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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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The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intra-oral radiography images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

The DEXIS sensor is an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology.

The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra-oral applications.

The DEXIS sensor supports USB 2.0 and USB 1.1 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.

The provided text is a 510(k) Summary for the DEXIS Sensor, a digital X-ray device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them. It doesn't detail:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a "test set."
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or effect size of human improvement with AI.
6. Standalone performance of an algorithm without human-in-the-loop.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

Instead, the document asserts substantial equivalence by comparing the DEXIS Sensor's characteristics and intended use to two legally marketed predicate devices: Schick Technologies, CDR (K072134) and Suni Medical Imaging, Inc., SuniRay II Digital Radiographic System (K070219).

The key comparison points in the "Substantial Equivalence" table are:

• Indications for Use: All three devices are for acquiring dental intra-oral radiography images, to be operated by healthcare professionals.
• Number of Sensors: DEXIS Sensor has 1, CDR has 3, SuniRay II has 2.
• Sensor Size (mm): DEXIS is 30 x 39; CDR has sizes 31 x 22, 37 x 24, 43 x 30; SuniRay II has sizes 39.5 x 26, 43.5 x 31.5.
• Technology: All three use CMOS.
• Interface to PC: All three use USB.
• Dynamic Range: DEXIS Sensor has 16,384:1; both predicates have 4096:1. (The DEXIS Sensor exceeds the predicate devices in this specification, which is generally considered a positive attribute.)
• Sensor Cable Length (m): DEXIS is 2.8; CDR is 2; SuniRay II is 1.

The conclusion drawn in the document is that the DEXIS Sensor is "substantially equivalent in intended use and technical characteristics" to the predicate devices. This type of submission does not typically include the detailed clinical study information requested.

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