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510(k) Data Aggregation
(131 days)
Xelis Dental 2.0
Xelis Dental 2.0, is a standard PC based software application used for the display and 3D visualization of DICOM medical image files from CT or CBCT. Xelis Dental 2.0, is intended to be used by authorized healthcare professionals such as radiologists, clinicians, refering physicians and other qualified individuals to retrieve, process, review, store, print, distribute images to assist in diagnosis. Xelis Dental 2.0, also provides 3D visualization, 2D analysis and various MPR (Multi-Planar Reconstruction) functions and can be used as a preoperative software application used for the planning and verification of dental implants. There is no population and age restrictions for patients using this software. Xelis Dental 2.0, is not intended for use with or for the primary diagnostic interpretation of Mammography images.
Xelis Dental 2.0, is a software device used for viewing and manipulating DICOMcompliant images from CBCT (Cone beam computed tomography). Xelis Dental 2.0 is an advanced, easy-to-use dental software providing various tools to dental facilities. Xelis Dental 2.0. provides a practical tool for 3D (three dimensional) and 2D (two dimensional) viewing to optimize dental treatment planning and placement. This stand-alone, Windows-compatible software provides 3D volume rendering (VR), multi-planar reconstruction (MPR) and image segmentation. Xelis Dental 2.0, offers dental implant planning, canal draw, bone density assessment, segmentation and report functionalities. The subject device (Xelis Dental 2.0) is based upon the predicate device, Xelis Dental, (K102684). Xelis Dental 2.0 has updated the software from the predicate to reflect current computer technology and also has a number of new/improved functions. Both the subject device and the predicate are from INFINITT Healthcare Co. Ltd.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Xelis Dental 2.0 device, structured to answer your specific questions.
Based on the provided document, Xelis Dental 2.0 is a Picture Archiving and Communications System (PACS) software, which is traditionally not subject to the same kind of performance studies as AI/CADe medical devices that provide diagnostic interpretations or measurements. The document indicates that this is software for display, 3D visualization, 2D analysis, MPR functions, and pre-operative planning for dental implants. Its premarket notification (K193369) focuses on demonstrating substantial equivalence to a predicate device (Xelis Dental, K102684) rather than proving performance against specific clinical acceptance criteria in a comparative effectiveness study.
The document emphasizes that "The new device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices."
Therefore, many of your requested items will be "Not Applicable" or refer to general software validation rather than clinical performance for diagnostic accuracy.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied from the document) | Reported Device Performance and Evidence |
|---|---|---|
| Functional Equivalence | Device functions similarly to the predicate device (Xelis Dental, K102684) in general function, application, and intended use. | Reported: "The subject device and primary predicate are both PACS, which are indicated for dental medical image management, review, and data distribution. Both systems have been developed to replace traditional film handling in radiology. The subject device and the predicate device are substantially equivalent in the areas of general function, application, and intended use." |
| Demonstrated through a detailed comparison table. | ||
| Safety and Efficacy | Any new/improved functions or technological advancements do not introduce new or increased safety risks and maintain equivalent efficacy. | Reported: "Any differences between the predicate and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices." |
| Specific differences (e.g., Computer platform & OS, Image Layout, Common toolbar edits, Implant report, Annotation List, DICOM Report Send, Arch List, Bone density color map, Canal Thickness, Auto Project Save) are addressed individually, stating no impact on safety or efficacy. | ||
| Software Validation | All input functions, output functions, and actions performed by Xelis Dental 2.0 meet predetermined acceptance criteria from a Validation Test Plan. | Reported: "The Xelis Dental 2.0. PACS has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by Xelis Dental 2.0, and followed the process documented in the Validation Test Plan. ... Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met." |
| Regulatory Compliance | Adherence to relevant standards and regulations (e.g., DICOM, risk management, cybersecurity, software lifecycle processes). | Reported: "The following Standards were used to develop Xelis Dental 2.0, and the device has met all the requirements listed in the Standards except for inapplicable requirements: ISO14971, NEMA PS 3.1 - 3.20 (DICOM), IEC 62304, FDA Guidance on Cyber Security, FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
Additional Requested Information:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate clinical test set for diagnostic performance. The validation testing likely involved a set of DICOM images and system functionalities, but specific numbers for "cases" are not provided. The focus is on software functionality and equivalence, not diagnostic accuracy of an AI algorithm on a patient dataset.
- Data Provenance: Not specified in terms of country of origin or retrospective/prospective. The testing appears to be internal software validation ("assessed and tested at the factory").
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The approval is for a PACS and visualization software, not a diagnostic AI/CADe device that requires expert-established ground truth for performance evaluation in a clinical context. The "ground truth" for software validation would be adherence to functional specifications and absence of bugs, not a medical diagnosis.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is not a clinical study assessing diagnostic performance, an adjudication method for ground truth is not relevant.
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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. An MRMC study was not done. Xelis Dental 2.0 is described as a visualization and planning tool, not an AI or CADe device intended to assist human readers in making a primary diagnosis or as a detection aid where reader improvement would be measured.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. Xelis Dental 2.0 is a software application for human users to review and manipulate images; it is not an "algorithm" with a standalone diagnostic performance claim.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable in the clinical diagnostic sense. The "ground truth" for this device's validation relates to whether the software functions as designed, displays images correctly, and performs its visualization and planning tasks accurately, as per its specifications and intended use. This is validated through internal software testing against requirements.
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The sample size for the training set:
- Not Applicable. Xelis Dental 2.0 is not described as an AI/machine learning device that requires a training set. It is a traditional medical imaging software.
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How the ground truth for the training set was established:
- Not Applicable. As it’s not an AI/ML device, there's no training set or ground truth in that context.
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(14 days)
XELIS DENTAL
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.
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