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 and diagnostic support in adult and pediatic care. Devices of the i-C AT 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 was developed as an upgrade to the existing i-CAT Scanner. i-CAT FLX, 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. It is a device 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.

Cone Beam Volumetric Tomography is a medical imaging technique that uses X-rays to obtain crosssectional images of the head or neck. The proposed device utilizes cone beam X-ray technology, which generates conical x-ray beams that rotate around the patient's head and 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the i-CAT FLX Cone Beam 3D and 2D Panoramic Dental Imaging System:

The provided document is a 510(k) summary for the i-CAT FLX system, rather than a detailed study report with specific acceptance criteria metrics. In 510(k) submissions, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to meet pre-defined quantitative acceptance criteria against a specific benchmark. Therefore, the "acceptance criteria" discussed here are focused on demonstrating equivalence in performance, safety, and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration of Equivalence)	Reported Device Performance
Equivalence in Indications for Use: i-CAT FLX's indications for use (ENT and maxillofacial areas, TM Joint, mandible & maxilla for implant planning, diagnostic support in adult and pediatric care) must be within the scope of, or substantially equivalent to, the predicate devices.	The proposed indications for use of i-CAT FLX include expansions into ENT and pediatric care, which were verified and validated to satisfy the requirements derived from these indications. The device provides 2D images and 3D volume reconstructions of the head, including ENT and maxillofacial areas, for planning and diagnostic support in adult and pediatric care.
Equivalence in Technological Characteristics: i-CAT FLX's components and operating principles must be substantially similar to predicate devices.	i-CAT FLX shares the same architectural components as predicate devices (X-ray source on gantry, collimation, 2D X-ray detector, patient positioning system, software for 3D reconstructions). The minor technological difference in image volume shape does not affect imaging of intended anatomical structures.
Equivalent Diagnostic Quality of Images: The images produced by i-CAT FLX must be of comparable diagnostic quality to the predicate devices.	Through Design Verification and Validation, i-CAT FLX can produce volumetric and panoramic images of the maxillofacial (including ENT) areas in the head, and they are of equivalent diagnostic quality as GALILEOS (a predicate).
Safety and Effectiveness: Demonstration that i-CAT FLX is as safe and effective as the predicate devices.	Performance bench testing was conducted to ensure safety and effectiveness. Biocompatibility, EMC, and Electrical Safety testing were performed and met relevant ISO/IEC standards. Clinical images acquired were reviewed to be of acceptable clinical effectiveness. ISI concludes that i-CAT FLX is substantially equivalent.
Biocompatibility: Patient-contacting parts must be biocompatible.	Biocompatibility evaluation was conducted on patient-contacting accessory parts and found to be in conformance with ISO 10993-10.
EMC and Electrical Safety: The device must meet relevant electromagnetic compatibility and electrical safety standards.	EMC and Electrical Safety testing was performed by Intertek Testing Services and found to meet all requirements in IEC 60601-1-6:2010, IEC 62366:2007, IEC 60601-2-63:2012, and IEC 60601-1-2:2007.

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

The document does not specify a distinct "test set" in the context of an algorithm's performance evaluation. The testing described is more akin to design verification and validation for a hardware/software system.

"Clinical Test Data" for "acceptable clinical effectiveness": The document states "Sample clinical images acquired using i-CAT FLX were reviewed to be of acceptable clinical effectiveness for the proposed indications for use."
- Sample Size: Not specified. It refers to "Sample clinical images," implying a subset, but no number is given.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It only states images were "acquired using i-CAT FLX."

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

Number of Experts: Not specified. The document mentions "When interpreted by a trained physician, these images provide useful diagnostic information" but does not detail the number or role of experts in the "acceptable clinical effectiveness" review.
Qualifications of Experts: Not specified. It generally refers to "trained physician."

4. Adjudication Method for the Test Set

Adjudication method: Not specified. The phrase "reviewed to be of acceptable clinical effectiveness" suggests an expert review process, but details of how disagreements or consistency were handled are not provided.

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

MRMC Study: No, an MRMC comparative effectiveness study, especially one involving human readers with and without AI assistance, was not described. The goal of this submission was to demonstrate substantial equivalence of a new imaging system to existing ones, not to evaluate an AI's impact on human performance. The "AI" would be the image reconstruction software, which is intrinsic to the device, not an add-on for comparative effectiveness with human readers.

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

Standalone Performance: The "algorithm" in this context refers to the image reconstruction software within the i-CAT FLX system. Its "standalone performance" is implicitly evaluated through the "Design Verification and Validation" which determined that the system "can produce volumetric and panoramic images... and they are of equivalent diagnostic quality as GALILEOS." This is a system-level performance evaluation, not a focused algorithm-only study against a specific metric.

7. The Type of Ground Truth Used

Type of Ground Truth: For the "acceptable clinical effectiveness" of sample images, the ground truth appears to be expert consensus/interpretation by unspecified "trained physician(s)" that the images provided "useful diagnostic information" and were of "acceptable clinical effectiveness." This is inferred, as no explicit ground truth methodology is detailed. For the physical and technical performance (e.g., image quality compared to a predicate, biocompatibility, electrical safety), the ground truth is based on compliance with established standards and direct comparison to a predicate device's known performance.

8. The Sample Size for the Training Set

Sample size for training set: Not applicable and not specified. This document describes an imaging system, not a machine learning model developed with a distinct "training set" in the modern AI sense. The software package for image reconstruction is an integral part of the device.

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

Ground truth for training set: Not applicable and not specified, as there is no separate "training set" for an AI algorithm described in this submission. The software development and verification would have relied on engineering principles and established image processing techniques, rather than a labeled training dataset in the context of supervised machine learning.

Summary

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DEXIS°

Image /page/0/Picture/1 description: The image shows the word "GENDEX" in a bold, sans-serif font. The "G" is stylized with a circular shape, and the "X" has a sharp, angular design. The overall appearance of the logo is modern and professional.

Image /page/0/Picture/2 description: The image shows a logo and some text. The text "MAY 14 2014" is at the top left of the image. Below that is the text "Imaging Sciences International" along with a logo that appears to be the letters "IS" stylized. There is also some handwritten text on the right side of the image, but it is difficult to read.

1910 NORTH PENN ROAD HATFIELD, PA 19440, USA PHONE: 215.997.5666 215.997.5665 FAX:

510(K) SUMMARY 6

Submitter:

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

Date of Summary: April 10, 2014

Contact person:

Ruth Pui, Sr. Regulatory Affairs Specialist or Saniay Ahuja, Ph.D., Director, Regulatory Affairs

Device Name:

Trade Name i-CAT FLX Cone Beam 3D and 2D Panoramic Dental Imaging System ●
Common Name X-ray, Tomography, Computed, Dental .
Classification name Computed tomography x-ray system (21 CFR §892.1750, Product Code . OAS)

Devices for Which Substantial Equivalence is Claimed:

. i-CAT Scanner, K061284
GALILEOS Comfort Plus, K 123070 ●

Device Description:

Cone Beam Volumetric Tomography is a medical imaging technique that uses X-rays to obtain crosssectional images of the head or neck. The proposed device utilizes cone beam X-ray technology, which

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Image /page/1/Picture/0 description: The image shows the word "DEXIS" in a bold, sans-serif font. The letters are outlined in black and filled with a textured pattern that resembles a rough or distressed surface. The overall appearance of the word is strong and prominent.

Image /page/1/Picture/1 description: The image shows the word "GENDEX" in a bold, sans-serif font. The "G" is stylized with a circular shape, and the "X" has a small dot above it. The text is black against a white background.

Image /page/1/Picture/2 description: The image shows the logo for Imaging Sciences International. The logo consists of the words "Imaging Sciences International" stacked on top of each other on the left side of the image. To the right of the words is a stylized logo that appears to be the letters "IS" inside of a square.

1910 NORTH PENN ROAD HATFIELD, PA 19440, USA PHONE: 215.997.5666 FAX: 215.997.5665

generates conical x-ray beams that rotate around the patient's head and 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.

Indications for Use:

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.

The proposed indications for use above of i-CAT FLX include expansions into ENT (ear nose throat) region and pediatric care. The proposed device has been verified and validated to satisfy the requirements derived from the indications for use.

Summary of Technological Characteristics:

i-CAT FLX shares the same architectural components as both predicate devices including:

An X-ray source on a motorized gantry .
Collimation of X-ray ●
. Two-dimensional (2D) X-ray detector
. A patient positioning and support system to ensure stability of the patient during scan.
A software package which prepares and displays three dimensional (3D) reconstructions of the . acquired data.

As evidenced through the Design Verification and Validation, i-CAT FLX can produce volumetric and panoramic images of the maxillofacial (including ENT) areas in the head, and they are of equivalent diagnostic quality as GALILEOS. 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 safety and effectiveness of the proposed i-CAT FLX is substantially equivalent to the predicate devices, i-CAT Scanner (K061284) and GALILEOS Comfort Plus (K123070) and does not raise any new concerns.

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Image /page/2/Picture/0 description: The image shows the word "DEXIS" in a bold, outlined font. The letters are large and spaced closely together. The overall impression is of a strong, recognizable brand name.

Image /page/2/Picture/1 description: The image shows the word "GENDEX" in a bold, sans-serif font. The "G" is stylized with a curved shape, and the "X" has a sharp, angular design. There is a small dot to the right of the "X". The text is black against a white background.

Image /page/2/Picture/2 description: The image shows the logo for Imaging Sciences International. The logo consists of the company name written in a simple, sans-serif font, with the word "Imaging" on the first line, "Sciences" on the second line, and "International" on the third line. To the right of the company name is a stylized graphic that appears to be the letters "I" and "S" combined into a single shape.

1910 NORTH PENN ROAD HATFIELD, PA 19440, USA PHONE: 215.997.5666 FAX: 215.997.5665

Non-Clinical Test Data:

Performance bench testing was conducted as part of design control to ensure the safety and effectiveness of i-CAT FLX is equivalent to the predicate devices. The safety and effectiveness of i-CAT FLX 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 use of i-CAT FLX for pediatric care, including considerations for proper positioning of pediatric patients for image acquisition, has also been verified and validated. Biocompatibility evaluation was conducted on patient contacting accessory parts and found to be in conformance with ISO 10993-10. EMC and Electrical Safety testing on i-CAT FLX was performed by Intertek Testing Services and found to meet all the requirements in standards IEC 60601-1-6:2010, IEC 62366:2007, IEC 60601-2-63:2012 and IEC 60601-1-2:2007.

Clinical Test Data:

Sample clinical images acquired using i-CAT FLX were reviewed to be of acceptable clinical effectiveness for the proposed indications for use.

Conclusion:

Based on the comparison of intended use, design, technological characteristics, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, the minor differences between i-CAT FLX device, and the predicate devices, i-CAT Scanner (K062184) and GALILEOS Comfort Plus (K123070), do not raise new concerns in safety and effectiveness for the proposed indications of use. ISI concludes that i-CAT FLX is substantially equivalent to the predicate devices.

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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's official name and national affiliation. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gi604 Silver Spring, MD 20993-0002

May 14, 2014

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

Re: K133620

Trade/Device Name: Cone Beam 3D and 2D Panoramic Dental Imaging System (i-CAT FLX) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: 11 Product Code: OAS Dated: April 11, 2014 Received: April 14, 2014

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 (IPMA), 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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Page 2-Ms. Pui

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

hun://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

l or

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

. K 133620

Device Name

i-CAT FLX, Cone Beam 3D and 2D Panoramic Dental Imaging System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

FORM FDA 3881 (9/13)

PSC Publishers Sers rees ( 1411 1 a 1,4 % = Page 15 of 1799

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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.