The Model MCT-1 EXF is an x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and threedimensional images. The device is operated and used by physicians, dentists, and x-ray technologists.

Device Description

The MCT-1 EX F is an X-ray CT using the limited cone beam. MCT-1 EX F makes diagnosis be possible due to its high resolution three dimensional images for small diagnosis be possible add to the extremely complex morphology of the hard tissue of the head and neck region. High resolution images are obtained in the same short period as that of the Panoramic Radiology. Low X-ray radiation dosage is realized and the overall system structure is assembled to be compact unit. The J.MORITA. MFG. CORP. has manufactured the MCT-1EX as the original model of such kind of X-ray scanner, and modify the device for MCT-1 EX F by replacing the image receptor , XII for FPD ( Flat Panel Detector).

AI/ML Overview

The provided 510(k) summary for the "3D Accu-I-tomo XYZ Slice View Tomograph MCT-1 EX F" is a submission for a modified device, primarily claiming substantial equivalence to a previously cleared device (MCT-1 EX, K030450) by replacing the image receptor. Therefore, the information provided focuses on demonstrating equivalence rather than establishing new performance criteria through a standalone study with acceptance criteria.

The submission does not contain specific acceptance criteria or an explicit study proving performance against such criteria in the way one might expect for a de novo device or a device claiming entirely new capabilities. Instead, it relies on the predicate device's established safety and effectiveness and notes that the technological change (replacement of the image receptor) does not raise new issues of safety or effectiveness.

However, based on the provided text, we can infer how "performance" is addressed within the context of demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance (Inferred)

Performance Aspect (Inferred "Acceptance Criteria")	Reported Device Performance
Imaging Technology	Replacement of X-ray image intensifier (XII) with Flat Panel Detector (FPD)
Image Resolution	"High resolution three-dimensional images for small diagnosis be possible"
Imaging Speed	"High resolution images are obtained in the same short period as that of the Panoramic Radiology."
X-ray Radiation Dosage	"Low X-ray radiation dosage is realized"
Safety Testing	VDE tested and certified for CE marking with CB report on MCT-1 EX F (NOTE-2)
Overall Performance	"Identical" to predicate device MCT-1EX (as per "Substantial Equivalent comparison summary table")

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate test set or sample size used for a performance study.
The primary justification for equivalence relies on the technological similarity and the minor modification of the image receptor.
Data Provenance: Not applicable in the context of specific a clinical performance study. The device itself is manufactured by J. Morita Mfg. Corp.

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

Not applicable. No expert review or ground truth establishment for a specific test set is described. The submission focuses on technical equivalence rather than a clinical performance study requiring expert adjudication of ground truth.

4. Adjudication Method for the Test Set

Not applicable. As there is no described test set or expert review, no adjudication method is mentioned.

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. An MRMC study was not conducted or mentioned. This device is a CT imaging system, not an AI/CAD device for diagnostic assistance. The focus is on the imaging hardware itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is an imaging device, not an algorithm. Therefore, a standalone algorithmic performance study is not relevant to this submission.

7. The Type of Ground Truth Used

Not applicable. The submission does not describe a performance study that uses "ground truth" in the clinical sense (e.g., pathology, outcomes data, or expert consensus) for assessing diagnostic accuracy. The safety and effectiveness are established by demonstrating substantial equivalence to the predicate device, which presumably was evaluated via standard methods for CT scanners (e.g., image quality metrics, dose measurements) when it was originally cleared.

8. The Sample Size for the Training Set

Not applicable. This device is an imaging hardware system, not an AI/machine learning model that requires a training set.

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

Not applicable. As it's not an AI/ML device, there is no training set or associated ground truth.

Summary

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DEC 2 7 2005

510(k) SUMMARY

J. Morita USA. Inc.'s

3D Accu-I-tomo XYZ Slice View Tomograph MCT-1 EX F

1. Submitter Name and Address with Phone/Fax :

Registration No. 2081055 Initial Distributor: J. Morita USA, Inc. 9 Mason Irvine, CA 92618 USA 949-581-9600 Telephone: 949-581-9688 Facsimile:

2. Contact Person

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331

August 31, 2005 3. Date summary prepared:
Device Name: 4. 3D Accu-I-tomo XYZ Slice View Tomograph Trade or Proprietary Name: MCT-1 EX F Model:

Cone beam x-ray CT Common Name: Computed tomography x-ray system Classification Name: ( 21CFR 892.1750 )

901AK Product Code :

1. Substantial Equivalency is claimed against the following device: 3D Accu-1-tomo XYZ Slice View Tomograph MCT-1 EX From 510k # K030450 J. MORITA MFG.CORP

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6. Description of the device:

High resolution images are obtained in the same short period as that of the Panoramic Radiology. Low X-ray radiation dosage is realized and the overall system structure is assembled to be compact unit.

The J.MORITA. MFG. CORP. has manufactured the MCT-1EX as the original model of such kind of X-ray scanner, and modify the device for MCT-1 EX F by replacing the image receptor , XII for FPD ( Flat Panel Detector).

7. Intended Use

The MCT-1 EX F is intended to be used for three dimensional X-ray Computed The ITCT + DF + 1 to med and neck by limited cone shaped x-ray beam projected on to an FPD to be operated and used by doctors, dentists, properly licensed professionals and other legally qualified professionals.

Safety and effectiveness of the device 8.

As the MCT-1 EX F is modified from our legally marketed device, MCT- 1 EX (K#030450) by replacing image receptor from XII to FPD with remaining all the other parts be common, so that the MCT-1 EX F is substantially equivalent to MCT-1EX as is shown in the comparison summary table below because they have . . similar general intended uses, technological characteristics and operating principles.

Any differences in the technological characteristics do not raise any new issues of safety or effectiveness.

	This new submission	Predicate	Difference
Name of the model	MCT-1 EX F	MCT-1EX	Different
Manufacturer	J.MORITA MFG. CORP.	J.MORITA MFG. CORP.	Identical
Construction	Rotating arm and base	Rotating arm and base	Same
Image Receptor	Flat Panel Detector	X-ray image intensifier	Different
Chin Rest	Equipped	Equipped NOTE-1	Identical
Performance spec.	Computed tomography	Computed tomography	Identical
Mechanical	MCT mechanism	MCT mechanism	Same
Electrical	MCT electric circuit	MCT electric circuit	Same
Software	MCT software	MCT software	Identical
Testing	VDE NOTE-2	VDE NOTE-2	Same

NOTE-I The original submission does not include Chin rest , but this is noluded in MCT-1EX through our in-house revision procedure named "510(K) memo " documentation as shown at Attachment 11 in this submission

NOTE-2 The notified body of VDE has tested and certified for CE marking with CB report on MCT-1 EX F which is to be accessed

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MCT-1 EX F to MCT-1EX
FDA file reference number	510k number of MCT-1EXK030450
TECHNOLOGICALCHARACTERISTICS	Comparison result
Indication for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Identical
Sterility	Similar
Biocompatibility	Similar
Mechanical safety	Similar
Chemical safety	Similar
Anatomical sites	Identical
Human factors	Identical
Energy used and/or delivered	Identical
Compatibility with environmentand other devices	Identical
Where used	Identical
Standards met	Similar
Electrical safety	Similar
Thermal safety	Similar
Radiation safety	Similar

Substantial Equivalent comparison summary table

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures, with three horizontal lines above a wavy line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 2005

J. Morita USA. Inc. c/o Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 11" Floor WASHINGTON DC 200005

Re: K052587

Trade/Device Name: 3D Accu-I-tomo XYZ Slice View Tomograph Model MCT-1 EXF Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 19, 2005 Received: October 11, 2005

Dear Mr. Barritt:

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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hodgdon

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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K052587

510(k) Number (if known):

3D Accu-I-tomo XYZ Slice View Tomograph Model MCT-1 EXF Device Name:

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

ANDIOR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Heymann

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .

Page 1 of

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.