(175 days)
Yes
The device description explicitly states that the SpineUs™ computer application segments ultrasound images using artificial intelligence. The summary also includes details about the training and testing datasets used for the Segmentation AI.
No
The device is intended for diagnostic imaging and assisting in acquiring, viewing, and measuring ultrasound images, not for treating or preventing a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The SpineUs™ system is a software-based, tracked, ultrasound imaging system and accessories, intended for diagnostic imaging." Additionally, the "Device Description" section refers to it as "The SpineUs™ System is a diagnostic ultrasound system."
No
The device description explicitly states that the SpineUs™ System consists of hardware components including an FDA cleared ultrasound scanner, a consumer PC, a tracking system with cameras and markers, and accessories, in addition to the SpineUs™ computer application software.
Based on the provided information, the SpineUs™ system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- SpineUs™ Intended Use: The SpineUs™ system is intended for diagnostic imaging using ultrasound. It directly images the spine within the patient's body.
- Device Description: The system uses an ultrasound scanner to acquire images in vivo (within the living body), not in vitro (in a lab setting using specimens).
Therefore, the SpineUs™ system falls under the category of diagnostic imaging devices, not In Vitro Diagnostic devices.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The SpineUs™ system is a software-based, tracked, ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging in the following applications: musculoskeletal (conventional, superficial). The system is intended for use by trained chiropractors and radiologists in a hospital or medical clinic.
The SpineUs™ system is intended for assisting trained chiropractors and radiologists in acquiring, viewing, and measuring ultrasound images of the spine in both clinic and hospital settings. The SpineUs™ system is intended to be used as an adjunct to conventional imaging method that allows trained chiropractors and radiologists to measure spine-related anatomical components on images (e.g., intervertebral angles and spine curvature). The system also allows the review and management of patient measurement data. Clinical judgment of anatomy and experience are required to properly use the SpineUs™ system.
Patient management decisions should not be made based solely on the results of the SpineUs™ computer application. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgement.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX, QIH
Device Description
The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application.
The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
The SpineUs™ system comprises the following:
Transducer / Scanner: Clarius Ultrasound Scanner, model C3 HD3 (K213436)
Software: SpineUs™ computer application
Tracking system: Motive Software, OptiTrack Cameras, SpineUs™ Active LED Markers, Power over Ethernet (PoE) switch
Accessories: USB-C charging cables, USB-C charging block, Wall mounted camera holders/covers, Tracker Reference (includes belt), Consumer PC
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Spinal region of the human body (spine)
Indicated Patient Age Range
Not Found. The test set demographic showed ages from 50.
Intended User / Care Setting
Trained chiropractors and radiologists in a hospital or medical clinic.
Description of the training set, sample size, data source, and annotation protocol
The Development Data used to train the Segmentation AI is separate from the Non-Clinical and Clinical Testing Datasets. This Development Data included a total of 81 ultrasound image sequences from 45 patients. In total. 17684 images were used in the development dataset. Ultrasound sequences were distributed between axially- and sagitally-orientated imaging, and thoracic and lumbar regions.
Image-level annotations were performed on a per-frame basis, where a team of trained clinical experts labelled bone surface structures. When available, corresponding thoracic CT imaging served as a ground truth to assist in the annotation process. All annotations were reviewed by a separate annotator. These annotations were used as the ground truth for the Segmentation AI training process.
The Development Data was acquired from a single site using the SpineUs TM system, and included a diverse patient population, as shown in the table below, and illustrates a balanced distribution of sex, age range, body mass index, and ethnicity.
Description of the test set, sample size, data source, and annotation protocol
Standalone Segmentation AI performance testing was performance to assess the ability of the Segmentation AI to delineate between bone surfaces and background on ultrasound images from a recorded ultrasound sequence. A set of recorded ultrasound sequences, acquired with the SpineUs™ system, was analyzed by the Segmentation AI, with the outputs annotated by at least two clinical experts, and the results were compared to an established historical control for the Non-Clinical and Clinical Performance Testing. The demographic information of the Testing Datasets is presented in the below table, and encompass a diverse patient population, where all data used in the Testing Datasets is obtained from clinical sites which are independent from those which are included in the Development dataset.
As with the development data, image-level annotations were performed on a per-frame basis, where a team of trained clinical experts labelled bone surface structures. All annotations were reviewed by a separate annotator. These annotations were used as the ground truth for the pixel-based metrics.
Sample Size (Non-Clinical and Clinical Performance Testing Dataset): n = 31
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
Study Type: Standalone Segmentation AI performance testing.
Sample Size: 31 patients.
Key Results:
Average Percentage of Transverse Processes Identified: 100.0% [100.0% - 100.0%] (Success Criteria: > 80 %)
Average Inference Time: 140.05 frames per second (Success Criteria: > 25 frames per second)
Pixel-Based Metrics:
Sensitivity: 41.80%.
Specificity: 99.19%.
Precision: 38.70%.
Dice Coefficient: 0.4019.
Balanced accuracy: 70.49%.
95th %ile HD: 12.91 mm.
Clinical Performance Testing:
Study Type: Measurement of scoliosis angle on SpineUs™ system images and X-ray images of the same patients by three different observers.
Sample Size: 31 patients.
Key Results: Absolute value of the difference between the SpineUs™ system and X-ray-based measurements for All Patients: 2.81 (2.36, 3.25) mm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Non-Clinical Performance Testing (Pixel-Based Metrics):
Sensitivity: 41.80%
Specificity: 99.19%
Precision: 38.70% (equivalent to PPV)
Dice Coefficient: 0.4019
Balanced accuracy: 70.49%
95th Percentile Hausdorff Distance: 12.91 mm
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.
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. 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). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging 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.
0
October 7, 2024
Image /page/0/Picture/1 description: The image contains 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.
Verdure Imaging Christopher Schlenger President, Verdure Imaging 4560 N. Pershing Ave., Ste. A Stockton, California 95219
Re: K241029
Trade/Device Name: SpineUs™ System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, ITX, QIH Dated: September 5, 2024 Received: September 6, 2024
Dear Christopher Schlenger:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K241029
Device Name
SpineUs™ System
Indications for Use (Describe)
The SpineUs™ system is a software-based, tracked, ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging in the following applications: musculoskeletal (conventional, superficial). The system is intended for use by trained chiropractors and radiologists in a hospital or medical clinic.
The SpineUs™ system is intended for assisting trained chiropractors and radiologists in acquiring, viewing, and measuring ultrasound images of the spine in both clinic and hospital settings. The SpineUs™ system is intended to be used as an adjunct to conventional imaging method that allows trained chiropractors and radiologists to measure spine-related anatomical components on images (e.g., intervertebral angles and spine curvature). The system also allows the review and management of patient measurement data. Clinical judgment of anatomy and experience are required to properly use the SpineUs™ system.
Patient management decisions should not be made based solely on the results of the SpineUs™ computer application. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgement.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
K241029
| Sponsor: | Verdure Imaging, Inc.
4560 N. Pershing Ave. Ste. A
Stockton, CA 95219 |
|-----------------------|-----------------------------------------------------------------------------|
| Contact Person: | Christopher Schlenger |
| Device name: | SpineUs™ System |
| Common Name: | Ultrasonic imaging system; Diagnostic ultrasonic transducer |
| Trade Name: | SpineUs™ system |
| Classification: | |
| Regulatory Class: | II |
| Regulatory Category: | 21CFR 892.1560, 892.1570, and 892.2050 (IYO, ITX, QIH |
| Classification Panel: | Radiology |
Legally Marketed Predicate Devices A.
The predicate device is the LOGIQ E10 (K231966), manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC.
Device Description: B.
The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application.
The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
The SpineUs™ system comprises the following:
| Transducer / Scanner | Clarius Ultrasound Scanner, model C3 HD3
(K213436) |
|----------------------|---------------------------------------------------------------------------------------------------------|
| Software | SpineUs™ computer application |
| Tracking system | Motive Software
OptiTrack Cameras
SpineUs™ Active LED Markers
Power over Ethernet (PoE) switch |
5
| Accessories | USB-C charging cables |
|---|---|
| USB-C charging block | |
| Wall mounted camera holders/covers | |
| Tracker Reference (includes belt) | |
| Consumer PC |
C. Intended Use / Indications for Use
The SpineUs™ system is a software-based, tracked, ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging in the following applications: musculoskeletal (conventional, superficial). The system is intended for use by trained chiropractors and radiologists in a hospital or medical clinic.
The SpineUs™ system is intended for assisting trained chiropractors and radiologists in acquiring. viewing, and measuring ultrasound images of the spine in both clinic and hospital settings. The SpineUs™ system is intended to be used as an adjunct to conventional imaging method that allows trained chiropractors and radiologists to measure spine-related anatomical components on images (e.g., intervertebral angles and spine curvature). The system also allows the review and management of patient measurement data. Clinical judgment of anatomy and experience are required to properly use the SpineUs™ system.
Patient management decisions should not be made based solely on the results of the SpineUs™ system. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgement.
| Subject Device | Predicate Device | |
|---|---|---|
| Criteria | SpineUs™ system | LOGIQ E10 |
| 510(k) Holder/ | ||
| Manufacturer | Verdure Imaging, Inc. | GE Medical Systems Ultrasound and Primary |
| Care Diagnostics, LLC. | ||
| Submission | ||
| Reference | Current Submission | K231966 |
| Regulatory Class | Class II | Class II |
| Product code(s) | IYO (primary), ITX, QIH | IYN (primary), IYO, ITX |
| Regulation | ||
| number | 21 CFR 892.1560 | |
| 21 CFR 892.1570 | ||
| 21 CFR 892.2050 | 21 CFR 892.1550 | |
| 21 CFR 892.1560 | ||
| 21 CFR 892.1570 | ||
| Regulation name | Ultrasonic Pulsed Echo Imaging System | |
| Diagnostic Ultrasonic Transducer | ||
| Medical image management and processing | ||
| system | Ultrasonic Pulsed Doppler Imaging System | |
| Ultrasonic Pulsed Echo Imaging System | ||
| Diagnostic Ultrasonic Transducer | ||
| Transducer | ||
| Models | Clarius C3 HD3 (FDA cleared, K213436) | Various |
| Transducer Types | Convex Array | Convex Array |
| Linear Array | ||
| Phased Array | ||
| Intracavity | ||
| Intended Use | Diagnostic ultrasound imaging of the spinal | |
| region of the human body | Diagnostic ultrasound imaging and fluid flow | |
| analysis of the human body | ||
| Indications for | ||
| Use and Clinical | ||
| Usage | The SpineUs™ system is a software-based, | |
| tracked, ultrasound imaging system and | ||
| accessories, intended for diagnostic imaging. It | ||
| is indicated for diagnostic ultrasound imaging in | ||
| the following applications: musculoskeletal | ||
| (conventional, superficial). The system is | ||
| intended for use by trained chiropractors and | ||
| radiologists in a hospital or medical clinic. |
The SpineUs™ system is intended for assisting
trained chiropractors and radiologists in
acquiring, viewing, and measuring ultrasound
images of the spine in both clinic and hospital
settings. The SpineUs™ system is intended to
be used as an adjunct to conventional imaging
method that allows trained chiropractors and
radiologists to measure spine-related anatomical
components on images (e.g., intervertebral
angles and spine curvature). The system also
allows the review and management of patient
measurement data. Clinical judgment of
anatomy and experience are required to properly
use the SpineUs™ system. | LOGIQ E10 is intended for use by a qualified
physician in a hospital or medical clinic, for
ultrasound evaluation of:
Fetal / ObstetricsAbdominal (including Renal,
Gynecology/Pelvic)PediatricSmall Organ (Breast, Testes,
Thyroid)Neonatal CephalicAdult CephalicCardiac (Adult and Pediatric)Peripheral VascularMusculoskeletal Conventional and
SuperficialUrology (including Prostate)TransrectalTransvaginalTransesophageal and Intraoperative
(Abdominal and Vascular) |
| | Patient management decisions should not be
made based solely on the results of the
SpineUs™ computer application. The user shall
retain the ultimate responsibility of ascertaining
the measurements based on standard practices
and clinical judgement. | |
| Tracking
technology | 3D Optical tracking using GPS-like technology | 2D/3D GPS tracking using GPS-like
technology. |
| Artificial
intelligence (AI)
technology | AI-based segmentation of vertebral bone tissue
in ultrasound image frames. | AI-based tools such as Breast Assistant and
Auto Lesion Segmentation powered by Koios
DS™™, Auto Doppler Assistant, and OB
Measurement Assistant. |
| Display | Consumer PC, provided by Verdure Imaging,
Inc. | Mobile console approximately 585 mm wide
(keyboard), 991 mm deep and 1300 mm high
that provides digital acquisition, processing, and
display capability. The user interface includes a
computer keyboard, specialized controls, 12-
inch-high resolution color touch screen and
23.8-inch High Contrast LED LCD monitor |
| Modes of
Operation | B-mode | B, M, PW Doppler, CW Doppler, Color
Doppler, Color M Doppler, Power Doppler,
Harmonic Imaging, Coded Pulse, 3D/4D
Imaging mode, Elastography, Shear Wave
Elastography, Attenuation Imaging and
Combined modes: B/M, B/Color, B/PWD,
B/Color/PWD, B/Power/PWD |
| Safety Standards | The SpineUs™ System complies with the following safety standards: | The LOGIQ E10 complies with the following safety standards: |
| | IEC 60601-1 | IEC 60601-1 |
| | IEC 60601-1-2 | IEC 60601-1-2 |
| | IEC 60601-2-37 | IEC 60601-2-37 |
| | ISO 10993-1 | ISO 10993-1 |
| | ISO 14971 | ISO 14971 |
| | NEMA PS 3.1 – 3.20 | NEMA PS 3.1 – 3.20 |
Comparison of the Subject Device and Predicate Device for Demonstration of Substantial D. Equivalence
6
7
Discussion of Similarities and Differences
Similarities to the Primary Predicate Device
The subject device has the same technological characteristics as the predicate as follows:
-
The Regulatory Class is the same for both devices.
-
The Product codes IYO and ITX are included in the Product codes of the subject and predicate devices.
-
- Both devices are indicated to be used with FDA cleared transducers, of Convex Array type.
-
The intended use is the same for both devices: diagnostic ultrasound of the human body.
-
Both devices are intended for use in professional healthcare environments by trained healthcare professionals for ultrasound evaluation of Musculoskeletal (conventional and superficial).
-
Both devices use tracking technology.
-
- Both devices use artificial intelligence technology for segmentation of ultrasound imaging frames.
-
- Both devices can be used in the B mode of operation.
-
- Both devices are compliant with the same safety standards.
- Both devices have tissue contact materials tested for biocompatibility. The only component with tissue contact material in the SpineUs™ system is the Clarius C3 HD3 (FDA cleared, K213436).
Differences from Primary Predicate Device
-
- In general, the subject device has fewer indications for use than the predicate device.
-
- The subject device is not indicated for Product code IYN.
-
- The predicate device is not indicated for Product code QIH.
-
- The subject device is indicated to be used with the transducer model C3 HD3 (FDA cleared, K213436), while the predicate device requires other FDA cleared transducer models.
-
- The subject device is indicated to be used only with transducers of Convex Array type, while the predicate device allows the use of additional transducer types.
-
- The subject device is indicated to be used only for diagnostic ultrasound imaging of the spinal region of the human body, while the predicate device can be used for diagnostic ultrasound imaging of other regions of the human body and fluid flow analysis.
-
- The subject device is indicated to be used only by trained chiropractors and radiologists, while the predicate device can be used by trained healthcare professionals.
-
- The subject device is indicated to be used only for ultrasound evaluation of Musculoskeletal (conventional and superficial), while the predicate device allows more uses.
-
- The subject device and predicate device use different tracking technologies. The subject device uses Optical tracking with passive LED optical markers, while the predicate device uses 2D/3D GPS tracking using GPS-like technology.
-
- The subject device uses artificial intelligence technology only for segmentation of vertebral bone tissue in ultrasound imaging frames, while the predicate device uses artificial intelligence technology for lesion segmentation and other applications.
- The subject device includes a consumer PC with the required software installed in it, provided by the
8
manufacturer, while the predicate device includes its own mobile console.
-
- The subject device is indicated to be used only in B-Mode, while the predicate device allows additional modes of operation.
Performance Testing for Technology Differences
The differences from the predicate device have been tested to ensure that these differences do not raise new questions of safety and effectiveness. Specifically, the primary differences identified above, such as the tracking technology, have been tested and the data provided in the verification and validation sections of this submission.
E. SpineUsTM Segmentation AI
Data Description - Development Dataset
The Development Data used to train the Segmentation AI is separate from the Non-Clinical and Clinical Testing Datasets. This Development Data included a total of 81 ultrasound image sequences from 45 patients. In total. 17684 images were used in the development dataset. Ultrasound sequences were were were were were were were were were were were were were were were were we distributed between axially- and sagitally-orientated imaging, and thoracic and lumbar regions.
Image-level annotations were performed on a per-frame basis, where a team of trained clinical experts labelled bone surface structures. When available, corresponding thoracic CT imaging served as a ground truth to assist in the annotation process. All annotations were reviewed by a separate annotator. These annotations were used as the ground truth for the Segmentation AI training process.
The Development Data was acquired from a single site using the SpineUs TM system, and included a diverse patient population, as shown in the table below, and illustrates a balanced distribution of sex, age range, body mass index, and ethnicity.
| Demographic | Development Data | |
|---|---|---|
| Gender | Male (%) | 55.5% |
| Female (%) | 42.2% | |
| Unknown (%) | 2.3% | |
| Age | Mean (years) | 51.2 |
| St. Dev. (years) | 16.6 | |
| Body Mass Index | Mean (kg/m2) | 27.3 |
| St. Dev. (kg/m2) | 6.5 | |
| Ethnicity | Caucasian or White (%) | 60.0% |
| African American or Black (%) | 37.7% | |
| Hispanic / Latino (%) | 0.0% | |
| Other (%) | 2.3% |
Non-Clinical and Clinical Testing Dataset
Standalone Segmentation AI performance testing was performance to assess the ability of the
9
Segmentation AI to delineate between bone surfaces and background on ultrasound images from a recorded ultrasound sequence. A set of recorded ultrasound sequences, acquired with the SpineUs™ system, was analyzed by the Segmentation AI, with the outputs annotated by at least two clinical experts, and the results were compared to an established historical control for the Non-Clinical and Clinical Performance Testing. The demographic information of the Testing Datasets is presented in the below table, and encompass a diverse patient population, where all data used in the Testing Datasets is obtained from clinical sites which are independent from those which are included in the Development dataset.
As with the development data, image-level annotations were performed on a per-frame basis, where a team of trained clinical experts labelled bone surface structures. All annotations were reviewed by a separate annotator. These annotations were used as the ground truth for the pixel-based metrics.
| Non-Clinical and Clinical Performance Testing Dataset (n = 31) | ||
|---|---|---|
| Mean (Years) | SD (Years) | |
| Age | 23.5 | 16.2 |
| Count | % | |
| Sex | ||
| Male | 13 | 41.9 |
| Female | 18 | 58.1 |
| Body Mass Index | ||
| 24.9 | 12 | 38.7 |
| Ethnicity | ||
| Caucasian or White | 8 | 25.8 |
| African American or Black | 11 | 35.5 |
| Hispanic | 4 | 12.9 |
| Asian | 5 | 16.1 |
| Other | 3 | 9.7 |
| Spinal Curvature | ||
| 40° | 4 | 12.9 |
Non-Clinical Performance Testing
| Name | Description | Success Criteria | Results |
|---|---|---|---|
| Average | |||
| Percentage of | |||
| Transverse | |||
| Processes | |||
| Identified* | The number of transverse processes | ||
| correctly identified relative to the | |||
| total real number of transverse | |||
| processes present in the 3D | |||
| reconstruction of the spine | > 80 % | 100.0% [100.0% - | |
| 100.0%] | |||
| Average | |||
| Inference | |||
| Time | The average time required to process | ||
| a single 2D ultrasound image frame | |||
| with the evaluated Segmentation AI | > 25 frames per | ||
| second | 140.05 frames per | ||
| second |
Segmentation AI Summary of Non-Clinical Endpoints, Success Criteria, and Results
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| model | |||
|---|---|---|---|
| Pixel-Based | |||
| Metrics | Various pixel-based metrics which are | ||
| used to identify relative performance | |||
| of individual image segmentations | |||
| (Sensitivity, Specificity, Precision, | |||
| Dice Coefficient, Balanced Accuracy, | |||
| 95th Percentile Hausdorff Distance) | N/A | Sensitivity: 41.80%. | |
| Specificity: 99.19%. | |||
| Precision: 38.70%. | |||
| Dice Coefficient: | |||
| 0.4019. | |||
| Balanced accuracy: | |||
| 70.49%. | |||
| 95th %ile HD: 12.91 | |||
| mm. |
- Primary Endpoints
Non-Clinical Performance testing was performed on the standalone Testing Dataset, which is separate to the Development Dataset. Breakdowns of performance in each of the patient subgroups are presented in the below table.
| Patient Subgroup | Number of Patients | Percentage of transverse processes identified (%) |
|---|---|---|
| All Patients | 31 | 100.0 [100.0 – 100.0] % |
| Gender | ||
| Male | 13 | 100.0 [100.0 – 100.0]% |
| Female | 18 | 100.0 [100.0 – 100.0] % |
| Age | ||
| 50 | 5 [55.6±3.9] | 100.0 [100.0 – 100.0]% |
| Body Mass Index | ||
| 25.0 | 12 [28.7 ± 2.4] | 100.0 [100.0 – 100.0] % |
| Ethnicity | ||
| Caucasian or White | 8 | 100.0 [100.0 – 100.0] % |
| African American or Black | 11 | 100.0 [100.0 – 100.0]% |
| Hispanic | 4 | 100.0 [100.0 - 100.0]% |
| Asian | 5 | 100.0 [100.0 – 100.0] % |
| Other | 3 | 100.0 [100.0 – 100.0] % |
| Spinal Curvature | ||
| 40° | 4 | 100.0 [100.0 - 100.0]% |
Clinical Performance Testing
Clinical performance testing was performed on the Testing Dataset by three different observers measuring scoliosis angle on the SpineUs™ system images and X-ray images of the same patients. The
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| Patient Subgroup | Number of Patients | Average error (mm, 95% CI) |
|---|---|---|
| All Patients | 31 | 2.81 (2.36, 3.25) |
| Sex | ||
| Male | 13 | 2.45 (1.99 - 2.92) |
| Female | 18 | 3.06 (2.35 - 3.76) |
| Age | ||
| 50 | 5 [55.6 ± 3.9] | 2.54 (1.83 - 3.24) |
| Body Mass Index | ||
| 25.0 | 12 [28.7 ± 2.4] | 2.55 (1.47 - 3.64) |
| Ethnicity | ||
| Caucasian or White | 8 | 2.59 (1.97 - 3.21) |
| African American or Black | 11 | 3.15 (2.11 - 4.20) |
| Hispanic | 4 | 2.50 (1.81 - 3.19) |
| Asian | 5 | 2.65 (1.80 - 3.49) |
| Other | 3 | 2.82 (1.58 - 4.07) |
| Spinal Curvature | ||
| 40° | 4 | 5.57 (3.52, 7.62) |
absolute value of the difference between the SpineUs™ system and X-ray-based measurements is shown in the table below for each patient subgroup.
F. Summary of Non-Clinical Performance Testing of the SpineUs™ system
The SpineUs™ system was designed and developed by Verdure Imaging, Inc. in accordance with the applicable requirements and standards to establish performance and safety of the device's safety and performance were verified by tests conducted by Verdure Imaging, Inc and accredited thirdparty laboratories. Validation testing was performed to ensure that the final product is capable of meeting the requirements for the specified clinical applications and performs as intended to meet users' needs, while demonstrating substantial equivalence to the predicate device.
Non-clinical performance testing of the SpineUs™ system demonstrate compliance to the following standards:
| Standard | Title of Standard |
|---|---|
| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility – Requirements and tests |
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| IEC 60601-2-37 | Medical electrical equipment – Part 2-37: Particular requirements for the
basic safety and essential performance of ultrasonic medical diagnostic and
monitoring equipment |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process |
| ISO 14971 | Medical Devices – Application of Risk Management to Medical Devices |
| NEMA PS 3.1 – 3.20 | Digital Imaging and Communications in Medicine (DICOM) Set |
Conclusion & Summary of Substantial Equivalence ੀ
Based on the information presented in this premarket notification, and based on the fundamental scientific technology, technological characteristics, intended use, environment of use, and indications for use, the SpineUs™ system has been determined to be substantially equivalent in terms of safety and effectiveness to the predicate device, the Logiq E10 (510(k)-cleared in K231966).
The differences in design between the subject device and the predicate device do not raise any issues related to safety or effectiveness.