The Signet DXIS® System is designed to replace the film cassettes with a digital sensor in existing dental panoramic x-rav systems that are already on the market. It consists of a digital x-ray sensor. interface equipment, software, and adapters for specific dental x-ray systems. The DXIS® is installed by a Signet authorized technician on existing compatible dental x-ray systems. Software provided by Signet and a user supplied computer permit the images from the digital sensor to be recorded and displayed.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Signet DXIS® Digital X-ray Imaging System, based on the provided 510(k) summary:

This 510(k) summary (K983283) focuses on demonstrating substantial equivalence to predicate devices rather than proving a specific performance metric against a set of acceptance criteria through a dedicated study. For devices cleared under substantial equivalence, the primary "acceptance criterion" is that the new device is as safe and effective as existing legally marketed devices.

However, we can infer some "acceptance criteria" through the comparison with existing devices.

1. Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating similar technological characteristics and intended use to the predicate devices. The performance is reported in terms of features and capabilities matching or improving upon the predicates.

Acceptance Criterion (Inferred from Predicate Comparison)	Reported Device Performance (DXIS®)
Ability to provide panoramic dental images	YES
Utilizes X-ray technology	YES
Replaces film cassettes in existing systems	YES
Performs digital processing of images	YES
Offers digital storage of images	YES
Provides hard copy (printing) capability	YES
Includes enhancement functions for images	YES
Utilizes a CCD acquisition sensor	YES (CCD DXIS Sensor)
Includes a computer interface board	YES
Includes acquisition software	YES (DXIS Acquisition Program)
Level of X-ray Radiation exposure comparable to or better than predicates	Up to 50% (of a baseline assumed to be comparable to or less than predicates like Trophy at 70%)
Panoramic Acquisition Board functionality (if applicable)	NO (but has a "Panoramic Correlator")
Panoramic Correlator functionality (if applicable)	YES (while Trophy has NO, implying a different approach to generating panoramic images)

Note: The radiation exposure reduction (up to 50%) is a key performance characteristic highlighted, implying it meets or exceeds the predicate's performance in this aspect. For other features, the performance is simply "YES," indicating it possesses the characteristic.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly describe a specific "test set" or a performance study with a defined sample size to prove the device meets acceptance criteria in the way a clinical trial would. The submission focuses on a comparative analysis of technological characteristics to predicate devices.

Therefore, information on:

Sample size used for the test set: Not specified.
Data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified, as no such study is detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no specific "test set" and corresponding performance study with ground truth establishment is detailed, this information is not provided in the 510(k) summary.

4. Adjudication Method for the Test Set

As no specific "test set" is described for performance evaluation, an adjudication method is not applicable/not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not described in this 510(k) summary. The submission focuses on device characteristics and substantial equivalence, not reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

The DXIS® is a digital imaging system, not an AI algorithm for diagnostic interpretation. Its primary function is to acquire, display, store, and print digital X-ray images. Therefore, the concept of "standalone algorithm performance" (without human-in-the-loop) in the context of recent AI/ML medical devices does not directly apply to this device as described. Its performance is related to image quality, radiation dose, and functionality compared to film-based or other digital systems.

7. The Type of Ground Truth Used

As no specific performance study requiring ground truth is detailed, the type of ground truth used is not specified. The primary "ground truth" for this 510(k) is the established performance and safety of legally marketed predicate devices.

8. The Sample Size for the Training Set

The DXIS® is an imaging hardware and software system, not a machine learning model that requires a "training set" in the conventional AI sense. Therefore, "sample size for the training set" is not applicable and not specified.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" in the context of AI/ML is not applicable to this device, how its "ground truth" would be established is not applicable/not specified.

Summary

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510(k) Summarv for DXIS® Digital X-ray Imaging System

510(k) # K983283

1. SPONSOR

Signet Radiology, Inc. 253 Logue Rd. P.O. Box 508 Minto, NB, E0E 1J0 Canada

Contact person: Alex Cetateanu (1)506-327-3931 Telephone:

Date prepared: September 4, 1998

DEVICE NAME 2.

Proprietary Name: Signet DXIS® Direct X-ray Imaging System Common/Usual Name: Digital x-ray imaging system Classification Name: Extra-oral source x-ray system

3. PREDICATE DEVICES

Trophy Digipan (K961826) Siemens Orthophos DS (K972312) Planmeca Dimax (510(k) # not known)

4. DEVICE DESCRIPTION

The Signet DXIS® is intended for dental radiographic examination and diagnosis of the teeth, jaw, and oral structure.

The DXIS® System is designed to replace the film cassettes with a digital sensor in existing dental panoramic x-rav systems that are already on the market. It consists of a digital x-ray sensor. interface equipment, software, and adapters for specific dental x-ray systems. The DXIS® is installed by a Signet authorized technician on existing compatible dental x-ray systems. Software provided by Signet and a user supplied computer permit the images from the digital sensor to be recorded and displayed.

ડ. INTENDED USE

The Signet DXIS® is intended for dental radiographic examination and diagnosis of the teeth, iaw. and oral structure.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIALLY EQUIVALENCE

The DXIS®, like the predicate devices, provides the ability to display, store, or print digital radiographic images of the teeth, jaw or oral structure. A comparison of the DXIS® and the predicate devices is provided in the table given below.

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	Comparison	SIGNETRadiology	TROPHY	PLANMECA	SIEMENS
1.	Trade Name	DXIS	DigiPan	PlanmecaDimax	OrthophosDS
2.	Panoramic Image	YES	YES	YES	YES
3.	X-Ray	YES	YES	YES	YES
4.	Replacement filmcassette	YES	YES	YES	YES
5.	Digital processing	YES	YES	YES	YES
6.	Level of X-rayRadiationexposure	Up to 50%	70%	Informationnotavailable	Informationnotavailable
7.	Acquisition sensor	CCDDXISSensor	CCDDigitalCassette	CCD Digital	CCD Array
8.	PanoramicAcquisition Board	NO	YES	Informationnotavailable	Informationnotavailable
9.	PanoramicCorrelator	YES	NO	Informationnotavailable	Informationnotavailable
10.	ComputerInterface Board	YES	YES	YES	YES
11.	AcquisitionSoftware	DXISAcquisitionProgram	TrophyWindowsImaging(TWI)	Informationnotavailable	SIDEXIS
12.	Enhancementfunctions	YES	YES	YES	YES
13.	Digital storage	YES	YES	YES	YES
14.	Hard copy	YES	YES	YES	YES

Comparison Table: DXIS® and predicate Devices

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 10008 NOV

Alex Cetateanu President Signet Radiology, Inc. 253 Logue Road P.O. Box 508 Minto, NB. EOE 1J0 Canada

Re:

K983283 Signet DIXS® Direct Dental X-ray Imaging System Dated: September 15, 1998 Received: September 18, 1998 Regulatory class: II 21 CFR 872.1800/Procode: 90 MUH

Dear Mr. Cetateanu:

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 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 yrity. 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/odrividsma/dsmamain.html".

Sincerely yours,

Lillian Yip, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal. Ear. Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: DXIS®

Indications For Use:

THE DXIS® IS INTENDED FOR DENTAL RADIOGRAPHIC EXAMINATION AND DIOGNOSIS OF DISEASES OF THE TEETH, JAW AND ORAL STRUCTURE.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Syzon

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

Prescription Use X (Per 21 CFR 801.109) Over - The - Counter - Use ___________________________________________________________________________________________________________________________________________________

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.