The ADX4000-L, DX3000-L Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using digital sensors.

Device Description

The ADX4000-L, DX3000-L are Cordless Portable Dental X-ray System operated by battery-powered and hand-held dental x-ray machine, This is a prescription device that can be used on pediatric and adult patients.

AI/ML Overview

Acceptance Criteria and Device Performance Study for ADX4000-L, DX3000-L

Based on the provided 510(k) summary (K083532), the device's acceptance criteria and performance study are primarily focused on demonstrating equivalence to a predicate device and adherence to consensus standards, rather than specific performance metrics against a predefined acceptance threshold.

The document indicates that the device's performance was evaluated through "Bench testing" and by meeting "consensus standards." It does not provide a table of quantitative acceptance criteria with corresponding device performance values, nor does it detail a study that directly measures performance against such criteria.

Here's an analysis of the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, a direct table of quantitative acceptance criteria and reported device performance is not present in the provided 510(k) summary.

The summary states that the device is "**equivalent to the predicate devices in its intended use and technological characteristics, including: *indications for use technological characteristics performance properties". This suggests that the "acceptance criteria" were met by demonstrating this equivalence and compliance with relevant standards.

The "reported device performance" is broadly stated as:

"This device meets consensus standards IEC 601-1, 60601-1-2, 60601-1-2, 60601-2-7 etc."
"Bench testing was also conducted to demonstrate performance specifications."

Without specific metrics from the bench testing, it's impossible to create a quantitative table.

2. Sample Size for Test Set and Data Provenance

The 510(k) summary does not specify any sample size for a "test set" in the context of clinical images or patient data. The testing mentioned (bench testing and meeting consensus standards) implies engineering/design verification rather than a clinical performance study using a test set of images or patient data.

Therefore, information regarding data provenance (country of origin, retrospective/prospective) is also not provided.

3. Number of Experts and Qualifications for Ground Truth

The 510(k) summary does not mention using experts to establish ground truth for a test set. The focus is on demonstrating technological equivalence and compliance with engineering standards.

4. Adjudication Method for the Test Set

Since no clinical "test set" with ground truth established by experts is mentioned, an adjudication method is not applicable and therefore not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The 510(k) summary does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The device is an X-ray system, not typically an AI-driven image analysis tool, so comparative effectiveness with human readers using or not using AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study

The 510(k) summary does not describe a standalone (algorithm only) performance study. The device is a hardware product (dental X-ray system), not an AI algorithm.

7. Type of Ground Truth Used

The term "ground truth" as typically used in AI/image analysis studies (e.g., pathology, outcomes data, expert consensus) is not applicable to the type of testing described in this 510(k) summary. The "ground truth" for the device's performance would be compliance with the functional and safety requirements defined by the IEC standards and internal performance specifications.

8. Sample Size for the Training Set

The 510(k) summary does not mention a training set. This device is a traditional medical imaging hardware product and does not involve machine learning or AI models that would require a training set.

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned (as explained in point 8), the method for establishing its ground truth is not applicable and therefore not provided.

In summary, the K083532 submission focuses on demonstrating substantial equivalence to a predicate device and compliance with recognized electrical and medical device safety standards through bench testing. It does not contain information about clinical performance studies, evaluation by expert readers, or the use of AI/machine learning, which would typically involve the detailed criteria requested in the prompt.

Summary

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KO83532

MAR 1 0 2009

510(K) SUMMARY

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

Submitter Information:	Dexcowin Co., Ltd#606, Woolim Lions Valley II 680, Gasan-dong,Geumcheon-gu, Seoul, Korea
Contact Person:	Claude Yang (Yang Ho Dong)Onbix Corporation#708 Le-Meilluer Town, 837-19 Yeuksam-dongGangnam-gu, Seoul, KoreaTel: +82-2-5663360 / Fax: +82-2-62803360Email: onbix@naver.com

Nov 25, 2008 Date Summary Prepared:

Device Name: Trade Name(s): ADX4000-L, DX3000-L Classification Name: X-Ray, Extraoral Source, Digital Radiology Panel: Product Code: MUH

Predicate Device Information: K070811 DexcoWinA ADX4000

Device Description:

Intended Use:

Comparison to Predicate Device(s):

This device is equivalent to the predicate devices in its intended use and technological characteristics, including:

*indications for use *technological characteristics *performance properties

Summary of Testing:

This device meets consensus standards IEC 601-1, 60601-1-2, 60601-1-2, 60601-2-7 etc. Bench testing was also conducted to demonstrate performance specifications.

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Image /page/1/Picture/0 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 a stylized emblem featuring three curved lines that resemble a person with outstretched arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2009

DEXCOWIN Co., Ltd. % Mr. Claude Yang, CEO Onbix Corporation #708 Le-Meilleur Town, 837-19 Yeuksam-dong, Gangnam-gu Seoul, 135-937 SOUTH KOREA

Re: K083532

Trade/Device Name: ADX4000-L, DX30000-L Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH

Dated: February 10, 2009

Received: February 12, 2009

Dear Mr. Yang:

We have reviewed vour 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 os 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.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(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 Biometrics' (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 Manufactures, 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.suppot/index.html.

Sincerely yours,

Janine M. Morris

anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

085532

510(k) Number (if known): 1

Device Name: ADX4000-L, DX3000-L

Indications for Use:

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jules Renner

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

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.