Midmark Extraoral Imaging System (EOIS)

{0}------------------------------------------------ August 6, 2020 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". Midmark Corporation % Mr. Mark Kenar Quality & Regulatory Affairs Manager 1001 Asbury Drive BUFFALO GROVE IL 60089 Re: K201667 Trade/Device Name: Midmark Extraoral Imaging System (EOIS) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS, MUH Dated: June 18, 2020 Received: June 19, 2020 Dear Mr. Kenar: 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). 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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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201667 Device Name Midmark Extraoral Imaging System (EOIS) #### Indications for Use (Describe) The intended use of the Midmark EOIS is to provide dental radiographic examination to aid in the diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will provide cephalometric radiographic examinations for use in orthodontic treatment planning and evaluation. When the system is equipped with the CBCT option, the system will also provide volumetric and tomographic images of the oral and maxillofacial region, for diagnostic examination of teeth, jaws, oral structures, and some cranial bones. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------|----------------------------------------------------------------| | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The icon is made up of two overlapping shapes, one in light blue and one in pink, creating a sense of connection and collaboration. #### Designing better care.™ Midmark Corporation 1001 Asbury Drive Buffalo Grove, IL 60089 1-800-MIDMARK midmark.com # 510(k) Summary – K201667 As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR §807.92, a 510(k) summary is provided below with the required information. #### 5.1 Administrative Information | Device Name | Midmark Extraoral Imaging System (EOIS) | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Date Summary<br>Prepared | June 18, 2020 | | 510(k) Sponsor<br>Address | 1001 Asbury Drive<br>Buffalo Grove, IL 60089, USA | | Contact Person | Mark Kenar | | Trade Name | Extraoral Imaging System (EOIS) | | Common Name | Extraoral X-ray System | | Classification Name | 21 CFR §892.1750 Computed tomography X-ray system<br>(Product Code OAS)<br>21 CFR §872.1800 Extraoral source X-ray system (Product Code<br>MUH) | | Device Class | 2 | | Review Panel | Radiology | {4}------------------------------------------------ | Manufacturer<br>Name | Trade Name | Regulation<br>Name and<br>Number | Device<br>Class | Product<br>Code | 510(k) No. | Decision Date | |------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-----------------|-----------------|------------|----------------------| | Acteon<br>Group | X-MIND TRIUM (Primary<br>predicate) | 21 CFR<br>§892.1750<br>Computed<br>tomography<br>X-ray system | 2 | OAS | K160166 | November 15,<br>2016 | | Midmark<br>Corporation | Progeny Vantage<br>Panoramic Extraoral<br>Radiation Imaging<br>System with<br>Cephalometric<br>Attachment (Secondary<br>predicate) | 21 CFR<br>§872.1800<br>Extraoral<br>source X-ray<br>system | 2 | MUH | K122643 | January 7, 2013 | ## 5.2 Equivalent Predicate Comparators ## 5.3 Indications for Use The intended use of the Midmark EOIS is to provide dental radiographic examination to aid in the diagnosis of diseases of the teeth, iaw and oral structures. When the system is equipped with the cephalometric option, the system will provide cephalometric radiographic examinations for use in orthodontic treatment planning and evaluation. When the system is equipped with the CBCT option, the system will also provide volumetric and tomographic images of the oral and maxillofacial region, for diagnostic examination of teeth, jaws, oral structures, and some cranial bones. ## 5.4 Device Description The Midmark Extraoral Imaging System (EOIS) is a diagnostic X-ray system using an extraoral source intended for dental radiographic examination and diagnosis of diseases for the following regions of the patient's anatomy: - . dental (teeth) - . oral and maxillofacial region (mouth and jaw) It produces the following radiographic images: - . Panoramic (PAN) images used for diagnostic examination of dentition (teeth), jaws and oral structures. - Cephalometric (CEPH) images of maxillofacial region and parts of the skull for CEPH examination, if equipped with the CEPH feature. - . Carpal images assisting in estimating bone-age, if equipped with the CEPH feature, and when the carpal attachment is used. {5}------------------------------------------------ - . Cone Beam Computed Tomography (CBCT) volumetric and tomographic images of the oral and maxillofacial region for diagnostic examination of dentition (teeth), jaws, oral structures, and some cranial bones, if equipped with the CBCT small or medium feature. The main modality is limited to PAN radiographic images but can be upgraded by installing the CEPH imaging feature, allowing the device to provide CEPH radiographic images for use in orthodontic treatment planning and evaluation. This extension is also intended to allow carpal imaging to assist in estimating bone-age. The Midmark EOIS can be upgraded by installing a 3D option allowing the device to produce computed volumetric and tomographic images of the listed above anatomy regions by computed tomographic reconstruction of the digital X-ray data. The X-ray data is captured by two dimensional images taken by exposing the patient anatomy at different anales with a cone shaped X-ray beam. Reconstruction software converts these two-dimensional images into a three-dimensional data set. EOIS is also available with CEPH and CBCT modalities at the time of purchase. The table below shows available configurations. ## System Configurations: - 1. V8001, Extraoral Imaging System, Panoramic - 2. V8011, Extraoral Imaging System, Panoramic and Cephalometric - 3. V8101, Extraoral Imaging System, Small CBCT - 4. V8111, Extraoral Imaging System, Small CBCT and Cephalometric - 5. V8201, Extraoral Imaging System, Medium CBCT - 6. V8211. Extraoral Imagina System. Medium CBCT and Cephalometric #### Upgrade Kits: - 1. V8010, Cephalometric Feature Upgrade - 2. V8100, Small CBCT Feature Upgrade - 3. V8200, Medium CBCT Feature Upgrade From a clinical point of view, the Midmark EOIS can be applied for the following medical applications: - . Generic dentistry - Dental implantology . - . Dental surgery - Maxillofacial surgery - . CEPH analysis - . Carpus radiology (for determining skeletal age) The target patient population includes adults and pediatric patients. Joint FDA and ADA guidance describes the earliest appropriate age for panoramic imaging to be the eruption of the first permanent tooth, and FDA has indicated these guidelines also apply to CBCT imaging. {6}------------------------------------------------ The device is intended to be used by a qualified and authorized dentist or physician who meets the requirements provided by national and local laws in force in the country of installation; the operator must understand the language of the country where the device is installed. The Midmark EOIS consists of the following components. Image /page/6/Picture/3 description: The image shows a diagram of a dental x-ray machine and its components. The diagram includes a computer (1), the x-ray machine itself (2), a lead apron (3), and a control panel (4). The components are connected by lines to indicate their relationship to the overall system. The diagram provides a visual representation of the equipment used in dental radiography. 1 Workstation -The imaging workstation is provided for the 3D unit only. The workstation external PC allows the operator to perform these procedures: - . image visualization and post processing - . database management - . review, annotate images, and studies - . associate images and studies to patients 2 Midmark EQIS - The Midmark EOIS is a diagnostic X-ray system utilizing an extraoral source intended for dental radiographic examination and diagnosis of diseases for teeth, mouth and jaw. 3 Handswitch - The handswitch is a control connected to the cable entrance board intended to initiate and stop the X-ray irradiation when the operator remains in the vicinity of, but a safe distance from the EOIS. 4 Remote Exposure Station - The remote exposure station is a control device connected to the cable entrance board intended to initiate and stop the X-ray irradiation when the operator remains outside of the EOIS vicinity The EOIS software is considered to be of Moderate Level of Concern and consists of the device driver and CBCT visualization software. The device driver is composed of the following subsystems: - . Reconstruction Engines take projection images consisting of radiological data and reconstructs them, resulting in a 3D dataset composed of reconstructed projection images processed using user-selectable acquisition parameters. This feature is new with the EOIS device. {7}------------------------------------------------ - The system offers a choice between a reconstruction based only on Filtered o Back Projection (FBP) and one based on fully iterative reconstruction. The algorithm used for iterative reconstruction starts with the FBP scan data and generates projection images that it expects would be produced from the imaging of the selected volume. These images are used to evaluate the correctness of the reconstruction volume by comparing the simulated projection images to those acquired by the scanner. A metric is calculated for the correctness of the reconstructed volume and reconstruction progresses with a two-pass correction to rectify beam-hardening, scatter subtraction, and image regularization. - Acquisition Manager provides the communications exchange between non-● software subsystems and the software subsystem. It is responsible for delivering the image data from the digital sensor, through the appropriate reconstruction engine, and to the client API. In addition, it is responsible for the information relationship between the operator control panel software, real-time controller, and the connected digital sensor(s). This subsystem has been previously cleared. - . Operator Control Panel Software is used from the operator control panel to facilitate exams and service the system. It communicates with the acquisition manager software. This subsystem has been previously cleared. - . Client API provides a facility for connecting to the EOIS system and acquiring a radiological image. The Client API performs image post-processing and other tasks related to the transfer of images to an image management application. In the case of a cone beam computed tomography (CBCT) capable system, a dedicated 2D/3D visualization software application is provided (referred to as Visualization Software.) This subsystem has been previously cleared. For an EOIS system that includes the cone beam computed tomography (CBCT) feature, dedicated visualization software is provided. This software is new to the EOIS device and facilitates acquiring exams for all supported modalities of the system. It includes a patient database, image storage, and post-acquisition image processing functionality. The software provides interoperability via an exportable DICOM (Digital Imaging Communication in Medicine) dataset. The main differences between the EOIS device and predicate systems are the CBCT mode of operation and new digital detectors. EOIS has three distinct image acquisition modes: Panoramic, Cephalometric and CBCT. CBCT-capable image receptors used in EOIS can take a panoramic radiograph which results in just one detector in EOIS CBCT systems with panoramic imaging and two detectors when cephalometric imaging is added. Acteon X-Mind Trium also has three modes: Panoramic, Cephalometric and CBCT. CBCTcapable image receptors used in Acteon X-Mind Trium do not have enough vertical resolution to support a panoramic radiograph. Therefore, a separate panoramiccapable image receptor must be used, which results in Acteon X-Mind Trium having two detectors in CBCT systems with panoramic capability and three detectors in those with added cephalometric capability. Vantage has just two modes: Panoramic and Cephalometric. Vantage does not have a CBCT mode of operation. {8}------------------------------------------------ Section 5.5, Technological Characteristics, identifies the primary and secondary predicates and provides a comparison of technological characteristics of the EOIS with both predicates. ## 5.5 Technological Characteristics Refer to the table below for a comparison of Midmark EOIS technological characteristics with those of its predicates. | | Midmark Extraoral<br>Imaging System (EOIS)<br>(Subject Device) | Acteon X-MIND Trium<br>(Primary Predicate) | Vantage Panoramic<br>X-ray System<br>(Secondary Predicate) | | Midmark Extraoral | Acteon X-MIND Trium | Vantage Panoramic | |----------------------|----------------------------------------------------------------|--------------------------------------------|------------------------------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Owner | Midmark Corporation | Acteon (DE GOTZEN S.R.L) | Midmark Corporation | | Imaging System (EOIS) | (Primary Predicate) | X-ray System | | 510(k) Number | K201667 | K160166 | K122643 | | (Subject Device) | | (Secondary Predicate) | | Regulation<br>Number | 21 CFR 892.1750<br>21 CFR 872.1800 | 21 CFR 892.1750 | 21 CFR 872.1800 | Indications for Use | The intended use of the<br>Midmark Extraoral<br>Imaging System (EOIS) is<br>to provide dental<br>radiographic examination<br>to aid in the diagnosis of<br>diseases of the teeth, jaw<br>and oral structures. When<br>the system is equipped<br>with the cephalometric<br>option, the system will<br>provide cephalometric<br>radiographic<br>examinations for use in<br>orthodontic treatment<br>planning and evaluation.<br>When the system is<br>equipped with the CBCT<br>option, the system will also<br>provide volumetric and<br>tomographic images of<br>the oral and maxillofacial<br>region, for diagnostic<br>examination of teeth,<br>jaws, oral structures, and<br>some cranial bones. | X-MIND Trium is a digital<br>panoramic, cephalometric<br>and tomographic extra-<br>oral X-ra system, indicated<br>for use in:<br>- producing panoramic X-<br>ray images for diagnostic<br>examination of dentition<br>(teeth), jaws and oral<br>structures;<br>- producing radio graphs<br>of maxillofacial region and<br>parts of the skull for<br>cephalometric<br>examination, if equipped<br>with<br>CEPH arm;<br>- producing radiographs of<br>hands and wrists for carpus<br>examination, if equipped<br>CEPH arm;<br>- producing tomographic<br>images of the oral and<br>maxillofacial region, for<br>diagnostic examination of<br>dentition (teeth), jaws,<br>oral structures and some<br>cranial bones, if equipped,<br>with CBCT option.<br>From a clinical point of<br>view, the X-MIND Trium can<br>be applied for the<br>following medical<br>applications:<br>• Generic dentistry<br>• Dental implantology<br>• Dental surgery<br>• Maxillo-facial surgery<br>• Cephalometric analysis<br>• Carpus radiology<br>The intended population<br>can be whatever,<br>including pediatric patients<br>from 5 years old [- 21 kg (46<br>lb); 113 cm (44.5 in)<br>standing height]; anyway<br>the sustainability to X-ray<br>exposure must be<br>evaluated by qualified<br>and authorized physicians, | The intended use of the<br>Progeny Vantage Extraoral<br>X-Ray System is to provide<br>dental radiographic<br>examination and diagnosis<br>of diseases of the teeth, jaw<br>and oral structures. When<br>the system is equipped with<br>the cephalometric option,<br>the system will also provide<br>cephalometric<br>radiographic examinations<br>for use in orthodontic<br>treatment planning and<br>evaluation. | | Product Code | OAS & MUH | OAS & MUH | MUH | | | | | {9}------------------------------------------------ {10}------------------------------------------------ | | Midmark Extraoral<br>Imaging System (EOIS)<br>(Subject Device) | Acteon X-MIND Trium<br>(Primary Predicate) | Vantage Panoramic<br>X-ray System<br>(Secondary Predicate) | |----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Modalities | Panoramic<br>Cephalometric<br>CBCT | Panoramic<br>Cephalometric<br>CBCT | Panoramic<br>Cephalometric | | Technique Factor<br>Voltage Range: | | | | | Panoramic | 60 kV to 84 kV | 60 kV to 85 kV | 54 kV to 84 kV | | Cephalometric | 60 kV to 84 kV | 60 kV to 85 kV | 54 kV to 84 kV | | CBCT | 84 kV | 80-90 kV | N/A | | Technique Factor<br>Current Range: | | | | | Panoramic | 4 mA to 14 mA | 4 mA to 10 mA | 4 mA to 14 mA | | Cephalometric | 4 mA to 14 mA | 4 mA to 10 mA | 4 mA to 14 mA | | CBCT | 4 mA to 14 mA | 4 mA to 12 mA | N/A | | X-ray Tube Focal<br>Spot Size | 0.5 mm | 0.5 mm | 0.5 mm | | Irradiation Time<br>Range | | | | | Panoramic | 7.6 s to 15.9 s | 3.3 s to 13.5 s | 2.5 s to 16 s | | Cephalometric | 9.2 s to 15.6 s | 3.3 s to 13.5 s | 9.5 to 15.6 s | | CBCT | 4.7 s | 4 s to 12 s | N/A | | Half Value Layer: | | | | | Panoramic | 4.5 mm Al @ 85 kV | 3.4 mm Al @ 85 kV | 3.2 mm Al @ 85 kV | | Cephalometric | 4.5 mm Al @ 85 kV | 3.4 mm Al @ 85 kV | 3.2 mm Al @ 85 kV | | CBCT | 4.5 mm Al @ 85 kV | 5.2 mm Al @ 90 kV | N/A | | Image Receptor<br>Technology | CMOS | CMOS | CCD | | Image Receptor<br>Scintillator | CsI | CsI | CsI | | Image Receptor<br>Active Area | | | | | Panoramic | 152 × 6.5 mm | 148 × 6 mm | 146 × 6 mm | | Cephalometric | 228 × 6.5 mm | 223 × 6 mm | 220 × 6 mm | | CBCT | Small FOV:<br>147.3 × 112.0 mm;<br>Medium FOV:<br>150.5 × 150.5 mm | 121.6 × 123.1 mm | N/A | | Image Receptor<br>A/D Conversion<br>(Bit Depth) | 14 bits | 14 bits | 16 bits | | Image Sizes (l x h) | | | | | Panoramic | 307 × 147 mm | 260 × 148 mm | 300 × 140 mm | | Cephalometric | 300 × 210 mm<br>240 × 210 mm | 240 × 220 mm<br>240 × 180 mm<br>200 × 220 mm<br>200 × 180 mm | 300 × 210 mm<br>240 × 210 mm | | Field of View<br>(h × w), cm | Small FOV: 5×5, 8×7<br>Medium FOV: 5×5,<br>5×8 (child), 6×8 (child),<br>8×8 | 4×4, 6×6, 8×8, 8×11 | N/A | | CBCT Voxel Sizes | 78, 156, 195 µm | 75, 100, 150 µm | N/A | | | Midmark Extraoral<br>Imaging System (EOIS)<br>(Subject Device) | Acteon X-MIND Trium<br>(Primary Predicate) | Vantage Panoramic<br>X-ray System<br>(Secondary Predicate) | | Patient<br>Positioning,<br>PAN/CBCT | Chinrest<br>Forehead Support<br>Bite block<br>TMJ nose support | Chinrest<br>Forehead support<br>Bite block<br>TMJ nose support | Chinrest,<br>Positioning wands<br>Bite block<br>TMJ nose support | | | Image: Midmark Extraoral Imaging System | Image: Acteon X-MIND Trium | Image: Vantage Panoramic X-ray System | | Patient<br>Positioning, Ceph | Ear posts<br>Nasion support | Ear posts<br>Nasion support | Ear posts<br>Nasion support | | | Image: Patient Positioning Ceph Midmark | Image: Patient Positioning Ceph Acteon | Image: Patient Positioning Ceph Vantage | | Laser<br>Classification per<br>IEC 60825-1 | Class 2 | Class 1M | Class 2 | | Laser Wavelength | 650 nm | 650 nm | 650 nm | | Laser Power | 3 mW | 1 mW | 3 mW | | Laser Diffractive<br>Optics | Line, 40° | Line, 90° | Line, 40° | | Operating<br>Temperature | 5 °C to 40 °C | 10 °C to 30 °C | 5 °C to 40 °C | | Relative Humidity<br>(non-condensing) | 5 % to 85 % | 25 % to 75 % | 5 % to 85 % | | Atmospheric<br>Pressure | 70 kPa to 106 kPa | 85 kPa to 106 kPa | 70 kPa to 106 kPa | | Focal Spot Target<br>Material | Tungsten | Tungsten | Tungsten | | Filter Material | Aluminum & Copper | Aluminum (Pan/Ceph)<br>Aluminum & Copper<br>(CBCT) | Aluminum | | Image Receptor<br>Material | CMOS with Csl | CMOS with Csl | CCD with Csl | | Standards<br>Compliance | IEC 60601-1:2005+A1:2012<br>IEC 60601-1-3:2013<br>IEC 60601-1-6:2013<br>IEC 60601-2-63:2017<br>IEC 60601-1-2:2014<br>IEC 61223-3-4:2000<br>IEC 60825-1:2014<br>ISO 10993-1:2018 | IEC 60601-1 3rd ed<br>ANSI/AAMI ES60601-1: 2005<br>IEC 60601-1-3: 2008<br>IEC 60601-1-6: 2010<br>IEC 60601-2-63: 2012<br>IEC 60601-1-2:2007<br>IEC 62366:2007<br>ISO 14971 | IEC 60601-1:2005<br>IEC 60601-1-3: 2008<br>IEC 60601-1-6: 2010<br>IEC 60601-2-63: 2012<br>IEC 60601-1-2:2007<br>IEC 61223-3-4:2000<br>IEC 60825:2007<br>ISO 14971:2007 | | Midmark Extraoral<br>Imaging System (EOIS)<br>(Subject Device) | Acteon X-MIND Trium<br>(Primary Predicate) | Vantage Panoramic<br>X-ray System<br>(Secondary Predicate) | | | ISO 14971:2007<br>ISO 13485:2016 | | | | {11}------------------------------------------------ {12}------------------------------------------------ ## 5.6 Non-clinical Performance Data Non-clinical evaluations were performed for the EOIS. A summary of testing and results is shown in the table below. | Testing | Results | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | Medical electrical safety testing, including<br>X-ray safety, electromagnetic<br>compatibility, and usability (IEC 60601<br>standards) | Passed; the results of the third-party<br>testing demonstrate compliance of<br>the device to the standards. | | Imaging performance testing<br>(IEC 61223-3-4) | Internal verification testing was performed<br>in accordance with IEC 61223-3-4, and all<br>acceptance criteria were met. | | Dose comparison evaluation, including<br>predicate comparison, diagnostic<br>reference level (DRL) comparison, and<br>literature review. | Midmark EOIS was shown to produce<br>similar or less radiation dosage than<br>comparable devices on market. | | CBCT modality testing, including iterative<br>reconstruction performance, implant<br>performance, geometric normalization,<br>QC (DIN 6868-161), and uniform phantom<br>performance | CBCT-related functionality performs<br>according to specifications and produces<br>images of acceptable quality. | # 5.7 Clinical Performance Data The clinical testing performed for the EOIS consisted of a) an Image Performance study that evaluated image quality by having qualified clinicians evaluate images of phantoms and b) a usability study that examined use-related hazards with simulated use testing involving qualified clinicians. # Image Performance Study The clinical acceptability of Midmark EOIS panoramic, cephalometric, and CBCT images was assessed by a panel of dental practitioners. Images were generated using head and {13}------------------------------------------------ hand phantoms, provided to the clinicians and then rated for diagnostic acceptability. Results showed that all EOIS imaging protocols provided overall acceptable image quality. ## Usability The usability of the EOIS, as it relates to safety, was evaluated by 18 participants consisting of hygienists, dental assistants, and dentists. Participants were observed interfacing with the device to operate all imaging protocols and were also interviewed after. Results demonstrate that the final interface design of the EOIS facilitates safety for operators. # 5.8 Conclusion The Midmark EOIS is substantially equivalent to other legally marketed devices in the United States in terms of technical characteristics, intended use, and effectiveness; specifically, the Acteon X-MIND TRIUM system and the Progeny Vantage Panoramic X-ray System.