(60 days)
Not Found
Yes
The summary explicitly mentions "AI enabled automated segmentation" and the use of "artificial neural network (ANN) classifiers".
No.
The device is described as a Picture Archiving and Communications System (PACS) with tools for image display, manipulation, quantification, and reporting of digital medical images for diagnostic purposes, not for direct treatment or therapy.
Yes
The device aids in the identification and quantitative analysis of regions of interest (ROIs) that can be indicative of suspicious lesions, and it has high sensitivity in pre-selecting regions suspicious for metastatic disease, which are all diagnostic functions.
Yes
The device is described as a "cloud-based software platform with a web interface" and its function is centered around the processing, display, and analysis of digital medical images (DICOM files). There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that aPROMISE is for "acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images." It is a PACS system with additional clinical application tools for image analysis and reporting.
- Device Description: The description focuses on the software platform, web interface, DICOM file handling, image display, visualization tools, ROI marking, quantitative analysis of image data, and report generation.
- Input: The input is digital medical images (DICOM files) from PSMA PET/CT scans.
- Output: The output is image display, quantitative analysis results derived from the images, and reports based on the image analysis.
IVDs, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens. It analyzes medical images, which are a different type of data.
While the device provides tools for quantitative analysis and helps in identifying potential lesions, this analysis is performed on the image data itself, not on a biological sample. The output is information derived from the image, not a result of a test performed on a specimen.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
aPROMISE is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
aPROMISE (automated PROstate specific Membrane Antigen Imaging SEgmentation) consists of a cloud-based software platform with a web interface where users can upload body scans of PSMA PET/CT image data in the form of DICOM files, review patient studies and share study assessments within a team. The software complies with the Digital Imaging and Communications in Medicine (DICOM) 3 standard.
Multiple scans can be uploaded for each patient and the system provides a separate review for each study. The review page display studies in a 4-panel view showing PET, CT, PET/CT fusion and maximum intensity projection (MIP) simultaneously and includes the option to display each view separately. The device is used to review entire patient studies, using image visualization and analysis tools for users to identify and mark regions of interest (ROIs). While reviewing image data, users can mark ROIs by selecting from pre-defined hotspots that are highlighted when hovering with the mouse pointer over the segmented region, or by manual drawing, i.e selecting individual voxels in the image slices to include as hotspots. Selected or drawn hotspots are subject to automatic quantitative analysis. The user can review the results of this quantitative analysis and determine which hotspots should be reported as suspicious lesions.
To create a report the signing user is required to confirm quality control, and electronically sign the report preview. Signed reports are saved in the device and can be exported as a JPG or DICOM file.
Mentions image processing
Yes
Mentions AI, DNN, or ML
AI enabled automated segmentation of skeleton and soft tissue organs
Input Imaging Modality
nuclear medicine (NM) imaging, using PSMA PET/CT
Anatomical Site
body scans
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals and researchers / Healthcare clinics
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)
- Digital Phantom Validation Study. This study assessed the accuracy, linearity, and limit of detection of aPromise against the known values of a digital reference object (NEMA phantom). All SUV and volume quantification tests of aPROMISE met their predetermined acceptance criteria.
- Comparison to Predicate. This study demonstrated the equivalent performance of APROMISE as compared to the predicate KSWVWR (K160334) for standard functions in marking and quantitative assessments of user defined region of interest in PSMA PET/CT.
- Analytical Performance in Clinical Study. This study compared the performance of aPROMISE to that of clinicians and demonstrated that aPROMISE enables the automated quantification of tracer uptake in reference organs that are more reproducible, and consistent than those obtained manually. The study also demonstrated that aPROMISE has high sensitivity in pre-selection of regions of interest that are determined to be suspicious for metastatic disease.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The study also demonstrated that aPROMISE has high sensitivity in pre-selection of regions of interest that are determined to be suspicious for metastatic disease.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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July 27, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services (DHHS) logo on the left and the FDA wordmark on the right. The DHHS logo is a stylized depiction of a human figure embracing a globe. The FDA wordmark is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
EXINI Diagnostics AB % Donna-Bea Tillman, Ph.D. Senior Consultant Biologics Consulting Group 1555 King Street. Suite 300 ALEXANDRIA VA 22314
Re: K211655
Trade/Device Name: aPROMISE Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 27, 2021 Received: May 28, 2021
Dear Dr. Tillman:
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
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Indications for Use
510(k) Number (if known) K211655
Device Name aPROMISE
Indications for Use (Describe)
aPROMISE is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.
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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510(k) Summary
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for aPROMISE is provided below.
1. SUBMITTER
| Applicant: | EXINI Diagnostics AB
Ideon Science Park
Scheelevägen 27
223 70 Lund
Sweden |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Aseem Anand, Ph.D.
Vice President
EXINI Diagnostics AB
Ideon Science Park, Scheelevägen 27, SE-223 70
Lund, Sweden
Tel: +46706604084
aseem.anand@exini.com |
| Submission Correspondent: | Donna-Bea Tillman, Ph.D.
Senior Consultant
Biologics Consulting
1555 King Street, Suite 300
Alexandria, Virginia 22314
(410) 531-6542
dtillman@biologicsconsulting.com |
| Date Prepared: | May 28, 2021 |
2. DEVICE
| Device Trade Name: | aPROMISE |
|---|---|
| Device Common Name: | Picture Archiving and Communication System |
| Classification Name | 21 CFR 892.2050 Medical Image Management and |
| Processing System | |
| Regulatory Class: | II |
| Product Code: | LLZ |
3. PREDICATE DEVICE
Predicate Device:
Exini aBSI (K191262)
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Secondary Predicate Device: Keosys Medical Imaging Suite KSWVWR (K160334 Advanced Medical Imaging Software Suite)
DEVICE DESCRIPTION 4.
aPROMISE (automated PROstate specific Membrane Antigen Imaging SEgmentation) consists of a cloud-based software platform with a web interface where users can upload body scans of PSMA PET/CT image data in the form of DICOM files, review patient studies and share study assessments within a team. The software complies with the Digital Imaging and Communications in Medicine (DICOM) 3 standard.
Multiple scans can be uploaded for each patient and the system provides a separate review for each study. The review page display studies in a 4-panel view showing PET, CT, PET/CT fusion and maximum intensity projection (MIP) simultaneously and includes the option to display each view separately. The device is used to review entire patient studies, using image visualization and analysis tools for users to identify and mark regions of interest (ROIs). While reviewing image data, users can mark ROIs by selecting from pre-defined hotspots that are highlighted when hovering with the mouse pointer over the segmented region, or by manual drawing, i.e selecting individual voxels in the image slices to include as hotspots. Selected or drawn hotspots are subject to automatic quantitative analysis. The user can review the results of this quantitative analysis and determine which hotspots should be reported as suspicious lesions.
To create a report the signing user is required to confirm quality control, and electronically sign the report preview. Signed reports are saved in the device and can be exported as a JPG or DICOM file.
5. INTENDED USE/INDICATIONS FOR USE
aPROMISE is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging, using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.
SUBSTANTIAL EQUIVALENCE 6.
Comparison of Indications
Both aPROMISE and the predicate aBSI are software-only devices that are used in the acceptance, transfer, storage, image display, manipulation, quantification and reporting of nuclear medicine images by healthcare providers. Both devices perform segmentation of the body in the radiological image and automatically segment hotspots, regions with high tracer uptake. Both devices rely on the user to make the final selection of regions of interest that are considered as lesions. Both devices provide a quantitative metric of radiotracer uptake that can be used to inform patient care decisions.
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The subject aPROMISE device differs from the primary predicate device in that it is intended to be used with PSMA PET/CT images while the predicate device is intended to be used with bone scans.
These differences in the Indications for use do not affect the fundamental intended use of the devices, which is to provide a software tool to aid the user, a healthcare professional or researcher, to mark regions of interest as lesions and provide quantitative analysis. The intended use to aPROMISE in PET/CT is the same as that of aBSI in bone scan images – a PACS device with a clinical application of oncology to mark and quantify regions of interest, intended to be used by healthcare professionals and researchers. Therefore, aBSI can be used as a primary predicate for aPROMISE.
Technological Comparisons
The table below compares the key technological feature of the subject device aPROMISE to the predicate devices, Exini aBSI (K191262) and Keosys Medical Imaging Suite KSWVWR (K160334).
| Specification/
Characteristic | aPROMISE
(proposed device) | aBSI
(predicate device) | Comparison to predicate |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | | |
| Intended user | Health care professionals
and researchers | Health care professionals
and researchers | No difference |
| Intended use
environment | Healthcare clinics | Healthcare clinics | No difference |
| Classification | 21 CFR 892.2050
System, Image
Processing, Radiological
(LLZ) Class II | 21 CFR 892.2050
System, Image
Processing, Radiological
(LLZ) Class II | No difference |
| Installation | Cloud-based service and
access with personal log-in. | Cloud-based service and
access with personal log-in. | No difference |
| Operating system | Windows or macOS with
Chrome browser | Windows or macOS with
Chrome browser | No difference |
| DICOM
compatibility and
Imaging
Modalities | DICOM 3:
Whole body
• PET
• CT | DICOM 3:
Whole body
• Bone scans
• SPECT | The differences in DICOM 3
compatibility reflect the
different image modalities
which is supported by a
secondary predicate, the Keosys
Medical Imaging Suite
KSWVWR (K160334), as
discussed below. The difference |
| Specification/
Characteristic | aPROMISE
(proposed device) | aBSI
(predicate device) | Comparison to predicate |
| Image upload | Via file selector or drag
and drop from local
computer or
network. Upload can
handle zip files. | Via file selector on local
computer or network | does not affect the clinical use
of the device and does not raise
different questions of safety or
effectiveness.
The difference involves an
additional option for image
upload. The difference does not
affect the clinical use of the
device and does not raise
different questions of safety or
effectiveness. |
| Support for
multiple scans | Yes, multiple scans can
be analyzed one at a
time. | Yes, if multiple scans are
provided, the images are
automatically aligned
vertically | The difference in support for
multiple scans does not affect
the clinical use of the device
and does not raise different
questions of safety or
effectiveness. |
| Colormaps | A selection of commonly
used colormaps
supported:
For PET image:
Cool
• Inverted grayscale
• Grayscale with
overflow
• Hot Iron
• Spectrum
• Warm
For CT image:
• Grayscale | A selection of commonly
used colormaps
supported:
• Cool
• Electric
• Inverted grayscale
• Inverted grayscale
overflow
• Grayscale
• Thermal | Same feature, both devices
offer a selection of commonly
used colormaps. The
differences in colormaps are
dependent on the different
image modalities. The
difference does not affect the
clinical use of the device and do
not raise different questions of
safety or effectiveness. |
| Zoom | Automatically adjusted
image size.
Manually adjustable
zoom in planar views | Automatically adjusted
image size.
Manually adjustable
zoom in planar views | No difference |
| Windowing | Manual adjustment of
windowing. Slider for
PET. Click'n'drag and
by a drop-down menu
for CT. | Manual adjustment of
windowing. Slider for
bone scans. | Same feature, the difference in
windowing is an adjustment for
the different image modalities.
The difference does not affect
the clinical use of the device
and do not raise different |
| Specification/
Characteristic | aPROMISE
(proposed device) | aBSI
(predicate device) | Comparison to predicate |
| Image layouts | 4 panel view showing
PET, CT, PET/CT fusion
and MIP simultaneously
and option to display each
view separately.
Coronal, axial and sagittal
views can be displayed | Anterior and posterior
images shown side by
side | The difference in image layout
is dependent on the different
image modalities. The
difference does not affect the
clinical use of the device and do
not raise different questions of
safety or effectiveness. |
| Intensity display | Local intensity displayed
in left corner of the image
when hovering over
image | Local intensity displayed
in left corner of the image
when hovering over
image | No difference |
| Hotspot display | Segmented hotspots can
be displayed in planar
views | Segmented hotspots can
be displayed in planar
views | No difference |
| Organ
Segmentation | AI enabled automated
segmentation of skeleton
and soft tissue organs | AI enabled automated
segmentation of skeleton | Same feature but adjusted for
the different image modalities.
The difference does not affect
the clinical use of the device
and do not raise different
questions of safety or
effectiveness. |
| Normalization | Images are normalized so
that healthy bone tissue
intensities are
automatically set to a
predefined level. | Images are normalized so
that healthy bone tissue
intensities are
automatically set to a
predefined level. | No difference |
| Hotspot detection | Algorithm to detect high
intensity regions of
interest in the PET series
within the segmented
structures (skeleton and
soft tissue). | Algorithm to detect high
intensity regions of
interest within the
segmented structures
(skeleton). | Same feature but adjusted for
the different image modalities.
The difference does not affect
the clinical use of the device
and do not raise different
questions of safety or
effectiveness. |
| Hotspot pre-selection | All detected high
intensity ROIs can be
shown for review by the
user without pre-
selection. | Detected high intensity
ROIs are sorted into two
groups (high and low)
using artificial neural
network (ANN)
classifiers. Hotspots, | The devices have a difference
in hotspot preselection;
showing all detected high
intensity regions (no
preselection as of the
predicate), but both devices still |
| Specification/
Characteristic | aPROMISE
(proposed device) | aBSI
(predicate device) | Comparison to predicate |
| | | classified as high, are
preselected and displayed
to the user for review. | require the user to select and
make the final call of what
regions to include as lesions.
The difference does not affect
the clinical use of the device
and do not raise different
questions of safety or
effectiveness. |
| Hotspot
verification | The user can select pre-
defined segmentation of
hotspots or segment each
hotspot manually that are
considered to be lesions
by the user. | Preselected hotspots are
shown to and reviewed by
the user. The hotspot
selection is editable by
the user. | The difference in hotspot
verification constitutes of the
user to manually review and
select predefined- or draw
hotspots in the subject device,
instead of being presented
automatically preselected
hotspots to be reviewed as of
the predicate. The difference
does not affect the clinical use
of the device and do not raise different questions of safety or
effectiveness. |
| Hotspot
Quantification | -Bone Scan Index (BSI) | Standard Uptake Values
(SUV):
-SUV-max
-SUV-mean
-SUV-peak
-Volume
-Lesion Index (LI)
-Intensity-weighted
Tissue Lesion Volume
(ITLV) | The differences in calculated
values reflect the different
imaging modalities. The use of
the SUV calculation is
supported by a secondary
predicate, the Keosys Medical
Imaging Suite KSWVWR
(K160334), as discussed in
section 12.3.2. |
| Quality Control | SW enforced requirement
to verify the user review
of
- Image quality
- PET/CT image
alignment - Patient study data
- Reference values
- Study is not a
superscan | SW enforced requirement
to verify the user review
of - Image quality
- The skeletal outlining
(Atlas) - The selected hotspots | Same feature with adjustment
for the different image
modalities. The difference does
not affect the clinical use of the
device and do not raise different
questions of safety or
effectiveness. |
| Specification/
Characteristic | aPROMISE
(proposed device) | aBSI
(predicate device) | Comparison to predicate |
| User
confirmation for
report generation | User confirmation that the
requirements for image
assessment have been
followed is required for
report creation | User confirmation that the
requirements for BSI
assessment have been
followed is required for
report creation | No difference |
| Report (Summary
page export) | The user can export the
results of a study to the
hard drive as an image or
as a DICOM Secondary
Capture. | The user can export the
results of a study to the
hard drive as an image or
as a DICOM Secondary
Capture. | No difference |
| CSV export | Supports export of study
and lesion values as a
CSV file for all created
reports | Supports export of study
and BSI value as a CSV
file for all created reports | No difference |
Table 1: Technological Comparison
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7. PERFORMANCE DATA
Sterilization and Shelf Life
aPROMISE consists entirely of software; accordingly, there are no sterilization concerns. As a software only device, shelf-life (including performance date) is also not applicable because of low likelihood of time-dependent product degradation.
Biocompatibility Testing
There are no direct or indirect patient-contacting components of the subject device. Therefore, patient contact information is not needed for this device.
Electrical safety and electromagnetic compatibility (EMC)
Not applicable. The subject device is a software-only device. It contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a moderate level of concern.
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Bench Testing
Exini performed the following studies verify and validate the performance of aPROMISE.
- Digital Phantom Validation Study. This study assessed the accuracy, linearity, and limit . of detection of aPromise against the known values of a digital reference object (NEMA phantom). All SUV and volume quantification tests of aPROMISE met their predetermined acceptance criteria.
- Comparison to Predicate. This study demonstrated the equivalent performance of ● APROMISE as compared to the predicate KSWVWR (K160334) for standard functions in marking and quantitative assessments of user defined region of interest in PSMA PET/CT.
- . Analytical Performance in Clinical Study. This study compared the performance of aPROMISE to that of clinicians and demonstrated that aPROMISE enables the automated quantification of tracer uptake in reference organs that are more reproducible, and consistent than those obtained manually. The study also demonstrated that aPROMISE has high sensitivity in pre-selection of regions of interest that are determined to be suspicious for metastatic disease.
These results demonstrate that aPROMISE performs in accordance with specifications and meets user needs and intended uses.
Animal Testing
Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Data
Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.
CONCLUSION 8.
Based on the detailed comparison, the differences between the subject and predicate devices do not raise new questions of safety and effectiveness. The software verification (Section 16.9) and the performance testing demonstrates that the device performs according to the device requirements. Therefore, the aPROMISE device can be found substantially equivalent to the predicate device.