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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 DÜRR 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 reduced feature version of DBSWIN.

The provided document is a 510(k) summary for DÜRR DENTAL SE's DBSWIN and VISTAEASY Imaging Software (K190629). This submission focuses on establishing substantial equivalence to a predicate device (K161444) rather than presenting a study to prove performance against specific acceptance criteria for a novel device. Therefore, much of the requested information about device performance and study details is not explicitly available in this document.

However, based on the information provided, here's an attempt to answer the questions:

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

The document does not specify quantitative acceptance criteria for device performance. Instead, it asserts substantial equivalence to a predicate device by comparing technological characteristics and functionalities. The performance is implied to be equivalent to the predicate.

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

The document does not specify a separate "test set" or its sample size. The performance claims are based on "Bench testing, effectiveness, and functionality" and "Full functional software cross check testing." No information on data provenance (country of origin, retrospective/prospective) is provided, as no clinical study with patient data is mentioned.

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. The document does not describe a study involving expert-established ground truth for a test set, as it emphasizes technological equivalence and software verification/validation rather than clinical performance evaluation against a gold standard.

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

Not applicable. No expert-adjudicated test set 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 applicable. This document is for imaging software that aids in acquiring, displaying, editing, and distributing images, rather than an AI diagnostic tool. No MRMC study is mentioned.

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

Not applicable. The device is referred to as "clinical software applications" and a "diagnostic aide for licensed radiologists, dentists and clinicians," indicating a human-in-the-loop context. It processes and presents images, it does not perform standalone diagnosis.

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

Not applicable. As no clinical study validating diagnostic accuracy is presented, there is no mention of a ground truth type. The focus is on software functionality and technical specifications.

8. The sample size for the training set

Not applicable. This device is not described as an AI/machine learning model where a training set size would be relevant. It's a general imaging software.

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

Not applicable, for the same reason as above.

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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 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 describes a 510(k) premarket notification for "DBSWIN and VistaEasy Imaging Software." This submission is a "Special 510(k) Summary" for minor modifications to an already cleared predicate device (K143290). Therefore, the document focuses on demonstrating that the new version is substantially equivalent to the previous one and primarily relies on non-clinical testing rather than extensive new clinical studies for acceptance criteria.

Based on the provided text, a detailed breakdown of acceptance criteria and a study proving those criteria is challenging because the document primarily asserts substantial equivalence through a comparison to a predicate device and relies on generalized non-clinical testing rather than specific new performance metrics for the modified device.

Here's an attempt to extract the requested information based on the available text:

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

The document does not explicitly state numerical acceptance criteria like sensitivity, specificity, or accuracy for diagnostic performance. Instead, the "acceptance criteria" are implied to be the continued equivalent functionality and safety to the predicate device and compliance with relevant standards. The "reported device performance" is a confirmation that these functionalities are maintained.

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

The document does not specify a sample size for a test set in the context of clinical performance evaluation. The testing described is primarily non-clinical: "Bench testing," "Full functional software cross check testing." There is no mention of data provenance (country of origin, retrospective/prospective) because clinical data are not discussed.

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)

No information is provided regarding experts, ground truth establishment, or their qualifications because the document does not describe a clinical study requiring such a test set. The software is described as a "diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience." This implies that the human expert is the ultimate arbiter of diagnosis, not the software.

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

No information is provided regarding adjudication methods as no clinical test set requiring such expert review 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

No MRMC study was mentioned or implied. The device is imaging software, not explicitly an AI-assisted diagnostic tool in the sense of providing automated interpretations or significant decision support that would require such a study. It's a tool for acquiring, displaying, and editing images.

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

A "standalone" performance study for an algorithm in a diagnostic sense was not done. The software's performance is gauged through non-clinical functional testing and its ability to process images. Its role is as a "diagnostic aide" to a human professional.

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

No specific type of "ground truth" (e.g., pathology, expert consensus) is mentioned because the document does not describe the evaluation of a diagnostic algorithm against such a truth. The testing focuses on functional verification and compliance with standards.

8. The sample size for the training set

No information about a training set is provided. This type of submission (Special 510(k)) does not typically involve the training of new algorithms but rather the verification of modified software versions against established functionalities of previously cleared devices.

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

Not applicable, as no training set or specific diagnostic algorithm requiring ground truth for training is mentioned. The document describes a software update for an image management system.

Ask a specific question about this device

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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