Alphard Model X178 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.

Device Description

Alphard series 3D X-ray CT realizes wide area imaging by adopting the principle of cone beam CT and using high-resolution wide area flat panel detector (FPD). Alphard series enables dentist to take wide range imaging from small area to wide area with appropriate imaging mode according to various treatment objects. Combination of advanced FPD (dynamic range: 14bit) and micro focus X-ray tube provides high resolution CT image from soft tissue to hard tissue. Our original software AsahiVision freely displays high picture quality 3D image and MPR image.

AI/ML Overview

The provided text is a 510(k) summary for the Alphard Model X178 Dental Cone Beam CT system. This document focuses on demonstrating substantial equivalence to existing legally marketed devices rather than establishing specific performance acceptance criteria and a detailed study proving those criteria are met for the new device.

Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes for test/training, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) is not present in the provided 510(k) summary.

The document implicitly "proves" the device meets acceptance criteria by demonstrating substantial equivalence to predicate devices through a comparison of indications for use and technical specifications. The acceptance criterion is essentially that the device is "as safe and effective" as the predicates.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit via Substantial Equivalence): The primary "acceptance criteria" presented is that the Alphard Model X178 Dental Cone Beam CT system is substantially equivalent to the predicate devices (K052587 and K063622) in terms of safety, effectiveness, technological characteristics, and indications for use.

Reported Device Performance: The document provides technical specifications for the Alphard and compares them to the predicate devices. The "performance" is considered adequate if these specifications fall within acceptable ranges relative to the predicates, implying similar image quality and functional capabilities.

Feature / Criterion (Implicit)	Predicate Device 1 (K052587)	Predicate Device 2 (K063622)	Alphard Model X178 (Reported)
Indications for Use	Diagnostic support for head, neck, ENT, dentomaxillofacial areas via 360-degree rotational sequence. Operated by physicians, dentists, x-ray technologists.	Diagnostic support for head, neck, ENT, dentomaxillofacial areas via 360-degree rotational sequence. Operated by physicians, dentists, x-ray technologists.	Identical to Yoshida (Predicate 2).
Focal Spot	0.5mm x 0.5mm	0.2mm x 0.2mm	0.6mm x 0.6mm
Tube Voltage	60 ~ 90kV	90kV	60-100 kV
Tube Current	1 ~ 10mA	4mA	2-15 mA
Exposure Time	Under 18sec	19-37 sec	17 sec maximum
Input	2.0kVA	1.5kVA	3 kVA
Power Supply	AC100V, 50/60Hz	AC120V, 60Hz	AC 220V, 50/60 Hz
Projection Mode	CT, Panoramic	CT	CT, Panoramic
Detector Dimension	109mm x 111mm	120mm x 120mm	Two sizes: Varian 2520 (250mm x 200mm); Varian 3030 (300mm x 300mm)
Pixel Size	(Not specified)	200µm x 200µm	Varian 2520 (127µm x 127µm); Varian 3030 (194µm x 194µm)
Image Matrix Size	(Not specified)	608 x 616 pixels	Varian 2520 (1536 x 1920 pixels); Varian 3030 (1536 x 1536 pixels)

Conclusion on Equivalence: "After analyzing both bench and user testing data as well as external laboratory testing to applicable standards, it is the conclusion of Takara Belmont Corporation that the Alphard Model X178 Dental Cone Beam CT System is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices."

The following information is not provided in the 510(k) summary:

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

Not specified. The document mentions "bench, test laboratory and clinical testing" and "user testing data" but does not provide details on sample sizes, types of data (e.g., patient cases vs. phantoms), or provenance (country, retrospective/prospective).

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

Not specified. Given the nature of a substantial equivalence submission for imaging hardware, a detailed expert-based ground truth assessment of diagnostic performance (as would be seen in an AI software submission) is typically not required or detailed in this summary.

4. Adjudication method for the test set

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

No. This is a hardware submission, not an AI or software submission. An MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

No. This is a hardware submission. "Standalone performance" in the context of an algorithm is not applicable here.

7. The type of ground truth used

Not specified in detail. The document mentions "bench, test laboratory and clinical testing." For hardware, ground truth typically involves physical measurements, phantom studies for image quality metrics (resolution, noise, contrast), and potentially clinical assessments of image interpretability (without a formalized ground truth process for diagnostic accuracy as for AI).

8. The sample size for the training set

Not applicable/Not specified. This pertains to an imaging device itself, not an AI algorithm requiring a training set. The device produces images based on physical principles, not a trained model.

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

Not applicable/Not specified. See point 8.

Summary

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KD72574

510(k) Summary 510(k) Number

OCT 1 8 2007

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: September 7, 2007 Contact: Tomokuni Hasegawa, Senior VP

1. Identification of the Device: Proprietary-Trade Name: Alphard Model X178 Dental Cone Beam CT Classification Name: Computed Tomography X-Ray System Product Code 90 OAS Common/Usual Name: Dental CT
1. Equivalent legally marketed device: K052587 3D Accu-tomo XYZ Slice View Tomograph, manufactured by MORITA and K063622 Fine Cube, manufactured by YOSHIDA
1. Indications for Use (intended use) Alphard 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 ..
1. Description of the Device: Alphard series 3D X-ray CT realizes wide area imaging by adopting the principle of cone beam CT and using high-resolution wide area flat panel detector (FPD). Alphard series enables dentist to take wide range imaging from small area to wide area with appropriate imaging mode according to various treatment objects. Combination of advanced FPD (dynamic range: 14bit) and micro focus X-ray tube provides high resolution CT image from soft tissue to hard tissue. Our original software AsahiVision freely displays high picture quality 3D image and MPR image.

Imaging mode and range

Alphard VEGA in Alphard series (Alphard-3030)

. D mode (Dental CT mode: imaging area 51 mm in dia. X Height 51 mm)
t I mode (Implant CT mode: imaging area 102 mm in dia. X Height 102 mm)
. P mode (Panoramic CT mode: imaging area 154 mm in dia. X Height 154 mm)

C mode (Cephalo CT mode: imaging area 200 mm in dia. X Height 179 mm) . Alphard VEGA in Alphard series (Alphard-2520)

D mode (Dental CT mode: imaging area 51 mm in dia. X Height 51 mm) .
. I mode (Implant CT mode: imaging area 102 mm in dia. X Height 102 mm)
. P mode (Panoramic CT mode: imaging area 169 mm in dia. X Height 119 mm)
1. Safety and Effectiveness, comparison to predicate device. The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices.

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Manu-facturer	J. Morita Manufacturing.Corporation. K052587	Yoshida DentalK063622	TAKARABELMONT
ProductName	3D Accu-I-tomo XYZ SliceView Tomograph	FineCube	Alphard
Indicationfor use	The 3D Accu-I-tom0 is an x-rayimaging device that acquires a360 degreerotational sequence of the headand neck areas, including theENT and dentomaxillofacialareas, for use in diagnosticsupport. The deviceaccomplishes thistask by reconstructing a three-dimensional matrix of theexamined volume and producingtwo-dimensional views of thisvolume, displaying both two-and three dimensionalimages. The device can also beused for fluoroscopy duringsurgery, mostly for ENT andTMJ applications and mostlywith a contrast medium. Thedevice is operated and used byphysicians, dentists, and x-raytechnologists.	FineCube is an x-raydevice (cone beamcomputed tomography)that acquires a single360 degree rotationalsequence of the headand neck areas,including the ENT anddentomaxillofacial areafor use in diagnosticsupport.The device is operatedand used by physicians,dentists, and x-raytechnologists.	Identical to Yoshida: anx-ray device (cone beamcomputed tomography)that acquires a single360 degree rotationalsequence of the headand neck areas,including the ENT anddentomaxillofacial areafor use in diagnosticsupport.The device is operatedand used by physicians,dentists, and x-raytechnologists
Specificationcomparison	Focal spot:0.5mm x 0.5mmTube voltage: 60 ~ 90kVTube current: 1 ~ 10mAExposure time:Under 18secInput: 2.0kVAPower supply:AC100V, 50/60HzProjection mode:CT, PanoramicDetector dimension:109mm x 111mm	Focal spot:0.2mm×0.2mmTube voltage: 90kVTube current: 4mAExposure time: 19-37secInput: 1.5kVAPower supply: AC120V, 60HzProjection mode: CTDetector dimension:120mm x 120mmPixel size:200μm×200μmImage matrix size:608 x 616 pixels	Focal spot:0.6mm×0.6mmTube voltage 60-100 kVTube current: 2-15 mAExposure time: 17 secmaximumInput: 3 kVAPower supply: AC 220v, 50/60 Hz.Projection mode: CT,PanoramicDetector dimension:Two sizes available:Varian 2520: 250mm x200mm Pixel size127µm x 127µm1536 x 1920 pixelsVarian 3030, 300mm x300mm, Pixel size194µm x 194µm1536 x 1536 pixels

Substantial Equivalence Chart 6

7. Conclusion

After analyzing both bench and user testing data as well as external laboratory testing to applicable standards, it is the conclusion of Takara Belmont Corporation that the Alphard Model X178 Dental Cone Beam CT System is as safe and effective as the predicate devices, 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines that resemble a stylized human figure. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2007

Takara Belmont Corporation % Mr. Daniel Kamm Principal Engineer Kamm & Associates PO Box 7007 DEERFIELD IL 60015

Re: K072574

Trade/Device Name: Alphard Model X178 Dental Cone Beam CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 12, 2007 Received: September 13, 2007

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 either class II (Special Controls) or class III (PMA), 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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

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):

Device Name: Alphard Model X178 Dental Cone Beam CT

Indications For Use:

Prescription Use X AND/OR (Part 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

loye Thhay
(Division Sign-Off)

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

Page 1 of 1

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.