Devices of the i-CAT family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas (such as TM Joint studies, mandible & maxilla for implant planning, sinuses, airway), for use in planning and diagnostic support in adult and pediatric care.

Devices of the i-CAT family comprise a package of software modules capable of handling 2D and 3D data. This includes 3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data.

Device Description

i-CAT FLX V series / KaVo 3D eXam+ V series manufactured by Imaging Sciences International, is a Cone Beam Volumetric Tomography and Panoramic X-ray dental imaging system that consists of a scanner and a software package for image reconstruction. The two models, i-CAT FLX / KaVo 3D eXam+, are of identical design in the i-CAT Scanner family. The components of the system include the main affixed unit, the overhead, the gantry, the tube head, the X-ray source assembly and collimator, the receptor panel, and software package for image reconstruction. The system is an open design that allows patients to sit upright during a procedure. An electric powered seat is built into the scanner for proper patient positioning. The V series refer to 3 different fieldof-view configurations (V8, V10, V17) available on each model based on licensing of the acquisition software.

The software package includes a device specific software package (SmartScan STUDIO) that is required to operate the i-CAT FLX System through a visual touchscreen interface and a post-processing imaging software. The modules within the device specific software perform the Image Acquisition, Quality Assurance, Device Calibration, and Image Reconstruction and Processing functionalities of the device. The software utilizes a modified Feldkamp algorithm for reconstruction. There is a basic DICOM viewer component (with limited image viewing capabilities) for the operator to ensure that the data collection and image processing are correct. Also provided with the device is a postprocessing imaging software, such as TxSTUDIO marketed under K123519. It is a volumetric imaging software designed specifically for dental clinicians, intended for use as a planning and simulation software in the placement of dental implants, orthodontics and surgical treatment. The imaging software reads DICOM data from dental CT machines, such as devices in the i-CAT family.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Important Note: The provided document is a 510(k) summary from the FDA for a dental imaging system (i-CAT FLX V series / KaVo 3D eXam+ V series). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria for an AI algorithm's performance. Therefore, the information typically requested for AI/algorithm performance (like MRMC studies, specific expert adjudication details, ground truth establishment for a training set) is not present in this type of regulatory submission, as the device is a hardware imaging system with associated software for image acquisition and reconstruction, not an AI-driven diagnostic tool.

The "study" described here is more akin to a verification and validation of the imaging system itself to ensure it produces images of diagnostic quality compared to legally marketed predicate devices.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an imaging system and not an AI algorithm with specific performance metrics like sensitivity/specificity, the "acceptance criteria" revolve around demonstrating comparable image quality and functionality to predicate devices. The document implies that the acceptance criteria are met if the device can produce volumetric and panoramic images of the maxillofacial (including ENT) areas in the head, and these images are of equivalent diagnostic quality as the predicate devices. The specific quantitative metrics for image quality are implied through the comparison table and the general statement of "acceptable clinical effectiveness."

Acceptance Criteria (Implied)	Reported Device Performance
Preamble: Device produces volumetric and panoramic images of the head area (ENT and maxillofacial).	Confirmed. The device consists of an x-ray system providing two-dimensional images and three-dimensional volume reconstructions of the head area, including ENT and maxillofacial areas (TM Joint, mandible & maxilla for implant planning, sinuses, airway).
Image Quality: Images are of equivalent diagnostic quality as predicate devices.	"As evidenced through the Design Verification and Validation, the proposed device can produce volumetric and panoramic images of the maxillofacial (including ENT) areas in the head, and they are of equivalent diagnostic quality as the predicate devices.""Clinical images acquired using i-CAT FLX/KaVo 3D eXam+ were reviewed by qualified clinicians to be of acceptable clinical effectiveness for the proposed indications for use." No specific quantitative metrics (e.g., SNR, contrast, resolution values) from a comparative study are detailed in this summary.
Technological Equivalence/Safety: Minor technological differences do not affect imaging of anatomical structures or raise new safety concerns.	"The minor technological difference in the shape of image volumes does not affect imaging of the intended anatomical structures.""Based upon an analysis of the technological differences, and the substantiation through design verification and validation, ISI determines that the proposed i-CAT FLX / KaVo 3D eXam+ is substantially equivalent to the predicate devices... and does not raise any new concerns."Compliance with various IEC standards (IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-63, 62366) and biocompatibility testing was also reported.
Functional Equivalence: Device offers similar functionalities to predicate devices.	The device provides "3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data," similar to its predicates. It supports various imaging procedures (implants, TM Joints, reconstructed panoramic/cephalometrics, airway/sinus, nerve canal, conventional digital panoramic).

Study Details (as inferable from the document)

Sample Size used for the test set and the data provenance:
- Sample Size: Not specified quantitatively. The document states "Clinical images acquired using i-CAT FLX/KaVo 3D eXam+ were reviewed." This implies a set of clinical images were used, but the number of cases or patients is not provided.
- Data Provenance: Not specified (e.g., country of origin). It's a general statement about "clinical images." It reads as if the images were likely prospectively acquired using the device itself for testing purposes, rather than being a retrospective dataset.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The document states "reviewed by qualified clinicians."
- Qualifications of Experts: "Qualified clinicians" is the only description provided. Specifics like "radiologist with 10 years of experience" are not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. It merely says "reviewed by qualified clinicians." There's no indication of a consensus or adjudication process.
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:
- MRMC Study: No, an MRMC study was not detailed. This submission is for an imaging system hardware/software combination, not an AI-assistance diagnostic tool.
- Human Reader Improvement with AI: Not applicable, as this device itself is the image acquisition and reconstruction system, not an AI for image interpretation or reader assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable in the context of an AI algorithm. The "algorithm" here refers to the image reconstruction algorithm (modified Feldkamp algorithm), and its performance is inherently evaluated through the diagnostic quality of the reconstructed images, which were "reviewed by qualified clinicians to be of acceptable clinical effectiveness."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" for this type of submission is the diagnostic quality perceived by qualified clinicians when reviewing images produced by the device, implicitly compared against what they would expect from a predicate device. It's not a "ground truth" for a specific disease or condition in the way a pathology report would be.
The sample size for the training set:
- Sample Size: Not applicable. This document does not describe the development or training of a machine learning or AI model; it describes a medical imaging device. The "training set" concept does not apply here.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable, as there is no "training set" in the context of an AI model's development in this submission. The image reconstruction algorithms are based on physics and mathematical principles, not trained on a dataset with "ground truth" labels.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 10, 2016

Imaging Sciences International % Ms. Ruth Pui Regulatory Affairs Manager 1910 North Penn Road HATFIELD PA 19440

Re: K162085

Trade/Device Name: i-CAT FLX V series / KaVo 3D eXam+ V series Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: October 25, 2016 Received: October 26, 2016

Dear Ms. Pui:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robert Oals

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K162085

Device Name

Cone Beam 3D and 2D Panoramic Dental Imaging System (i-CAT FLX V series/ KaVo 3D eXam+ V series)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for i-CAT FLX V Series / KaVo 3D eXam+ V Series

series

1. Submitter Information:
Imaging Sciences International,
also dba DEXIS, Gendex Dental Systems
1910 North Penn Road,
Hatfield, PA 19440
Phone: 215-997-5666; Fax: 215-997-5665

Contact Person:	Ruth Pui
Title:	Regulatory Affairs Manager
Direct Phone No.:	(267) 954-1479

Date Prepared:	October 25, 2016
----------------	------------------

2. Device Name:
Proprietary Name:	i-CAT FLX V series / KaVo 3D eXam+ V
Common Name:	X-ray, Tomography, Computed, Dental
Classification Name:	Computed tomography x-ray system
CFR Number:	892.1750
Device Class:	II
Product Code:	OAS

3. Predicate Devices:
Proprietary Name:	GALILEOS family
510(k) Number	K123070
Common Name:	X-ray, Tomography, Computed, Dental
Classification Name:	Computed tomography x-ray system
CFR Number:	892.1750
Device Class:	II
Product Code:	OAS

Proprietary Name:	i-CAT FLX
510(k) Number	K133620
Common Name:	X-ray, Tomography, Computed, Dental
Classification Name:	Computed tomography x-ray system
CFR Number:	892.1750
Device Class:	II
Product Code:	OAS

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4. Description of Device:

Cone Beam Volumetric Tomography is a medical imaging technique that uses X-rays to obtain cross-sectional images of the head or neck. The proposed device is a CBCT dental system with 2 modes of operation: panoramic and CBCT. The X-ray incident upon the receptor that generate sufficiently contrasted images. Quality of the images depends on the level and amount of X-ray energy delivered to the tissue. When interpreted by a trained physician, these images provide useful diagnostic information. The scanner has the ability to capture data for 3D skull reconstruction for the following procedures:

CBCT mode:
- o Implants
- TM Joints O
- Reconstructed Panoramic o
- Reconstructed Cephalometrics O
- o Airway / Sinus, etc.
- Nerve Canal o
· Panoramic mode:
- o PAN Conventional Digital Panoramic Feature

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In addition, the user can choose to scan using the Standard protocol, the QuickScan protocol, or the QuickScan+ protocol. The user can choose to reduce the radiation exposure to patients by lowering the exposure time (from Standard to QuickScan), or by lowering all the loading factors (from Standard to QuickScan+). The radiation dose level, in the form of DAP value, is readily displayed on the protocol selection screen of the user interface so the user may make an informed choice.

1. Indications for Use:
  Devices of the i-CAT family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas (such as TM Joint studies, mandible & maxilla for implant planning, sinuses, airway), for use in planning and diagnostic support in adult and pediatric care.

The proposed indications for use above of i-CAT FLX / KaVo 3D eXam+ include specification of airway within the ENT and maxillofacial area. The proposed device has been verified and validated to satisfy the requirements derived from the indications for use.

1. Summary of Technological Characteristics:
  i-CAT FLX / KaVo 3D eXam+ models share the same architectural components as the predicate devices including:
An X-ray source on a motorized gantry a.
b. Collimation of X-ray
Two-dimensional (2D) X-ray detector (for Panoramic and Cone Beam mode) C.
A patient positioning and support system to ensure stability of the patient during d. scan.
A software package which prepares and displays three dimensional (3D) e. reconstructions of the acquired data.

The system architecture of the proposed device is identical to the predicate device, i-CAT FLX (K133620), see comparison table below for details.

Characteristics	Proposed Devicei-CAT FLX / KaVo 3DeXam+V series	Predicate DeviceGALILEOS Comfort Plus(K123070)	Predicate Devicei-CAT FLX(K133620)
Principle ofOperation	Cone Beam X-ray	Cone Beam X-ray	Cone Beam X-ray
Generator	High Frequency, ConstantPotential	N/A	High Frequency, ConstantPotential
X-ray tube	Stationary anode	Stationary Anode	Stationary anode
Characteristics	Proposed Devicei-CAT FLX / KaVo 3DeXam+V series	Predicate DeviceGALILEOS Comfort Plus(K123070)	Predicate Devicei-CAT FLX(K133620)
Tube Voltage	120 kV(peak)	98 kV	120 kV(peak)
Tube Current	3-7 mA	3-6 mA	3-7 mA
Scan time	4 to 40 seconds	14 seconds	4 to 40 seconds
Exposure	6-100mAs	30 mAs	6-100mAs
Target material	Tungsten	Tungsten	Tungsten
MinimumFiltration	> 10 mm of Al equivalent at120 kV	2.8 mm of Al equivalent at 98k V	> 10 mm of Al equivalent at120 kV
Focal spot	0.5 mm	0.5 mm	0.5 mm
Anode capacity	30 kHU	48 kHU	30 kHU
Detector*
Type	Amorphous Silicon	Image Intensifier	Amorphous Silicon
Conversion Screen	Direct Deposit CsI, DRZ Plus	Not Available	Direct Deposit CsI, DRZ Plus
Size	20 x 25 cm	Not Available	20 x 25 cm
Active InputWindow Size	N/A	215 mm diameter	N/A
Camera	N/A	Pixels: 1000^2, FPS: 15-30,Dynamics: 12 bits, (4096brightness values), 63 dB	N/A
Total Pixel Area	19.5 x 24.4 cm	Not Available	19.5 x 24.4 cm
Pixel Matrix	1536 x 1920	Not Available	1536 x 1920
Pixel Pitch	127 µm²	Not Available	127 µm²
LimitingResolution	3.94 lp/mm	Not Available	3.94 lp/mm
MTF	>48% @ 1 lp/mm	Not Available	>48% @ 1 lp/mm
DQE	>75% (1x1)	Not Available	>75% (1x1)
Energy Range	40 - 160 kVp	Not Available	40 - 160 kVp
Gantry
Resolution angle /Orbital angle	360°	204°	360°
Number ofprojections/ singleexposures	160, 300, 320, 600, 1100 or1200	200, 357	160, 300, 320, 600, 1100 or1200
Orientation	Vertical	N/A	Vertical
Source to Sensordistance	71.4 cm	59.0 cm	71.4 cm
Characteristics	Proposed Devicei-CAT FLX / KaVo 3DeXam+V series	Predicate DeviceGALILEOS Comfort Plus(K123070)	Predicate Devicei-CAT FLX(K133620)
Source to isocenterdistance	49.53 cm	41.3 cm	49.53 cm
Image Reconstruction
Field of view, axial	17 cm max	15.4 cm (diameter) sphericalimaging volume	17 cm max
Field of view, crosssectional	23 cm max		23 cm max
Other
Effective Dose(ICRP 2007)	4-171 µSv (Ludlow)	28-154µSv (Ludlow)	4-171 µSv (Ludlow)
Workstation	Intel based PC	Intel based PC	Intel based PC
Electricalrequirements	100VAC, 115VAC, 200VAC or230VAC 50/60 Hz (FactorySet)	200 V - 240 V, 50/60 Hz	100VAC, 115VAC, 200VACor 230VAC 50/60 Hz (FactorySet)
Patient Positioning	Seated	Standing or seated	Seated
Patient PositioningAccessories	Chin rest, chin cup, bite block,head rest, head strap, headholder, booster seat, foot stool	Chin rest, bite block, foreheadsupport and head fixationdevice	Chin rest, chin cup, bite block.head rest, head strap, headholder, booster seat, foot stool
Laser indication ofscanned area	Yes	Yes	Yes
Exposureparameters fordeterminingleakage radiation	7mA / 120 kV	6mA / 98 kV	7mA / 120 kV
Continuingcurrent forleakage radiationmeasurements	0.5 mA (at 130 kVp)	0.14 mA	0.5 mA (at 130 kVp)
Performance-relatedConformanceStandards	IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 60601-2-63IEC 62366	IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-2-63	IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 60601-2-63IEC 62366

Comnarison Table:

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*Receptor panels utilized in the proposed device has been previously cleared as a component of the device in K 133620.

As evidenced through the Design Verification and Validation, the proposed device can produce volumetric and panoramic images of the maxillofacial (including ENT) areas in the head, and they are of equivalent diagnostic quality as the predicate devices. The minor technological difference in the shape of image volumes does not affect imaging of the intended anatomical structures.

Based upon an analysis of the technological differences, and the substantiation through design verification and validation, ISI determines that the proposed i-CAT FLX / KaVo 3D eXam+ is substantially equivalent to the predicate devices, GALILEOS Comfort Plus (K123070) and i-CAT FLX (K133620), and does not raise any new concerns.

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7. Non-Clinical Performance Data:

Performance bench testing was conducted as part of design control to ensure the substantial equivalence of i-CAT FLX/KaVo 3D eXam+ to the predicate devices. The substantial equivalence for the proposed indications for use is substantiated through verification and validation testing on two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas, for use in planning and diagnostic support in adult and pediatric care. The verification and validation activities for the software package also supports the substantial equivalence of the proposed device. Biocompatibility evaluation was conducted on patient contacting accessory parts and found to be in conformance with ISO 10993-5:2009 and ISO 10993-10:2010. EMC and Electrical Safety testing were performed by Intertek Testing Services and found to meet all the requirements in standards IEC 60601-1: 2005 (R)2012 (AAMI ES60601-1:2005/(R)2012), IEC 60601-1-6:2010, IEC 62366:2007/(R)2013, IEC 60601-2-63:2012, IEC 60601-1-3:2008, IEC 60601-1-2:2007, and IEC 60825-1:2007.

8. Clinical Performance Data:

Clinical images acquired using i-CAT FLX/KaVo 3D eXam+ were reviewed by qualified clinicians to be of acceptable clinical effectiveness for the proposed indications for use.

9. Conclusion as to Substantial Equivalence:

Based on the substantial equivalence comparison of intended use, design, technological characteristics, performance, labeling, biocompatibility, standards, and other characteristics, the minor differences between i-CAT FLX/KaVo 3D eXam+, and the predicate devices, GALILEOS Comfort Plus (K123070) and i-CAT FLX (K133620), do not raise new concerns for the proposed indications of use. Imaging Sciences International concludes that the proposed device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.