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The DEXIS CariVu 3-in-1 by KaVo acquires patient images as a diagnostic aid for detection of smooth surface caries, occlusal caries, proximal caries, secondary caries, and tooth cracks. The DEXIS Cari Vu 3-in-1 by KaVo is designed for use by a trained professional in the field of dentistry.

The device is used as an intraoral camera to acquire images in the oral cavity of the patient. The camera combines three different known applications from available intraoral cameras in one device. These applications are standard camera functionality, transillumination and fluorescence caries detection. Therefore, the camera uses different light colors for each of the three applications to illuminate the tooth. In combination with an optical system, CMOS sensor, and an internal image processing unit, a digital image of the tooth is generated. The live images are transferred as a standard mjpg video stream via USB interface to a running computer and can interface with a dental imaging software such as for example CONEXIO for basic intraoral camera management functionality.

The device may be used as an aid for monitoring caries lesion size and shape by comparing images taken with the Dexis CariVu 3-in-1 by KaVo over time, by using different reference points, such as tooth contour and position the device to optimize capturing tooth features previously recorded in a still or video image.

For easy use the camera is equipped with an autofocus mechanism which will provide a sharp representation of the tooth which is placed in the center of the imaqe. The autofocus provides the ability to have sharp images from close distances of about 2mm to about 120mm distance.

The different operation modes are described as follows:

1.) Color mode:
For normal color images, a white LED for illumination is used. With this light the camera provides coloured images or videos. The camera can be used with or without a Tip Vision Full HD which is required for illumination for the transillumination mode.

2. Fluorescence mode:
   For the fluorescence mode the blue LED illumination is used. The blue light excites bacterial porphorines as an aid to detect caries.

To enhance the image quality and to minimize external light influence on the fluorescence effect the accessories Fluorescence Cover Vision Full HD can be used optionally with the camera. The Fluorescence Cover Vision Full HD is a rubber cap which can be slipped on the front camera head and prevent or minimize external light on the images surface of the tooth. After each usaqe the Fluorescence Cover Vision Full HD will be reprocessed separately.

The camera can be used with or without a Tip Vision Full HD which is required for illumination for the transillumination mode. This mode is used to record images and videos to aid in the diagnosis of caries (mainly in the occlusal area) and plaque by means of fluorescent effect.

3. Transillumination mode (by the use of near infrared light):
   The transillumination mode provides images to aid in the detection of caries. For this mode near infrared light will be used. The near infrared light penetrates the side of the tooth near gingiva and illuminates the enamel of the tooth to produce gray scale images whereby intact enamel appears bright, and defects such as caries or cracks result in diffusion of light path and create an area of dark appearance.

To use this mode, the Tip Vision Full HD must be attached to the device as the LEDs for the illumination are located inside the Tip Vision Full HD. The Tip Vision Full HD touches the side of the tooth and gingiva and illuminates it from two sides whereas the image is taken from the top.

The DEXIS CariVu 3-in-1 by KaVo is available in two similar models. The differences between the models are a wall mounted version to store the device with a cable length of 2.5 meters (model 1.011.4444) and a table holder version to store the device on a dental unit with a cable length of 1.55 meters (model 1.013.1700). All critical components within the DEXIS CariVu 3in-1 by KaVo are common. A disposable sheath is used with the device to mitigate the potential for cross contamination.

The provided text does not contain detailed information about specific acceptance criteria or an in-depth study proving the device meets those criteria, especially in the format requested. The document is a 510(k) summary for the DEXIS CariVu 3-in-1 by KaVo, primarily focusing on demonstrating substantial equivalence to predicate devices rather than presenting the results of a primary clinical study with predefined acceptance criteria.

However, I can extract the following information from the text:

1. Table of acceptance criteria and reported device performance:

The document does not provide a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or AUC. It focuses on comparison of capabilities and safety standards with predicate devices.

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

• Clinical Testing: "Clinical testing was not conducted on this product." This indicates that there was no clinical test set for performance evaluation in the context of this 510(k) submission.

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

• Since no clinical testing was performed, there were no experts used to establish ground truth for a test set.

4. Adjudication method for the test set:

• Since no clinical testing was performed, there was no adjudication method for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No MRMC study was done, as "Clinical testing was not conducted on this product."

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

• The device description indicates it's an intraoral camera with various modes (color, fluorescence, transillumination) "as a diagnostic aid for detection." It is designed "for use by a trained professional in the field of dentistry." This implies a human-in-the-loop scenario. No standalone performance data for an algorithm alone is provided.

7. The type of ground truth used:

• Not applicable as no clinical testing was performed to establish performance metrics against a ground truth.

8. The sample size for the training set:

• The document does not mention a training set or its size, as it states clinical testing was not conducted. This implies that the device's development and evaluation for this submission did not involve a supervised learning approach requiring a distinct training set in the context of a clinical performance study.

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

• Not applicable as no training set is mentioned in the context of clinical performance evaluation.

Summary of what is present in the document relevant to performance and equivalence:

The document primarily focuses on non-clinical bench testing to demonstrate performance according to international standards for medical electrical equipment, sterilization, biocompatibility, risk management, and cybersecurity. These are safety and engineering performance criteria, not clinical diagnostic performance criteria.

• Non-Clinical Test Data: Performance bench testing focused on:
  • IEC 60601-1-2 Forth Edition (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance)
  • ANSI AAMI ES60601-1 and IEC 60601-1:2005 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
  • CAN/CSA-C22.2 No. 60601-1 (Medical Electrical Equipment - Part 1: General Reg. for Basic Safety & Essential Performance)
  • IEC 62304: 2006 Edition 1.1 (Medical device software - Software life cycle processes)
  • ISO 17665-1 First edition (Sterilization of health care products - Moist heat)
  • AAMI / ANSI ST79 2017 (Comprehensive guide to steam sterility assurance in health care facilities)
  • ISO 10993-1 Fourth Edition (Biological evaluation of medical devices)
  • ISO 7405 Second edition (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry)
  • ISO 14971 2007 and 2012 (Medical devices - Application of risk management to medical devices)
  • Guidance for Industry and FDA Staff 2014-10-02 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
  • Guidance for Industry and FDA Staff 2017-06-09 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

The conclusion of the 510(k) process states: "Based upon a comparison of indications for use and technological characteristics, together with results from non-clinical performance testing, we believe that DEXIS CariVu 3-in-1 by KaVo is substantially equivalent to the predicate devices." This highlights that the equivalence was demonstrated without direct clinical performance data for the new device.

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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.

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