The I-MAX Touch (PAN and CEPH) is intented for dental radiographic examination of the teeth and specifically for panoramic examinations, TMJ studies, implantology and Cephalometry. It is to be only used by dental practitioners and/or radiologists.

The I-Max Touch (PAN and Ceph) is a digital image acquisition system to be used in conjunction with a Villa Sistemi Medicali Digital Panoramic X-ray System, such as I-Max Plus or Strato D, to capture images by a sensor, digitalize the image, review images and format images to be sent to a PC, according to a standard protocol, through the existing acquisition board of panoramic system.

Device Description

Extra oral source X-Ray System

AI/ML Overview

The provided text is a 510(k) summary for the OWANDY I-MAX Touch, a dental X-ray system. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel AI-powered diagnostic device would.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and human reader performance are not present in this type of document because the regulatory pathway for this device does not typically require them.

However, I can extract the information that is available and clarify what is not.

1. Table of Acceptance Criteria and Reported Device Performance

This document describes a substantial equivalence comparison rather than a study with defined acceptance criteria and performance metrics (e.g., sensitivity, specificity, accuracy). The "performance" assessment is based on comparing the technological characteristics and intended use of the I-MAX Touch to a predicate device, the STRATO 2000 D and OWANDY digital acquisition device.

The acceptance criteria here are implicitly that the new device is as safe and effective as the predicate device by demonstrating similar fundamental technological characteristics and intended use. The "reported device performance" is the direct comparison of features.

Feature / Characteristic	I-Max Touch (New Device)	Strato 2000 D (Predicate Device)	Acceptance (Stated Equivalence)
Intended Use	Dental radiographic examination of teeth, panoramic, TMJ, implantology, and Cephalometry.	Dental radiographic examination of teeth, panoramic, TMJ, implantology, and Cephalometry.	Substantially Equivalent
CEPH option	Yes	Yes	Equivalent
Digital acquisition Sensor	CCD	CCD	Equivalent
Computer Interface Board	Ethernet	USB	Different technology, but serves same function. Not deemed a difference in safety/effectiveness.
Digital Storage	USB memory stick	Compact flash card	Different technology, but serves same function. Not deemed a difference in safety/effectiveness.
High voltage value	86 KVp max	80 KVp max	Slight difference, likely within acceptable range for dental X-ray. Not deemed a difference in safety/effectiveness.
Tube current	12 mA max	12 mA max	Equivalent
Total filtration	2.5 mmAl	2.5 mmAl	Equivalent
Examination programs	Comprehensive list (Adult/Child, various panoramic, TMJ, Maxillary sinus, Ceph, Carpus)	Comprehensive list (Adult/Child, various panoramic, TMJ, Maxillary sinus, Ceph, Carpus)	Substantially Equivalent
X-ray exposure timing	13.8 Sec PAN adult, CEPH variable max 15 sec	15 Sec PAN adult, CEPH variable max 15 sec	Slight difference, likely within acceptable range for dental X-ray. Not deemed a difference in safety/effectiveness.
Electrical characteristics	6.6 A at 230V 50/60 Hz	18 A at 110V	Different electrical requirements, but device functionality maintained. Not deemed a difference in safety/effectiveness.
Positioning lights	Class 1 laser (EN60825-1+A1+A2)	Class 2 laser	Different class, but both are standard for positioning. Not deemed a difference in safety/effectiveness.
Focus receptor distance	500 mm	512 mm	Slight difference. Not deemed a difference in safety/effectiveness.
Minimum room size	2450X2000X1450	2320X1900X1300	Different physical dimensions. Not deemed a difference in safety/effectiveness.

2. Sample size used for the test set and the data provenance

This notification does not describe a clinical study with a "test set" in the context of an AI/algorithm performance evaluation. The substantial equivalence is based on engineering comparisons and intended use declarations, not on a dataset of clinical cases. Therefore, there is no mention of sample size or data provenance for a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No test set requiring expert-established ground truth is described.

4. Adjudication method for the test set

Not applicable. No test set or ground truth adjudication is described.

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. This device is an X-ray system, not an AI-assisted interpretation tool. The document does not describe any MRMC studies or AI integration.

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

Not applicable. This device is an X-ray system, not a standalone algorithm.

7. The type of ground truth used

Not applicable. No clinical ground truth is discussed in this regulatory document for establishing device equivalence. The "ground truth" for the submission is that the predicate device is legally marketed and has established safety and effectiveness.

8. The sample size for the training set

Not applicable. This document does not describe the development or training of any algorithms or AI components.

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

Not applicable. No training set or ground truth for a training set is described.

Summary

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OWANDY

I-MAX Touch 510(k)

510(K) SUMMARY

Premarket Notification for the I-MAX Touch K083057

JUN – 2 2009

Identification

Applicant	OWANDY6 Allee Kepler77420 Champs sur Marne - France
Contact person	Olivier DEROO, Quality and Regulations Manager
Email	oderoo@owandy.com

TRADE NAME :	I-MAX Touch (PAN and CEPH)
Common name :	Extra oral source X-Ray System
Classification :	according to 21CFR872-1800 , I-MAX Touch is in class 2

Intended use

The I-MAX Touch (PAN and CEPH) is intented for dental radiographic examination of the teeth and specifically for panoramic examinations, TMJ studies, implantology and Cephalometry.

It is to be only used by dental practitioners and/or radiologists.

Substantial equivalence and technological characteristics

The I-MAX Touch is defined as substantially equivalent to the STRATO 2000 D, manufactured by VILLA SISTEMI MEDICALI (X-ray system) and OWANDY (digital acquisition device) and cleared by FDA with K002432 (VILLA) and K041120 (OWANDY). See comparison table in Chapter 3.

The following table compares the two units :

Trade Name	I-Max Touch	Strato 2000 D
K number	K083057	K002432+K041120
Intended use	extra-oral source X-ray system fordental radiographic examination of theteeth and specifically for panoramicexaminations, TMJ studies andCephalometry.	extra-oral source X-ray system fordental radiographic examination of theteeth and specifically for panoramicexaminations, TMJ studies,implantology and Cephalometry.
CEPH option	Yes	Yes
Digital acquisition Sensor	CCD	CCD
Computer Interface Board	Ethernet	USB
Digital Storage	USB memory stick	Compact flash card
High voltage value	86 KVp max	80 KVp max
Tube current	12 mA max	12 mA max
Total filtration	2.5 mmAl	2.5 mmAl

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OWANDY	I-MAX Touch 510(k)
Examination programs	Adult / Child selectionSmall / Medium / Large size selectionStandard panoramicRight Semi-PanoramicLeft Semi-PanoramicPanoramic with improved orthogonalityReduced dose panoramicIncisor block panoramicTMJMaxillary sinusLateral CephFrontal CephCarpus	Adult / Child selectionSmall / Medium / Large size selectionStandard panoramicRight Semi-PanoramicLeft Semi-PanoramicPanoramic with improvedorthogonalityReduced dose panoramicIncisor blockTMJMaxillary sinusLateral CephFrontal CephCarpus
X-ray exposure timing	13,8 Sec PAN adult, CEPH exposuretime variable according to the type ofresolution and format selected. Max 15sec	15 Sec PAN adult, CEPH exposuretime variable according to the type ofresolution and format selected. Max15 sec
Electrical characteristics	6,6 A at 230V 50/60 Hz	18 A at 110V
Positioning lights	Class 1 laser according to EN60825-1+A1+A2	Class 2 laser
Focus receptor distance	500 mm	512 mm
Minimum room size	2450X2000X1450	2320X1900X1300

i .

and the comments of the comments of

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract symbol of a human figure and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The symbol is composed of three curved lines that resemble a stylized human form, and it is positioned to the right of the text.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OWANDY

JUN - 2 2009

% Mr. Claude Berthouin Official Correspondent Denterprise International, Inc. RF America, Inc. 110 W. Granada Blvd., Suite 207 ORMOND BEACH FL 32176

Re: K083057

Trade/Device Name: I-Max Touch Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: April 10, 2009 Received: April 13, 2009

Dear Mr. Berthouin:

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; good manufacturing practice requirements as set forth in the quality systems (OS) 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	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(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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OWANDY

I-MAX Touch 510(k)

INDICATION FOR USE STATEMENT

Applicant: OWANDY

510(k) Number : K083057

Device Name: I-Max Touch

Indication For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices KOSROST 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.