Point 500 HD/500C HD which is the dental panoramic/panoramic and cephalometric device is intended to produce diagnostic quality radiographic images by acquiring digital 2D X-ray images. The cephalometric system produces cephalomertric radiographic images that maybe used in orthodontic diagnosis procedures.

Device Description

The Point 500 HD/500C HD is a dental panoramic and cephalometric device which is digital X-ray imaging device. It is intended for dental radiographic examinations of teeth, jaw and TMJ areas by exposing X-ray and then converts this information to the digital signals to acquire images. High-defined images are provided by controlling acquired image with computer and this is used to obtain panoramic and cephalometric images for dental purpose. This equipment is equipped with an X-ray generator and Sensor for panoramic and cephalometric at Rotation unit which are supported by Main frame and Column. When rotation unit is rotating around the patient's teeth and jaw for acquiring panoramic image, X-ray exposes and sensor detects the data from X-ray generator. Detected data from each frame is transferred to PC, and combined together to display panoramic image on PC screen by installed software on PC.

AI/ML Overview

The provided documentation describes the PointNix Dental Digital X-ray Imaging Device models Point 500HD and Point 500C HD. However, it does not contain details about specific acceptance criteria or a study that evaluates the device against such criteria beyond general non-clinical safety and performance testing.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided document. The document focuses on establishing substantial equivalence to a predicate device (Panoura 18S - K111231) through comparison of intended use, operating characteristics, and radiation properties, as well as reporting on non-clinical safety standards. It does not define specific acceptance criteria for image quality or diagnostic performance, nor does it present a study to demonstrate performance against such criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not available as no clinical test involving a test set is discussed. The document explicitly states: "Discussion of Clinical Tests Performed: Not Required".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not available as no clinical test involving a ground truth is discussed.

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

This information is not available as no clinical test involving adjudication is discussed.

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

This information is not available. The device described is a dental X-ray imaging system, not an AI-powered diagnostic tool. No MRMC study is mentioned.

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

This information is not available. The device is an imaging hardware system, not a standalone algorithm.

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

This information is not available as no clinical test utilizing a ground truth is discussed.

8. The sample size for the training set

This information is not available. The document describes a medical device (an X-ray imaging system), not a machine learning or AI algorithm that would typically involve a training set.

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

This information is not available, as no training set or ground truth for such a set is discussed.

Summary of what the document does provide regarding device evaluation:

The document outlines the following evaluations:

Substantial Equivalence: The primary method of demonstrating safety and effectiveness is by showing substantial equivalence to a legally marketed predicate device (Panoura 18S - K111231). Key comparisons include intended use, operating characteristics (tube voltage, tube current, focal spot size, scan time), and radiation.
Non-Clinical Tests:
- Electrical, mechanical, and environmental safety and performance testing: Performed according to international standards (EN/IEC 60601-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, and EN/IEC 60601-2-32).
- EMC testing: Conducted in accordance with EN/IEC 60601-1-2.
- Results: All test results were reported as "satisfactory."
Clinical Tests: Explicitly stated as "Not Required."

This type of submission (510(k)) often relies on demonstrating equivalence to an existing device rather than on extensive clinical performance data against specific, pre-defined acceptance criteria, especially for established device types like X-ray systems.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for PointNix. The logo includes a stylized flower-like graphic to the left of the word "SMART". To the right of "SMART" is the phrase "Digital Leader" above the word "PointNix". The word "PointNix" is in a bold, sans-serif font.

Twin Tower 1. 212-1. Kuro-Dong, Kuro-Ku, Seoul, Korea -854-8315 / Fax: 82-2-839-4973

510(K) SUMMARY

JAN 2 4 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is K121800. Date: January 17, 2013

1. Submitter's Identification:

PointNix Co., Ltd. #302~303, 3F, Ace Twin Tower 1, 212-1, Kuro-Dong, Kuro-Ku, Seoul, Korea Tel: +82-2-854-8315(ext. 309) Fax: +82-2-839-4973 E-mail: support@pointnix.com info@pointnix.com

2. Name of the Device:

Dental Digital X-ray Imaging Device models Point 500HD and Point 500C HD.

3. Common or Usual Name:

Usual Name : Dental Digital X-ray Imaging System Classification : Class II 21 CFR 872.1800 System, x-ray, extraoral source, digital Class Code : MUH

4. Predicate Device Information:

The Yoshida Dental MFG. Co., LTD.: Panoura 18S - K111231

5. Device Description:

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

K121800

Image /page/1/Picture/1 description: The image shows the logo for PointNix. The logo includes a stylized graphic to the left of the text. Above the word "PointNix" is the phrase "Digital Leader" in a smaller font.

3F, Ace Twin Tower 1, 212-1, Kuro-Dong, Kuro-Ku, Seoul, Korea Tel: 82-2-854-8315 / Fax: 82-2-839-4973

equipped with an X-ray generator and Sensor for panoramic and cephalometric at Rotation unit which are supported by Main frame and Column. When rotation unit is rotating around the patient's teeth and jaw for acquiring panoramic image, X-ray exposes and sensor detects the data from X-ray generator. Detected data from each frame is transferred to PC, and combined together to display panoramic image on PC screen by installed software on PC.

6. Intended Use:

7. Comparison to Predicate Devices:

Characteristic	Model Proposed :Point 500HD, Point 500CHD	Predicated :Panoura 18S
510(k) Number	-	K111231
Intended Use	Point 500 HD/500C HDwhich is the dentalpanoramic/panoramic andcephalometric device isintended to producediagnostic qualityradiographic images byacquiring digital 2D X-rayimages. The cephalometricsystem producescephalomertric radiographicimages that maybe used inorthodontic diagnosisprocedures.	The Panoura 18S dentalpanoramic andcephalometric device isintended for dentalradiographic examinations ofteeth, jaw and TMJ areas byproducing conventional 2DX-ray images as well as X-ray projection images. Thedevice must only beoperated and used bydentist and other legallyqualified professionals.
Tube Voltage	50-90kV	58-82kV
Tube Current	4-16mA	2-10mA
Focal Spot Size	0.5 x 0.5 mm	0.5 x 0.5 mm
Scan Time	Only Panorama Mode(Point500HD) : 16sec,Added cephalo Mode(Point500C HD) : 0.8sec	Panorama Mode: 16secCephalo Mode: 10sec

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

K121800

Image /page/2/Picture/1 description: The image shows the logo for PointNix. The logo includes a stylized flower-like graphic to the left of the word "SMART". To the right of "SMART" is the word "PointNix", with the words "Digital Leader" above it. The logo is black and white.

3F, Ace Twin Tower 1, 212-1, Kuro-Dong, Kuro-Ku, Seoul, Korea
Tel: 82-2-854-8315 / Fax: 82-2-839-4973

Statement of substantial equivalence 8.

The characteristics of the Point 500HD/500C HD are similar to those of the Panoura 18S (K111231) listed below:

Intended use
· Operating characteristics
· Radiation

Difference between Point 500HD/500C HD and Panoura 18S (K111231) is listed below:

· Detector type
This difference of detector does not raise any new safety or effectiveness concerns compared to the Panoura 18S (K111231).

9. Discussion of Non-Clinical Tests Performed:

Electrical, mechanical, environmental safety and performance testing according to standards EN/IEC 60601-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, and EN/IEC 60601-2-32 were performed, and EMC testing was conducted in accordance with a standard EN/IEC 60601-1-2. All test results were satisfactory.

Discussion of Clinical Tests Performed: 10.

Not Required

11. Conclusions:

The PointNix Co., model Point 500HD and Point 500C HD have been developed and validated according to all applicable standards. Evaluations have proven that the system is safe and effective for the intended use. Risk analysis and safety certifications reveal that there is no new safety issues associated with this system as compared with the predicate devices.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized eagle with its wings spread. The eagle is composed of three curved lines, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle.

Public Health Service

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

January 24, 2013

PointNix Company, Limited C/O Mr. Jigar Shah MDI Consultants, Incorporated #302~303, 3F, Ace Twin Tower 1, 212-1, Kuro-Dong Kuro-Ku, Seoul, Korea

Re: K121800

Trade/Device Name: Dental Digital X-ray imaging system point 500 HD and point 500C HD Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: II Product Code: MUH Dated: January 10, 2013 Received: January 15, 2013

Dear Mr. Shah:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

Page 2 - Mr. Shah

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame Q. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Image /page/5/Picture/0 description: The image contains a logo for a company called "PointNix". The logo features a stylized graphic to the left of the text, with the word "SMART" underneath. Above the company name, the words "Digital Leader" are printed in a smaller font. The logo is simple and modern, with a focus on the company name.

Twin Tower 1, 212-1, Kuro-Dong, Kuro-Ku, Seoul, Korea 82-2-854-8316 / Fax: 82-2-839-

Section 2: Indications for Use

Page 1 of 1

K 21 800 510(k) Number (if known):

Device Name: PointNix Co., Ltd. Dental Digital X-ray Imaging System Point 500 HD and Point 500C HD

Indications For Use:

Prescription Use × (Per 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)

Susan Runner DDS, MA-115:22:50 -05'00'

ﻟﺴﻤﺮ

Division Sign-Off) 'ivision of Anesthesiology, General Hospital ifection Control, Dental Devices

510(k) Number:

2-1

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.