MCT-1EX-1F8/F17 is intended to be used for head and neck three dimensional X-ray Computed Tomography by a limited, cone-shaped x-ray beam projected onto a flat panel X-ray detector, to be operated and used by doctors, dentists, properly licensed professionals and other legally qualified professionals.

Applications include diagnosis for Temporal, Nasal, Orbita, Maxilla, Mandibula, Cerviales, Cranium and Basicranium area.

The Model MCT-1EX-1F8/F17 is a x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dento maxillofacial 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 twor and threedimensional images.

Device Description

The MCT-1EX-1F8/F17 is an x-ray imaging device that acquires 360 degree rotational sequence of the head and neck areas, mainly for dentistry. The imaging data are once stored at three dimensional matrix of the examined volume, and are reconstructed by image processing through the Personal Computer, then finally displayed as both two and three dimensional images on the monitor.

It consists of rotation arm part, main body part, base part and accessories including personal computer and software.

This MCT-1EX-1F8/F17 is a slightly modified device from the MCT-1EXF ( K#052587) of J.MORITA MFG. CORP replacing the solid state x-ray imaging device of "Flat Panel Detector (FPD)" with some other additional modifications.

AI/ML Overview

This 510(k) summary (K073645) for the J. Morita USA Inc.'s 3D Accu-I-tomo XYZ Slice view Tomograph Model: MCT-1EX-1F8/F17 contains very limited information regarding performance criteria and study details. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (MCT-1EXF, K052587) based on similarities in intended use, technological characteristics, and operating principles, rather than presenting a detailed performance study with defined acceptance criteria.

Therefore, it is not possible to provide a table of acceptance criteria and reported device performance from the provided text, nor can a detailed study analysis be performed. The document explicitly states: "The MCT-1EX-1F8/F17 covered by this submission is developed from our legally marketed device, MCT-1EXF (K#052587), modified slightly by replacing FPD to enlarge the radiographic area by using larger field of FPD, without any significant changes for the other components or performances." This indicates that the safety and effectiveness are largely assumed by the substantial equivalence to the predicate, rather than through independent, new performance studies with specific statistical criteria.

However, I can extract the general claims about performance and the basis for these claims as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, no specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, resolution in specific metrics) are stated, nor are specific performance metrics reported for the new device. The submission relies on demonstrating substantial equivalence to the predicate device. The "Performance spec." row in the comparison table mentions "International standards," but does not specify which standards or what performance level was achieved.

Criteria Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Overall Performance	Substantially equivalent to predicate device (MCT-1EXF, K05257)	"reserves the same general intended use, similar principles of operation, and similar technological characteristics as the predicate device MCT-1EXF."
Image Quality	Not explicitly stated as specific criteria; implied by "higher image quality" with enlarged radiographic areas.	"The enlarged sizes of radiographic areas are obtained with higher image quality such as high speed, high fidelity or high resolution other than standard mode." (Note-3 under "Performance")
Safety	Compliance with International standards, and various safety aspects (electrical, thermal, radiation) identical to predicate.	"International standards" met for performance specs. Electrical, Thermal, Radiation safety are "Identical" to predicate. No new issues of safety or effectiveness are raised.

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

The document does not describe a specific test set or any sample size used for performance evaluation of the new device.
The data provenance is not mentioned because a separate performance study for the new device is not detailed. The submission relies on the predicate device's established performance.

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

Not applicable. No independent test set with expert-established ground truth is described for the new device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No independent test set is described.

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 mentioned. This device is an imaging system, not an AI-assisted diagnostic tool.

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

Not explicitly described. The device is an X-ray imaging system; its "performance" is inherently based on the images it produces for human interpretation. There isn't an "algorithm only" performance reported in the context of diagnostic output separate from physician use.

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

Not applicable. No independent performance study requiring ground truth is detailed for the new device. The ground truth for the predicate device's performance, if ever assessed, is not specified here.

8. The sample size for the training set:

Not applicable. This device is an X-ray imaging system, not a machine learning or AI algorithm in the context of this submission. Thus, there is no "training set" in the sense of data used for algorithm development or machine learning.

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

Not applicable. As above, no training set is described.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented is primarily a comparative analysis demonstrating "substantial equivalence" of the new device (MCT-1EX-1F8/F17) to a legally marketed predicate device (MCT-1EXF, K052587). The core argument is based on the new device being a "slightly modified device" with component changes (specifically, replacing the Flat Panel Detector, FPD, to enlarge the radiographic area) that do not "raise any new issues of safety or effectiveness."

The evidence provided to support substantial equivalence includes:

Similar Intended Use: Both are "head and neck three dimensional X-ray Computed Tomography" devices for diagnostic support in dentistry and other specified anatomical areas.
Similar Technological Characteristics: Both are cone beam x-ray CT systems with similar construction (except for the FPD and rotating arm design), image receptors (FPD), and operational principles.
Identical/Similar Safety Standards: Both meet "International standards" for performance and have identical or similar electrical, thermal, and radiation safety characteristics.
Claim of "Higher Image Quality": Note-3 under the comparison table states: "The enlarged sizes of radiographic areas are obtained with higher image quality such as high speed, high fidelity or high resolution other than standard mode." This is a qualitative claim without specific metrics or a comparative study detailed in the summary.

In conclusion, this 510(k) submission does not contain a traditional performance study with explicit acceptance criteria and corresponding results for the new device. Instead, it leverages the established safety and effectiveness of a predicate device through a claim of substantial equivalence for a slightly modified product.

Summary

{0}------------------------------------------------

K073645

APR - 9 2008

510(k) SUMMARY J. Morita USA Inc.'s 3D Accu-I-tomo XYZ Slice view Tomograph Model : MCT-1EX-1F8/F17

1. Submitter Name and Address with Phone/Fax :

Registration No. 2081055	Registration No. 3002807636
Initial Distributor:	Manufacturer:
J. Morita USA, Inc.	J. MORITA MFG. CORP.
9 Mason	680 Higashihama Minami-cho
Irvine, CA 92618	Fushimi-ku, Kyoto
USA	Japan 612-8533
Telephone: 949-581-9600	+81-75-611-2141
Facsimile: 949-581-9688	+81-75-605-2353

2. Contact Person

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1 100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331

3. Date summary prepared: January 24, 2008

whose details are shown in Table-A below.

···

1. Device Name:
  Trade or Proprietary Name: 3D Accu-I-tomo XYZ Slice view tomograph Model: MCT-1EX-1F8/F17 Note: The name is abbreviated to MCT-1EX-1F8/F17 in the 510(k) submission , and includes two kinds of actual models, MCT-1EX-1F8 and MCT-1EX-1F17

Common Name:	Cone beam x-ray CT
Classification Name:	Computed tomography x-ray system(21CFR892.1750)
Product Code:	JAK

{1}------------------------------------------------

Division	Actual model number	Main differences
		Size ofradiographicarea sizeD x H (mm)	FPD used	Rotationarm
Thissubmission	MCT-1EX-1F8	40x4060x6080x80	Made byHamamatsu	Linear-shaped-C-arm
	MCT-1 EX-1F17	Note-1	Made byVarian
Thepredicate	MCT-1EXF	40x4060x60	Made byHamamatsu	Round-shapedC-arm

The MCT-1EX-1F8/F17 includes the actual model numbers specified with the main
differences as shown in Table-A below.

Note-1: Selectable between 170 x 120mm and 40 x 40mm. (Diameter x Height)

Table-A Actual model numbers in MCT-1EX-1F8/F17

5. Substantial Equivalency is claimed against the following devices:

3D Accu-I-tomo XYZ Slice View Tomograph MCT-1EXF (K052587)

6. Description of the device:

It consists of rotation arm part, main body part, base part and accessories including personal computer and software.

As the main hardware and software are used common, this new MCT-IEX-1F8/F17reserves the same general intended use, similar principles of operation, and similar technological characteristics as the predicate device MCT-1EXF. It is selfexplanatory that the MCT-1EX-1F8/F17 is substantially equivalent to MCT-1EXF.

2 / 4

{2}------------------------------------------------

7. Intended Use

Intended use

Applications include diagnosis for Temporal, Nasal, Orbita, Maxilla, Mandibula, Cerviales, Cranium and Basicranium area.

8. Safety and effectiveness of the device

SUBSTANTIAL EQUIVALENCE

The MCT-1EX-1F8/F17 covered by this submission is developed from our legally marketed device, MCT-1EXF (K#052587), modified slightly by replacing FPD to enlarge the radiographic area by using larger field of FPD, without any significant changes for the other components or performances. The comparison including the differences are described at the Table-1 titled " Comparison chart: MCT-1EX-1F8/F17 to MCT-1EXF" at Attachment 5 of this submission.

As is shown in the following comparison summary chart and table , MCT-1EX-1F8/F17 is substantially equivalent to MCT-1EXF because they have similar general intended uses, technological characteristics and operating principles. As described above, any differences in the technological characteristics do not raise any new issues of safety or effectiveness.

	This new submission	Predicate device	Difference
Name ofmodel	MCT-1EX-1F8/F17	MCT-1EXF	Different
Manufacturer	J.MORITAMFG. CORP.	J.MORITAMFG. CORP.	Identical
Construction	1)Slightly modifiedRotating arm2) The same conventionalbase/chair/support tower	1)ConventionalRotating arm2)Conventionalbase/chair/support tower	Similar
ImageReceptor	Flat panel detecter	Flat panel detecter	Same
Performancespec.	International standards	International standards	Similar
Mechanical	Morita made mechanism	Morita made mechanism	Similar
Electrical	Morita made electric circuit	Morita made electric circuit	Similar
Software	Morita made software	Morita made software	SlightlyDifferent
Testing	Mainly done by VDE	Mainly done by VDE	Same

Table-1 Comparison summary chart

{3}------------------------------------------------

Table-2 Comparison summary table

FDA file reference number

Attachment inside notification submission file 510k FDA website print out.

TECHNOLOGICAL CHARACTERISTICS	Comparison result
Model name of Predicate Device	MCT-1EXF
510(k) number of Predicate Device	K052587
Indication for use	Identical
Target population	Similar
Design	Slightly changed	Note-1
Materials	Slightly changed	Note-2
Performance	Slightly changed	Note-3
Sterility	Similar
Biocompatibility	Similar
Mechanical safety	Similar
Chemical safety	Similar
Anatomical sites	Similar
Human factors	Similar
Energy used and/or delivered	Similar
Compatibility with environment and other devices	Similar
Where used	Identical
Standards met	Identical
Electrical safety	Identical
Thermal safety	Identical
Radiation safety	Identical

Note- l

This new devices are designed to enlarge the sizes of radiographic areas, so that some modifications are done over the arm assembly, FPD and software or else Note-2

The new larger size FPD is introduced.

Note-3

The enlarged sizes of radiographic areas are obtained with higher image quality such as high speed, high fidelity or high resolution other than standard mode.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

MAY 20 2010

J. Morita USA. Inc. % Mr. Keith A. Barritt, Attorney Fish & Richardson P.C. 1425 K St. N.W., Suite 1100 WASHINGTON DC 20005

Re: K073695

Trade/Device Name: 3D Accu-I-tomo Slice View Tomograph, Model MCT-1EX-1F8/F17 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 24, 2008 Received: March 25, 2008

Dear Mr. Barritt:

This letter corrects our substantially equivalent letter of April 9, 2008.

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 or mry vith 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

{5}------------------------------------------------

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 vours.

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(K) Number : unknown

Device Name: 3D Accu-I-tomo XYZ Slice view tomograph, Model: MCT-1EX-1F8/F17

Indications for Use:

The device is operated and used by physicians, dentists and x ray technologists.

Prescription Use

(Par2! CFR801 Subpert D)

AND/OR

Over-The-Counter Use (Part21 CFR807 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 Anesthesiology, General Hospital, Infection Control, Dental Devices

510(K) Number :

Prescription Use (Part21CFR801.109)

Over-The-Counter Use (Optional Format 1-2-96)

hozi K. Wtz

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices No73695 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.