The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intra-oral radiography images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intraoral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

Device Description

The DEXIS sensor is an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology.

The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra-oral applications.

The DEXIS sensor supports USB 2.0 and USB 1.1 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.

AI/ML Overview

The provided text is a 510(k) Summary for the DEXIS Sensor, a digital X-ray device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them. It doesn't detail:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a "test set."
Number or qualifications of experts for ground truth establishment.
Adjudication method for a test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or effect size of human improvement with AI.
Standalone performance of an algorithm without human-in-the-loop.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a study.
Sample size for a training set.
How ground truth for a training set was established.

Instead, the document asserts substantial equivalence by comparing the DEXIS Sensor's characteristics and intended use to two legally marketed predicate devices: Schick Technologies, CDR (K072134) and Suni Medical Imaging, Inc., SuniRay II Digital Radiographic System (K070219).

The key comparison points in the "Substantial Equivalence" table are:

Indications for Use: All three devices are for acquiring dental intra-oral radiography images, to be operated by healthcare professionals.
Number of Sensors: DEXIS Sensor has 1, CDR has 3, SuniRay II has 2.
Sensor Size (mm): DEXIS is 30 x 39; CDR has sizes 31 x 22, 37 x 24, 43 x 30; SuniRay II has sizes 39.5 x 26, 43.5 x 31.5.
Technology: All three use CMOS.
Interface to PC: All three use USB.
Dynamic Range: DEXIS Sensor has 16,384:1; both predicates have 4096:1. (The DEXIS Sensor exceeds the predicate devices in this specification, which is generally considered a positive attribute.)
Sensor Cable Length (m): DEXIS is 2.8; CDR is 2; SuniRay II is 1.

The conclusion drawn in the document is that the DEXIS Sensor is "substantially equivalent in intended use and technical characteristics" to the predicate devices. This type of submission does not typically include the detailed clinical study information requested.

Summary

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K090458

Section III - 510(k) Summary of Safety and Effectiveness

MAY 2.8 2009

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Claudia Ortiz - Contact Person

Date Summary Prepared: February 2009

Device Name:

Trade Name DEXIS Sensor .
Common Name Digital X-ray ●
Classification Name Extraoral source x-ray system, per 21 CFR § 872.1800 .

Devices for Which Substantial Equivalence is Claimed:

Schick Technologies, CDR (K072134) ●
Suni Medical Imaging, Inc., SuniRay II Digital Radiographic System (K070219) .

Device Description:

The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra-oral applications.

The DEXIS sensor supports USB 2.0 and USB 1.1 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.

Intended Use of the Device:

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Substantial Equivalence:

DescriptiveInformation	DEXIS Sensor	CDR (K072134)	SuniRay II DigitalRadiographic System(K070219)
Indicationsfor Use	The DEXIS sensor is aUSB-driven digital sensorwhich is intended toacquire dental intra-oralradiography images. TheDEXIS sensor shall beoperated by healthcareprofessionals, who areeducated and competent toperform the acquisition ofdental intra-oralradiographs. The DEXISsensor can be used either incombination with specialpositioning devices tofacilitate positioning andalignment with the x-raybeam or it may also bepositioned by hand with theassistance of the patient.	The computed oral radiologysystem is intended for intra-oral x-ray examinations andindicated for dental patients. Itproduces instant, digital, intra-oral x-ray images of apatient's mouth whilereducing the necessary x-raydosage.	The SuniRay II DigitalRadiography System is usedto collect dental x-rayphotons and convert theminto electronic impulses thatmay be stored, viewed, andmanipulated for diagnosticuse by dentists.
Number ofSensors	1	3	2
Sensor Size(mm)	30 x 39	31 x 2237 x 2443 x 30	39.5 x 2643.5 x 31.5
Technology	CMOS	Same	Same
Interface toPC	USB	Same	Same
DynamicRange	16,384:1	4096:1	4096:1
Sensor CableLength (m)	2.8	2	1

Conclusion: The DEXIS Sensor is substantially equivalent to other legally marketed devices in the The DEXIS Sensor is substantially equivalent in intended use and technical United States. characteristics to the CDR marketed by Schick Technologies, Inc. and SuniRay II Digital Radiographic System marketed by Suni Medical Imaging, Inc.

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Image /page/2/Picture/0 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or bird with its wings spread, facing to the right. The bird's body is represented by three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

MAY 28 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEXIS, LLC

% Ms. Claudia Ortiz

Compliance Director, Regulatory Affairs & Quality Assurance Sybron Dental Specialties, Inc. 1717 West Collins Drive

ORANGE CA 92656

Re: K090458

Trade/Device Name: DEXIS Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: May 8, 2009 Received: May 11, 2009

Dear Ms. Ortiz:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)

(240) 276-0115 (240) 276-0115 (240) 276-0120 (240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K090458

Device Name: DEXIS Sensor

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090454

Page 1 of 1

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.