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VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

VixWin Platinum Software has the following functionality which compares with the functionality provided for VixWin PRO predicate cleared under K060178. The functionality has been updated to remove legacy hardware no longer supported by the VixWin Platinum Software.

• Controls scanning and intake of x-ray images from imaging plates with the Photo-Stimulable ● Phosphor (PSP) scanners.
• Controls the direct capture of x-ray images from intra-oral sensors and extra-oral systems. ●
• Allows View and capture color images from intra-oral and extra-oral cameras. ●
• . Export and import digital images (such as those obtained by scanning a film).
• . Process images with dental specific tools to enhance their diagnostic value.
• . Analyze and enhance images to gather additional diagnostic information which may not be immediately apparent on initial visual inspection.
• Obtaining and storing patient data pertaining to those images
• Both the viewing of the images and storage of the images and their associated data. ●
• Managing (locally and remotely) a database of patients and related data.
• Allows the update of existing patient information and the creation and storage of new patient information in a database over the network.
• . Allows access to patient files from multiple workstations via network connectivity.
• . Allows printing images and image related information over the network.

VixWin Platinum can be utilized either locally or over a networked environment. If VixWin Platinum is installed on several computers, the patient and image database can be shared among them and used from different workstations.

The provided text describes a 510(k) premarket notification for the device "VixWin Platinum." This document is a regulatory submission for a medical device that aims to demonstrate its substantial equivalence to a legally marketed predicate device, not typically a study proving performance against acceptance criteria for an AI/ML device in the sense of accuracy, specificity, or sensitivity. Therefore, much of the requested information (sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not present in this type of regulatory submission.

The document primarily focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than a quantitative performance study.

Here's an analysis based on the provided document:

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

There are no specific quantitative "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, AUC) or reported performance metrics against such criteria in this document. The "performance" described relates to the functionality of the software.

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

• Not applicable / Not provided. The document states that "All internal verification and validation has been completed," but does not detail a specific test set, its size, or data provenance for proving diagnostic performance equivalence. The comparison is primarily structural and functional.

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 provided. Ground truth establishment is not mentioned as part of this type of regulatory submission for a Picture Archiving and Communication System (PACS) software primarily focused on processing and displaying images.

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

• Not applicable / Not provided.

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 software, not an AI-assisted diagnostic tool.

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

• Not applicable / Not provided. This is a PACS software, not an autonomous algorithm for diagnosis.

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

• Not applicable / Not provided. The "performance data" refers to functional verification and validation that the software operates as intended and equivalently to its predicate, not against a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

• Not applicable / Not provided. This software is not an AI/ML model that would require a distinct training set in the conventional sense.

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

• Not applicable / Not provided.

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CLIOSOFT is a clinical software application that receives images and data from CLIO sensor and various imaging sources (e.g., radiographic devices, digital video capture devices, and generic image devices such as scanners). In addition, CLIOSOFT enables the storage of clinical notes and clinical exam data.

It is intended to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute images using standard PC hardware.

CLIO/CLIOSOFT is a system for general dental diagnostic imaging. CLIO is an intraoral x-ray sensor and CLIOSOFT is a software program. CLIO has size 1 and size 2 sensors. CLIO sensor connects to the PCcompatible computer via an USB port. CLIOSOFT controls capture, display, treatment, review, store, print, and distribute digital x-ray images from CLIO sensors. It can also handle other types of images acquired by digitizing film with a flatbed scanner, or color images from an intraoral dental camera such as the Claris i310 series. CLIO/CLIOSOFT runs on standard PC-compatible computers.

CLIO connects to the computer via USB port.

When properly installed in your computer, CLIOSOFT lets you:

• . Control the direct capture of digital x-ray images from the intraoral sensor CLIO.
• . View and capture live image from intraoral cameras via USB 2.0 or video capture card.
• . Import images from various sources such as radiographic devices, flatbed scanner, digital camera, and generic image devices.
• . Export, e-mail, and print images.
• . Process digital images with several tools to enhance their diagnostic value.
• . Create a database of patients and store images in patient folders.

The provided text describes CLIO/CLIOSOFT, a dental imaging system, and its substantial equivalence to predicate devices, but does not contain information about explicit acceptance criteria or a study designed to prove the device meets those criteria, as typically found in a clinical performance study for a novel device.

The submission is a 510(k) for a device that is seen as substantially equivalent to existing, legally marketed devices. The "study" referenced implicitly in the document is a comparison to predicate devices and adherence to relevant safety and performance standards.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance

There are no specific quantitative acceptance criteria or reported device performance metrics in the document that would typically be found in a clinical performance study (e.g., sensitivity, specificity, accuracy). The submission focuses on demonstrating substantial equivalence based on technical characteristics and adherence to safety and EMC standards.

Description of the "Study" (Implicitly, the Basis for Substantial Equivalence)

The "study" in this context is not a clinical trial with performance endpoints but rather a demonstration of technical equivalence and compliance with regulatory standards.

1. Sample size used for the test set and the data provenance:

   • Test Set: Not applicable in the context of a clinical performance study with "test sets" for diagnostic accuracy. The assessment relies on the inherent design, specifications, and compliance with standards.
   • Data Provenance: The 'data' underpinning the claims of safety and effectiveness comes from technical testing reports (IEC 60601-1, EN 60601-1-2) and the product specifications themselves compared against predicate devices. No information on geographical origin is given for these technical tests. They are not "retrospective" or "prospective" in the sense of a patient data study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. There is no "ground truth" establishment by medical experts mentioned for a diagnostic performance test set. The validation is based on engineering and regulatory compliance.

3. Adjudication method for the test set:

   • Not applicable. No diagnostic ground truth was established necessitating adjudication.

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 MRMC study was done. This device is a dental image management system and sensor, not an AI-powered diagnostic tool, and therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

   • Not applicable. This device is an imaging acquisition and management system, not a standalone diagnostic algorithm.

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

   • Not applicable for clinical performance. The "ground truth" for the claims made relates to adherence to specified engineering standards (e.g., electrical safety, EMC) and technical specifications (e.g., dynamic range, sensor size) being equivalent to an already cleared device.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

   • Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

Summary:

The K110886 submission for CLIO/CLIOSOFT is a 510(k) premarket notification that demonstrates substantial equivalence to predicate devices, primarily based on technical specifications, indications for use, and adherence to recognized safety and EMC standards. It does not involve a clinical performance study with patient data, diagnostic accuracies, or expert-established ground truths. The "study" mentioned within the document implicitly refers to the technical testing and comparisons outlined to support the substantial equivalence claim.

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