Volumetric Tomography is intended to be used for producing crosssectional (tomographic) radiographic images from the edentulous or dentate area of the jaws. The cross-sectional images provide dimensional information for dental implant planning and information about location of impacted teeth.

Device Description

The Volumetric Tomography imaging option for Orthopantomograph® OP100 and OP200 product families utilizes Statistical Inversion (SI) that is used to reconstruct tomographic images from a set of pre-acquired projection radiographic images of the object. To reconstruct means producing cross-sectional images from a set of projection images by using computer calculation. Projection image means a radiographic image from a certain angle in which the structures of the object are seen superimposed. Tomographic means viewing an object as a series of thin slices. Projection images are captured with a digital panoramic unit using scanning as the imaging method. Scanning projection images is previously known technique and commonly used for example in digital cephalometric units. Along with the object a set of fiducials are recorded on the projection images to be used for geometry refinement and cross-registration between the reconstructed image set and a separate panoramic scout image. Tomographic images are then reconstructed from the projection images with a computer. For dimensional information for dental implant planning and information about location of impacted teeth all three imaging modalities can be used: projection image set, the panoramic image and the reconstructed image set. The tomographic slice and the slice angle are selectable after reconstruction to ensure the correct positioning of the slice referenced to the anatomy. In addition to the selection of the tomographic slice also the slice angle is user adjustable to ensure the correct position and angle compared to the anatomy.

AI/ML Overview

The provided text is a 510(k) summary for the Volumetric Tomography device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot populate the table or answer most of the specific questions based on the provided text. The document focuses on regulatory submission details rather than a detailed technical study report.

Here's what can be extracted:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or report specific device performance metrics (e.g., accuracy, sensitivity, specificity, image quality scores) from a study. It generally states that the device is "similar in design, composition and function" to a predicate device and that "The comparison of characteristics supports substantial equivalence."

Study Information

The document references two scientific publications that describe the "Statistical Inversion" algorithm more thoroughly:

"Statistical inversion for medical x-ray tomography with few radiographs: I. General theory;" Phys. Med. Biol. 48 (2003) 1437–1463
"Statistical inversion for medical x-ray tomography with few radiographs: II. Application to dental radiology;" Phys. Med. Biol. 48 (2003) 1465–1490

However, the provided 510(k) summary itself does not contain the details of these studies regarding sample sizes, data provenance, ground truth, experts, or performance metrics. It only cites them as a description of the underlying algorithm.

Here's a breakdown of what cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: Not provided.
Sample sizes used for the test set and the data provenance: Not provided within this document. The referenced studies might contain this.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided within this document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided within this document.
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 provided within this document. The device is a reconstruction algorithm, not explicitly an AI-assisted diagnostic tool in the sense of comparing human readers with and without AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No specific standalone performance study details are presented here.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided within this document.
The sample size for the training set: Not provided within this document.
How the ground truth for the training set was established: Not provided within this document.

Summary

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Image /page/0/Picture/0 description: The image shows the word "INSTRUMENTARIUM" in a simple, sans-serif font. To the left of the word is a stylized logo. The logo appears to be a lowercase "i" inside of a circle. The logo and the word are both in black.

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K063773
page 1 of 3

JAN $ 1 7007

510(k) Summary

Date

December 15, 2006

Manufacturer

Instrumentarium Dental, PaloDEx Group Oy P.O.Box 20 (Street address: Nahkelantie 160) FIN-04301 Tuusula, Finland

Tel: +358 45 7882 2000 Fax: +358 45 7882 2506

Contact person: Mr. Jouni Onnela, Tel +358 40 747 2550

United States Sales Representative (U.S. Designated agent)

INSTRUMENTARIUM DENTAL INC. 300 West Edgerton Ave. Milwaukee, WI 53207 -6025 Tel: +1 414 747 1030, 800 558 6120 Fax: +1 414 481 8665

Contact Person: Mr. Frank Kashinski, Tel +1 414 747 6315

Trade name:

Volumetric Tomography

Common name:

Film/digital dental panoramic X-ray equipment with cephalostat.

Classification name:

Extraoral source X-ray system (21 CFR 872.1800, product code EHD)

Description:

Projection images are captured with a digital panoramic unit using scanning as the imaging method. Scanning projection images is previously known technique and commonly used for example in digital cephalometric units. Along with the object a set of fiducials are recorded on the projection images to be used for geometry refinement and cross-registration between the reconstructed image set and a separate panoramic scout image.

Instrumentarium Dental

Street address:	Nahkelantie 160, 04300 Tuusula Finland
Postal address:	P.O. Box 20, FI-04301 Tuusula, Finland
Tel.	+358 45 7882 2000
Fax	+358 45 7882 2506

Bank

SWIFT Nordea Bank NDFAFIHH Account: Fl9015963000046864

PaloDEx Group Oy, Tuusula, FINLAND

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2043773
Page 2 of 3

Tomographic images are then reconstructed from the projection images with a computer. For dimensional information for dental implant planning and information about location of impacted teeth all three imaging modalities can be used: projection image set, the panoramic image and the reconstructed image set. The tomographic slice and the slice angle are selectable after reconstruction to ensure the correct positioning of the slice referenced to the anatomy. In addition to the selection of the tomographic slice also the slice angle is user adjustable to ensure the correct position and angle compared to the anatomy.

When comparing this method to previously known tomographic techniques like continuous linear tomography (such as the OrthoTrans option for OP100 and OP200 film units), the Volumetric Tomography imaging concept can be thought as a discrete tomography in which several slices can be produced from a set of projection images.

The calculation algorithm - Statistical Inversion - is more thoroughly described in the following scientific publications:

Statistical inversion for medical x-ray tomography with few radiographs: I. General theory; Phys. Med. Biol. 48 (2003) 1437-1463 Pli: S0031-9155(03)57800-9

Statistical inversion for medical x-ray tomography with few radiographs: II. Application to dental radiology; Phys. Med. Biol. 48 (2003) 1465-1490 Pli: S0031-9155(03)57801-O

The Volumetric Tomography option comes with a complete image handling software, CliniView, offering the same familiar and intuitive user interface as with the conventional modalities (i.e. Panoramic, cephalometric and intraoral radiographic images). In addition to the Volumetric Tomography specific functionality Cirilifiew features include dynamic zooming, brightness and contrast adjustments, edge enhancement, and measurements. The software runs on Windows 2000 and XP operating systems.

Intended use:

Volumetric Tomography is intended to be used for producing cross-sectional (tomographic) radiographic images from the edentulous or dentate area of the jaws. The cross-sectional images provide dimensional information for dental implant planning and information about location of impacted teeth.

Instrumentarium Dental

Street address: Postal address: ابع آ -3x

Nahkelantie 160, 04300 Tuusula Finland P.O. Box 20, FI-04301 Tuusula, Finland +358 45 7882 2000 +358 45 7882 2506

Bank

SWIFT Nordea Bank NDEAFIHH Account: Fl9015963000046864

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Image /page/2/Picture/0 description: The image shows the word "INSTRUMENTARIUM" in all capital letters. To the left of the word is a logo that appears to be the letter "i" inside of a circle. The logo and the word are both in black. The background of the image is white.

K063773
Page 36

Substantial Equivalence:

We consider Volumetric Tomography is similar in design, composition and function to the following predicate device introduced into commercial distribution after May 28, 1976:

Orthopantomograph® OP100/Orthoceph® OC100 with OrthoTrans linear tomography option #K973642.

The comparison of characteristics supports substantial equivalence.

Instrumentarium Dental

Street address: Postal address: Tel. Fax

Nahkelantie 160, 04300 Tuusula Finland P.O. Box 20, FI-04301 Tuusula, Finland +358 45 7882 2000 +358 45 7882 2506

Bank

SWIFT Nordea Bank NDEAFIHH Account: F19015963000046864

PaloDEx Group Oy, Tuusula, FiNLAND

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form. The symbol consists of three curved lines that appear to be interconnected.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 6 2007

Instrumentarium Dental, PaloDEx Group OY % Mr. Frank Kashinski Official Correspondent Instrumentarium Dental, Inc. 300 West Edgerton Ave. MILWAUKEE WI 53207-6025

Re: K063773

Trade/Device Name: Volumetric Tomography Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH and OAS Dated: December 15, 2006 Received: December 21, 2006

Dear Mr. Kashinski:

This letter corrects our substantially equivalent letter of January 31, 2007.

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 (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 (PMA), it may be subject to 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.

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

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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. Brogdon

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): _ C o 63773

Device Name: Volumetric Tomography

Indications for Use:

Prescription Use Prescription Ose _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdom and Radiological Devices 510(k) Number __

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.