Tomographic X-ray System, which is intended for diagnostic dental radiography at the dento-maxillofacial region and additionally cephalometry. The imaging methods are narrow beam radiography and spiral tomography and central projection cephalometry.

Device Description

Cranex Tome Ceph is a high frequency Tomographic, Radiographic system capable of producing dental panoramic and tomographic images, TMJ (TemporoMandibular Joint) tomographic images and cephalometric images. It is available in two models with (Cranex Tome Ceph) and without (Cranex Tome) the cephalometric option. The Cranex TOME uses the principle of autotomography with a spiral blurring movement. This movement, which is similar to the movement used by the Soredex SCANORA®, is achieved by tilting and rotating the C-arm at the same time.

The Cranex Tome comprises of

moving column
C-arm
An adjustable two-position chin support is used to carry out all exposure procedures.
Four-point head support and bite-block system
A large adjustable mirror
The patient positioning lights
control panel
graphical display
wide range of x-ray programs for mandible, maxilla, temporomandibular joint,

sinus, and cephalometric exposures.

high-frequency generator

-15x30 cm panoramic cassette for paroramic and tomographic imaging

And the following with the cephalometric unit

Soft tissue filter adjustment with LED positioning indicators
selectable magnification ratio and a rotatable head support with positioning stops every 45 degrees.

-The system software makes it impossible to take an exposure if the cephalometric cassette is the wrong size or incorrectly positioned.

-Accepts 18x24, 8"x10" or 24x30 cm cephalometric cassettes

The cephalometric arm can be mounted on either the left- or the right-hand side of the unit

-An cephalometric kit is available so that Cranex TOME can be upgraded to a Cranex TOME Ceph .

AI/ML Overview

The submitted text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format typically required for modern medical device submissions. This document is a 510(k) summary from 1998, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance metrics from a dedicated study.

However, based on the provided text, I can infer and extract some information:

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

The document broadly states "Safety and effectiveness is demonstrated by: - clinical tests - software verification, validation and certification procedures - risk analysis - risk management file". It concludes that the device is "safe and effective when the unit is used as labeled." However, no specific performance metrics like sensitivity, specificity, accuracy, or quantitative image quality assessments are provided, nor are numerical acceptance criteria against which they would be measured.

Acceptance Criteria	Reported Device Performance	Comments
Safety	Demonstrated through clinical tests, software verification/validation/certification, risk analysis, and risk management file.	No specific quantitative safety metrics or thresholds are provided.
Effectiveness	Demonstrated through clinical tests, software verification/validation/certification, risk analysis, and risk management file.	No specific quantitative effectiveness metrics (e.g., image quality scores, diagnostic accuracy) or thresholds are provided. The general statement is that it's "effective when the unit is used as labeled" for producing X-ray images for dentistry, TMJ, and skull.
Substantial Equivalence	The Cranex Tome Ceph is substantially equivalent to predicate devices (Scanora, Oralix DC III Ceph/Cranex 3 Ceph) in design, operational, and functional features.	This is the primary "performance" metric for a 510(k) submission of this era.

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

The document mentions "clinical tests" as part of the safety and effectiveness demonstration. However, it does not provide any details about:

The sample size of patients or images used in these clinical tests.
The data provenance (e.g., country of origin, retrospective or prospective nature).

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)

The document does not provide any information about experts involved in establishing ground truth for any tests, nor their qualifications.

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

The document does not provide any information about an 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

This document is from 1998, well before AI assistance in radiology was prevalent. It does not mention any MRMC study or AI assistance. The focus is on the device itself as an imaging system, not on software-assisted interpretation.

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

Given the device is an X-ray imaging system, and the submission date, the concept of "standalone algorithm performance" as understood today (e.g., for AI/CAD systems) is not relevant. The device's performance is inherently tied to producing images for human interpretation. Therefore, no standalone algorithm-only performance assessment would have been conducted or reported in this context.

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

The document does not explicitly state the type of ground truth used for its "clinical tests." However, for an imaging device, ground truth often involves clinical diagnosis, expert radiological interpretation, or in some cases, pathology, depending on the specific application. Without further detail, it's impossible to specify.

8. The sample size for the training set

The device is a hardware imaging system, not an AI algorithm that requires a training set in the modern sense. Therefore, the concept of a "training set sample size" as applies to machine learning models does not apply to this submission.

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

As explained above, the concept of a "training set" in the context of an AI algorithm does not apply to this device. Therefore, this question is not applicable.

Summary

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MAR 27 1998

510 (k) Summary Statement for the Soredex Cranex Tome Tomographic, Radiographic System

I General Information

Submitter:	Orion Corporation Soredex
	Nilsiänkatu 10-14
	FIN 00510, Helsinki
	Finland

Telephone: + 358-9-3937402

Fax: + 358-9-7015261

Contact Person:

Kai Lanér, Vice President

Summary Preparation Date: December 19, 1997

Names

Proprietary Name: Cranex Tome or Cranex Tome Ceph

Common or Usual Name: Tomographic X-ray system

Classification Name: System, Tomographic, Radiographic 90 IZF

III Substantial Equivalent Devices

Scanora (K884650) marketed by Orion Corporation Soredex, Tomographic functions Oralix Pan DC III Ceph (or Cranex 3 Ceph) (K880982) marketed by Orion Corporation Soredex , cephalometric functions

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IV Product Description

The Cranex Tome comprises of

moving column
C-arm
An adjustable two-position chin support is used to carry out all exposure procedures.
Four-point head support and bite-block system
A large adjustable mirror
The patient positioning lights
control panel
graphical display
wide range of x-ray programs for mandible, maxilla, temporomandibular joint,

sinus, and cephalometric exposures.

high-frequency generator

-15x30 cm panoramic cassette for paroramic and tomographic imaging

And the following with the cephalometric unit

Soft tissue filter adjustment with LED positioning indicators
selectable magnification ratio and a rotatable head support with positioning stops every 45 degrees.

-The system software makes it impossible to take an exposure if the cephalometric cassette is the wrong size or incorrectly positioned.

-Accepts 18x24, 8"x10" or 24x30 cm cephalometric cassettes

The cephalometric arm can be mounted on either the left- or the right-hand side of the unit

-An cephalometric kit is available so that Cranex TOME can be upgraded to a Cranex TOME Ceph .

V Inteded Use of the Device

The Cranex Tome Ceph is intended for producing x-ray images of dentistry, TMJ and skull.

The Cranex Tome is intended for producing x-ray images of dentistry and TMI.

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VI Indications for Use/Rationale for Substantial Equivalence

Cranex Tome Ceph, Tomographic x-ray system is used as an extra-oral source for x-rays in dental radiography.

It has similar instructions for use and installation, used materials, design, mode of x-ray generation (DC), operational and functional features as the substantial equivalent devices. It does not have all the different imaging programs of Scanora , however a substantial portion of those. Patient supporting, imaging programs and technique factor selection in cephalometric imaging is similar to Oralix Pan DC III Ceph (or Cranex 3 Ceph).

VII Summary of technological charasteristics

Cranex Tome Ceph is

a high-frequency DC X-ray equipment
imaging programs for panoramic and tomographic examinations of the dentistry
imaging programs for tomographic examinations of the TMJ
imaging programs for cephalometric examinations of the skull.

VIII Safety and Effectiveness Information

Safety and effectiveness is demonstrated by:

clinical tests
software verification, validation and certification procedures
risk analysis
- risk management file

All the above items and evaluations lead to the conclution that Cranex Tome and Cranex Tome Ceph are safe and effective when the unit is used as labeled.

IX Conclution

Crane Tome Ceph Tomographic, Radiographic system is substantially equivalent to the predicate devices : Scanora and Oralix DC III Ceph (or Cranex 3 Ceph).

The unit has similar design .operational and functional features as the current marketed predicative devices.

The device has been shown to be safe and effective when it is used as labelled.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 27 1998

Re:

Kai Laner V.P. Orion Corporation Soredex P.O. Box 79 FIN-00511 Helsinki Finland

K974877 Cranex Tome Ceph, or Cranex Tome . Dated: December 19, 1998 Received: December 29, 1998 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD

Dear Mr. Laner:

We have reviewed your Section 510(x) 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 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). 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 (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 (OS) 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro disgnostic 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.ida.gov/odrh/dsmaldsmamain.html".

Sincerely yours,
Kilian Yin

Lillian Yin, Ph.D. 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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Image /page/4/Picture/0 description: This image shows a document page. The page is labeled as "Page 1 of 1". The document includes the text "FDA/CDRH/ODE/DMC" and the date "2 FEB 93 16 23".

K974877 510 (k) NUMBER :

CRANEX TOME CEPH, or CRANEX TOME DEVICE NAME :

INDICATIONS FOR USE :

The method of image reception is film / intensifying screens.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Elmer C. Anderson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT 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.