CLEARTOOTH DIGITAL X-RAY SYSTEM

• K Number: K033147
• Device Name: CLEARTOOTH DIGITAL X-RAY SYSTEM
• Manufacturer: CLEARTOOTH ELECTRONICS, INC.
• Date Cleared: 2003-12-30 ( 91 days)
• Product Code: MUH
• Regulation Number: 872.1800
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K013271
• Predicate For: N/A

Intended Use

An extra-oral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.

Device Description

The Cleartooth Digital X-Ray System software processes standard dental images captured from a sensor device that is placed in a patient's mouth as if it were dental X-ray film. It provides users with a familiar personal computer moveable window interface, including pushbuttons, tool bars, pull-down menus, and pop-up menus. It allows users to access its features by point and click, and it allows them to work with images using intuitive and responsive features like orienting an image.

AI/ML Overview

This device, the Cleartooth Digital X-Ray System, is a Class II medical device that produces digital radiographs intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and supporting oral structures.

Based on the provided information, the submission describes a substantial equivalence determination, not a study demonstrating the device meets pre-defined acceptance criteria for performance metrics (like sensitivity, specificity, etc.) against a specific ground truth.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or reported device performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, it states that the device was found to have "similar technological characteristics and to be equivalent" to a predicate device.

Acceptance Criteria Category	Predicate Device Characteristic (DXS Digital X-Ray System K013271)	Cleartooth Digital X-Ray System	Met?
Intended use	Same as Cleartooth	Same as Predicate	Yes
Indications for use	Same as Cleartooth	Same as Predicate	Yes
Target population	Same as Cleartooth	Same as Predicate	Yes
Design	Similar	Similar	Yes
Materials	Similar	Similar	Yes
Performance	Similar	Similar	Yes
Biocompatibility	Similar	Similar	Yes
Mechanical safety	Similar	Similar	Yes
Chemical safety	Similar	Similar	Yes
Anatomical sites	Similar	Similar	Yes
Where used	Similar	Similar	Yes
Standards met	Similar	Similar	Yes
Thermal safety	Similar	Similar	Yes
Radiation safety	Similar	Similar	Yes

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

• Sample size: Not applicable or not provided. The submission relies on a comparison of technological characteristics to a predicate device, not on clinical performance testing with a specific test set.
• Data provenance: Not applicable or not provided.

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

• Not applicable or not provided, as no specific test set requiring expert ground truth for performance evaluation is described.

4. Adjudication method for the test set:

• Not applicable or not provided.

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 conducted or described. This device is an X-ray system that produces digital radiographs, not an AI-powered diagnostic tool for interpretation.

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

• Not applicable. The device is described as "software processes standard dental images captured from a sensor device," indicating it's an imaging system, not an algorithm providing standalone diagnostic output. Its performance is evaluated based on its technical similarity to a predicate device.

7. The type of ground truth used:

• Not applicable. The submission is based on a substantial equivalence to a predicate device, meaning the comparison is based on technical specifications and intended use, not a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set:

• Not applicable. The device is an imaging system, not a machine learning algorithm that requires a training set.

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

• Not applicable.

Summary

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TAB 4 - SUMMARY

Image /page/0/Picture/3 description: The image shows the logo for "cleartooth electronics". The logo consists of a stylized "C" shape enclosed in a rounded square on the left, followed by the word "cleartooth" in a bold, sans-serif font with a trademark symbol. Below "cleartooth" is the word "electronics" in a smaller, sans-serif font.

240 SAINT PAUL STREET SUITE 305 DENVER CO 80206 Phone: [phone] Fax: [phone]

SUMMARY

Submitter's name:

Cleartooth Electronics, Inc.

Address:

240 St. Paul St., Suite 305 Denver, CO 80206

Phone:

Name of contact person:

303-733-1999

Greg Holland Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] fax: [phone]

Date the summary was prepared: September 15, 2003

September 15, 2003

Name of the device:	Cleartooth Digital X-Ray System
Trade or proprietary name:	Cleartooth Digital X-Ray System
Common or usual name:	Extra-oral source x-ray system
Classification name:	System, x-ray, extra-oral source, digital

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

DXS DIGITAL X-RAY SYSTEM

Description of the device:

The Cleartooth Digital X-Ray System software processes standard dental images captured from a sensor device that is placed in a patient's mouth as if it were dental X-ray film. It provides users with a familiar personal computer moveable window interface, including pushbuttons, tool bars, pull-down menus, and pop-up menus. It allows users to access its features by point and click, and it allows them to work with images using intuitive and responsive features like orienting an image.

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K33141
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Indications:

An extra-oral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.

Summary of the technological characteristics of our device compared to the predicate device:

The predicate DXS Digital X-Ray System K013271 and Cleartooth Digital X-Ray System were compared in the following areas and found to have similar technological characteristics and to be equivalent.

Intended use Indications for use Target population Design Materials Performance Biocompatibility Mechanical safety Chemical safety Anatomical sites Where used Standards met Thermal safety Radiation safety Standards met

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cleartooth Electronics, Inc. % Mr. Greg Holland Regulatory Specialist Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606

Re: K033147

Trade/Device Name: Cleartooth Digital X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: September 29, 2003 Received: October 2, 2003

Dear Mr. Holland:

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 (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.

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.

DEC 3 0 2003

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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 the letter:

8xx. 1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogden

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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): KD33147

Device Name: Cleartooth Digital X-Ray System

Indications For Use:

An extra-oral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

	Nancyc brondon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
REGULATORY SPECIALISTS, INC.	510(k) Number: K033147	Page 11

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.