The BELMAX CM dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Description

The BELMAX CM Model X168 X-Ray System is the next generation of the Takara Belmont digital dental X-ray systems. Similar to the prior Takara Belmont ANA-BEL, ANA-BEL CM equipped with the Takara Belmont ADR Plus SSXI, the BELMAX CM Model X168 X-Ray System offers digital imaging with panoramic and cephalometric imaging programs with the same exposure levels (KV/mA). Modifications resulting in the device include a new sized CCD sensor including three rather than two of the same sensor array grids mounted in a removable cartridge rather than bolted in place.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the BELMAX CM Model X168 X-Ray System. The study conducted for this device is a clinical trial comparing its performance to film images.

Here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" for the clinical study in the form of a pre-defined threshold that the device needed to meet to be considered successful. Instead, it presents comparative performance metrics against film images, aiming to demonstrate that the BELMAX CM digital images are "better than" or "as good as" film.

Acceptance Criteria (Implied)	Reported Device Performance (BELMAX CM Digital Images)	Comparator (Film Images)
Clear observation of skeletal hard tissue structures	97% of subjects	81% of subjects
Sufficient depiction of soft tissue structures	87% of images	43% of images
Overall image quality	Rated better than film images	-
Sufficient clarity for landmark identification	93.6% average percentage	81.6% average percentage

2. Sample size used for the test set and the data provenance

Sample Size: 30 patients
Data Provenance: Retrospective, conducted in Japan at the Department of Oral Radiology, Asahi University School of Dentistry.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Five specialists
Qualifications of Experts: Specialists in orthodontic dentistry. (Further details on experience level, e.g., years of experience, are not provided).

4. Adjudication method for the test set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It mentions that "Readings were performed by five specialists in orthodontic dentistry." It's implied that these experts performed the evaluations that led to the reported percentages, but the method for resolving discrepancies among their readings, if any, is not detailed.

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 Comparative Effectiveness Study: A comparative study was done between digital images and film images, and human readers (specialists) were involved in reading both. However, this was not a study on AI assistance for human readers. It was a comparison between different imaging modalities (digital X-ray vs. film X-ray).
Effect Size of Human Readers with AI vs. without AI assistance: Not applicable, as the device is an X-ray system, not an AI-powered assistant for image interpretation.

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

No, a standalone (algorithm only) performance study was not done. The study specifically involved human readers (specialists) evaluating both digital and film images. The device itself is an imaging system, not an independent diagnostic algorithm.

7. The type of ground truth used

Expert Consensus/Expert Reading: The "ground truth" for evaluating image quality and clarity was established through the readings and ratings performed by five specialists in orthodontic dentistry. The document uses phrases like "rated as sufficient" and "rated better than," indicating subjective expert assessment. No objective pathology or outcomes data is mentioned as ground truth.

8. The sample size for the training set

The document does not mention a "training set" or any machine learning components for which a training set would be required. The BELMAX CM Model X168 is an X-ray imaging system, not an AI-driven diagnostic tool. Therefore, the concept of a training set as used in AI/ML is not directly applicable here. The focus of the study was on the image quality produced by the device for human interpretation, not on training an algorithm.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary

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K062529

	510(k) Summary		807.92(c)
Sponsor		SubmitterTAKARA BELMONT USA, INC.BELMONT Equipment Division101 Belmont DriveSomerset, New Jersey 08873-1204
	Contact Person:Telephone:	Robert Schiff973-227-1830
	Date Prepared:	September 26, 2006
Manufacturing Facility:Asahi Roentgen Ind. Co., Ltd376-3 Tsukiyama-cho, Kuze,Minami-ku, Kyoto, Japan
	Corresponding Official:Mr. Masahiro Kanaya
	Device Name		807.92(a)(2)
	Proprietary Name:Common/Usual Name:	BELMAX CM Model X168Dental Panoramic and Cephalometric X-RaySystem
Classification Name:Regulation Number:Classification Code:		System, X-Ray, Extraoral Source, Digital872.1800MUH
Predicate Devices			807.92(a)(3)
	Predicate Device #1:	Takara Belmont ANA-BEL, ANA-BEL CM,K040748
	Predicate Device #2:	Takara Belmont ADR Plus SSXI, K041834
	Predicate Device #3:	Generic X-Ray film/screen, a pre-amendmentdevice

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Device Description

Device Intended Use

The BELMAX CM Model X168 X-Ray System is an extraoral source dental panoramic and cephalometric X-ray System intended to produce X-rays for dental radiographic examination and diagnosis of disease of the teeth, jaw, and oral structures.

Device Technological Characteristics 807.92(a)(6)

BELMAX CM, Takara ANA-BEL and ANA-BEL CM with Takara ADR Plus SSXI Imaging Device all employ X-ray tube with maximum rated peak tube potential of 90 kV, and a CCD digital acquisition sensor in a replacement film cassette. Digital processing is used.

Nonclinical and Clinical Tests	807.92(b)
--------------------------------	-----------

807.92(b)(1) Nonclinical Tests Discussion

The nonclinical tests included

physical characteristics unique to the BELMAX CM, such as tolerance . limits and effects of power noise on the operation of the device
operational function tests such as procedure for taking an exposure .
functional characteristics such as plotting of the latent image decay . characteristic as a function of time and temperature, recovery time for radiographic device to be able to accept the next exposure
exposure characteristics such as quantitative measurements of the input . dose required to generate an image equivalent to that provided by a predicate device
safety features such as a ready signal provided to indicate the SSXI is . prepared to accept and process an X-ray input

807.92(a)(4)

807.92(a)(5)

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Clinical Tests Discussion

807.92(b)(2)

A clinical trial was sponsored and conducted by the Department of Oral Radiology, Asahi University School of Dentistry and included 30 patients receiving a dental examination. Readings were performed by five specialists in orthodontic dentistry. Digital images were observed on a computer monitor using the contrast, brightness, and magnification adjustment function of the ANA-BEL CM software, while X-ray films were observed on a conventional view box.

On BELMAX CM digital images, skeletal hard tissue structures were clearly observed in 97% of the subjects, whereas this fell to 81% for film images. For the depiction of soft tissue structures, 87% of BELMAX CM digital images were rated as sufficient whereas only 43% for film images. The BELMAX CM digital images were rated better than the film images on overall image quality. For landmark identification, the average percentage of sufficient clarity on BELMAX CM digital images was 93.6% and on X-ray film images it was 81.6%.

The BELMAX CM digital images were rated better than the film images for landmark identification.

Statement of Compliance with Federal X-ray Performance Standards

The BELMAX CM Model X168 X-Ray System is in compliance with the Federal X-ray performance standards.

Conclusion

807.92(b)(3)

The modified device has the same intended use and principle of operation as the prior Takara Belmont devices, as well as substantially equivalent technical specifications. The modifications were implemented to improve the ease of use. maintenance, and image quality, and do not change the intended use or fundamental scientific technology of the device. A hazard analysis, validation testing and clinical study against the generic X-ray film/screen predicate similar to those submitted for the prior Takara Belmont devices were presented to support the substantial equivalence of the modified Takara Belmont system.

The conclusions drawn from the nonclinical and clinical tests demonstrate that the BELMAX CM Model X168 X-Ray System is as safe, as effective and performs as well as or better than the Takara ANA-BEL and ANA-BEL CM Panoramic X-ray system with Takara ADR Plus SSXI Imaging Device and than the Generic X-Ray film.

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The BELMAX CM, Takara ANA-BEL and ANA-BEL CM Panoramic X-ray system with Takara ADR Plus SSXI Imaging Device and with the Generic X-Ray film are substantially equivalent.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings and a wavy line representing the body.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

OCT - 5 2006

Takara Belmont USA, Inc. Dr. Robert Schiff c/o Schiff & Company 1129 Bloomfield Avenue WEST CALDWELL-N1 07006

Re: K062529

Trade/Device Name: BELMAC CM, Model X168 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: August 28, 2006 Received: August 29, 2006

Dear Dr. Robert Schiff:

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/4/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are located at the bottom of the logo.

Protecting and Promoting Public Health

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Page 2 -

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 equivatence 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 STATEMENT

510(k) Number (if known): Device Name:

KD62529
Not assigned yet

Indications for Use:

Prescription Use X

(Per 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

Office of Device Evaluation (ODE)

David A. Ingram

(Division Sian-Off Division of Reproductive, Abd and Radiological Device 510(k) Number

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012

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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.