The Veraview IC 5 (XDP1) is an extraoral source x-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints and skull by exposing an X-ray image receptor to ionizing radiation.

Device Description

The Veraview IC5 Model XDP1( hercinafter XDP1) is an extragral source dental panoramic x-ray system intended to produce x-rays for dental radiographic examination and diagnosis of disease of the teeth, jaw and oral structure. The XDP Ican be used to take standard panoramic images, Pedodontic panoramic images, and TMJ quadruple images. This XDP1 is a device modified from the X550P-D-UL which is one of Veraview epocs Model VE ( K#030699) of J.MORITA MFG. CORP. Both XDP1and X550P-D-UL are dental panoramic device, XDP1 is provided with automatic exposure control by CCD sensor while the latter is incapable of such automatic exposure control. Except automatic exposure control, the main hardware is used unchanged in the same way as the previous, and the XDP1 reserves the same general intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate device, so that the XDP1 is substantially equivalent to Veraviewepocs Model VE ( K#030699).

AI/ML Overview

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K053220 for Veraview IC 5 XDP1) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific acceptance criteria and detailed performance studies for the new device.

Therefore, no explicit acceptance criteria or detailed performance metrics are stated in the document as would be found in a formal validation study. The closest information available pertains to the similarities in performance specifications and standards met.

Acceptance Criteria (Inferred/General)	Reported Device Performance (from document)
Image Quality / Diagnostic Utility	The device is intended to "obtain dental x-ray panoramic tomography pictures by digital processing with a CCD sensor which is capable of electronic imaging over the whole Dento-maxillofacial area such as teeth, periodontal tissues or chin- bone etc." While no specific image quality metrics (e.g., resolution, contrast-to-noise ratio) are provided, the device is considered "substantially equivalent" to its predicate device (Veraviewepocs Model VE, K030699). The predicate device was cleared for producing dental radiographic examinations. The key difference in the new device is the replacement of film with a CCD sensor and the addition of automatic exposure control, which are presented as not raising new questions of safety or effectiveness. The document states "Performance spec. - International standards" and "Similar" to the predicate. This implies that the device is expected to meet the performance standards of similar dental panoramic X-ray units.
Safety (Electrical, Thermal, Radiation)	The device is stated to meet "International standards" and is "Similar" to the predicate device in terms of "Testing - VDE." Specifically, "Electrical safety - Similar," "Thermal safety - Identical," and "Radiation safety - Identical" to the predicate device are noted. This suggests the safety profile of the new device is considered equivalent to the predicate, which would have met established safety criteria for medical X-ray devices.
Functional Equivalence	The device performs "standard panoramic images, Pedodontic panoramic images, and TMJ quadruple images," which aligns with the functionality of the predicate and the intended use of such devices. The main difference (CCD sensor and automatic exposure control) is presented as an enhancement rather than a change in core functionality that would require new performance criteria.

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

The document does not describe any specific clinical or technical test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective study) for the Veraview IC 5 XDP1. The 510(k) pathway, especially for modifications to existing devices, often relies on engineering testing and comparison to a predicate rather than extensive clinical studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document does not describe a study involving expert review for establishing ground truth.

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, the document does not mention any Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is an X-ray imaging system, not an AI-powered diagnostic aid.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is an X-ray imaging system, not an algorithm, so standalone algorithm performance is not a concept relevant to this submission. The device is used by a human operator (the dentist/radiographer) to acquire images for diagnosis by a human clinician.

7. The Type of Ground Truth Used

Not applicable in the context of a conventional diagnostic study. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence primarily relies on:

Engineering and technical specifications comparisons.
Conformity to international safety standards (e.g., VDE).
The known performance and safety profile of the legally marketed predicate device (Veraviewepocs Model VE, K030699).
The implicit ground truth is that the images produced by the new device are diagnostically acceptable and clinically equivalent to those from the predicate device.

8. The Sample Size for the Training Set

Not applicable. The device is an X-ray hardware system, not a machine learning algorithm that requires a training set of data.

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

Not applicable. As there is no training set mentioned, this question is not applicable.

Summary

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

K053220

JAN 6 2006

510(k) SUMMARY J. Morita USA Inc.'s Veraview IC 5 XDP1

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 949-581-9600 Telephone: +81-75-611-2141 Facsimile: 949-581-9688 +81-75-605-2354

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

3. Date summary prepared: October 17, 2005

4. Device Name:

Trade or Proprietary Name:	Veraview IC 5 Model XDP1
Common Name:	Dental Panoramic X-ray Unit
Classification Name:	Extraoral Source dental X-ray System(21CFR872.1800)
Product Code :	MUH

1. Substantial Equivalency is claimed against the following device: Veraviewepoes Model VE from J. MORITA MFG.CORP.
  510k # : K030699

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

6. Description of the device:

The XDP Ican be used to take standard panoramic images, Pedodontic panoramic images, and TMJ quadruple images.

This XDP1 is a device modified from the X550P-D-UL which is one of Veraview epocs Model VE ( K#030699) of J.MORITA MFG. CORP. Both XDP1and X550P-D-UL are dental panoramic device, XDP1 is provided with automatic exposure control by CCD sensor while the latter is incapable of such automatic exposure control.

Except automatic exposure control, the main hardware is used unchanged in the same way as the previous, and the XDP1 reserves the same general intended use, similar principles of operation, and similar technological characteristics as the previously cleared predicate device, so that the XDP1 is substantially equivalent to Veraviewepocs Model VE ( K#030699).

7. Intended Use

The XDPI is used with the purpose to obtain dental x-ray panoramic tomography pictures by digital processing with a CCD sensor which is capable of electronic imaging over the whole Dento-maxillofacial area such as teeth, periodontal tissues or chin- bone etc.

8. Safety and effectiveness of the device

This Model XDPI is a modified device from the Veraviewepoes Model VE ( K#030699) of J.MORITA MFG. CORP. by climinating the film image receptor to CCD sensor. However, not only the main hardware is used unchanged in the same way as the predicate device, but also the XDP1 reserves the same general intended use, similar principles of operation, and similar technological characteristics, so that the XDP is substantially equivalent to the Veraviewepoes Model VE ( K#030699).

Although there are minor differences in the characteristics between the Model XDP I and the predicate device as is shown at Table-1 and Table-2, these differences do not raise new questions of safety or effectiveness because they are able to be considered as almost same .

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

	This new submission	Predicate	Difference
Name of the model	XDP1	X550P-D-UL	Different
Manufacturer	J.MORITA MFD. CORP.	J.MORITA MFD. CORP.	Identical
Construction	Rotating arm and base	Rotating arm and base	Similar
Image Receptor	X-ray CCD sensor	X-ray film and X-ray CCD sensor	Different
Performance spec.	International standards	International standards	Similar
Mechanical	XDP1 mechanism	X550P mechanism	Similar
Electrical	XDP1 electric circuit	X550P electric circuit	Similar
Software	XDP1software	X550P software	Different
Testing	VDE	VDE	Similar

Table-1 Comparison summary chart

Table-2 Comparison summary table

FDA file reference number 510k number ; K030699

Attachment inside notification submission file 510k FDA website print out

Model name of Predicate Device	X550P-D-UL
510(k) number of Predicate Device	K030699
TECHNOLOGICAL CHARACTERISTICS	Comparison result
Indication for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Similar
Sterility	Similar
Biocompatibility	Similar
Mechanical safety	Similar
Chemical safety	Identical
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	Similar
Thermal safety	Identical
Radiation safety	Identical

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 6 2006

2006

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

Re: K053220 Trade/Device Name: Veraview IC 5(XDP1)

Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system

Regulatory Class: II Product Code: MUH Dated: November 15, 2005 Received: November 17, 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 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/3/Picture/13 description: The image shows a logo with a circular border containing text. Inside the circle is a stylized drawing of an eagle or similar bird, depicted with three curved lines representing its body and wings. The text around the border appears to be part of the organization's name, but it is difficult to read due to the image quality and orientation.

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

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 (o 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. brigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

to known 510(k) Number (if known):

K053220

XDP1 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)

David A. Lyman

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

Page 1 of

00220

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.