(48 days)
Not Found
No
The summary describes a standard dental X-ray system with panoramic, cephalometric, and CBCT capabilities. It mentions image processing and reconstruction but does not mention any AI or ML algorithms being used for image analysis, diagnosis, or other functions. The lack of mention of AI/ML in the "Mentions AI, DNN, or ML" section and the absence of descriptions of training or test sets further support this conclusion.
No.
The device is described as a diagnostic X-ray system used to provide radiographic examinations and images to aid in the diagnosis of diseases of the teeth, jaw, and oral structures, but it does not claim to treat any conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "to provide dental radiographic examination to aid in the diagnosis of diseases of the teeth, jaw and oral structures." It further mentions "for diagnostic examination of teeth, jaws, oral structures, and some cranial bones." The "Device Description" also refers to it as a "diagnostic X-ray system."
No
The device description clearly states it is a diagnostic X-ray system using an extraoral source, which is a hardware component. While it includes software for image processing and reconstruction, it is not solely software.
Based on the provided information, the Midmark EOIS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Midmark EOIS Function: The Midmark EOIS is an X-ray imaging system that directly examines the patient's anatomy (teeth, jaw, oral structures, etc.) using radiation. It produces images for diagnostic purposes, but it does not analyze biological samples.
The device's intended use, device description, input imaging modality (X-ray), and anatomical sites all point to it being an in vivo diagnostic imaging device, not an in vitro one.
N/A
Intended Use / 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, 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.
Product codes
OAS, MUH
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.
- 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.
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 Midmark EOIS consists of the following components:
- 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
- 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.
- 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.
- 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.
- 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.
- Operator Control Panel Software is used from the operator control panel to facilitate exams and service the system.
- 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.)
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray (Panoramic, Cephalometric, Cone Beam Computed Tomography (CBCT))
Anatomical Site
teeth, jaw, oral structures, maxillofacial region, some cranial bones, hands and wrists (for carpus examination)
Indicated Patient Age Range
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.
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical evaluations were performed for the EOIS.
- Medical electrical safety testing, including X-ray safety, electromagnetic compatibility, and usability (IEC 60601 standards): Passed; the results of the third-party testing demonstrate compliance of the device to the standards.
- Imaging performance testing (IEC 61223-3-4): Internal verification testing was performed in accordance with IEC 61223-3-4, and all acceptance criteria were met.
- Dose comparison evaluation, including predicate comparison, diagnostic reference level (DRL) comparison, and literature review: Midmark EOIS was shown to produce similar or less radiation dosage than comparable devices on market.
- CBCT modality testing, including iterative reconstruction performance, implant performance, geometric normalization, QC (DIN 6868-161), and uniform phantom performance: CBCT-related functionality performs according to specifications and produces images of acceptable quality.
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. Images were generated using head and hand phantoms, provided to the clinicians and then rated for diagnostic acceptability. Results showed that all EOIS imaging protocols provided overall acceptable image quality.
b) a usability study that examined use-related hazards with simulated use testing involving qualified clinicians. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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). 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.
1
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
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 Summary | |
| Prepared | June 18, 2020 |
| 510(k) Sponsor | |
| Address | 1001 Asbury Drive |
| 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 |
| (Product Code OAS) | |
| 21 CFR §872.1800 Extraoral source X-ray system (Product Code | |
| MUH) | |
| Device Class | 2 |
| Review Panel | Radiology |
4
| Manufacturer
Name | Trade Name | Regulation
Name and
Number | Device
Class | Product
Code | 510(k) No. | Decision Date |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|-----------------|-----------------|------------|----------------------|
| Acteon
Group | X-MIND TRIUM (Primary
predicate) | 21 CFR
§892.1750
Computed
tomography
X-ray system | 2 | OAS | K160166 | November 15,
2016 |
| Midmark
Corporation | Progeny Vantage
Panoramic Extraoral
Radiation Imaging
System with
Cephalometric
Attachment (Secondary
predicate) | 21 CFR
§872.1800
Extraoral
source X-ray
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:
-
- 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.
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
Imaging System (EOIS)
(Subject Device) | Acteon X-MIND Trium
(Primary Predicate) | Vantage Panoramic
X-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) |
| Regulation
Number | 21 CFR 892.1750
21 CFR 872.1800 | 21 CFR 892.1750 | 21 CFR 872.1800 | Indications for Use | The intended use of the
Midmark Extraoral
Imaging System (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. | X-MIND Trium is a digital
panoramic, cephalometric
and tomographic extra-
oral X-ra system, indicated
for use in:
- producing panoramic X-
ray images for diagnostic
examination of dentition
(teeth), jaws and oral
structures; - producing radio graphs
of maxillofacial region and
parts of the skull for
cephalometric
examination, if equipped
with
CEPH arm; - producing radiographs of
hands and wrists for carpus
examination, if equipped
CEPH arm; - producing tomographic
images of the oral and
maxillofacial region, for
diagnostic examination of
dentition (teeth), jaws,
oral structures and some
cranial bones, if equipped,
with CBCT option.
From a clinical point of
view, the X-MIND Trium can
be applied for the
following medical
applications:
• Generic dentistry
• Dental implantology
• Dental surgery
• Maxillo-facial surgery
• Cephalometric analysis
• Carpus radiology
The intended population
can be whatever,
including pediatric patients
from 5 years old [- 21 kg (46
lb); 113 cm (44.5 in)
standing height]; anyway
the sustainability to X-ray
exposure must be
evaluated by qualified
and authorized physicians, | The intended use of the
Progeny Vantage Extraoral
X-Ray System is to provide
dental radiographic
examination and diagnosis
of diseases of the teeth, jaw
and oral structures. When
the system is equipped with
the cephalometric option,
the system will also provide
cephalometric
radiographic examinations
for use in orthodontic
treatment planning and
evaluation. |
| Product Code | OAS & MUH | OAS & MUH | MUH | | | | |
9
10
| | Midmark Extraoral
Imaging System (EOIS)
(Subject Device) | Acteon X-MIND Trium
(Primary Predicate) | Vantage Panoramic
X-ray System
(Secondary Predicate) |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Modalities | Panoramic
Cephalometric
CBCT | Panoramic
Cephalometric
CBCT | Panoramic
Cephalometric |
| Technique Factor
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
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
Spot Size | 0.5 mm | 0.5 mm | 0.5 mm |
| Irradiation Time
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
Technology | CMOS | CMOS | CCD |
| Image Receptor
Scintillator | CsI | CsI | CsI |
| Image Receptor
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:
147.3 × 112.0 mm;
Medium FOV:
150.5 × 150.5 mm | 121.6 × 123.1 mm | N/A |
| Image Receptor
A/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 mm
240 × 210 mm | 240 × 220 mm
240 × 180 mm
200 × 220 mm
200 × 180 mm | 300 × 210 mm
240 × 210 mm |
| Field of View
(h × w), cm | Small FOV: 5×5, 8×7
Medium 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 Extraoral
Imaging System (EOIS)
(Subject Device) | Acteon X-MIND Trium
(Primary Predicate) | Vantage Panoramic
X-ray System
(Secondary Predicate) |
| Patient
Positioning,
PAN/CBCT | Chinrest
Forehead Support
Bite block
TMJ nose support | Chinrest
Forehead support
Bite block
TMJ nose support | Chinrest,
Positioning wands
Bite block
TMJ nose support |
| | Image: Midmark Extraoral Imaging System | Image: Acteon X-MIND Trium | Image: Vantage Panoramic X-ray System |
| Patient
Positioning, Ceph | Ear posts
Nasion support | Ear posts
Nasion support | Ear posts
Nasion support |
| | Image: Patient Positioning Ceph Midmark | Image: Patient Positioning Ceph Acteon | Image: Patient Positioning Ceph Vantage |
| Laser
Classification per
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
Optics | Line, 40° | Line, 90° | Line, 40° |
| Operating
Temperature | 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 % |
| Atmospheric
Pressure | 70 kPa to 106 kPa | 85 kPa to 106 kPa | 70 kPa to 106 kPa |
| Focal Spot Target
Material | Tungsten | Tungsten | Tungsten |
| Filter Material | Aluminum & Copper | Aluminum (Pan/Ceph)
Aluminum & Copper
(CBCT) | Aluminum |
| Image Receptor
Material | CMOS with Csl | CMOS with Csl | CCD with Csl |
| Standards
Compliance | IEC 60601-1:2005+A1:2012
IEC 60601-1-3:2013
IEC 60601-1-6:2013
IEC 60601-2-63:2017
IEC 60601-1-2:2014
IEC 61223-3-4:2000
IEC 60825-1:2014
ISO 10993-1:2018 | IEC 60601-1 3rd ed
ANSI/AAMI ES60601-1: 2005
IEC 60601-1-3: 2008
IEC 60601-1-6: 2010
IEC 60601-2-63: 2012
IEC 60601-1-2:2007
IEC 62366:2007
ISO 14971 | IEC 60601-1:2005
IEC 60601-1-3: 2008
IEC 60601-1-6: 2010
IEC 60601-2-63: 2012
IEC 60601-1-2:2007
IEC 61223-3-4:2000
IEC 60825:2007
ISO 14971:2007 |
| Midmark Extraoral
Imaging System (EOIS)
(Subject Device) | Acteon X-MIND Trium
(Primary Predicate) | Vantage Panoramic
X-ray System
(Secondary Predicate) | |
| ISO 14971:2007
ISO 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, including | |
| X-ray safety, electromagnetic | |
| compatibility, and usability (IEC 60601 | |
| standards) | Passed; the results of the third-party |
| testing demonstrate compliance of | |
| the device to the standards. | |
| Imaging performance testing | |
| (IEC 61223-3-4) | Internal verification testing was performed |
| in accordance with IEC 61223-3-4, and all | |
| acceptance criteria were met. | |
| Dose comparison evaluation, including | |
| predicate comparison, diagnostic | |
| reference level (DRL) comparison, and | |
| literature review. | Midmark EOIS was shown to produce |
| similar or less radiation dosage than | |
| comparable devices on market. | |
| CBCT modality testing, including iterative | |
| reconstruction performance, implant | |
| performance, geometric normalization, | |
| QC (DIN 6868-161), and uniform phantom | |
| performance | CBCT-related functionality performs |
| according to specifications and produces | |
| 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
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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.