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.

Device Description

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.

AI/ML Overview

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:

Acceptance Criteria (Implied/Stated)	Reported Device Performance
Functionality as a digital radiograph scanning, archiving, electronic transmission, and diagnostic review system	"XrayVision is a software package designed to be a fully functional digital radiograph scanning, archiving, electronic transmission and diagnostic review system."
Image acquisition from various sources	"permits the acquisition of images directly from commercially available scanners, digital cameras, intra-oral cameras, etc."
Image organization and archiving	"permits the user to easily organize and archive digital radiographs, images, and other patient related files to various archiving media"
Image enhancement without altering diagnostic content	"provides tools that permit the user to enhance images... 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... 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."
Ability to place markers and annotations	"permits the user to... place markers and annotations on radiographs to aid in the diagnostic process."
Association of custom information with images	"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."
Electronic transmission capabilities	"Electronic transmission capabilities are provided so that images can be sent to specialists and insurance companies for claims processing and diagnostic review."
Security features (digital signatures, encryption, etc.)	"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."
Compatibility with standard PC operating systems	"capable of running Windows 95 or higher (32-bit operating systems)."
Utilization of standard interfaces (TWAIN, FTP, Email, etc.)	Explicitly listed under "Technological Characteristics" (e.g., TWAIN, standard image file formats, FTP, C/S, Email, Disk I/O).
Data integrity through lossless compression	"Primary file format uses lossless date compression (ensures data integrity)."
Use of industry standard encryption	"Industry standard encryption algorithms used for ensuring data integrity."

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:

Sample size used for the test set and the data provenance: Not applicable/Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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.
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.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided.
The sample size for the training set: Not applicable/Not provided.
How the ground truth for the training set was established: Not applicable/Not provided.

Summary

{0}------------------------------------------------

K983111

Image /page/0/Picture/2 description: The image shows the logo for Apteryx, a software development company. The logo features the company name in a stylized, cursive font, with a horizontal line underlining the name. Above the name is a black feather, possibly representing a quill, which adds a creative and symbolic element to the logo.

Apteryx, Inc. . 554 White Pond Dr. Suite A . Akron, OH 44320 . (330) 867-607

apteryx@apteryxware.com · www.apteryxware.col

Safety and Effectiveness Informatio

Submitter:	Apteryx, Inc.554 White Pond Dr. Suite AAkron, OH 44320(330) 867-6077
Contact Person:	Kevin Crucs
Date Prepared:	September 2, 1998
Device Name:	XrayVision
Equivalent Device:	TigerView, FDA registration number 955237

Device Description -----------------------------------------------------------------------------------------------------------------------------------------------------------

{1}------------------------------------------------

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.

Intended Use -----------------------------------------------------------------------------------------------------------------------------------------------------------------

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 �

Technological Characteristics

Utilization of the TWAIN interface standard to acquire images from imaging 1. devices (scanner, digital cameras and interoral cameras, etc.).
Utilizes standard image processing algorithms to improve image contrast, 2. sharpness and quality.
1. Utilizes standard image file formats for the storage and retrieval of images. Primary file format uses lossless date compression (ensures data integrity). Supports JPEG (lossy) only as an import/export format.
1. Telephone: common J/O and TAPI interface supported for transferring images over conventional phone lines.

FTP: File transfer protocol.

C/S: Standard Internet transfer method for sending files via Internet client-server connection.
Email: MIMI attachments utilized to transfer files via standard Internet email.

{2}------------------------------------------------

Disk: Standard PC I/O

1. Archiving utilizes a knowledge base for recording the location used to store files related to a patient.
1. Utilizes standard markers and annotations to draw attention to problem areas in an image (ellipse, arrow, text, freehand line, dots, rectangles, etc).
1. Industry standard encryption algorithms used for ensuring data integrity.

XrayVision has the same technological characteristics as the predicate device, TigerView and TigerScan [510(k) K95-5237]. A summary of the technologies used by these devices is as follows:

End of 510(k) SUMMARY

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 1998

Kevin Crucs President Apteryx, Inc. 554 White Pond Dr. Suite A Akron, OH 44320

Re:

K983111

X-Ray Vision (PACS) Dated: September 4, 1998 Received: September 4, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Crucs:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsmadsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reprodu Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 Of 1

510 (k) Number (if known): K983111

Device Name: Xray Vision

Indications For Use:

Uses for XrayVision in the dental industry are as follows:

Permits sending of data by email, client/server, flp, 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 mcasurements �
Anows asor to and canbretted as sharpening, colorizing, resizing, ctc. (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 which using xiny is tof the case as 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Usc (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David A. Segner

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi

510(k) Number K983111

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).