The NewTom 5G 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 5G 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 5G is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images. It 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 5G can measure distances and thickness on two-dimensional images. Such images can be printed or exported on magnetic and optical media.

The NewTom 5G hardware, including a scanner unit (comprised of the X-ray source, flat panel detector and the motorized arm) and a motorized patient support, facilitates the acquisition of a full X-ray sequence by the device software. The NewTom 5G software runs on an x86 architecture based workstation. The NewTom 5G reconstructs a three-dimensional model of X-ray images similar to the three-dimensional model obtained using the parent NewTom VG Computed Tomography X-Ray System.

AI/ML Overview

This document describes the NewTom 5G Computed Tomography X-Ray System. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a standalone study for a new AI/software component. Therefore, much of the requested information regarding AI device performance, sample sizes for test/training sets, expert consensus for ground truth, and MRMC studies is not available in the provided text.

The submission highlights minor technological differences between the NewTom 5G and its predicate device, the NewTom VG, primarily concerning patient positioning and image quality/reliability improvements through hardware and software modifications. The core imaging principle (360-degree rotational X-ray sequence to reconstruct 3D models for diagnostic support in dento-maxillofacial radiology) remains the same.

Here's the information that can be extracted or inferred from the provided text, along with a clear indication of what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	The NewTom 5G computed tomography X-ray system met all requirements, and functioned as intended and is therefore safe and effective for its intended use. (This is a general statement about meeting regulatory requirements rather than specific performance metrics.)
Technological Equivalence	The NewTom 5G and the predicate NewTom VG are substantially equivalent. Both use a 360-degree rotational X-ray sequence to reconstruct 3D models and produce 2D views for diagnostic support in dento-maxillofacial radiology and maxillofacial surgery. Minor hardware/software changes for ergonomics and improved image quality/reliability do not affect overall safety or effectiveness.
Electrical Safety, EMC/EMI	Electrical safety, EMC/EMI testing was performed. The system met all requirements.
Verification and Validation	Verification and validation testing was performed to support hardware and software modifications. The system met all requirements and functioned as intended.

2. Sample Sizes for Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document primarily focuses on demonstrating substantial equivalence through technological comparison and general safety/effectiveness testing, not a detailed clinical performance study with a specific test set for AI.
Data Provenance: Not specified.

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

Number of Experts: Not applicable/not specified. The provided text does not describe a clinical study involving experts establishing ground truth for a test set. This type of information is typically part of a performance study for AI/software, which is not the primary focus of this 510(k) summary.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not specified.

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

MRMC Study Done? No. The document does not describe an MRMC study comparing human readers with and without AI assistance. This device is an imaging system, and while it produces images that humans interpret, it doesn't describe an AI-powered diagnostic aid that would typically be evaluated with an MRMC study in this context.
Effect Size of Human Readers with/without AI: Not applicable, as no such study was described.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done? No. This submission describes an imaging device, not a standalone algorithm. The "software" mentioned is for image acquisition and reconstruction, not autonomous diagnostic interpretation.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable/not specified in the context of a performance study. The "ground truth" for this device's evaluation is primarily its ability to produce diagnostically acceptable images and function safely and effectively, demonstrating substantial equivalence to its predicate device. This is assessed through engineering tests, V&V, and comparison of technical characteristics, not by comparing its outputs against independent clinical ground truth like pathology for specific disease detection in a clinical study.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not specified. The device is not described as using machine learning models that require a "training set" in the conventional sense for AI clinical applications. Its software performs image reconstruction, not learned pattern recognition from a large dataset.

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

How Ground Truth for Training Set Was Established: Not applicable/not specified, as there is no mention of a training set for an AI algorithm.

Summary

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APR - 6 2511

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Special 510(k) Summary

for

NewTom 5G Computed Tomography X-Ray System

1. 510(K) SUBMITTER/MANUFACTURER

QR s.r.l. Via Silvestrini, 20 37135 Verona, Italy

Phone: +39 045 8202727 Fax: +39 045 8203040

Contact Person: Lorenzo Bortolotti Phone: +39 045 8202727 e-mail lorenzo.bortolotti@grverona.it

Contact Person: Marco Serafini Phone: 439 045 8250256 e-mail marco.serafini@qrverona.it

DEVICE NAME 2.

Proprietary Name: NewTom 5G Other Model Name: NewTom 5G version FP Common/Classification Name: Computed Tomography X-Ray System

3. PREDICATE DEVICES

NewTom VG Computed Tomography X-Ray System K072357

4. DEVICE DESCRIPTION

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The NewTom 5G 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.

క. INTENDED USE

The NewTom 5G 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 5G accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both twodimensional images and three-dimensional renderings.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The technological characteristics of the NewTom 5G computed tomography X-ray system and the parent NewTom VG Computed Tomography X-Ray System are substantially equivalent since 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 5G and the parent NewTom VG 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 5G and the NewTom VG both use an X-ray imaging system that acquires a 360 degrees rotational X-ray sequence and reconstructs a threedimensional matrix of the examined volume and produces two-dimensional views of this volume, displaying both two- and three-dimensional images.

The proposed NewTom 5G hardware includes a scanner unit and a motorized patient support whereas the parent NewTom VG system consists of the same components of the scanner unit (X-ray source, flat panel detector and motorized arm) with a different

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patient support. The proposed NewTom 5G allows imaging to be performed in a supine position and the parent NewTom VG system only allows imaging to be performed in sitting and standing position. The above differences do not impact safety or effectiveness since both the parent NewTom VG and the proposed NewTom 5G system are identical in that they are computer controlled dedicated X-ray imaging devices that constructs three-dimensional models from images taken during a rotational X-ray sequence. The technological characteristics for both the proposed New Tom 5G and the parent NewTom VG devices provide the user with a method of constructing a threedimensional models from images taken during a rotational X-ray sequence. Therefore, hardware and software modification to support the new ergonomics and to improve image quality and reliability represent minor technological differences that do not affect the overall safety or effectiveness of the proposed NewTom 5G 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 5G 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird image.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

AUG 2 3 2013

Mr. Lorenzo Bortolotti Quality and Regulatory Affairs Manager QR srl Via Silvestrini 20 VERONA 37135 ITALY

Re: K110260

Trade/Device Name: NewTom 5G Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: February 28, 2011 Received: March 10, 2011

Dear Mr. Bortolotti:

This letter corrects our substantially equivalent letter of April 6, 2011.

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,

Janine M. Morris

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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Indications for Use

510(k) Number (if known):

Device Name: NewTom 5G

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Pastel

(UMsion Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K116260

QR s.r.l. 510(k) NewTom 5G X-Ray System January 14, 2011

CONFIDENTIAL Page xvi

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.