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VixWin PRO controls capture, display, treatment, analysis and saving of X-ray digital images from DenOptix®, Visualix®/GX-S, Orthoralix 9200 DPI and DDE digital imaging systems produced by Gendex. It can also handle other types of digital images, e.g. color images from an intraoral dental camera, such as the Gendex Concept IV series, or images acquired by digitizing film with a flat bed scanner

Vix Win is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, treatment, analysis and saving of xray digital images from DenOptix ®, Visualix ® / GX-S, KaVo Dig eXam, Orthoralix DPI & DDE series imaging systems by Gendex ®. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from an intraoral or extraoral dental camera such as the AcuCam Concept IV and eZ1 series. When properly installed in your computer, VixWin lets you:

• Control scanning and intake of x-ray images from image plates with the DenOptix . scanner (*).
• Control the direct capture of x-ray images from the intraoral sensor Visualix / GX-S, 미 KaVo Dig eXam, Orthoralix DPI & DDE series systems (*).
• View and capture color images from certain cameras, such as a dental camera, via a suitable video capture card (*).
• Export and import digital images (such as those obtained by scanning a film) in several 프 standard file formats.
• Process images with dental specific tools, to enhance their diagnostic value. 제
• 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 .. .

The provided text describes a 510(k) premarket notification for the "VixWin Pro" dental image management system. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth is not explicitly available in the provided text.

Here's an analysis of the available information:

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

The document doesn't present specific performance-based acceptance criteria in the typical sense of a clinical study (e.g., sensitivity, specificity thresholds). Instead, it compares the technical specifications and functionalities of VixWin Pro to two predicate devices: DentalEye 2 (K012439) and KaVo ERGOcom®/ERGOcam® (K050744).

General Acceptance Criteria (Implied by 510(k) process for this device):

• Substantial Equivalence: The primary acceptance criterion for a 510(k) device like VixWin Pro is demonstrating that it is as safe and effective as a legally marketed predicate device. This is achieved by showing that it has the same intended use and the same technological characteristics as the predicate, or, if there are different technological characteristics, that the different characteristics do not raise new questions of safety and effectiveness and are shown to be at least as safe and effective as the predicate device.
• Compliance with Product Specifications: The document states, "This is based on testing to verify compliance with product specifications." This implies that internal testing was conducted to ensure the software met its defined functional and performance requirements. However, the specific product specifications and the results of this internal testing are not elaborated upon in the provided summary.
• Intended Use Compatibility: The device must effectively control capture, display, treatment, analysis, and saving of X-ray digital images as specified in its Indications for Use. The comparison table implicitly supports this by showing similar image handling capabilities to predicate devices.

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

• Not Applicable: The provided 510(k) summary does not describe a clinical study with a "test set" of patient data in the context of diagnostic performance (e.g., for sensitivity/specificity). The testing mentioned refers to verification of compliance with product specifications, which is typically internal engineering and software testing, not patient-level data analysis. Therefore, information on sample size or data provenance is not provided for such a "test set."

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

• Not Applicable: As there's no diagnostic performance study with a "test set" of patient data described, there is no mention of experts establishing ground truth for such a test set.

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

• Not Applicable: Given the absence of a diagnostic performance study, no adjudication method for a test set is mentioned.

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: The document does not describe an MRMC comparative effectiveness study, nor does it mention AI assistance. VixWin Pro is described as a "Dental Image Management System" that processes, analyzes, and manipulates images, but there's no indication of AI algorithms for diagnostic assistance that would necessitate an MRMC study to evaluate human reader improvement.

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

• No: The document describes VixWin Pro as a software system for image management, display, and processing. It is inherently a tool for human users (dentists/maxillofacial diagnosticians). There is no mention of a standalone algorithm for automated diagnosis or a standalone performance evaluation.

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

• Not Applicable: Since no diagnostic performance study is described, no specific "ground truth" for patient data is mentioned in this document. If any "ground truth" was involved in the "testing to verify compliance with product specifications," it would likely relate to objective technical parameters of image quality or software functionality, rather than clinical diagnoses.

8. The sample size for the training set:

• Not Applicable: As VixWin Pro is presented as an image management and processing software without explicitly stated AI or machine learning components requiring a "training set" for model development, this information is not provided.

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

• Not Applicable: For the reasons stated above (no defined AI/ML training set), there's no information on how ground truth for a training set would be established.

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The Orthoralix 8500 Panoramic Dental X-ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.

The Orthoralix 8500 is a system for rotational panoramic radiography of the dentomaxillo-facial area. The system consists of:

• Column to be mounted to the wall .
• Motor-driven overhead assembly with controls for patient postioning, setting of . technique factors and radiographic projection geometry.
• Cassette drvie system with flat cassette for 15 x 30 cm film .
• X-ray tubehead, with DC power supply ●
• Remote control box and handswitch ●
  During a panoramic exposure, the x-ray tubehead and cassette holder move around the patient's head. The beam from the x-fay tabe is commans locks the radiation scattered from the patient. Patient positioning is simple, accurate and consistent by means of three postioning lasers, a bite guide and head stabilizers. During the exposure, the patient postioning lasers, a bitc guite and nead backless. All movements for the panoramic remains still with e tholorized components retater traiser traotors, which are microprocessor controlled.
  Along wit the Standard Panoramic mode, the Orthoralix 8500 provides a special child Along with the Bandard Fanolania me adiation dosage to the child, and confining the image to the dentition.

This is a 510(k) premarket notification for the Gendex Orthoralix 8500 Panoramic Dental X-ray System, which is a submission to the FDA demonstrating substantial equivalence to a predicate device. 510(k) submissions typically do not contain details of specific acceptance criteria and detailed study reports in the same way a PMA (Premarket Approval) submission would.

The document provides a general overview of the device and its intended use, focusing on demonstrating equivalence to predicate devices already on the market. Therefore, the specific information requested about acceptance criteria and detailed study methodology is largely not present within this 510(k) summary.

Here's an analysis based on the provided text, highlighting what is (and isn't) available:

1. Table of Acceptance Criteria and Reported Device Performance

• Not available in this 510(k) summary.
• 510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness, or that any differences do not raise new questions of safety and effectiveness and that the data submitted demonstrate the device is as safe and effective as the predicate device. Specific quantitative acceptance criteria for performance metrics (e.g., image resolution, dose levels) and detailed performance data against those criteria are not typically included or required in the public 510(k) summary document for this type of device.

2. Sample Size Used for the Test Set and Data Provenance

• Not available in this 510(k) summary.
• There is no mention of a dedicated "test set" in the context of clinical or performance evaluation data. The submission relies on the established safety and effectiveness of the predicate devices.
• Data provenance (e.g., country of origin, retrospective/prospective) is also not discussed, as there are no explicit studies being described in this summary to evaluate the device against specific performance metrics.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable/Not available.
• Since no specific study involving expert-derived ground truth (e.g., for diagnostic accuracy) is described, information on experts or their qualifications is not provided.

4. Adjudication Method

• Not applicable/Not available.
• As there's no diagnostic accuracy study described, an adjudication method is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study is not mentioned.
• This type of study is more common for evaluating AI-driven diagnostic tools where the goal is to quantify the improvement in human reader performance with AI assistance. The Orthoralix 8500 is an X-ray system, not an AI diagnostic algorithm, and its 510(k) submission does not include such a study.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study is not applicable or mentioned.
• This device is an X-ray imaging system, not a standalone algorithm. Its performance is inherent in its imaging capabilities and technical specifications, which are established through engineering design and testing (not explicitly detailed in this summary) and benchmarked against predicate devices.

7. Type of Ground Truth Used

• Not applicable/Not available in this context.
• For an X-ray system, "ground truth" might refer to phantoms or calibrated targets used during technical performance testing (e.g., for resolution, dose, geometry). However, no specific studies using such ground truth are detailed in this 510(k) summary. The submission primarily relies on the equivalency to predicate devices.

8. Sample Size for the Training Set

• Not applicable/Not available.
• This device is an X-ray system, not a machine learning or AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable/Not available.
• As there is no training set mentioned, this information is not relevant.

In summary, this 510(k) summary for the Gendex Orthoralix 8500 Panoramic Dental X-ray System is a regulatory document focused on demonstrating substantial equivalence to pre-existing predicate devices. It does not contain the detailed study information, acceptance criteria, or performance metrics typically found in more comprehensive clinical trial reports or new technology evaluations. The FDA's acceptance of this 510(k) primarily signifies that the device is deemed as safe and effective as the predicate devices, based on its similar intended use, materials, design, operational characteristics, and functional features.

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