prime sensors and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, SOTA Cloud Imaging enables the storage of clinical notes and clinical exam data.
SOTA Cloud Imaging is intended to acquire, display, process, edit (e.g., resize, adjust contrast, annotate, etc.), review, store, print, and distribute images using standard PC hardware. SOTA Cloud Imaging is also intended for use for diagnostic and non-diagnostic purposes in the field of Dentistry by dental professionals who are responsible for providing dental care.
SOTA Cloud Imaging is a cloud-based dental imaging software that allows access to diagnostic images on any PC with an active internet connection. SOTA Cloud Imaging's single page application design makes the inbrowser imaging experience fast, familiar, and simple to operate. SOTA Cloud Imaging is feature rich, including full feature parity with traditional client-server based dental imaging software. With SOTA Cloud Imaging, you can use digital dental imaging devices in a manner consistent with your existing imaging solutions, and bridge patient information either from your existing client-server-based practice management software or modern cloud-based practice management software.
SOTA Cloud Imaging is a Class II dental imaging software that includes the ability to acquire, view, annotate, and organize dental radiographs and color images. SOTA Cloud Imaging integrates with most major client-server and web-based practice management software. Images stored using SOTA Cloud Imaging are saved using lossless compression, and can be exported as DICOM, PNG, JPEG, or PDF files.
SOTA Cloud Imaging is a software-only dental image device which allows the user to acquire images using standard dental imaging devices, such as intraoral X-ray sensors and intraoral cameras.
SOTA Cloud Imaging is imaging software designed for use in dentistry. The main SOTA Cloud Imaging software functionality includes image acquisition, organization, and annotation. SOTA Cloud Imaging is used by dental professional for the visualization of patient images retrieved from a dental imaging device or scanner, for assisting in case diagnosis, review, and treatment planning. Doctors, dental clinicians, and other qualified individuals can display and review images, apply annotations, and manipulate images.
SOTA Cloud Imaging is a standalone product but is designed to work cooperatively with dental practice management software that is used for scheduling, clinical note taking, and billing,
The software operates upon standard PC hardware and displays images on the PC's connected display/monitor.
SOTA Cloud Imaging neither contacts the patient nor controls any life sustaining devices. Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.
The provided text describes the 510(k) premarket notification for "SOTA Cloud Imaging," a dental imaging software. The document asserts the device's substantial equivalence to a predicate device, "XV Web." However, it does not contain details about acceptance criteria, a specific study design to prove device performance against those criteria, or quantitative results from such a study.
The document states:
- "SOTA Imaging has conducted extensive non-clinical (bench) performance testing and validation and verification testing of SOTA Cloud Imaging. All the different components of the SOTA Cloud Imaging have been stress tested to ensure that the SOTA Cloud Imaging provides all the capabilities necessary to operate in a manner substantially equivalent to the XV Web predicate." (Section I)
- "SOTA Imaging has performed performance testing to compare SOTA Cloud Imaging to the XV Web predicate. Based on the performance testing of the XV Web predicate and SOTA Cloud Imaging, SOTA Cloud Imaging is substantially equivalent in performance specification to the XV Web predicate. Test information can be located within the Software Documentation included with this submission." (Section J)
- "Additionally, the results of the performance testing, which included positive and negative testing against the device requirements, predicate testing and human factors testing, has demonstrated that SOTA Cloud Imaging is safe and effective for its intended use and that SOTA Cloud Imaging is substantially equivalent to the currently marketed XV Web predicate." (Section J)
These statements indicate that testing was performed, but they do not provide the specific details requested in your prompt. The document focuses on demonstrating substantial equivalence based on similar intended use and technical characteristics to a predicate device, rather than proving performance against quantitative acceptance criteria in a clinical study. This is typical for a 510(k) submission for this class of device, which often relies on bench testing and comparison to predicates rather than large-scale clinical trials.
Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document refers to "Test information" being in "Software Documentation included with this submission," which is not part of this extract.
Here's a summary based on what is available:
Absence of Detailed Performance Study Information
The provided 510(k) summary for "SOTA Cloud Imaging" asserts substantial equivalence to a predicate device, "XV Web," based on intended use, indications for use, and technological characteristics. While it mentions "extensive non-clinical (bench) performance testing and validation and verification," and "performance testing to compare SOTA Cloud Imaging to the XV Web predicate," it does not include specific acceptance criteria, quantitative performance metrics, or the details of any human reader study or standalone algorithm performance study. The focus is on functionality comparison rather than a formal clinical performance study with defined endpoints and ground truth.
1. Table of acceptance criteria and reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NOT PROVIDED | NOT PROVIDED |
| (The document states "extensive non-clinical (bench) performance testing and validation and verification testing" and "performance testing to compare SOTA Cloud Imaging to the XV Web predicate," but does not detail acceptance criteria or specific quantitative results.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be non-clinical/bench testing and "predicate testing" rather than a clinical study on patient data from a specific geography.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The document does not describe a clinical ground truth establishment process for a test set. This device is described as imaging software where "Diagnosis is not performed by this software but by doctors and other qualified individuals. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed." This implies human interpretation remains central.
4. Adjudication method for the test set
- Not applicable/Not specified.
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
- No MRMC comparative effectiveness study is described or implied. The software is a "Medical Image Management and Processing System" that displays and allows manipulation of images, not an AI-assisted diagnostic tool that would typically undergo such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a "software-only dental image device" intended to be used by "dental professionals" for "diagnostic and non-diagnostic purposes." Its function is to acquire, display, process, and manage images, not to provide standalone diagnostic output. Thus, a standalone performance evaluation in the context of diagnostic accuracy is not relevant to its stated function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not specified. The document does not describe a process for establishing ground truth for diagnostic accuracy, as the device itself does not perform diagnosis.
8. The sample size for the training set
- Not applicable/Not specified. The document does not describe an AI/ML model for which a training set would be required. The software appears to be rule-based or feature-based image processing and management, not an AI/ML diagnostic algorithm.
9. How the ground truth for the training set was established
- Not applicable/Not specified (as no AI/ML training set is mentioned).
§ 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).