(167 days)
Yes
The device description explicitly states that the software application implements "artificial intelligence (Al), including non-adaptive machine learning algorithms" and uses an "artificial intelligence (AI) image segmentation algorithm."
No
This device is an image processing software that provides measurements and supplementary information; it does not directly treat or prevent a medical condition.
No
The device is described as an "image processing software application" that assists in non-invasive measurements of musculoskeletal structures. It semi-automatically places calipers and provides "supplementary information to the user regarding tendon thickness measurements." The description explicitly states, "Clarius Al is intended to inform clinical management and is not intended to replace clinical decision-making. The clinician retains the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment." This indicates its role as a tool for measurement and information, not for diagnosis itself.
No
The device is described as a software application that is "incorporated into the Clarius App software for use as part of the complete Clarius Ultrasound Scanner system product offering". It explicitly states it is intended for use with specific Clarius Ultrasound Transducers (L7 and L15) and the Clarius App software for iOS and Android. This indicates it is a component of a larger hardware-software system, not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Clarius AI device processes ultrasound images to assist in measuring musculoskeletal structures. It does not perform any tests on biological samples.
- Intended Use: The intended use is to semi-automatically place calipers on ultrasound data for non-invasive measurements. This is an imaging analysis tool, not a diagnostic test performed on a sample.
- Device Description: The description clearly states it is a "radiological (ultrasound) image processing software application."
Therefore, while it is a medical device that uses AI and image processing, its function and intended use fall outside the scope of In Vitro Diagnostics.
No
The letter does not 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
Clarius AI is intended to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (e.g., Achilles' tendon, plantar fascia, patellar tendon) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., L7 and L15). The user shall be a healthcare professional trained and qualified in MSK (musculoskeletal) ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment.
Product codes
QIH
Device Description
Clarius AI is a radiological (ultrasound) image processing software application which implements artificial intelligence (AI), including non-adaptive machine learning algorithms, and is incorporated into the Clarius App software for use as part of the complete Clarius Ultrasound Scanner system product offering in musculoskeletal (MSK) ultrasound imaging applications. Clarius AI (MSK model) is intended for use by trained healthcare practitioners for non-invasive measurements of ultrasound data from musculoskeletal (MSK) ultrasound imaging acquired by the Clarius Ultrasound Scanner system using an artificial intelligence (AI) image segmentation algorithm. Clarius AI (MSK model) is intended to semi-automatically place adjustable calipers and provide supplementary information to the user regarding tendon thickness measurements (i.e., foot/plantar fascia, ankle/Achilles' tendon, knee/patellar tendon). Clarius AI is intended to inform clinical management and is not intended to replace clinical decision-making. The clinician retains the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius AI is indicated for use in adult patients only.
During the ultrasound imaging procedure, the anatomical site is selected through a preset software selection (e.g., foot, ankle, knee), in which the Clarius AI will engage to segment the correlating tendon. Clarius AI analyzes ultrasound images in real-time and outputs probabilities for each pixel within the image for determination of the particular tendon thickness.
The combination of all the pixels meeting a programmed threshold will render an overlay being displayed on top of the ultrasound image with a pre-programmed transparency so that the ultrasound greyscale is still visible. Once the user has obtained the best view, imaging can be manually paused, in which the Clarius AI will further analyze the tendon segmentation to determine the greatest thickness, in number of pixels, and subsequently place two measurement calipers that correspond to the top and bottom of the tendon at its thickest region, outputting a value in millimeters. The user can then manually alter the measurement calipers to make any necessary adjustments if desired. Clarius AI does not perform any functions that could not be accomplished manually by a trained and qualified user.
Clarius AI (MSK model) is incorporated into the Clarius App software and is intended for use with the following Clarius Ultrasound Scanner system transducers (previously 510(k)-cleared in K180799, K192107, and K213436):
| Clarius Ultrasound Transducers | L7 and L15 |
|---|---|
| Clarius App Software | Clarius Ultrasound App (Clarius App) for iOS; Clarius Ultrasound App (Clarius App) for Android |
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Achilles' Tendon, Plantar Fascia, Patellar Tendon (Foot, Ankle, Knee)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Healthcare professional trained and qualified in MSK (musculoskeletal) ultrasound / Healthcare setting (e.g., hospital, clinic)
Description of the training set, sample size, data source, and annotation protocol
Three datasets of ultrasound images of Achilles' Tendons, Plantar Fascia and Patellar Tendons, were used in the study. All the images had segmentation ground truth. The images in the dataset were classified into tendon and background. Images were captured in-house from volunteer subjects and by clinical partners in outpatient clinics mainly located in the USA. The data was anonymized and queried from Clarius Cloud storage. Ultrasound recordings were acquired with the subjects in various positions depending on preference. Tendons were imaged in longitudinal views. The plantar fascia was imaged in dorsiflexion, plantar flexion, and neutral positions. The Achilles' tendon was imaged with the ankle at 90 degrees. The knee was imaged in 30 degrees flexion. Images with and without the structures of interest were collected to create a dataset that was large and heterogeneous. Images were acquired in different depths to mitigate different use cases for users. The data were acquired using two Clarius ultrasound linear probes with a frequency of 5 - 15 MHz and 4 - 13 MHz. A total of 20,287 images were acquired. For the training phase, the tendon regions in the images were annotated by a clinical scientist as the ground truth.
Description of the test set, sample size, data source, and annotation protocol
A total of 73 subjects were used to evaluate the performance of the AI model in the validation phase. Each subject had multiple studies of the above-mentioned tendons, resulting in a total of 2,503 ultrasound images/frames. Data source is from previous section (images captured in-house from volunteer subjects and by clinical partners in outpatient clinics mainly located in the USA, anonymized and queried from Clarius Cloud storage). Annotation protocol is from previous section (tendon regions in the images were annotated by a clinical scientist as the ground truth).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Al model training and validation: Training consisted of a basic hyperparameter exploration over a static dataset optimizing towards a static validation set sampled from the training data. U-net with MobileNetV2 backbone was used as the model architecture. A total of 73 subjects were used to evaluate the performance of the Al model in the validation phase, resulting in a total of 2,503 ultrasound images/frames. The reported average Dice score was 96% and the mean IoU was 94% for tendon segmentation.
Verification testing (Measurement Accuracy): Retrospective analysis of anonymized ultrasound images. The objective was to determine whether the Clarius Al (MSK model) software measurement output adequately aligned with expert clinicians' manual caliper placement. The features tested were tendon thickness measurement and segmentation mask. Tested if Clarius Al auto-measurements are non-inferior to manual measurements performed by licensed clinicians with relevant (i.e., musculoskeletal) ultrasound experience. The absolute percent (%) difference between reviewer pairs was calculated and compared to the absolute percent (%) difference between the automatic thickness measurement and mean reviewer measurement using a one-sided t-test and an equivalence margin of 20%. The automatic thickness measurement was found to be non-inferior (p value of 9.0 x 10^-5). The mean difference between differences was 0.03% (95% CI (-0.05)-(-0.01)). A difference of >20% constitutes a clinically significant difference for all structures, which corresponds to the following differences based on normal thickness measurements: 0.6 mm for plantar fascia; 1 mm for patellar tendon; 1.2 mm for Achilles' tendon.
Design validation study: Performed to validate the essential functionality of Clarius AI as incorporated into the Clarius App software for the specified application and intended use in automatic segmentation highlight, semi-automatic caliper placement with manual caliper adjustment, and persistent storage, to determine if Clarius AI is clinically usable and meets user needs in musculoskeletal ultrasound applications. The results demonstrated that Clarius as intended and meets user needs in musculoskeletal ultrasound applications for use in automatic segmentation highlight, semi-automatic caliper placement with manual caliper adjustment, and persistent storage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dice score: 96%
Mean IoU: 94%
P-value (non-inferiority): 9.0 x 10^-5
Mean difference between differences: 0.03% (95% CI (-0.05)-(-0.01))
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Clarius Mobile Health Corp. Agatha Szeliga Director, Regulatory Affairs 130-2985 Virtual Way Vancouver, British Columbia V5M 4X7 Canada
Re: K222406
January 23, 2023
Trade/Device Name: Clarius AI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: December 16, 2022 Received: December 21, 2022
Dear Agatha Szeliga:
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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222406
Device Name Clarius AI
Indications for Use (Describe)
Clarius AI is intended to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (e.g., Achilles' tendon, plantar fascia, patellar tendon) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., L 7 and L15). The user shall be a healthcare professional trained and qualified in MSK (musculoskeletal) ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical iudgment.
| 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
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR § 807.92.
| Subject Device Trade Name: | Clarius Al |
|---|---|
| Subject Device Model: | MSK |
| Device Classification Name: | Automated Radiological Image Processing Software |
Regulation Number, Name and Product Code:
| Regulation Number | Regulation Name | Product Code |
|---|---|---|
| 21 CFR § 892.2050 | Medical Image Management and Processing System | QIH |
| FDA 510(k) Review Panel: | Radiology | |
| Classification: | Class II | |
| Manufacturer: | Clarius Mobile Health Corp. | |
| 130-2985 Virtual Way | ||
| Vancouver, BC V5M 4X7 Canada | ||
| Contact Name: | Agatha Szeliga | |
| Director, Regulatory Affairs | ||
| agatha.szeliga@clarius.com | ||
| Date 510(k) Summary Prepared: | December 15, 2022 |
Predicate Device Information:
| Device Trade Name: | LVivo Software Application |
|---|---|
| 510(k) Reference: | K200232 |
| Manufacturer Name: | DiA Imaging Analysis Ltd |
| Regulation Name: | Medical Image Management and Processing System |
| Device Classification Name: | Automated Radiological Image Processing Software |
| Product Code(s): | QiH |
| Regulation Number: | 21 CFR § 892.2050 |
| Regulatory Class: | Class II |
Note: The predicate device has not been subject to a design-related recall.
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Image /page/4/Picture/0 description: The image shows the Clarius Ultrasound logo. The logo consists of an orange icon that resembles three concentric letter C's, followed by the word "clarius" in dark teal. To the right of "clarius" are the words "ultrasound anywhere" stacked on top of each other, also in dark teal.
Reference Device #1 Information:
| Device Trade Name: | CoLumbo |
|---|---|
| 510(k) Reference: | K220497 |
| Manufacturer Name: | Smart Soft Healthcare AD |
| Regulation Name: | Medical Image Management and Processing System |
| Device Classification Name: | Automated Radiological Image Processing Software |
| Product Code(s): | QIH |
| Regulation Number: | 21 CFR § 892.2050 |
| Regulatory Class: | Class II |
Reference Device #2 Information:
| Device Trade Name: | Al-Rad Companion (Musculoskeletal) |
|---|---|
| 510(k) Reference: | K193267 |
| Manufacturer Name: | Siemens Medical Solutions USA, Inc. |
| Regulation Name: | Computed tomography x-ray system |
| Device Classification Name: | Computed tomography x-ray system |
| Product Code(s): | JAK |
| Regulation Number: | 21 CFR § 892.1750 |
| Regulatory Class: | Class II |
Device Description
Clarius AI is a radiological (ultrasound) image processing software application which implements artificial intelligence (Al), including non-adaptive machine learning algorithms, and is incorporated into the Clarius App software for use as part of the complete Clarius Ultrasound Scanner system product offering in musculoskeletal (MSK) ultrasound imaging applications. Clarius Al (MSK model) is intended for use by trained healthcare practitioners for non-invasive measurements of ultrasound data from musculoskeletal (MSK) ultrasound imaging acquired by the Clarius Ultrasound Scanner system using an artificial intelligence (AI) image segmentation algorithm. Clarius AI (MSK model) is intended to semi-automatically place adjustable calipers and provide supplementary information to the user regarding tendon thickness measurements (i.e., foot/plantar fascia, ankle/Achilles' tendon, knee/patellar tendon). Clarius Al is intended to inform clinical management and is not intended to replace clinical decision-making. The clinician retains the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Al is indicated for use in adult patients only.
During the ultrasound imaging procedure, the anatomical site is selected through a preset software selection (e.g., foot, ankle, knee), in which the Clarius Al will engage to segment the correlating tendon. Clarius Al analyzes ultrasound images in real-time and outputs probabilities for each pixel within the image for determination of the particular tendon thickness.
The combination of all the pixels meeting a programmed threshold will render an overlay being displayed on top of the ultrasound image with a pre-programmed transparency so that the ultrasound greyscale is still visible. Once the user has obtained the best view, imaging can be manually paused, in which the Clarius Al will further analyze the tendon segmentation to determine the greatest thickness, in number of
5
Image /page/5/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol that looks like three concentric letter C's, followed by the word "clarius" in dark teal. To the right of "clarius" are the words "ultrasound anywhere" stacked on top of each other, also in dark teal.
pixels, and subsequently place two measurement calipers that correspond to the top and bottom of the tendon at its thickest region, outputting a value in millimeters. The user can then manually alter the measurement calipers to make any necessary adjustments if desired. Clarius Al does not perform any functions that could not be accomplished manually by a trained and qualified user.
Clarius AI (MSK model) is incorporated into the Clarius App software and is intended for use with the following Clarius Ultrasound Scanner system transducers (previously 510(k)-cleared in K180799, K192107, and K213436):
| Clarius Ultrasound Transducers | L7 and L15 |
|---|---|
| Clarius App Software | Clarius Ultrasound App (Clarius App) for iOS; |
| Clarius Ultrasound App (Clarius App) for Android |
Indications for Use for Clarius AI (MSK)
Clarius AI is intended to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (e.g., Achilles' tendon, plantar fascia, patellar tendon) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., L7 and L15). The user shall be a healthcare professional trained and qualified in MSK (musculoskeletal) ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical iudgment.
Comparison of the Subject Device and Legally Marketed Devices for Demonstration of Substantial Equivalence
The following table provides a comparison of the subject device, Clarius Al, to the predicate device and reference devices. A comparison of the subject device to the predicate and reference devices shows that the subject device has similar indications for use, is based on a similar Al algorithm, and provides automated radiological image processing with segmentation and measurement of anatomical structures, comparable to the legally marketed devices referenced herein.
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Image /page/6/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange symbol that looks like three concentric letter C's, followed by the word "clarius" in dark teal. To the right of "clarius" are the words "ultrasound anywhere" stacked on top of each other, also in dark teal.
Table 1 - Comparison of the Subject Device to the Legally Marketed Devices
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE #1 | REFERENCE DEVICE #2 | RATIONALE
(if subject device
differs from predicate
device) |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Clarius Al | LVivo Software
Application | Columbo | Al-Rad Companion
(Musculoskeletal) | |
| 510(k) Holder/
Manufacturer | Clarius Mobile Health
Corp. | DiA Imaging Analysis
Ltd | Smart Soft Healthcare
AD | Siemens Medical
Solutions USA, Inc. | Not applicable |
| Submission Reference | Current Submission | K200232 | K220497 | K193267 | Not applicable |
| Product Code(s) | QIH | QIH | QIH | JAK | Same as predicate
device and reference
device #1 |
| Device Classification
Name | Automated
Radiological Image
Processing Software | Automated
Radiological Image
Processing Software | Automated
Radiological Image
Processing Software | Computed
tomography x-ray
system | Same as predicate
device and reference
device #1 |
| Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.1750 | Same as predicate
device and reference
device #1 |
| Regulation Name | Medical Image
Management and
Processing System | Medical Image
Management and
Processing System | Medical Image
Management and
Processing System | Computed
tomography x-ray
system | Same as predicate
device and reference
device #1 |
| Intended Use | Non-invasive
processing of
ultrasound images
using automatic image
segmentation and
measurement of
anatomical structures
utilizing artificial
intelligence
algorithms. | Non-invasive
processing of
ultrasound images
using automatic image
segmentation and
measurement of
anatomical structures
utilizing artificial
intelligence
algorithms. | Non-invasive
processing of MR
images using
automatic image
segmentation and
measurement of
anatomical structures
utilizing artificial
intelligence
algorithms. | Non-invasive
processing of CT
images using
automatic image
segmentation and
measurement of
anatomical structures
utilizing artificial
intelligence
algorithms. | Same as predicate
device and similar to
reference devices |
| Indications for Use | Clarius Al is intended
for use by trained
healthcare
professionals to semi-
automatically place | LVivo platform is
intended for non-
invasive processing of
ultrasound images to
detect, measure, and | Columbo is an image
post-processing and
measurement
software tool that
provides quantitative | Al-Rad Companion
(Musculoskeletal) is an
image processing
software that provides
quantitative and | Clarius Al indications
for use are similar to
the predicate device's
indications for use as
both devices are |
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE #1 | REFERENCE DEVICE #2 | RATIONALE (if subject device differs from predicate device) |
| | Clarius Al | LVivo Software Application | CoLumbo | Al-Rad Companion (Musculoskeletal) | |
| | calipers for non-invasive anatomical measurements on ultrasound data acquired by the Clarius Ultrasound Scanner. | calculate relevant medical parameters of structures and function of patients with suspected disease. | spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting out-of-range measurements:
-Feature segmentation;
-Feature measurement;
Threshold based labeling of out of range measurement; and
-Export of measurement results to a written report for user's review, revise and approval. CoLumbo does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to | qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of musculoskeletal disease. It provides the following functionality:
-Segmentation of vertebrae
-Labelling of vertebrae
-Measurements of heights in each vertebra and indication if they are critically different
-Measurement of mean Hounsfield value in volume of interest within vertebra. Only DICOM images of adult patients are considered to be valid input. | indicated for non-invasive processing of ultrasound data/ images for measurements of anatomical structures. |
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE #1 | REFERENCE DEVICE #2 | RATIONALE
(if subject device
differs from predicate
device) |
| | Clarius Al | LVivo Software
Application | CoLumbo | Al-Rad Companion
(Musculoskeletal) | |
| | | | more easily identify
and classify features in
lumbar MR images and
compile a report. The
user is responsible for
confirming/ modifying
settings, reviewing and
verifying the software-
generated
measurements,
inspecting out-of-
range measurements,
and approving draft
report content using
their medical
judgment and
discretion.
The device is intended
to be used only by
hospitals and other
medical institutions.
Only DICOM images of
MRI acquired from
lumbar spine exams of
patients aged 18 and
above are considered
to be valid input.
Columbo does not
support DICOM images
of patients that are
pregnant, undergo
MRI scan with contrast
media, or have post- | | |
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE #1 | REFERENCE DEVICE #2 | RATIONALE
(if subject device |
| | Clarius Al | LVivo Software
Application | CoLumbo | Al-Rad Companion
(Musculoskeletal) | differs from predicate
device) |
| Radiological
application/ Supported
modality | Ultrasound | Ultrasound | operational
complications,
scoliosis, tumors,
infections, fractures. | CT | Same as predicate
device |
| Principle of Operation/
Technology | Ultrasound image
processing software
implementing artificial
intelligence including
non-adaptive machine
learning algorithms
trained with clinical
and/or artificial data
intended for non-
invasive segmentation
and measurements of
ultrasound data. | Ultrasound image
processing software
implementing artificial
intelligence including
non-adaptive machine
learning algorithms
trained with clinical
and/or artificial data
intended for non-
invasive segmentation
and measurements of
ultrasound data. | Radiological image
processing software
implementing artificial
intelligence including
non-adaptive machine
learning algorithms
trained with clinical
and/or artificial data
intended for non-
invasive segmentation
and measurements of
MR data | Radiological image
processing software
implementing artificial
intelligence including
non-adaptive machine
learning algorithms
trained with clinical
and/or artificial data
intended for non-
invasive segmentation
and measurements of
CT data | Same as predicate
device |
| Segmentation | Yes - Segmentation of
anatomical structures
(tendons) | Yes - Segmentation of
anatomical structures
(LV, RV, bladder) | Yes - Segmentation of
anatomical structures
(spinal vertebrae) | Yes - Segmentation of
anatomical structures
(spinal vertebrae) | Similar to predicate
device and reference
devices |
| Measurement | Yes - Measurement of
anatomical structures
(tendons) | Yes - Measurement of
anatomical structures
(LV, RV, bladder) | Yes - Measurement of
anatomical structures
(spinal vertebrae) | Yes - Measurement of
anatomical structures
(spinal vertebrae) | Similar to predicate
device and reference
devices |
| Al Algorithm | Image segmentation,
anatomical
identification, and
measurement utilizing
the machine learning-
based algorithm
Exception U-Net | Image segmentation
for border detection.
Algorithm combines
image processing and
Deep Learning Neural
Network for analysis. | Deep Convolutional
Image-to-Image Neural
Network | 3D Deep Image-to-
Image Network | Similar to predicate
device and reference
devices |
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE #1 | REFERENCE DEVICE #2 | RATIONALE
(if subject device
differs from predicate
device) |
| | Clarius Al | LVivo Software
Application | CoLumbo | Al-Rad Companion
(Musculoskeletal) | |
| Automation
(Yes or No) | Yes | Yes | Yes | Yes | Same as predicate
device and reference
devices |
| Display Calipers | Yes | Yes | Yes | Yes | Same as predicate
device and reference
devices |
| Manual adjustment/
Manual editing by user
capability
(Yes or No) | Yes | Yes | Yes | Yes | Same as predicate
device and reference
devices |
| Anatomical Site | Foot, Ankle, Knee | Bladder, Heart | Lumbar Spine | Thoracic Spine | Although the
anatomical sites/
structures for use of
the predicate device
(bladder, heart) are
different from the
subject device (foot,
ankle, knee), the
predicate device and
subject device share a
very similar intended
use in terms of
identifying/ viewing,
measuring/
quantifying and
reporting results
acquired by ultrasound
devices for non-
invasive
measurements of
anatomical structures
utilizing artificial |
| Criteria | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE #1 | REFERENCE DEVICE #2 | RATIONALE
(if subject device |
| | Clarius Al | LVivo Software
Application | CoLumbo | Al-Rad Companion
(Musculoskeletal) | differs from predicate
device) |
| | | | | | intelligence
algorithms. |
| Environment of Use | Healthcare setting
(e.g., hospital, clinic) | Healthcare setting
(e.g., hospital, clinic) | Healthcare setting
(e.g., hospital, clinic) | Healthcare setting
(e.g., hospital, clinic) | Same as predicate
device and reference
devices |
| Intended Users | Licensed healthcare
professionals | Licensed healthcare
professionals | Licensed healthcare
professionals | Licensed healthcare
professionals | Same as predicate
device and reference
devices |
| Patient Population | Adults | Adults | Adults | Adults | Same as predicate
device and reference
devices |
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Image /page/12/Picture/0 description: The image shows the Clarius logo. The logo consists of an orange icon on the left and the word "clarius" in dark teal on the right. To the right of the word "clarius" is the phrase "ultrasound anywhere" in a smaller font, also in dark teal. The icon on the left is a stylized "C" made up of three curved lines.
Non-Clinical Performance Testing Summary
Clarius Al (MSK) was designed and developed by Clarius Mobile Health Corp. in accordance with the applicable requirements, design controls, and standards to establish safety and effectiveness of the device.
Non-clinical performance testing has demonstrated that Clarius Al (MSK) complies with the following FDArecognized consensus standards:
| Standard
Recognition
| Number | Title of Standard |
|---|---|
| 13-79 | IEC 62304:2006 + A1:2015 - Medical device software — Software life cycle processes |
| 5-40 | ISO 14971:2019 Medical devices — Application of risk management to medical devices |
| 12-300 | NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set |
| 5-114 | IEC 62366-1:2015 + A1:2020 Medical devices — Part 1: Application of usability engineering to |
| medical devices | |
| 5-117 | ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling |
| and information to be supplied |
Safety and performance of Clarius Al (MSK) has been evaluated through verification and validation testing in accordance with software specifications and applicable performance standards. The traceability analysis provides traceability between requirements, design specifications, risks, and verification testing of the subject device. All software requirements and risk analysis have been successfully verified and traced. Software verification and validation activities were conducted per IEC 62304:2006 + AMD1:2015 – Medical device software – Software lifecycle processes and ISO 14971:2019 Medical devices – Application of risk management to medical devices, and in accordance with FDA guidance documents, General Principles of Software Validation, Final Guidance for Industry and FDA Staff (issued January 11, 2002), Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005), and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014).
Applicable software documentation for a Moderate Level of Concern software, per FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) has been provided.
A comprehensive risk analysis was performed for the subject device and appropriate risk controls have been implemented to mitigate hazards.
Clarius conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient.
Clarius Al (MSK) was tested and found to be safe and effective for the intended users, uses, and use environments, as demonstrated through verification and validation testing was performed to ensure that the final product is capable of meeting the requirements for the specified clinical application and performs as intended to meet users' needs, while demonstrating substantial equivalence to the predicate device.
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Image /page/13/Picture/0 description: The image shows the Clarius logo. On the left is an orange symbol that looks like three curved lines that form a C shape. To the right of the symbol is the word "clarius" in dark teal. To the right of "clarius" are the words "ultrasound anywhere" stacked on top of each other, also in dark teal.
Clinical Performance Testing Summary
Clarius performed Al model training to create a documented baseline of the Al model. Training consisted of a basic hyperparameter exploration over a static dataset optimizing towards a static validation set sampled from the training data. U-net with MobileNetV2 backbone was used as the model architecture for Clarius AI.
Three datasets of ultrasound images of Achilles' Tendons, Plantar Fascia and Patellar Tendons, were used in the study. All the images had segmentation ground truth. The images in the dataset were classified into tendon and background. Images were captured in-house from volunteer subjects and by clinical partners in outpatient clinics mainly located in the USA. The data was anonymized and queried from Clarius Cloud storage. Ultrasound recordings were acquired with the subjects in various positions depending on preference. Tendons were imaged in longitudinal views. The plantar fascia was imaged in dorsiflexion, plantar flexion, and neutral positions. The Achilles' tendon was imaged with the ankle at 90 degrees. The knee was imaged in 30 degrees flexion. Images with and without the structures of interest were collected to create a dataset that was large and heterogeneous. Images were acquired in different depths to mitigate different use cases for users. The data were acquired using two Clarius ultrasound linear probes with a frequency of 5 - 15 MHz and 4 - 13 MHz. A total of 20,287 images were acquired. For the training phase, the tendon regions in the images were annotated by a clinical scientist as the ground truth.
A total of 73 subjects were used to evaluate the performance of the Al model in the validation phase. Each subject had multiple studies of the above-mentioned tendons, resulting in a total of 2,503 ultrasound images/frames. The reported average Dice score was 96% and the mean loU was 94% for tendon segmentation.
Verification testing was performed to verify if Clarius Al auto-measurements are non-inferior to manual measurements performed by licensed clinicians with relevant (i.e., musculoskeletal) ultrasound experience. Verification testing of Clarius Al was performed through a retrospective analysis of anonymized ultrasound images. The objective was to determine whether the Clarius Al (MSK model) software measurement output adequately aligned with expert clinicians' manual caliper placement. The features tested during the verification study were tendon thickness measurement and segmentation mask. The difference between auto-measurements and mean manual measurements was found to be no greater than the mean difference between manual measurements within the clinically significant margin and with a statistical significance level of 0.05.
Measurement Accuracy:
The absolute percent (%) difference between reviewer pairs was calculated and compared to the absolute percent (%) difference between the automatic thickness measurement and mean reviewer measurement using a one-sided t-test and an equivalence margin of 20%. The automatic thickness measurement was found to be non-inferior (p value of 9.0 x 10'). The mean difference between differences was 0.03% (95% CI (-0.05)-(-0.01)).
A difference of >20% constitutes a clinically significant difference for all structures, which corresponds to the following differences based on normal thickness measurements: 0.6 mm for plantar fascia; 1 mm for patellar tendon; 1.2 mm for Achilles' tendon.
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Image /page/14/Picture/0 description: The image shows the Clarius Ultrasound logo. The logo consists of an orange symbol resembling three curved lines forming a C shape, followed by the word "clarius" in dark teal. To the right of "clarius" is the text "ultrasound anywhere" also in dark teal, with "ultrasound" stacked above "anywhere".
Verification testing of Clarius Al was successfully completed with the results demonstrating that Clarius Al (MSK model) software measurement output adequately aligned with expert clinicians' manual caliper placement. As such, Clarius Al has been verified for tendon thickness measurement and segmentation mask for use in musculoskeletal ultrasound applications.
A design validation study was performed to validate the essential functionality of Clarius Al as incorporated into the Clarius App software for the specified application and intended use in automatic segmentation highlight, semi-automatic caliper placement with manual caliper adjustment, and persistent storage, to determine if Clarius Al is clinically usable and meets user needs in musculoskeletal ultrasound applications. The results of the validation study demonstrated that Clarius as intended and meets user needs in musculoskeletal ultrasound applications for use in automatic segmentation highlight, semi-automatic caliper placement with manual caliper adjustment, and persistent storage.
Conclusion & Summary of Substantial Equivalence
Based on the information presented in this Traditional 510(k) premarket notification and based on the fundamental scientific technology utilizing artificial intelligence algorithms, technological characteristics, principle of operation, intended use, environment of use, and indications for use, Clarius Al has been determined to be substantially equivalent in terms of safety and effectiveness to the legally marketed predicate/reference devices.
Performance testing of Clarius Al, including results from verification studies, has demonstrated that Clarius Al software measurement output adequately aligns with expert clinicians' manual measurements, and thereby performs as intended for automatic segmentation with semiautomatic caliper placement with manual caliper adjustment in musculoskeletal ultrasound applications, meeting user needs.
The subject device and the predicate device are both radiological (ultrasound) image processing software applications which implement artificial intelligence (Al) including non-adaptive learning algorithms trained with clinical and/or artificial data intended for non-invasive measurements of ultrasound data, utilizing similar machine-learning based algorithms to detect, measure, and calculate relevant medical parameters of structures with manual adjustment capability by the user.
Any minor differences in the indications for use/anatomical structures between the subject device and the legally marketed devices do not raise any issues related to safety or effectiveness, thereby demonstrating that Clarius Al is as safe and effective as the legally marketed devices, and therefore substantially equivalent.