(14 days)
Xelis DENTAL is a software device that is intended to provide tools for the reading and review of a DICOM compliant series of medical imagers which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data.
Xelis DENTAL is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction). These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data.
Xelis DENTAL is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Xelis Dental is a PC-based application used for storing and displaying medical images. The application conforms to the DICOM 3.0 standard to allow interoperability with other DICOM compliant systems. The implementation of Xelis Dental DICOM interface has been carefully tested to assure compliance with the DICOM Conformance Statement. However, the Conformance Statement and the DICOM standard do not guarantee interoperability of INFINITT's products and products of other vendors. The user must compare the relevant Conformance Statements and if a successful interconnection should be possible, the user is responsible to specify an appropriate test suite and to validate the required interoperability. A network environment may need additional functions out of the scope of DICOM.
Xelis Dental provides viewing of optimized images for 3D dental CT images. It comprises the following features.
- 3D VR, MPR, MIP, minIP .
- MPR rotating, curve, 3D zoom .
- Nerve (canal) drawing .
- Dental implant simulation and bone-density analysis .
The subject device and the predicate devices are supplied to end users in both Windows 32 bit and 64 bit operations systems. XELIS DENTAL software can connect to other workstations, PACS server/software, and modalities, through the DICOM communication standard.
The provided text describes a 510(k) premarket notification for a medical device called XELIS DENTAL. However, it does not include information about acceptance criteria or specific studies to prove device performance against such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics, general function, application, and intended use. It mentions nonclinical testing and validation but does not provide details on specific acceptance criteria or performance metrics.
Therefore, for most of your requested points, the information is not available in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document states that "predetermined acceptance criteria were met" during validation testing, but it does not specify what those criteria were or provide a table of performance results against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available: The document mentions "nonclinical testing" and "validation testing" but does not describe any specific test set, its sample size, or data provenance.
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)
- Not Applicable / Not Available: Since no specific test set or clinical study is described, there's no information on experts establishing ground truth for a test set. The device is a viewing and analysis tool, and diagnosis is performed by medical professionals, not the software.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Available: No test set or clinical study with adjudication is described.
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
- Not Available: The document states, "Note: The subject device does not include any automated or semi-automated process for the detection of nodules or other shapes." This indicates that it's a visualization and analysis tool rather than an AI-driven diagnostic aid that would typically undergo MRMC studies to evaluate reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Available: Given the device's function as a viewing and analysis tool for medical professionals, and the explicit statement that it does not perform diagnosis or automated detection, a standalone performance study in the context of an "algorithm only" is not relevant or described. The device is intended to be used by humans.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Available: As no specific performance study against a ground truth is reported, this information is not present. The device processes existing DICOM images; it does not generate diagnostic outputs requiring a ground truth for validation in the typical sense of a CAD system.
8. The sample size for the training set
- Not Applicable / Not Available: The device is described as a software application for storing, displaying, and analyzing medical images. It does not appear to be an AI/machine learning model that would require a "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not Available: As there's no indication of a training set, this information is not relevant or provided.
In summary: The provided document is a 510(k) summary focused on substantial equivalence demonstration for a medical image viewing and analysis software. It attests to internal nonclinical testing and validation meeting acceptance criteria, but it does not detail those criteria or the specific performance studies that would address most of your questions, which are typically relevant for AI/CAD devices or devices with specific diagnostic claims.
§ 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).