Spinal Guides PACS is intended to perform: operations relating to the acceptance of spinal X-ray medical images and patient demographic information, their display, digital processing, review and editing, measurements report generation with respective storage and teleradiology exchange capabilities. They are intended to be used by a physician to view the images and use as an aid in calculation of alteration of motion segment integrity (AOMSI) of human spine. This device is not intended to be used for mammography images and does not require usage of 5 Mega pixel monitors.

Device Description

The device is represented by a software computer program installed on regular computers. The device has two types of users: a web and a local user. The web user submits an image set for processing to the local user via internet to the device's database. The local user is viewing the images of the image set, process the image set and sends a PDF report with calculations for the web user.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Spinal Guides PACS device:

Important Note: The provided document is a Traditional 510(k) Submission for a PACS system, specifically focusing on spinal X-ray image analysis for Alteration of Motion Segment Integrity (AOMSI). It is crucial to understand that for a PACS system like this, the primary "performance" is often related to its ability to accurately display and facilitate measurements, not to provide an automated diagnostic output like many modern AI-driven devices. Therefore, the "acceptance criteria" and "device performance" will relate more to software functionality, display accuracy, and the ability to perform the intended measurements as per established medical protocols, rather than diagnostic accuracy metrics like sensitivity or specificity.

Acceptance Criteria and Study Analysis for Spinal Guides PACS

The provided 510(k) submission document for the Spinal Guides PACS system describes its intended use and a "testing" section. However, it does not explicitly state quantitative acceptance criteria or provide a detailed study report with specific performance metrics beyond general conformance to standards.

Instead, the submission primarily focuses on establishing substantial equivalence to a predicate device (Opal-Rad™) by demonstrating similar intended use, technological characteristics, and control methods. The "testing" mentioned is nonclinical software verification and validation, not a clinical performance study with human subjects or a direct comparison of its measurement accuracy against a "gold standard" using specific statistical thresholds.

Given this, I will interpret "acceptance criteria" in the context of what the document implies are the necessary characteristics for the device to be cleared, and "reported device performance" based on the confirmation of these characteristics being met.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Submission)	Reported Device Performance (Summary from Submission)
A. Functional Requirements:
1. Acceptance of spinal X-ray medical images.	Implied: The system is designed to accept spinal X-ray images, as described in its workflow.
2. Acceptance of patient demographic information.	Implied: The system is designed to accept and manage patient demographic data.
3. Display of images.	The device is primarily intended for viewing digital spinal X-ray images.
4. Digital processing for AOMSI calculation.	The device performs automated calculations for AOMSI (e.g., automatic limitation of points, 4th point positioning, mathematical calculations).
5. Review and editing capabilities.	Includes buttons for "Undo," "Zoom In/Out," "Reset to Original," "Trace Image," "Test Points," indicating review and editing functionality.
6. Measurements report generation.	Generates a PDF report with calculations for AOMSI.
7. Storage and teleradiology exchange capabilities.	System includes a database server and web server for storage and teleradiology exchange via internet.
8. Facilitates AOMSI calculation by a physician.	Intended to be used by a physician as an aid in calculation of AOMSI.
B. Quality Control/Error Management:
1. Notification of improper point order.	If points are placed incorrectly, the 4th point is placed away from the column, making the operator aware.
2. Requires image calibration.	No points can be placed without prior calibration.
3. Image quality review/rejection.	Local user reviews image quality; poor quality images can be rejected.
C. Compliance & Standards:
1. Conformance to DICOM standard.	Conformance to DICOM standard PS3 NEMA 3.0 1/1/2008.
2. Non-mammography image handling.	Does not process images for mammography and does not require 5M pixel monitors.
3. Software Verification and Validation.	Nonclinical tests for software verification and validation performed in conformance to specifications.

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

The document does not specify a sample size for a "test set" in the way one would for a clinical performance study involving diagnostic accuracy. The testing described is "nonclinical tests for Spinal Guides PACS (software verification and validation)." This typically involves testing software functionality, data integrity, user interface, and compliance with specifications, rather than using a dataset of patient images with established ground truth for performance metrics.

Therefore, information on:

Sample size for the test set: Not provided.
Data provenance (e.g., country of origin, retrospective or prospective): Not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Since the document does not describe a clinical performance study with a "test set" and ground truth establishment in the traditional sense for diagnostic accuracy, this information is not provided in the submission. The acceptance relates to the software's ability to facilitate measurements, where the "ground truth" for those measurements would be the established medical protocols and the physician's expertise. The submission emphasizes that analyses are to be performed by "a licensed medical practitioner who is knowledgeable of specific spinal anatomy and specific protocols for image analysis" (page 3).

4. Adjudication Method for the Test Set

As no specific "test set" for clinical performance evaluation is described, an adjudication method is not applicable and not mentioned in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the provided document. The submission focuses on substantial equivalence based on functional and technical characteristics, and nonclinical software validation. There is no mention of evaluating human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the sense of the algorithm providing an automated diagnostic output without human interaction is not described. The device is intended to be an "aid in calculation" for a physician, implying a human-in-the-loop. The "automated part of the reporting process" refers to tasks like placing the 4th point based on others, mathematical calculations, and quality control notifications, not a fully automated diagnostic output.

7. The Type of Ground Truth Used

For the nonclinical software verification and validation, the "ground truth" would be the functional specifications, established DICOM standards, and the medical protocols for AOMSI calculation (e.g., AMA 6th Edition criteria for spinal evaluations). The software's correct execution of these specifications and protocols is what was validated.

8. The Sample Size for the Training Set

There is no mention of a training set in the document. This is because the device, as described, is a PACS system with automated calculation assistance, not a machine learning or AI model trained on a dataset to learn patterns or make predictions. Its rules for automation (e.g., 4th point placement, mathematical calculations) are explicitly programmed based on anatomical and mathematical principles, not learned from a training set.

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

As there is no mention of a training set, the method for establishing its ground truth is not applicable and not provided.

Summary

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MAR ] 3 2010

Page 1 of 11

Traditional 510 (k) Submission

Submission Date: K092427

3/2/2010

Revised 510(k) Summary

Spinal Guides PACS (PACS Medical Imaging Display Workstation)

Picture Archiving and communications Common/Classification Name: system (PACS)

LLZ

Classification Product Code

Proprietary Name:

510 (K) Letter Owner

Address

Phone number Fax e-mail

109-33 71st Road, #11B Forest Hills, NY 11375 718-261-4812 718-261-4812 albertydavydov@yahoo.com

Spinal Guides PACS

Albert Davydov, DDS, PC

Albert Davydov, DDS Submitter's Contact person:

August 1, 2009 Date the Summary was prepared:

A. LEGALLY MARKETED PREDICATE DEVICE

The predicate device name	Opal-RadTM
Applicant Name	Viztek, Inc.6491 Powers Ave.Jacksonville, FL 32217
510(K) Number	K063337
Regulation # 21 CFR	892.2050

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Traditional 510 (k) Submission

Submission Date: K092427

3/2/2010

LLZ Classification Product Code

B. DEVICE DESCRIPTION

The device is represented by a software computer program installed on regular computers.

The device has two types of users: a web and a local user.

The web user submits an image set for processing to the local user via internet to the device's database.

The local user is viewing the images of the image set, process the image set and sends a PDF report with calculations for the web user.

Workflow details

Working a mage is transferred to the device database by a web user. An operator (a local user) then uses a workstation to analyze AOMSI and generate a PDF (a look abol ations, which is then available for viewing on the web for the web user.

The local user/operator/server is installed at only one core location and X-ray images from different users are sent to the location for analyses.

The device is primarily intended for viewing digital spinal X-ray images and to prepare analyses of alteration of motion segment integrity (AOMSI).

Automated part of the reporting process

1. Automatic limitation of points placed respective to the number of vertebras
1. Automation of 4th point positioning.
1. Automatic mathematical calculations
1. Automatic notice to calibrate an image upon placement of first point on an image in image editor window
1. Automation of notification of an improper order of points
1. Automatic user password retrieval
1. Automatic submission of PDF report via e-mail to the web user

What is needed to perform the analysis?

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Traditional 510 (k) Submission

Submission Date: K092427

3/2/2010

1. The analyses are to be performed only by a licensed medical practitioner who is knowledgeable of specific spinal anatomy and specific protocols for image analysis
1. Medical Device Spinal Guides PACS
Spinal pure lateral X-ray views in flexion and extension taken with the calibrator 3. in place
1. Computer hardware
1. Internet with enough available speed

Processing

For all square vertebras the first point (I) is placed on the superior anterior

external line angle of the vertebral body.

For all square vertebras the second point (II) is placed on the superior

posterior external line angle of the vertebral body.

For all square vertebras the third point (III) is placed on the inferior

posterior external line angle of the vertebral body.

For all square vertebras the forth point is computer generated. The 4th

point (IV) is placed to the location to make the inferior side of the figure equal and

parallel to the same of the upper.

For the vertebra without vertebral body (C1) the point locations are as follows:

The first point is placed on the Superior Anterior External Line 1.
Angle formed by dens of C2 and the most proximal point to it on C1

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Traditional 510 (k) Submission

Submission Date: K092427

3/2/2010

The second point is placed on the Superior Posterior Internal Line 2. Angle formed by radiographic laminar-pedicle junction of C1 and the superior border of C1 at the end point of that junction

The third point is placed on the Inferior Posterior Internal Line 3. Angle formed radiographically by laminar-pedicle junction of C1 and the inferior border of C1 at the very end point of that junction. The forth point is computer generated, as described above

For triangular vertebra (C2):

The first point is placed on the Inferior Anterior External Line 4. Angle of the vertebral body.

The second point is placed on the Inferior Posterior External Line 5. Angle of the vertebral body.

The third point is placed on the next Superior Posterior External 6. Line Angle formed between transverse processus of C2 and the dens of C2 vertebrae

The forth point is computer generated

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Traditional 510 (k) Submission

Submission Date: K092427

3/2/2010

Once the third point is placed, the fourth one is generated by a computer.

The fourth point is placed to complete a proper quadrangle to form square, parallelogram or rhombus.

The fourth point is placed by a computer to make the lower side equal and

parallel to the upper side and the opposing internal line angles equal to each other.

Measuring

Before placement of points the local user has to calibrate the image.

Once we have placed the points we can relate them to each other by

calculating degrees of their planes.

After the points are placed and proper geometrical figures are created the

device will measure relative metric discrepancies.

The device measures relative angulation as well as specific metric relationship of shifts in millimeters and in percentages relative specific points.

Then, the data is compared with known norms and abnormalities respective to the specific points and spinal parts.

Significance of the study

In order to treat the patient better, estimate prognosis of the patient's condition and quantify the patient's impairment due to damages to the spine the AMA published certain criteria by which a doctor has to formulate a diagnosis

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Traditional 510 (k) Submission

Submission Date: K092427

3/2/2010

and treatment plan, as well as quantify the patient's permanent impairment rating. The last edition, the 6th Edition of AMA published in 2008 specific limitations in norm and abnormalities for spinal evaluations of alteration of motion segment integrity calculations.

Using computerized technology installed within the device a doctor can spend almost no time in completion of otherwise lengthy mathematical calculations and get precise diagnostic report ready to apply for the best patient's care.

Once specific measurements of relationship of one vertebra to another are obtained, they are compared to norms and abnormalities.

The patient will be treated better and treatments will get better outcomes.

The individual and third party payers will save money when treatments are not indicated.

The device does not read pathologies. It is an AOMSI (alteration of motion segment integrity) specific.

Quality control functionality

If the order of the points placed are not followed the above protocol (not as 1, 2, 1. 3, but 1, 3, 2) the 4th point will be placed away from the field of the column by the computer making the operator aware of the error made.

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Traditional 510 (k) Submission

Submission Date: K092427

3/2/2010

The error figure will be seen by the local user immediately during

processing.

No points can be placed on an image without prior calibration

X-ray images have to be taken with the calibrator, a small quadrangular metal plate with known dimensions. The calibrator will be affixed on the patient's skin in the designated area with the help of special, made out of paper, holder. The holder will position the metal plate vertically. The plate will be shown on an image as a quadrangle. A local user (operator) will be adjusting the image's size according to the calibrator's image and its known dimensions. The image set will be reviewed for quality before the processing can be done. If images sent are not in the appropriate quality, the image set will be rejected by the local user. The web user will see the specific image set rejected and why and will consider for a resubmission a better quality image

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Traditional 510 (k) Submission

న.

Submission Date: K092427

3/2/2010

Buttons: 1) "Undo"- returns to the previous state,

"Zoom In"- increases the image in size,
"Zoom Out"- decreases the image in size,
"Reset to Original"- returns the image to the

original size,

"Trace Image" guides the operator through the

processing of the image

"Test Points" retrieves the points from the

database on the processed image from the database

The architecture of the device is represented by the following diagram:

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Image /page/8/Figure/2 description: This image shows a diagram of a traditional 510(k) submission process. The submission date is 3/2/2010, and the submission number is K092427. The diagram includes a web browser, a web server, a database server, and a local application. The web browser sends image set data to the web server via HTTP, and the web server generates an image set and MSI report. The web server also gets completed image set calculations from the SQL server via TCP/IP and inserts the image set into the image storage.

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Traditional 510 (k) Submission

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3/2/2010

C. INTENDED USE

ー、

They are intended to be used by a physician to view the images and use as an aid in calculation of alteration of motion segment integrity (AOMSI) of human spine. This device is not intended to be used for mammography images and does not require usage of 5 Mega pixel monitors.

D. SUBSTANTIAL EQUIVALENCE SUMMARY

"Spinal Guides" PACS has substantially same indications for use as the legally marketed predicate device Opal-Rad manufactured by Viztek, Inc., K063337 with major differences being:

1. It does not process images for mammography and does not require 5M pixel monitors, nor does it display 3D images acquired from CT and MR modalities.
1. It was created in C# computer language
1. Spinal Guides PACS were specifically made viewing of the images and for calculation of Alteration of Motion Segment Integrity (AOMS) of human spine.

This indication difference does not modify the intended use- to assist users performing quantifications and qualifications common to the general medicine, orthopedic, radiologic, and chiropractic specialty.

The new device has substantially the same control methods and operating principles as the predicate (both are computer systems and software installed in them, both intended for viewing of images) with the following major differences:

1. Images for Spinal Guides are to be taken with the calibrator affixed on the patient's skin
Web users are opening the images and enter all required demographic information 2. and complete an image set for submission to database in "Pending" status
1. Local users are able to open image sets and view the images as well as process the images using automatic calculation process and formulate a PDF report turning "In process" and "Waiting for Completion" and "Complete", or turn the image sets into "Reject" to reject the image set.

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Traditional 510 (k) Submission

Submission Date: K092427

.3/2/2010

1. Once the image set turned to "Complete" by the local user the PDF report is automatically available to the web user
  Descriptive characteristics and data provided in this submission are sufficiently precise, to the best of our knowledge, to assure substantial equivalence.

E. TECHNOLOGICAL CHARACTERISTICS

Both the new device and the predicate are software applications installed on standard computers and servers, and utilize teleradiology via internet.

The technological characteristics are substantially the same in the proposed and predicate devices, with major differences are as follows:

1. Visual Studio 3.5.net C# programming language
1. The new device does not require usage of 5 megapixel monitors since the application is not intended to use mammography images

F. TESTING

Nonclinical tests for Spinal Guides PACS (software verification and validation) have been performed in conformance to specifications and the application is in conformance to DICOM standard PS3 NEMA 3.0 1/1/2008

G. CONCLUSIONS

This 510(k) has demonstrated Substantial Equivalence of Spinal Guides PACS and Opal-Rad ™ as defined in the Federal Food, Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/11/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract bird or a flowing design, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002

MAR 1 3 2010

Albert Davydov, DDS 109-33 7156 Road, #11B FOREST HILLS NY 11375

Re: K092427

Trade/Device Name: Spinal Guides PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 2, 2010 Received: March 9, 2010

Dear Dr. Davydov:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

Submission Date:

3/2/2010

Indications for use Statement

510(k) Number:

K092427

Spinal Guides PACS

Device Name:

Indications For Use:

Spinal Guides PACS is intended to perform: operations relating to the acceptance of spinal Xray medical images and patient demographic information, their display, digital processing, review and editing, measurements report generation with respective storage and teleradiology exchange capabilities. They are intended to be used by a physician to view the images and use as an aid in calculation of

alteration of motion segment integrity (AOMSI) of human spine.

This device is not intended to be used for mammography images and does not require usage of 5 Mega pixel monitors.

Prescription Use AND/OR Over-The-Counter Use No Yes (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Beview Evaluation Page 1 of

(Division Sign-On)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K092427

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).