(113 days)
No
The document describes standard digital image acquisition and processing algorithms, which are not inherently AI/ML. There is no mention of AI, ML, deep learning, or any related concepts in the provided text.
No
The device is a diagnostic imaging system used for visualizing anatomical structures through X-rays to aid in diagnosis, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies." Additionally, it mentions its purpose to "help medical professionals with viewing images to for patient diagnosis."
No
The device description explicitly states that the ADAM Imaging System software is integrated into the Platinum dRF Imaging System, which includes hardware components such as a radiological examination table, control panel, electrical panel, generator, panel detector, detector collimator, and X-ray tube. Therefore, it is not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Platinum dRF Imaging System is an X-ray imaging system. It visualizes anatomical structures within the body by converting X-ray patterns into visible images. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "radiographic and fluoroscopic studies" and "to visualize anatomical structures by converting a pattern of X-ray into a visible image." This aligns with diagnostic imaging, not in vitro diagnostics.
Therefore, the Platinum dRF Imaging System falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including: general radiology and diagnostic fluoroscopy examinations, conventional linear tomography and pediatrics examinations.
The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from, but not limited to, gastrointestinal, cranial, skeletal, thoracic, lung and urogenital tract examinations.
It may also be used in: lymphography, endoscopy, myelography, venography and arthrography.
The Platinum dRF may also be used for outpatient or emergency services, as well as for mobile transport examinations (wheelchair and bed).
The Platinum dRF is not indicated for use in interventional radiology.
Product codes
JAA
Device Description
The subject of this Special 510(k) application is the change to the imaging software system to the ADAM Imaging System. As the resources are now available, Apelem-DMS Group was able to develop their own Imaging System called the ADAM Imaging System. The ADAM Imaging System will now be developed by Apelem-DMS Group. The predicate device (K160301) had an Off the Shelf Software Imaging System called DUET DRF Imaging System which was developed by Thales.
The ADAM Imaging System is a digital image acquisition system to be used in conjunction with a detector during radiography or fluoroscopy X-ray examinations to acquire, display, process and export images according to DICOM protocol via a network connection.
The ADAM Imaging System software interfaces with an X-Ray detector to acquire raw pixel data and image processing algorithms which transform raw pixel data into images and image sequences to help medical professionals with viewing images to for patient diagnosis.
The Duet DRF requires the use of the THALES RF4343 FL detectors, whereas ADAM Imaging System requires the use of the VIEWORKS VIVIX-D 1717G detector. Both detectors employ the same state-of-the-art indirect conversion technology based on CsI scintillator and photo-diodes. The detector Vivix-D 1717G is connected to the x-ray system by cable. The integration with the PLATINUM dRF system has been established and appears adequate. The VIEWWORKS VIVIX-D 1717G detector is only compatible with the ADAM Imaging System.
The Duet DRF and ADAM Imaging System are designed to support general radiography (excluding mammography) and fluoroscopy imaging procedures.
The Apelem-DMS Group ADAM Imaging System is not a stand-alone device. It is integrated into the Platinum dRF Imaging System and functions as a platform for FDA cleared or registered components (i.e. generator, panel detector, detector collimator, X-ray tube and software imaging packages), that are installed with a Apelem-DMS Group manufactured radiological examination table, control panel with system controller software, and electrical panel.
The Platinum dRF remote controlled table is a radiologic table equipped with a flat panel electronic detector. This table is used to perform general digital radiological, fluoroscopy and peripheral angiography.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
X-ray
Anatomical Site
gastrointestinal, cranial, skeletal, thoracic, lung and urogenital tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital or clinical setting by a licensed doctor, orthopedic surgeon, radiologist, radiological technician, or technician authorized by the manufacturer
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)
Not Found
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
January 22, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Apelem-DMS Group % Mr. Scott Blood Senior Regulatory Affairs Consultant MEDIcept, Inc. 200 Homer Avenue ASHLAND MA 01721
Re: K203010
Trade/Device Name: Platinum dRF Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA Dated: December 21, 2020 Received: December 28, 2020
Dear Mr. Blood:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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) K203010
Device Name Platinum dRF Imaging System
Indications for Use (Describe)
The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including: general radiology and diagnostic fluoroscopy examinations, conventional linear tomography and pediatrics examinations.
The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from, but not limited to, gastrointestinal, cranial, skeletal, thoracic, lung and urogenital tract examinations.
It may also be used in: lymphography, endoscopy, myelography, venography and arthrography.
The Platinum dRF may also be used for outpatient or emergency services, as well as for mobile transport examinations (wheelchair and bed).
The Platinum dRF is not indicated for use in interventional radiology.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters, while "CEPT" is in a cursive, purple font. Below the company name is the phrase "Trusted Solutions, Rapid Response" in a smaller font.
1. 510(K) SUMMARY K203010
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR ട്ല 807.92.
1.1. Submitter's Information
Name: Apelem-DMS Group Address: Parc Scientifique Georges Besse, 175 Allee Von Neumann, 30035 Nimes cedex 1 France
33 466 29 09 07 Phone:
Official FDA Contact:
MEDIcept Inc. 200 Homer Ave Ashland, MA 01721 Scott Blood sblood@medicept.com 978-729-5978
Date Prepared: November 4th, 2020
1.2. Device Administrative Information
| Trade Name: | Platinum dRF Imaging System |
|---|---|
| Device Name: | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Common Name: | System, X-Ray Fluoroscopic, Image-Intensified |
| Regulatory Class: | Class II per 21 CFR 892.1650 |
| Product Code: | JAA- 21 CFR 892.1650, Image-intensified fluoroscopic |
| x-ray system | |
| Classification Panel: | Radiology |
5
Image /page/5/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters, while the word "CEPT" is in a cursive, purple font. Below the company name is the phrase "Trusted Solutions, Rapid Response" in a smaller, gray font.
2. LEGALLY MARKETED PREDICATE DEVICE
The following is the identified predicate device:
The predicate referenced below has not been subject to a design-related recall.
Apelem-DMS Group Group – K160301–Platinum dRF Imaging System
- Indications for Use: ●
Indications for Use for DMS Platinum dRF Imaging System:
The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, diagnostic fluoroscopy, conventional linear tomography, angiography and pediatric examinations.
The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, digital angiography and digital subtraction angiography (DSA).
The Platinum dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
The Platinum dRF is not indicated for use in interventional radiology.
6
Image /page/6/Picture/0 description: The image is a logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters. The word "CEPT" is in a stylized purple font. Below the words is the phrase "Trusted Solutions, Rapid Response" in a smaller font, with "Trusted Solutions" in gray and "Rapid Response" in purple.
3. DEVICE DESCRIPTION
The subject of this Special 510(k) application is the change to the imaging software system to the ADAM Imaging System. As the resources are now available, Apelem-DMS Group was able to develop their own Imaging System called the ADAM Imaging System. The ADAM Imaging System will now be developed by Apelem-DMS Group. The predicate device (K160301) had an Off the Shelf Software Imaging System called DUET DRF Imaging System which was developed by Thales.
The ADAM Imaging System is a digital image acquisition system to be used in conjunction with a detector during radiography or fluoroscopy X-ray examinations to acquire, display, process and export images according to DICOM protocol via a network connection.
The ADAM Imaging System software interfaces with an X-Ray detector to acquire raw pixel data and image processing algorithms which transform raw pixel data into images and image sequences to help medical professionals with viewing images to for patient diagnosis.
The Duet DRF requires the use of the THALES RF4343 FL detectors, whereas ADAM Imaging System requires the use of the VIEWORKS VIVIX-D 1717G detector. Both detectors employ the same state-of-the-art indirect conversion technology based on CsI scintillator and photo-diodes. The detector Vivix-D 1717G is connected to the x-ray system by cable. The integration with the PLATINUM dRF system has been established and appears adequate. The VIEWWORKS VIVIX-D 1717G detector is only compatible with the ADAM Imaging System.
The Duet DRF and ADAM Imaging System are designed to support general radiography (excluding mammography) and fluoroscopy imaging procedures.
The Apelem-DMS Group ADAM Imaging System is not a stand-alone device. It is integrated into the Platinum dRF Imaging System and functions as a platform for FDA cleared or registered components (i.e. generator, panel detector, detector collimator, X-ray tube and software imaging packages), that are installed with a Apelem-DMS Group manufactured radiological examination table, control panel with system controller software, and electrical panel.
The Platinum dRF remote controlled table is a radiologic table equipped with a flat panel electronic detector. This table is used to perform general digital radiological, fluoroscopy and peripheral angiography.
3.1. Indications for Use (Proposed Device)
Indications for Use for DMS Platinum dRF Imaging System:
The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including: general radiology and diagnostic fluoroscopy examinations, conventional linear tomography and pediatrics examinations.
7
Image /page/7/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters, while "CEPT" is in a stylized purple font. Below the logo is the text "Trusted Solutions, Rapid Response" in a smaller font, with "Trusted Solutions" in purple and "Rapid Response" in gray.
The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from, but not limited to, gastrointestinal, cranial, skeletal, thoracic, lung and urogenital tract examinations.
It may also be used in: lymphography, endoscopy, myelography, venography and arthrography.
The Platinum dRF may also be used for outpatient or emergency services, as well as for mobile transport examinations (wheelchair and bed).
The Platinum dRF is not indicated for use in interventional radiology.
8
Image /page/8/Picture/0 description: The image shows the logo for MEDICEPT. The first part of the logo, "MEDI", is in blue, while the second part, "CEPT", is in purple. Below the logo is the text "Trusted Solutions, Rapid Response" in a smaller font size.
SUBSTANTIAL EQUIVALENCE COMPARISON AND DISCUSSION 4.
| | Proposed Device
(This Submission):
ADAM Imaging System integrated
into the DMS Platinum dRF
Imaging System | Predicate Device:
(K160301)
Duet Imaging System integrated
into the DMS Platinum dRF
Imaging System |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Product
Code | JAA | JAA |
| Single
Use/Reusable | Reusable | Same |
| Indications for
Use | The Platinum dRF Imaging System is
intended to be used as a universal
diagnostic imaging system for
radiographic and fluoroscopic studies.
Using a digital flat detector, it can
perform a range of applications
including: general radiology and
diagnostic fluoroscopy examinations,
conventional linear tomography and
pediatrics examinations.
The Platinum dRF is a device
intended to visualize anatomical
structures by converting a pattern of
X-ray into a visible image. The
system has medical applications
ranging from, but not limited to,
gastrointestinal, cranial, skeletal,
thoracic, lung and urogenital tract
examinations.
It may also be used in: lymphography,
endoscopy, myelography, venography
and arthrography.
The Platinum dRF may also be used
for outpatient or emergency services,
as well as for mobile transport
examinations (wheelchair and bed).
The Platinum dRF is not indicated for
use in interventional radiology. | The Platinum dRF Imaging System is
intended to be used as a universal
diagnostic imaging system for
radiographic and fluoroscopic studies.
Using a digital flat detector, it can
perform a range of applications
including general R/F, diagnostic
fluoroscopy, conventional linear
tomography, angiography and
pediatric examinations.
The Platinum dRF is a device
intended to visualize anatomical
structures by converting a pattern of
X-ray into a visible image. The
system has medical applications
ranging from but not limited to
gastrointestinal examinations, cranial,
skeletal, thoracic and lung exposures
as well as examination of the
urogenital tract.
The units may also be used in
lymphography, endoscopy,
myelography, venography, pediatrics,
arthrography, digital angiography and
digital subtraction angiography
(DSA).
The Platinum dRF may be used for
outpatient and emergency treatment, |
| | Proposed Device
(This Submission):
ADAM Imaging System integrated
into the DMS Platinum dRF
Imaging System | Predicate Device:
(K160301)
Duet Imaging System integrated
into the DMS Platinum dRF
Imaging System |
| | | as well as for mobile transport
(wheelchair and bed) examinations.
The Platinum dRF is not indicated for
use in interventional radiology. |
| Use Environment | Hospital or clinical setting by a
licensed doctor, orthopedic
surgeon, radiologist, radiological
technician, or technician
authorized by the manufacturer | Same |
| Patient Contact | The patient does not come into
direct contact with the ADAM
Imaging System component or the
Detector. The patient comes in
contact with the examination table
only. | Same |
| Flat Detector | VIEWORKS VIVX-D 1717G | RF4343 FL |
| Frame Rate | 12f/sec (RAD)
18f/sec fluoroscopy (large field),
No change | Same |
| Image Specifications | No Change | Same |
| Lead Shield | Included | Same |
| Platinum
examination
remote control
table | No change | Same |
| Imaging System
Component | ADAM Imaging System | Duet DRF Imaging System |
| | Proposed Device
(This Submission):
ADAM Imaging System integrated
into the DMS Platinum dRF
Imaging System | Predicate Device:
(K160301)
Duet Imaging System integrated
into the DMS Platinum dRF
Imaging System |
| Control Panel
with System
Controller
Software | No change | Same |
| Electrical Panel | No change | Same |
| Platinum Software | No change | Same |
9
Image /page/9/Picture/0 description: The image shows the logo for MEDICEPT. The first part of the logo, "MEDI", is in blue, while the second part, "CEPT", is in purple. Below the logo is the text "Trusted Solutions, Rapid Response", with "Trusted Solutions" in purple and "Rapid Response" in gray.
10
Image /page/10/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDI" is in large, bold, blue letters, while "CEPT" is in a stylized, cursive, purple font. Below the logo, the words "Trusted Solutions, Rapid Response" are written in a smaller font, with "Trusted Solutions" in purple and "Rapid Response" in gray.
The technological characteristics of the Detector are summarized in the table below:
| Detector
Information | Proposed: ADAM Imaging
System Detector Information | Predicate: Duet Imaging
System Detector
Information (K160301) | Comment |
|-----------------------------|-------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Manufacturer
of detector | VIEWORKS | THALES | Different
manufacturers
but similar
technology |
| Model Name | VIVIX-D 1717G | PIXIUM RF 4343 FL | Different
manufacturers
but similar
technology |
| Scintillator | CsI | CsI | Same |
| Pixel Pitch | 140µm | 148µm | ADAM
Imaging
System's
detector has a
smaller pixel
pitch which
means better
detail
detectability |
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Image /page/11/Picture/0 description: The image shows the logo for MEDICEPT. The word "MEDICEPT" is written in a combination of blue and purple colors. Below the logo is the text "Trusted Solutions, Rapid Response" in a smaller font size.
| Detector
Information | Proposed: ADAM Imaging
System Detector Information | Predicate: Duet Imaging
System Detector
Information (K160301) | Comment | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|-----|-------------------------------------------------------------------------------------------|--|--|-----------------------|--|--|--|--|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------|--|--|--|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------|
| Pixel Matrix | 3072 x 3072 pixels | 2874 x 2840 pixels | Adam
Imaging
System's
detector has a
larger pixel
matrix which
means a
larger
detection
field. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Image Size | 17" x 17" | 17" x 17" | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Grayscale | 16 bits | 16 bit | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Resolution | 3.5 linepairs/mm | 3.4 linepairs/mm | The
performance
of both
detectors are
similar
enough
(>3%) for the
procedures
indicated | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Modulation
Transfer
Function
(MTF) | MTF IEC
0.5 lp/mm
MTF IEC
1 lp/mm
MTF IEC
2 lp/mm
MTF IEC
3 lp/mm
MTF IEC
Nyquist | Minimal Typical 78 % 83 % 50 % 55 % 20 % 25 % 5 % 10 % - - | | | | | | | | | | | | | Minimal Typical 79% | | | | | MTF IEC
0.5 lp/mm
MTF IEC
1 lp/mm
MTF IEC
2 lp/mm
MTF IEC
3 lp/mm
MTF IEC
Nyquist | Minimal Typical 55% 66% 25 % 35 % 10 % 19 % 7 % 15 % | | | | | | | | | | | | | Performance
of both
detectors are
sufficient for
general
radiographic
procedures. |
| Detective
Quantum
Efficiency
(DQE) | 75% | Minimal Typical DQE
0.5 lp/mm Minimal Typical 60 % 65 % | | | | | | | | | 78% | Minimal Typical DQE
0 lp/mm Minimal Typical 65 % 73 % | | | | | | | | | | See Notes
below. | | | | | | | | | | | | |
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Image /page/12/Picture/0 description: The image shows the logo for MediCept. The logo has the word "MEDI" in blue and the word "CEPT" in purple. Below the logo is the text "Trusted Solutions, Rapid Response" in a smaller font size.
| Detector
Information | Proposed: ADAM Imaging
System Detector Information | Predicate: Duet Imaging
System Detector
Information (K160301) | Comment |
|-------------------------|-------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | 471 x 471 x 35 mm | 500 x 490 x 45.5 mm | VIEWORKS
detector is
smaller than
the predicate
which will
enable easier
installation. |
| Weight | 10 kg | 9.1kg | VIEWORKS
detector is
heavier than
the predicate
but as the
difference is
less than 1 kg
there is no
impact. |
Notes:
Differences in Detective Quantum Efficiency (DQE):
The predicate device has a DQE of 78% if the shot noise was the only cause to be taken into account, i.e. the proportion of photons that are detected. This is close to the value found for the subject device detector (75%). The difference between the two detector DQE values is low enough to be considered equivalent because:
-
- The difference in the required dose to obtain a given image quality is small enough (ratio of 78% to 75%) not to have any clinical significance (