The CDR PanX Model 4792 is indicated for individuals requiring extra-oral dental exams. It exposes and acquires radiographic images at the dento-maxillofacial region.

Device Description

The CDR PanX Model 4792 is a digital panoramic device. A high voltage power supply charges an x-ray tube that emits a pulse which is attenuated by the patient's head. An FDA approved digital receptor receives the resultant image and transmits the data to a computer. The receptor and x-ray source both revolve on a motion stage such that multiple projections may be generated thereby resulting in a panoramic view of the skull. The computer processes and displays the image data on a monitor.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, though it's important to note that this 510(k) summary (K031291) from 2003 offers limited detail on performance criteria and specific study methodologies typical of more modern submissions for AI/software devices. The device described is a traditional X-ray system, not an AI/software device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion	Reported Device Performance
Radiation Safety	Device exposes patient to similar radiation as the predicate.	"A radiation survey has confirmed that the device exposes the patient to similar radiation as the predicate."
Electrical Safety	Conforms with electrical safety standards.	"In addition, the device conforms with electrical safety standards"
Regulatory Compliance (General)	Conforms with 21CFR 1020.30-31.	"and 21CFR 1020.30-31."
Image Acquisition/Functionality	Acquire radiographic images at the dento-maxillofacial region (as per Indications for Use).	The device's description and indication for use implicitly demonstrate this, as it is a "digital panoramic device" for "extra-oral dental exams."
Substantial Equivalence	Equivalent to legally marketed predicate devices.	"Schick Technologies has demonstrated through careful analysis and validation studies that the device is substantially equivalent to the already cleared and marketed devices."

Study Information

Given this is a K031291 (approved in 2003) for a digital X-ray machine (not an AI/software device), the depth of information regarding "acceptance criteria" and "study" in the context of performance metrics (like sensitivity, specificity, etc.) is very limited compared to what would be found in a modern AI/software device submission. The "study" here primarily refers to comparative testing against a predicate device to establish substantial equivalence.

Sample size used for the test set and the data provenance: Not explicitly stated. The submission mentions "a radiation survey" and "careful analysis and validation studies," but does not provide details on the number of patients, images, or the origin (country, retrospective/prospective) of any data used for these comparisons.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not stated. Ground truth, in the context of an X-ray machine demonstrating "similar radiation" or "conforming to electrical standards," would likely refer to engineering measurements and comparisons rather than expert interpretation of images for diagnostic accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not stated.
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: Not applicable. This device is a traditional digital X-ray machine, not an AI-powered diagnostic tool. Therefore, no MRMC study for AI assistance would have been performed or relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the stated criteria (radiation and electrical safety), the ground truth would be based on engineering measurements and established regulatory standards. For the image quality aspect (implied by substantial equivalence to a device producing panoramic radiographs), the ground truth would likely be the visual and diagnostic quality of images produced by the predicate device. Specifics are not provided.
The sample size for the training set: Not applicable. This is a hardware device; there is no mention of a "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable. As above, this is a hardware device.

Summary

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Ko3 1291

MAY - 5 2003

Exhibit IV: 510(k) Summary

Schick CDR PANX MODEL 4792

Common/Classification Name: "DIGITAL X-RAY EXTRAORAL SOURCE! SYSTEM" 21CFR872.1800

Schick Technologies, Inc. 30-00 47th Avenue Long Island City, NY 11101 718-937-5765, 718-937-5962 (FAX) Contact: Daniel Michaeli, Prepared: April 10, 2003

A. Legally Marketed Predicate Devices

The Soredex Cranex Tome system is a legally marketed predicate device that emits x-ray radiation for panoramic radiographs. By default, the Soredex system utilizes x-ray film, however a digital receptor that subsequently received clearance under K982661, may also be used with the device. Schick Technologies has now demonstrated equivalence of a new integrated digital panoramic machine to the Soredex system.

B. Device Description

C. Indications for Use

The CDR PanX Model 4792 is indicated for individuals requiring extra-oral dental exams. It exposes and acquires radiographic images at the dento-maxillofacial region.

D. Substantial Equivalence Summary

The CDR PanX Model 4792 is substantially equivalent to digital panoramic units currently marketed in the U.S. The Soredex Cranex Tome is similar in that it is

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indicated for, among other things, panoramic x-ray examinations of the maxillofacial region, although it traditionally utilizes film. It can, however, be retrofit with the CDR – PAN MODEL 4700, which is the same sensor as is utilized in this new integrated product.

E. Testing

A radiation survey has confirmed that the device exposes the patient to similar radiation as the predicate. In addition, the device conforms with electrical safety standards and 21CFR 1020.30-31.

F. Conclusions

Schick Technologies has demonstrated through careful analysis and validation studies that the device is substantially equivalent to the already cleared and marketed devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2003

Schick Technologies % Mr. Donald J. Sherratt Medical Stream Director Intertek Testing Services 70 Codman Hill Road BOXBOROUGH MA 01719 Re: K031291

Trade/Device Name: CDR PanX Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II

Product Code: 76 MUH

Dated: April 22, 2003 Received: April 23, 2003

Dear Mr. Sherratt:

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 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 r 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.

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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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon.

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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of I Page 1

1163 1291 510(k) Number (if known):_

Device Name:_CDR PanX

Indications For Use:

The CDR PanX Model 4792 is indicated for individuals requiring extra-oral dental exams. It exposes and acquires radiographic images at the dento-maxillofacial region.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription Use ✓

Daniel R. Seymm

Sign-Off I Reproductive mner

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.