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Uses for XrayVision in the dental industry are as follows:

• Permits sending of data by email, client/server, ftp, phone and floppy disk .
• Organize and archive x-rays and patient related files .
• Facilitate sharing and transmission of information between doctors, other applications and other computers
• Ability to place markers and annotations on x-rays for diagnostic purposes .
• Allows user to take calibrated measurements .
• Provide image-processing tools such as sharpening, colorizing, resizing, etc. (none of which physically alter images).
• Electronic transmission of images to insurance companies or specialist .

When using XrayVision for diagnostic purposes the general public will be the doctor/dentist population. This software is primarily used to store a patient's imaging data (i.e. x-rays) in a form compatible with today's networked online practice management software. This software may also be used to transmit radiographs to specialists who will be treating the patient or the insurance company for approval of procedure and etc.

XrayVision is a software package designed to work with standard PC compatible computers capable of running Windows 95 or higher (32-bit operating systems). This software is designed to be a fully functional digital radiograph scanning, archiving, electronic transmission and diagnostic review system. XrayVision permits the acquisition of images directly from commercially available scanners, digital cameras, intra-oral cameras, etc. Once an image has been converted into digital form, Xray Vision permits the user to easily organize and archive digital radiographs, images, and other patient related files to various archiving media (e.g. removable media, storage servers, hard drives, etc.). XrayVision provides tools that permit the user to enhance images and place markers and annotations on radiographs to aid in the diagnostic process. The image enhancements provided by this software package utilize industry standard algorithms that do not result in the alteration of an image's or a radiograph's content. Unlike a direct digital system, XrayVision does not control the x-ray taking system and does not generate x-ray images directly from the physical world (XrayVision processes images and radiographs produced from other devices and physical media). XrayVision only permits enhancing radiographs for diagnostic purposes and does not allow the introduction of false data or the modification of the images and radiographs in any way. To facilitate better correlation of information with images, XrayVision permits direct association of custom information with an image. Using these associations the user is able to relate doctor information, a patient's information, procedure, etc. with an image. When an image is transferred to another location, these associations guarantee that the correct information is always associated with an image (it is stored along with the image). Electronic transmission capabilities are provided so that images can be sent to specialists and insurance companies for claims processing and diagnostic review. To ensure the originality and security of information, XrayVision contains security features such as digital signatures, encrypted transfers, image tracking and password protection to keep radiographs and other information safe from others and to prevent image modifications.

The provided documentation for K983111, for the Apteryx XrayVision device, does not contain information about specific acceptance criteria or a study that proves the device meets such criteria in terms of diagnostic performance statistics.

Instead, the documentation describes the device's functionality and its substantial equivalence to a predicate device (TigerView and TigerScan K95-5237) based on technological characteristics and intended use. The review process appears to focus on whether the XrayVision software performs its stated functions (archiving, transmitting, enhancing, annotating) without altering the diagnostic content of images, rather than on a quantitative evaluation of its impact on diagnostic accuracy or clinical outcomes.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the provided text:

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

No information is provided for the following points as the filing focuses on substantial equivalence based on functional and technological characteristics, not on a clinical performance study measuring diagnostic accuracy:

2. Sample size used for the test set and the data provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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/Not provided. The device focuses on image management and enhancement, not AI-assisted diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. The device is a tool for dentists, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided.
8. The sample size for the training set: Not applicable/Not provided.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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