The NewTom VG Computed Tomography X-ray System is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.

The NewTom VG accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two-dimensional images and three-dimensional renderings.

Device Description

The NewTom VG Computed Tomography X-Ray System (NewTom VG) is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images. It then reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of such volume, displaying both two- and three-dimensional images. The NewTom VG can measure distances and thickness on two-dimensional images. Such images can be printed or exported on magnetic and optical media.

The NewTom VG hardware, including a scanner unit (comprised of an X-ray source, flat panel detector and a motorized arm) and a control box. facilitates the acquisition of a full X-ray sequence by the device software. The NewTom VG software runs on an x86 architecture based workstation. The NewTom VG reconstructs a three-dimensional model of x-ray images similar to the threedimensional model obtained using the parent NewTom 3G Computed Tomography X-Ray System (NewTom 3G).

AI/ML Overview

This 510(k) summary for the NewTom VG Computed Tomography X-Ray System indicates that the device met all requirements during performance testing. However, it does not explicitly state acceptance criteria or provide a detailed study that proves the device meets specific performance criteria. Instead, it relies on substantial equivalence to a predicate device (NewTom 3G Computed Tomography X-Ray System K041137) and general performance testing for electrical safety, EMC/EMI, and verification/validation.

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

Here's a breakdown of what can be inferred or cannot be found:

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

Acceptance Criteria	Reported Device Performance
Specific image quality metrics (e.g., spatial resolution, contrast-to-noise ratio, dose efficiency)	Not specified in the document. The document states, "The NewTom VG Computed Tomography X-Ray System met all requirements, and functioned as intended and is therefore safe and effective for its intended use." However, no specific performance metrics or thresholds are provided.
Electrical Safety Standards	"Electrical safety... testing were performed."
EMC/EMI Standards	"EMC/EMI testing... were performed."
Verification and Validation Testing Standards	"Verification and validation testing were performed."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Number of Experts: Not specified. This type of information would typically be relevant for studies evaluating diagnostic accuracy, which is not detailed in this 510(k) summary.
Qualifications of Experts: Not specified.

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

Adjudication Method: Not specified.

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

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. This device is an X-ray system, not an AI-assisted diagnostic tool. The document focuses on the system's ability to acquire and reconstruct images, not on its impact on human reader performance in conjunction with AI.
Effect Size of AI Improvement: Not applicable.

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

Standalone Performance: Not explicitly detailed in terms of qualitative or quantitative metrics. The document describes the system's ability to reconstruct 3D models and produce 2D views, which implies its standalone image generation capabilities. However, no specific performance study of the algorithm's output quality as a standalone component is described with measurable results.

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

Type of Ground Truth: Not specified. Given the nature of a 510(k) for an imaging device, ground truth for image quality might be related to objective phantom measurements or comparison to established imaging standards. However, details of such a process are not provided in this summary.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This document describes an X-ray imaging system, not an AI model that requires a training set.

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

Ground Truth for Training Set Establishment: Not applicable.

Summary

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K072357

SEP | 8 2007

Special 510(k) Summary for NewTom VG Computed Tomography X-Ray System

1. SPONSOR

AFP Imaging Corporation 250 Clearbrook Road Elmsford, NY 10523

Phone: 941-592-6100 Fax: 941-592-6148

Contact Person: David Vozick Telephone: 914 542 6100 ext. 204

Date Prepared: August 21, 2007

2. DEVICE NAME

Proprietary Name:	NewTom VG Computed Tomography X-Ray System
Common/Usual Name:	X-Ray System
Classification Name:	Computed Tomography X-Ray System

3. PREDICATE DEVICES

NewTom 3G Computed Tomography X-Ray System K041137

4. DEVICE DESCRIPTION

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The NewTom VG is designed for use in diagnostic support both in dento-maxillofacial radiology, with a particular reference to "planning" and to monitoring of implantations, and in the field of maxillofacial surgery.

న్. INTENDED USE

The NewTom VG is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The NewTom VG accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The technological characteristics of the NewTom Computed Tomography X-ray System and the parent NewTom 3G Computed Tomography X-ray Systems are substantially equivalent in that they are devices designed to provide images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The proposed NewTom VG and the parent NewTom 3G are computer controlled dedicated x-ray imaging devices that construct three-dimensional models from images taken during a rotational x-ray sequence. It is optimized for bone morphology analysis of the maxillofacial region.

The proposed NewTom VG and the NewTom 3G both use an X-ray imaging system that acquires a 360 degrees rotational x-ray sequence and reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of this volume, displaying both two- and three-dimensional images.

The proposed NewTom VG hardware, including a control box and framework comprised of an x-ray source, detector and either a fixed or rotating arm whereas the NewTom 3G system consists of the same components with only a fixed arm. The

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proposed NewTom VG allows imaging to be performed in both a sitting and standing position and the parent NewTom 3G system only allows imaging to be performed in a supine position. The above differences do not impact safety or effectiveness since both the parent NewTom 3G and the proposed NewTom VG system are identical in that they are computer controlled dedicated x-ray imaging devices that constructs threedimensional models from images taken during a rotational x-ray sequence. The technological characteristics for both the proposed NewTom VG and the parent NewTom 3G devices provide the user with a method of constructing a threedimensional models from images taken during a rotational x-ray sequence. Therefore, the addition of hardware to improve image quality and flexibility of design represent minor technological differences that do not affect the overall safety or effectiveness of the proposed NewTom VG Computed Tomography X-ray System.

7. Performance Testing

Electrical safety, EMC/EMI testing, and verification and validation testing were performed to support the hardware and software modifications. The NewTom VG Computed Tomography X-Ray System met all requirements, and functioned as intended and is therefore safe and effective for its intended use.

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Image /page/3/Picture/0 description: The image shows a circular logo with the words "OF HEALTH & HUMAN SERVICES USA" written around the perimeter of the circle. Inside the circle is a symbol that appears to be three stylized lines that resemble a bird in flight. The logo is black and white and has a simple, clean design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 1 8 2007

AFP Imaging Corporation % Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Consultant Medical Device Consultants. Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K072357

Trade/Device Name: NewTom VG Computer Tomography X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: August 21, 2007 Received: August 22, 2007

Dear Ms. McNamra-Cullinane:

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 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "PA" in a stylized font. Below the letters, the word "Centennial" is written in cursive. Three stars are arranged in a horizontal line below the word "Centennial". The logo appears to be a commemorative emblem for a centennial celebration.

Prossing and Promoting Publio Hoalth

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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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology).	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: NewTom VG Computed Tomography X-ray System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C) প্লফ্ল্

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hels Perman

(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.