Search Results

DBSWIN and VistaEasy imaging software are intended for use by qualified dental professionals for windows based diagnostics. The software is a diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience, DBSWIN and VistaEasy are clinical software applications that receive images and data from various imaging sources (i.e., radiography devices and digital video capture devices) that are manufactured and distributed by Duerr Dental and Air Techniques. It is intended to acquire, display, edit (i.e., resize, adjust contrast, etc.) and distribute images using standard PC hardware. In addition, DBSWIN enables the acquisition of still images from 3rd party TWAIN compliant imaging devices (e.g., generic image devices such as scanners) and the storage and printing of clinical exam data, while VistaEasy distributes the acquired images to 3rd party TWAIN compliant PACS systems for storage and printing.

DBSWIN and VistaEasy software are not intended for mammography use.

DBSWIN and VistaEasy imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. DBSWIN and VistaEasy software runs on user provided PC-compatible computers and utilize previously cleared digital image capture devices for image acquisition.

VistaEasy is included as part of DBSWIN. It provides additional interfaces for Third Party Software. VistaEasy can also be used by itself, as a defeatured version of DBSWIN.

The provided text is a 510(k) Summary for a medical device (DBSWIN and VistaEasy Imaging Software). It describes the device, its intended use, and its similarities to a predicate device to establish substantial equivalence for FDA clearance.

However, this document does not contain information about specific acceptance criteria related to a study proving the device meets performance metrics. It focuses on demonstrating equivalence to a legally marketed predicate device rather than presenting results from a standalone performance study with defined acceptance criteria.

The "Clinical and Non-Clinical Testing" section mentions:

• "DBSWIN/VistaEasy was developed in compliance with the harmonized standard of IEC 62304 for medical device software life cycle requirements."
• "DBSWIN product has been in sales and distribution in the European dental market for over 15 years serving and performing the same intended use, functionality, and hardware compatibility interfaces with 3rd party software."
• "Bench testing, effectiveness, and functionality were successfully conducted and verified between DBSWIN and VistaEasy, and image capture devices."
• "DBSWIN is DICOM compliant."
• "Risk Analysis based design development and design reviews were conducted."
• "Full functional software cross check testing was performed."

These points indicate software development and general testing, but none of them are described as a quantitative performance study with specific acceptance criteria that would fall under the categories requested in your prompt (e.g., performance metrics like sensitivity, specificity, or reader improvement).

Therefore, based only on the provided text, I cannot answer the questions about acceptance criteria and the specifics of a study proving the device meets them because such details are not present. The clearance is based on substantial equivalence to an existing predicate device (Visix Imaging - K082623), meaning the FDA determined it performs as safely and effectively as the predicate, not necessarily through novel clinical performance studies for this specific submission.

If this were a more complex AI/ML device, the FDA would likely require a more detailed study with quantitative performance metrics as part of the 510(k) submission. This document, however, describes a "Picture archiving and communications system" which primarily functions for image management and display, and its clearance relies on demonstrating it is technologically similar and has similar indications for use as a previously cleared device.

Ask a specific question about this device

The VistaCam iX "Proof" is intended to be used as an aid in the detection and diagnosis of dental caries.

The VistaCam iX "Proof" aids in the detection and diagnosis of caries. It consists of a toothbrush-sized handpiece and a "Proof" head. A USB cable connects the handpiece to a personal computer with PACS software such as DBSWIN to enable communication between a PC computer and the handpiece.

After a camera cover is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the tooth to be examined. The camera functions by illuminating the tooth surface with a light that causes the bacteria resident in carries to fluoresce. The fluoresced light is then converted into an electrical signal, sent to a computer, converted into an image (by imaging software) and presented on a monitor in multiple colors to illustrate suspected areas of decay.

Here's an analysis of the provided text regarding the acceptance criteria and study for the VistaCam iX "Proof" device, formatted to answer your questions.

It's important to note that this document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive standalone clinical trial. Therefore, detailed information on certain aspects you asked for (like MRMC study effect sizes or ground truth establishment for a training set) might not be explicitly present if the submission relies heavily on non-clinical comparative data.

Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence to a predicate device (Air Techniques' Spectra Fluorescence Caries Detection Aid Device, 510K# K090169). Therefore, the "acceptance criteria" are implicitly tied to demonstrating similar performance attributes rather than a specific clinical performance metric like sensitivity or specificity.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

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

   • The document does not specify a sample size for a clinical "test set" in terms of patients or lesions. The studies mentioned are primarily non-clinical validation and verification tests comparing the new device to the predicate device in terms of LED illumination, output, image quality, and color separation.
   • The data provenance is not explicitly stated as country of origin, nor is it classified as retrospective or prospective clinical data, as this is a non-clinical equivalence submission for performance.

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

   • This information is not provided as the submission relies on non-clinical performance comparison rather than a clinical study requiring expert-established ground truth on patient data.

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

   • This information is not provided as there is no described clinical test set with human 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, an MRMC comparative effectiveness study was not done. This device is a "Laser Fluorescence Caries Detection Device," not an AI-based system. The submission focuses on comparing its physical and functional characteristics to a predicate device.

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

   • This is not applicable in the context of an AI algorithm, as this device is a hardware-based fluorescence detection system. The "algorithm" mentioned (page 7) refers to the image processing algorithm for fluorescence ratios, which is the same as the predicate device. The performance evaluated was the device's ability to produce similar illumination, output, image quality, and color separation to the predicate.

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

   • For the non-clinical performance tests (LED illumination, output, image quality, color separation), the "ground truth" was effectively the established performance characteristics of the predicate device. The new device had to demonstrate performance "similar" or "equivalent" to the predicate.
   • For biocompatibility, the ground truth was compliance with ISO 10993 standards.
   • For electrical safety, the ground truth was compliance with IEC 60601 standards.

7. The sample size for the training set:

   • This information is not applicable as the document describes a hardware device using fluorescence technology and a shared image processing algorithm (the same as the predicate), not a machine learning or AI model that requires a training set.

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

   • This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

Ask a specific question about this device