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The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.

The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.

The provided text is a 510(k) premarket notification approval letter for the "DEXIS Software." This document primarily focuses on the regulatory approval process and does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance.

Therefore, I cannot provide the information requested from the given text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include the results of performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications.

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The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital images from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.

The DEXIS Software is a software program for general dental and maxillo-facial diagnostic imaging. It controls capture, display, enhancement and saving of x-ray digital images from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intraoral or extraoral dental cameras. DEXIS Software allows the following functionality:

• Control scanning and intake of x-ray images from imaging plates with the DenOptix scanner.
• Control the direct capture of x-ray images from the intraoral sensor Visualix / GX-S. KaVo Dig eXam, Orthoralix DPI & DDE series systems.
• View and capture color images from certain cameras, such as dental camera, via a suitable video capture card.
• Export and import digital images (such as those obtained by scanning a film) in several standard file formats.
• Process images with dental specific tools, to enhance their diagnostic value.
• Analyze and manipulate images in order to gather additional diagnostic information which may not be immediately apparent on initial visual inspection.
• Create a database of patients and easily store images in patient folders.

This document is a 510(k) summary for the DEXIS Software, dated February 4, 2009. It describes the software's functionality and its intended use as a dental imaging device. The submission claims substantial equivalence to two predicate devices: DEXIS Model 601 (K962631) and Gendex Dental Systems, VixWin Pro (K060178).

Based on the provided text, there is no specific study that proves the device meets acceptance criteria in the traditional sense of a clinical trial or performance study with defined metrics. This 510(k) submission is for a software update to an already cleared device, focusing on technical changes (rewritten in 32-bit code for newer Windows versions) rather than a novel diagnostic algorithm. The acceptance criteria and "device performance" in this context are related to demonstrating that the modified software maintains the same intended use and technical characteristics as the predicate devices and the original cleared version of DEXIS Software.

Here's an attempt to extract the requested information, noting where details are not present in the provided document:

Acceptance Criteria and Device Performance for DEXIS Software (K090431)

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission as a software update and re-affirmation of substantial equivalence, the "acceptance criteria" are implied by the claim of maintaining the same intended use and technical characteristics as predicate devices. The "reported device performance" is the statement that these characteristics have been retained despite the software rewrite.

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

The document does not specify a test set sample size or data provenance for any performance evaluation directly related to this 510(k) submission. As this is a software update for an already cleared device, the submission focuses on compatibility and equivalence rather than new performance data from a specific test set.

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

The document does not mention using experts to establish ground truth for a test set, as no specific performance study is detailed.

4. Adjudication method for the test set

The document does not mention any adjudication method, as no specific performance study is detailed with a test set.

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 comparative effectiveness study was done or reported in this 510(k) submission. The DEXIS Software, as described, is a dental imaging management system, not an AI-assisted diagnostic tool providing interpretations that would typically be evaluated in an MRMC study comparing human performance with and without AI.

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

No standalone algorithm performance study was mentioned or reported. The software's function is to control, display, enhance, and save images for human interpretation, not to provide independent diagnostic outputs.

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

The document does not describe the use of ground truth data for performance evaluation in this 510(k) submission. The basis for clearance is substantial equivalence to legally marketed predicate devices, implying that their prior clearance (which would have involved demonstrating performance appropriate for their intended use) serves as the "ground truth" for the current device's capabilities.

8. The sample size for the training set

The document does not mention a training set sample size. As this primarily describes an update to an existing imaging software, not a machine learning or AI algorithm development, a "training set" in that context would not be applicable.

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

Not applicable, as no training set (in the context of machine learning/AI) is mentioned.

Summary of Filing Focus:

This 510(k) submission (K090431) for the DEXIS Software primarily serves as an update to an already cleared medical device (K962631). The key points for its clearance are:

• The software has been rewritten into 32-bit code for compatibility with newer operating systems (Windows XP, 2000).
• It retains "backward compatibility" with earlier Windows versions.
• Critically, it asserts "no change to the intended use or technical characteristics" compared to its previously cleared version and the identified predicate devices (DEXIS Model 601 and Gendex VixWin Pro).

The FDA's review and clearance of this 510(k) is based on the claim of substantial equivalence, meaning the updated software is as safe and effective as the predicate devices, without requiring new clinical or performance studies that would typically involve specific acceptance criteria, test sets, experts, or ground truth establishment for novel diagnostic claims.

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