ORTHOPHOS 3/3 CEPH/3 DS by SIRONA DENTAL SYSTEMS GMBH

The Orthophos 3/3 Ceph/3 DS is an extraoral x-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The system allows for panoramic tomographic imaging and teleradiography.

Device Description

The Orthophos 3/3 Ceph/3 DS is an extraoral x-ray system.

AI/ML Overview

This appears to be a 510(k) clearance letter from the FDA for a dental X-ray system (Orthophos 3/3 Ceph/3 DS), issued in 1999. This type of document typically focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a robust study proving performance as one might find for a novel AI/software as a medical device (SaMD) cleared under a different pathway or with more recent guidance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types is not available within the provided text segments. The FDA 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and intended use, rather than requiring extensive clinical performance studies with detailed acceptance criteria as would be expected for a novel AI device today.

To answer your questions based only on the provided text:

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

Not Available. The document does not describe specific performance acceptance criteria for the Orthophos 3/3 Ceph/3 DS or report its performance against such criteria. It states that the device is "substantially equivalent" to predicate devices.

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

Not Available. The document does not describe any specific test set, its sample size, or data provenance.

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)

Not Available. The document does not describe the establishment of a ground truth for a test set.

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

Not Available. The document does not describe any test set or adjudication method.

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

Not Applicable / Not Available. This device is a traditional X-ray system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not have been conducted. The document does not mention any MRMC studies.

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

Not Applicable / Not Available. This device is hardware (an X-ray system), not a standalone algorithm. The document does not describe any standalone algorithm performance testing.

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

Not Available. The document does not refer to ground truth data.

8. The sample size for the training set

Not Available. The document does not describe any training set as this is an X-ray system, not an AI model.

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

Not Available. The document does not describe any training set or its ground truth establishment.

In summary, the provided FDA 510(k) clearance letter for the Orthophos 3/3 Ceph/3 DS, being from 1999 and for a conventional X-ray device, does not contain the detailed performance study information typically required for modern AI/ML medical devices. The focus of this type of clearance is demonstrating substantial equivalence to a pre-existing device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of what appears to be an abstract symbol, possibly representing people or services.

APR 3 0 1999

Sirona Dental Systems, GMBH C/O Sheila Hemeon-Heyer, Esq., RAC Senior Staff Consultant Medical Device Consultants 49 Plain Street North Attleboro, Massachusetts 02760-4153

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

RE: K990528 Orthophus 3/3 Ceph/3 DS Dated: April 28, 1999 Received: April 28, 1999 Regulatory Class: II 21 CFR 872.1800 and 872.1830 Procode: 90 MUH and 76 EAG

Dear Ms. Hemeon-Heyer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 dass 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K990528

Device Name: Orthophos 3/3 Ceph/3 DS

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Severson

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

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Sirona Dental Systems 510(k) Orthophos 3/3 Ceph/3 DS

February 18, 1999

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.