This is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists. Not for mammographic use.

Device Description

The Bel-Cat series is a set of arm type X-ray CT diagnostic devices which has exposure modes can be customized to meet a wide variety of diverse diagnostic imaging needs. The Bel-Cat series is a true all-in-one system capable of offering diverse acquisition modes that deliver the high-definition images demanded in dental fields.

AI/ML Overview

The provided text describes a 510(k) summary for the Bel-Cat Dental Cone Beam CT device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics of the device itself. Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets, how ground truth for the training set was established) are not explicitly present in the provided information.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are implied to be "as safe and effective as the predicate device" and having "few technological differences, and no new indications for use." The device's performance is demonstrated through a comparison of its specifications to the predicate device.

Feature	Acceptance Criteria (Implied: Equivalent to Predicate)	Reported Bel-Cat Device Performance
Indication for Use	An x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. Operated by physicians, dentists, and x-ray technologists.	SAME (as predicate device)
Focal spot	0.6mm x 0.6mm	0.5mm x 0.5mm (Slight difference, but deemed substantially equivalent)
Tube voltage	60-100 kV	60-95 kV (Within predicate range for lower end, slightly lower max)
Tube current	2-15 mA	2-12 mA (Within predicate range for lower end, slightly lower max)
Exposure time	17 sec maximum	17 sec maximum
Input	3 kVa	2 kVa (Lower, indicates potentially less power consumption, not a safety concern for equivalence)
Power supply	AC 220 v, 50/60 Hz	AC 220 v, 50/60 Hz
Projection mode	CT, Panoramic	CT, Panoramic
Detector dimension	Varian 2520: 250mm x 200mm, 127µm x 127µm, 1536 x 1920 pixels; Varian 3030: 300mm x 300mm, 194µm x 194µm, 1536 x 1536 pixels	Varian 2520: 250mm x 200mm, 127µm x 127µm, 1536 x 1920 pixels; Varian 1313: 130mm x 130mm, 127µm x 127µm, 1024 x 1024 pixels (Offers a different, smaller detector option than one of the predicate's options, but also deemed substantially equivalent)

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

The document states that "The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices," and mentions "bench test data as well as external laboratory testing to applicable standards." However, no specific sample size or details about the data provenance (e.g., country of origin, retrospective/prospective) for any "test set" are provided. The submission focuses on technical specifications and equivalence, not a clinical trial with a defined test set.

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

Not provided. This type of information is not typically included in a 510(k) summary for a device demonstrating substantial equivalence through technical specification comparison, especially if no specific clinical test set is detailed.

4. Adjudication method for the test set

Not provided. As no specific clinical test set with human assessments is described, no adjudication method would be presented.

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

No MRMC study was done or reported. This device is a diagnostic imaging system, not an AI-assisted interpretation device. The submission focuses on the safety and effectiveness of the imaging system itself, not the improvement of human readers with AI assistance.

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

Not applicable/Not provided. This is a hardware device (CT scanner). The concept of "standalone algorithm performance" does not apply directly to this type of medical device submission.

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

Not explicitly detailed. The "ground truth" for demonstrating substantial equivalence appears to be established through engineering specifications, performance tests (bench and laboratory), and implied clinical consensus on the diagnostic utility of the images produced, as it is equivalent to an already marketed device. There's no mention of specific pathology or outcomes data from a new clinical study.

8. The sample size for the training set

Not applicable/Not provided. This device is a conventional CT scanner, not a machine learning or AI-based system that undergoes "training."

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

Not applicable/Not provided. As there is no "training set" for this type of device, no ground truth establishment method for it is relevant.

Summary

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JUL 19 2011

510(k) Summary 510(k) Number K10 1 / 8 / TAKARA BELMONT CORPORATION 1-1-2 CHOME, HIGASHI-SHINSAIBASHI, CHUO-KU Osaka 542 Japan Tel: 81-6-6213-5945 Fax: 81-6-6212-3680 Date Prepared: April 19, 2010 Tomokuni Hasegawa, Senior VP Contact:

1. Identification of the Device: Proprietary-Trade Name: Bel-Cat Dental Cone Beam CT Classification Name: Computed Tomography X-Ray System Product Code 90 OAS Common/Usual Name: Dental CT
Equivalent legally marketed device: TAKARA BELMONT Alphard K072574 2.
1. Indications for Use (intended use) Bel-Cat is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists. (Not for mammographic use.)
1. Description of the Device: The Bel-Cat series is a set of arm type X-ray CT diagnostic devices which has exposure modes can be customized to meet a wide variety of diverse diagnostic imaging needs. The Bel-Cat series is a true all-in-one system capable of offering diverse acquisition modes that deliver the high-definition images demanded in dental fields.

Model	Bel-Ca:	Bel-Ca: PA	Bel-Ca1 CM
Exposure modes
CCDPanoramic
CCDCephalometric
FPDPanoramic
CT

Safety and Effectiveness, comparison to predicate device. The results of bench, test 5. laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices.

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Model	TAKARA BELMONT AlphardK072574	TAKARA BELMONT Bel-Cat
Indicationfor use	An x-ray device (cone beam computedtomography) that acquires a single 360degree rotational sequence of the headand neck areas, including the ENT anddentomaxillofacial area for use indiagnostic support. The device is operatedand used by physicians, dentists, and x-ray technologists.	SAME
Specificationcomparison	Focal spot: 0.6mm×0.6mmTube voltage 60-100 kVTube current: 2-15 mAExposure time: 17 sec maximumInput: 3 kVaPower supply: AC 220 v, 50/60 Hz.Projection mode: CT, PanoramicDetector dimension:Two sizes available:Varian 2520: 250mm x 200mm Pixel size127µm x 127µm1536 x 1920 pixelsVarian 3030, 300mm x 300mm, Pixelsize194µm x 194µm1536 x 1536 pixels	Focal spot: 0.5mm×0.5mmTube voltage 60-95 kVTube current: 2-12 mAExposure time: 17 sec maximumInput: 2 kVaPower supply: AC 220 v, 50/60 Hz.Projection mode: CT, PanoramicDetector dimension:Two sizes available:Varian 2520: 250mm x 200mm Pixel size127µm x 127µm1536 x 1920 pixelsVarian 1313, 130mm x130mm, Pixelsize127µm x 127µm1024 x 1024 pixels

6. Substantial Equivalence Chart

7. Conclusion

After analyzing both bench test data as well as external laboratory testing to applicable standards, it is the conclusion of Takara Belmont Corporation that the Bel-Cat Dental Cone Beam CT System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Takara Blemont Corp. % Mr. Daniel Kamm, P.E. Regulatory Engineer, Submission Correspondent Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

JUL 19 2011

Re: K101181

Trade/Device Name: Bel-Cat (various models) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: May 25, 2011 Received: May 27, 2011

Dear Mr. Kamm:

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.

Mary Pastel

Mary S. Pastel, Sc.D. 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): K10 // 81

Device Name: Bel-Cat (various models)

Indications For Use:

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiologica Office of In Vitro Diagnostic Device Evaluati

510K

Page 15 of 263

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.