(48 days)
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.
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.
- . 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.
The provided text focuses on the K201667 510(k) submission for the Midmark Extraoral Imaging System (EOIS), detailing its indications for use, technological characteristics, and non-clinical performance data.
However, it does not contain detailed information about acceptance criteria for an AI device, nor does it describe a study that explicitly proves an AI device meets such criteria. The document describes a traditional medical imaging device (X-ray system) and its performance, not an AI/ML medical device.
Therefore, I cannot extract the specific information requested in the prompt regarding AI device acceptance criteria and study details. The document describes:
- Non-clinical Performance Data (Section 5.6): This includes medical electrical safety testing, imaging performance testing (against IEC 61223-3-4), dose comparison evaluation, and CBCT modality testing.
- Clinical Performance Data (Section 5.7): This mentions an "Image Performance study" (evaluating image quality of phantom images by dental practitioners for diagnostic acceptability) and a "Usability study" (examining use-related hazards with simulated use involving clinicians).
None of these describe an AI study with its specific acceptance criteria as detailed in the prompt's numbered requests. The "Reconstruction Engines" and "iterative reconstruction" mentioned in Section 5.4 are image reconstruction algorithms, not AI algorithms designed for diagnosis or specific clinical tasks requiring the kind of rigorous AI validation outlined in the prompt.
Given the provided text, I must state that the information required to answer the prompt's specific questions about AI device acceptance criteria and a study proving it meets them is NOT present.
The document discusses imaging system performance and safety, but not AI model performance against explicit clinical acceptance criteria.
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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). 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 of medical device-related adverse events) (21 CFR 803); 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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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.
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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Midmark. The logo consists of the word "midmark" in a sans-serif font, with a stylized icon above it. 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 SummaryPrepared | June 18, 2020 |
| 510(k) SponsorAddress | 1001 Asbury DriveBuffalo 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(Product Code OAS)21 CFR §872.1800 Extraoral source X-ray system (Product CodeMUH) |
| Device Class | 2 |
| Review Panel | Radiology |
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| ManufacturerName | Trade Name | RegulationName andNumber | DeviceClass | ProductCode | 510(k) No. | Decision Date |
|---|---|---|---|---|---|---|
| ActeonGroup | X-MIND TRIUM (Primarypredicate) | 21 CFR§892.1750ComputedtomographyX-ray system | 2 | OAS | K160166 | November 15,2016 |
| MidmarkCorporation | Progeny VantagePanoramic ExtraoralRadiation ImagingSystem withCephalometricAttachment (Secondarypredicate) | 21 CFR§872.1800Extraoralsource X-raysystem | 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.
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- . 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:
-
- V8001, Extraoral Imaging System, Panoramic
-
- V8011, Extraoral Imaging System, Panoramic and Cephalometric
-
- V8101, Extraoral Imaging System, Small CBCT
-
- V8111, Extraoral Imaging System, Small CBCT and Cephalometric
-
- V8201, Extraoral Imaging System, Medium CBCT
-
- V8211. Extraoral Imagina System. Medium CBCT and Cephalometric
Upgrade Kits:
-
- V8010, Cephalometric Feature Upgrade
-
- V8100, Small CBCT Feature Upgrade
-
- 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.
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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.
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- 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.
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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 ExtraoralImaging System (EOIS)(Subject Device) | Acteon X-MIND Trium(Primary Predicate) | Vantage PanoramicX-ray System(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) | ||
| RegulationNumber | 21 CFR 892.175021 CFR 872.1800 | 21 CFR 892.1750 | 21 CFR 872.1800 | Indications for Use | The intended use of theMidmark ExtraoralImaging System (EOIS) isto provide dentalradiographic examinationto aid in the diagnosis ofdiseases of the teeth, jawand oral structures. Whenthe system is equippedwith the cephalometricoption, the system willprovide cephalometricradiographicexaminations for use inorthodontic treatmentplanning and evaluation.When the system isequipped with the CBCToption, the system will alsoprovide volumetric andtomographic images ofthe oral and maxillofacialregion, for diagnosticexamination of teeth,jaws, oral structures, andsome cranial bones. | X-MIND Trium is a digitalpanoramic, cephalometricand tomographic extra-oral X-ra system, indicatedfor use in:- producing panoramic X-ray images for diagnosticexamination of dentition(teeth), jaws and oralstructures;- producing radio graphsof maxillofacial region andparts of the skull forcephalometricexamination, if equippedwithCEPH arm;- producing radiographs ofhands and wrists for carpusexamination, if equippedCEPH arm;- producing tomographicimages of the oral andmaxillofacial region, fordiagnostic examination ofdentition (teeth), jaws,oral structures and somecranial bones, if equipped,with CBCT option.From a clinical point ofview, the X-MIND Trium canbe applied for thefollowing medicalapplications:• Generic dentistry• Dental implantology• Dental surgery• Maxillo-facial surgery• Cephalometric analysis• Carpus radiologyThe intended populationcan be whatever,including pediatric patientsfrom 5 years old [- 21 kg (46lb); 113 cm (44.5 in)standing height]; anywaythe sustainability to X-rayexposure must beevaluated by qualifiedand authorized physicians, | The intended use of theProgeny Vantage ExtraoralX-Ray System is to providedental radiographicexamination and diagnosisof diseases of the teeth, jawand oral structures. Whenthe system is equipped withthe cephalometric option,the system will also providecephalometricradiographic examinationsfor use in orthodontictreatment planning andevaluation. |
| Product Code | OAS & MUH | OAS & MUH | MUH |
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| Midmark ExtraoralImaging System (EOIS)(Subject Device) | Acteon X-MIND Trium(Primary Predicate) | Vantage PanoramicX-ray System(Secondary Predicate) | |
|---|---|---|---|
| Modalities | PanoramicCephalometricCBCT | PanoramicCephalometricCBCT | PanoramicCephalometric |
| Technique FactorVoltage 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 FactorCurrent 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 FocalSpot Size | 0.5 mm | 0.5 mm | 0.5 mm |
| Irradiation TimeRange | |||
| 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 ReceptorTechnology | CMOS | CMOS | CCD |
| Image ReceptorScintillator | CsI | CsI | CsI |
| Image ReceptorActive 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:147.3 × 112.0 mm;Medium FOV:150.5 × 150.5 mm | 121.6 × 123.1 mm | N/A |
| Image ReceptorA/D Conversion(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 mm240 × 210 mm | 240 × 220 mm240 × 180 mm200 × 220 mm200 × 180 mm | 300 × 210 mm240 × 210 mm |
| Field of View(h × w), cm | Small FOV: 5×5, 8×7Medium FOV: 5×5,5×8 (child), 6×8 (child),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 ExtraoralImaging System (EOIS)(Subject Device) | Acteon X-MIND Trium(Primary Predicate) | Vantage PanoramicX-ray System(Secondary Predicate) | |
| PatientPositioning,PAN/CBCT | ChinrestForehead SupportBite blockTMJ nose support | ChinrestForehead supportBite blockTMJ nose support | Chinrest,Positioning wandsBite blockTMJ nose support |
| Image: Midmark Extraoral Imaging System | Image: Acteon X-MIND Trium | Image: Vantage Panoramic X-ray System | |
| PatientPositioning, Ceph | Ear postsNasion support | Ear postsNasion support | Ear postsNasion support |
| Image: Patient Positioning Ceph Midmark | Image: Patient Positioning Ceph Acteon | Image: Patient Positioning Ceph Vantage | |
| LaserClassification perIEC 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 DiffractiveOptics | Line, 40° | Line, 90° | Line, 40° |
| OperatingTemperature | 5 °C to 40 °C | 10 °C to 30 °C | 5 °C to 40 °C |
| Relative Humidity(non-condensing) | 5 % to 85 % | 25 % to 75 % | 5 % to 85 % |
| AtmosphericPressure | 70 kPa to 106 kPa | 85 kPa to 106 kPa | 70 kPa to 106 kPa |
| Focal Spot TargetMaterial | Tungsten | Tungsten | Tungsten |
| Filter Material | Aluminum & Copper | Aluminum (Pan/Ceph)Aluminum & Copper(CBCT) | Aluminum |
| Image ReceptorMaterial | CMOS with Csl | CMOS with Csl | CCD with Csl |
| StandardsCompliance | IEC 60601-1:2005+A1:2012IEC 60601-1-3:2013IEC 60601-1-6:2013IEC 60601-2-63:2017IEC 60601-1-2:2014IEC 61223-3-4:2000IEC 60825-1:2014ISO 10993-1:2018 | IEC 60601-1 3rd edANSI/AAMI ES60601-1: 2005IEC 60601-1-3: 2008IEC 60601-1-6: 2010IEC 60601-2-63: 2012IEC 60601-1-2:2007IEC 62366:2007ISO 14971 | IEC 60601-1:2005IEC 60601-1-3: 2008IEC 60601-1-6: 2010IEC 60601-2-63: 2012IEC 60601-1-2:2007IEC 61223-3-4:2000IEC 60825:2007ISO 14971:2007 |
| Midmark ExtraoralImaging System (EOIS)(Subject Device) | Acteon X-MIND Trium(Primary Predicate) | Vantage PanoramicX-ray System(Secondary Predicate) | |
| ISO 14971:2007ISO 13485:2016 |
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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, includingX-ray safety, electromagneticcompatibility, and usability (IEC 60601standards) | Passed; the results of the third-partytesting demonstrate compliance ofthe device to the standards. |
| Imaging performance testing(IEC 61223-3-4) | Internal verification testing was performedin accordance with IEC 61223-3-4, and allacceptance criteria were met. |
| Dose comparison evaluation, includingpredicate comparison, diagnosticreference level (DRL) comparison, andliterature review. | Midmark EOIS was shown to producesimilar or less radiation dosage thancomparable devices on market. |
| CBCT modality testing, including iterativereconstruction performance, implantperformance, geometric normalization,QC (DIN 6868-161), and uniform phantomperformance | CBCT-related functionality performsaccording to specifications and producesimages 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
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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.
§ 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.