Search Results

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

Additional Requested Information:

1. 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").

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Ask a specific question about this device

INFINITT RT PACS is a software medical device intended to be used for reviewing and assessment of DICOM based datasets which may occur in a radiotherapy environment. It is used by qualified specialist to load and display data generated by different DICOM devices including: RT-STRUCTURE, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR and PET. The software can connect to a HIS and provides the radiotherapy specialist with the necessary visualization and image manipulation tools to review, present or compare DICOM, RT related datasets including the geometrical super imposition of 3D plan data. INFINITT RT PACS, is intended for reviewing purposes only and is not capable to generate new or modified RT plan data. Users of INFINITT RT PACS, should be trained medical professionals including, radiologists, oncologists, physicians, medical technologists, and dosimetrists. Users should be familiar with the different sources of input data (such as images, structure sets, treatment plans, and calculated dose) as well as how to understand and interpret derived metrics (e.g., dose-volume histograms).

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA. INFINITT RT PACS, is not intended for diagnostic image review on mobile devices.

Infinitt RT PACS, is a radiation therapy image Management solution dedicated to the oncology department. By using Infinitt RT PACS, the treatment planning system of various vendors can be stored and managed. It also transfers DICOM RT type plan images and information to EMR through HL7or database links.

Infinitt RT PACS, provides the function to acquire and view DICOM data generated from RTP (Radiotherapy Planning) System in the form of DICOM C-Store. Supported data includes CT (Computerized Tomography) DICOM image, DICOM RT PLAN data, DRR (Digitally Reconstruct Radiography) image and DICOM RT-Structure, dose information of DICOM RT-Dose and DVH (Dose-Volume Histogram) data. In addition, it supports Axial, Coronal, Sagittal view to check the location of the corresponding Axial CT image and dose distribution to Coronal, Sagittal View through scout line.

Infinitt RT PACS, provides DICOM conformant services for both short and long-term image storage and retrieval of digital image data. The application uses DICOM as the interface to the external world and enables interoperability between different devices.

Infinitt RT PACS, accepts DICOM association requests for the purpose of storing images and for query and retrieval of images. It also initiates DICOM association requests for the purpose of sending images to an external application entity.

The provided text is a 510(k) summary for INFINITT RT PACS. It outlines the device's intended use, comparison to a predicate device, and a brief mention of non-clinical performance data. However, the document does not contain the detailed information required to answer many of your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document states:

• "The Validation Test Plan was designed to evaluate output functions, and actions performed by Infinitt RT PACS, 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."

This indicates that a study was performed and acceptance criteria were met, but the specifics of what those criteria were and how the study was conducted (e.g., sample size, expert involvement, ground truth method) are not provided in this public summary.

Therefore, I can only provide limited information based on the text.

Here's a breakdown of what can be inferred and what is not present in the provided document:

Summary of Device Performance and Acceptance Criteria (Based on available information):

The INFINITT RT PACS is a Picture Archiving Communications System (PACS) specifically designed for radiation therapy environments. Its primary function is to review and assess DICOM based datasets, including RT-STRUCTURE, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR, and PET. It provides visualization and image manipulation tools for review, presentation, or comparison of DICOM and RT-related datasets. The device is not capable of generating new or modified RT plan data.

The document broadly states that the device was assessed and tested, and "passed all predetermined testing criteria" and "demonstrated that the predetermined acceptance criteria were met." However, the specific numerical or qualitative acceptance criteria and the corresponding reported device performance metrics are not detailed in this summary. The performance data section focuses on compliance with standards rather than specific quantitative performance metrics.

Detailed Answers to Your Questions:

1. A table of acceptance criteria and the reported device performance:

   • Not provided in the document. The document states that "predetermined acceptance criteria were met" but does not list those criteria or specific performance results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not provided in the document. The document mentions "Validation Test Plan" and "nonclinical testing results" but gives no details on sample size, data origin, or whether the study was retrospective or prospective.

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 provided in the document. The document mentions "designated individuals performed all verification and validation activities" but does not specify their number, qualifications, or their role in establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not provided in the document.

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 applicable/Not provided. This device is a PACS for reviewing, not an AI-assisted diagnostic tool designed to improve human reader performance. The document does not indicate any AI components or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable/Not provided. The device is a viewing and management system, not a standalone diagnostic algorithm. The testing described is functional validation of the PACS system itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not provided in the document. The mention of "Validation Test Plan" implies a comparison against some form of expected output or "ground truth," but the nature of this ground truth is not elaborated. Given the device's function as a PACS, the "ground truth" would likely relate to accurate display, retrieval, and manipulation of DICOM data as per specifications, rather than clinical outcomes or pathology.

8. The sample size for the training set:

   • Not applicable/Not provided. This device is a PACS, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable/Not provided. This device is a PACS, not an AI model that requires a training set.

In conclusion, the provided FDA 510(k) summary for INFINITT RT PACS confirms that non-clinical testing was performed and "predetermined acceptance criteria were met," leading to a determination of substantial equivalence. However, the details of these criteria, the study design, sample sizes, expert involvement, and ground truth methodologies are not included in this public summary document. This document primarily focuses on the device's functionality, its comparison to a predicate device, and compliance with relevant standards and regulations.

Ask a specific question about this device

Infinitt PACS 7.0,"is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.

Only preprocessed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA.

Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.

Infinitt PACS 7.0™ device is PACS software capable of viewing and handling DICOM 3.x medical images. The System allows displaying of images and image studies that may not in the location as the modality. With its Web features, it is possible to review, modify, and approve studies located in a remote server.

INFINITT PACS is a software device that does not contact the patient, nor does it control any life sustaining devices. The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not the software. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.

Infinitt PACS 7.0 is a web-based, 3D-enabled DICOM view station running on Windows 7/8.1/10. Infinitt PACS 7.0 is an integral component of INFINITT's complete INFINITT PACS/RIS solution. Infinitt PACS 7.0 fully supports DICOM standards and such functions as advanced DICOM viewing, Hanging Protocol, various 3D display such as MPR, Volume Rendering, MIP and fusion. Infinitt PACS 7.0 allows users to take full advantage of the radiographic images from various modalities in order to obtain invaluable mission critical diagnostic data and images.

With Infinitt PACS 7.0, users can access their own diagnostic environment anywhere, anytime. This is made possible because Infinitt PACS 7.0 is deployed through a network and supports hanging protocol. Also, Infinitt PACS 7.0 uses JPEG 2000 features so that it takes less time to transfer images through a network.

Infinitt PACS 7.0 is based upon the INFINITT G3 PACS (predicate device). The features and functions of Infinitt PACS 7.0 have similar features and functions of G3 PACS with an updated operating system due to current advances in computer technology.

The provided text is a 510(k) Summary for Infinitt PACS 7.0. It describes the device, its intended use, and compares it to a predicate device (INFINITT G3 PACS). However, it does not contain information about a study that describes specific acceptance criteria and detailed device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies for an AI-powered device.

The document states:

• "The software does not provide any diagnostic assistance to the physician." (Page 4)
• "A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed." (Page 4)

This indicates that Infinitt PACS 7.0 is a Picture Archiving and Communication System (PACS) and an image processing system, not an AI/CAD (Computer-Aided Detection/Diagnosis) device. As such, the type of performance studies, acceptance criteria, and ground truth establishment typically associated with AI devices (as requested in the prompt) are not applicable or detailed in this 510(k) summary.

The "Testing" section broadly states that the device "passed all in-house pre-determined testing criteria without significant failures" and "performs as required according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy." This refers to functional and system testing, not diagnostic performance testing against specific clinical endpoints or ground truth, as would be expected for an AI/CAD device.

Therefore, I cannot extract the requested information (performance metrics, sample sizes, expert qualifications, MRMC studies, etc.) from the provided text because it describes a PACS system without an AI diagnostic assistance component.

Ask a specific question about this device