ScanDiags Ortho L-Spine MR-Q

K242607 · Scandiags AG · QIH · Feb 21, 2025 · Radiology

Device Facts

• Record ID: K242607
• Device Name: ScanDiags Ortho L-Spine MR-Q
• Applicant: Scandiags AG
• Product Code: QIH · Radiology
• Decision Date: Feb 21, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

ScanDiags Ortho L-Spine MR-Q software is an image-processing and measurement software tool that provides quantitative 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, and documenting area and distance measurements of relevant anatomical structures (vertebral body, intervertebral disc, neuroforamina, thecal sac) of the lumbar spine: Feature Segmentation; Feature measurement; and Export of measurement results to a PDF report containing measurement results and overlay images for user's review, revise and approval. ScanDiags Ortho L-Spine MR-Q software does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to more easily identify and classify features in lumbar MR images and compile a report. The user is responsible for reviewing and verifying the software-generated 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 22 and above are considered to be valid input. ScanDiags Ortho L-Spine MR-Q software does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, have post-operational complications or infections.

Device Story

Software-as-a-medical-device (SaMD) for lumbar spine MRI analysis; inputs previously acquired DICOM images. Uses deep convolutional neural networks (DCNN) and regression-based machine learning for semi-automatic segmentation of vertebral bodies, intervertebral discs, neuroforamina, and thecal sacs. Calculates area and distance measurements (heights, diameters). Operates in hospitals/medical institutions; used by clinicians. Provides a viewing application for user review, manual correction, and approval of measurements. Outputs a PDF report containing quantitative data and overlay images to the clinician's PACS. Automates manual tracing tasks to save time; does not provide diagnosis or treatment recommendations. Radiologist retains final responsibility for clinical interpretation.

Clinical Evidence

Retrospective multicenter study (n=100) using MRI from GE, Siemens, and Philips. Ground truth established by three board-certified MSK radiologists via pixel-based majority opinion and averaged measurements. Primary endpoints: ICC (0.74-0.95), Dice Similarity Coefficient (0.86-0.95), and Mean Absolute Error (0.79-1.26 mm). Subgroup analyses performed for age, sex, ethnicity, weight, and manufacturer. Bench testing confirmed software verification and validation.

Technological Characteristics

SaMD; DCNN and regression-based machine learning architecture. Inputs: DICOM MRI. Outputs: PDF report with measurements and overlays. Connectivity: PACS integration. Cybersecurity: HIPAA compliant, DICOM-TLS/SSL encryption, vulnerability/penetration testing performed. No hardware components.

Indications for Use

Indicated for adult patients (≥ 22 years) undergoing lumbar spine MRI. Used for visualization and quantitative measurement of vertebral bodies, intervertebral discs, neuroforamina, and thecal sacs. Contraindicated for pregnant patients, patients undergoing MRI with contrast media, or patients with post-operational complications or infections.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• CoLumbo (K220497)

Submission Summary (Full Text)

{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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

ScanDiags AG Stefan Voser COO, Product Manager Zwicky-Platz 1 Wallisellen, 8304 Switzerland

February 21, 2025

Re: K242607

Trade/Device Name: ScanDiags Ortho L-Spine MR-O Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: January 21, 2025 Received: January 21, 2025

Dear Stefan Voser:

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 Rue"). 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 ([e-mail]) or phone [phone] 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

{3}------------------------------------------------

#### Indications for Use

Submission Number (if known)

K242607

Device Name

ScanDiags Ortho L-Spine MR-Q

#### Indications for Use (Describe)

ScanDiags Ortho L-Spine MR-Q software is an image-processing and measurement software tool that provides quantitative 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, and documenting area and distance measurements of relevant anatomical structures (vertebral body, intervertebral disc, neuroforamina, thecal sac) of the lumbar spine:

Feature Segmentation;

Feature measurement; and

Export of measurement results to a PDF report containing measurement results and overlay images for user's review, revise and approval.

ScanDiags Ortho L-Spine MR-Q software does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to more easily identify and classify features in lumbar MR images and compile a report. The user is responsible for reviewing and verifying the software-generated 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 22 and above are considered to be valid input. ScanDiags Ortho L-Spine MR-Q software does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, have post-operational complications or infections.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

r-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for ScanDiags, a company that specializes in AI interpreting orthopaedic MRI. The logo consists of a blue square with a smaller square inside, followed by the company name in large, bold, blue letters. Below the logo, in smaller gray letters, is the text "ScanDiags AG Page 1 of 7".

# K242607

# 1. Submitter

ScanDiags AG

Switzerland

Zwicky-Platz 1

Wallisellen, 8304

Contact Person:

Stefan Voser

[e-mail]

[phone]

Date Prepared: January 21, 2025

# 2. Device Identification

#### 2.1 Device

| Trade Name | ScanDiags Ortho L-Spine MR-Q |
|---------------------|--------------------------------------------------|
| Common Name | Ortho L-Spine MR-Q |
| Classification Name | Automated Radiological Image Processing Software |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | QIH |
| Regulatory Class | Class II |

#### 2.2 Predicate Device

| Trade Name | CoLumbo |
|-------------------------|------------------------------------------------|
| 510(k) Submitter/Holder | Smart Soft Healthcare AD |
| 510(k) Number | K220497 |
| Classification Name | Medical image management and processing system |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | QIH |

{5}------------------------------------------------

# 3. Device Description

ScanDiags Ortho L-Spine MR-Q software is a software as a medical device (SaMD) intended for visualization, and quantification of lumbar spine anatomical structures including vertebral bodies, intervertebral discs, neuroforamina, thecal sacs from a set of standard lumbar spine MRI images in DICOM (Digital Imaging and Communications in Medicine) format. The semi-automatic segmentation of these structures forms the bases for the distance and area measurement outputs. The software has features for log-in, viewing, revising, and saving measurement results in addition to generating PDF reports. The PDF report includes images, measurements.

ScanDiags Ortho L-Spine MR-Q software includes a viewing application (ScanDiags DICOM Viewer) to visualize, review, and apply corrections to the measurement results shown as overlay on the original lumbar spine MRI images. Pre-existing MR images of the lumber spine are uploaded into the software for analysis. The semi-automatic segmentations are based on deep convolutional neural networks (DCNN) which are developed by applying well-established supervised deep learning methods on unstructured MRI scans (DICOM image format). ScanDiags Ortho L-Spine MR-Q combines deep learning, image analysis, as well as regression-based machine methods. The segmentations and distance measurements are user modifiable. Results are reviewed and approved by the radiologist's user before a PDF report is generated. Once approved, the result PDF report is sent to the clinician's PACS system. The PACS system stores the PDF report within the corresponding patient MRI study.

ScanDiags Ortho L-Spine MR-Q does not interface directly with any MR or data collection equipment; instead, the software uploads data files previously generated by such equipment. Its functionality is independent of the vendor type of the acquisition equipment. The analysis results are available on the ScanDiags DICOM Viewer screen and can be edited, saved, and approved. The approved measurement results are sent back to the PACS system as a Measurement Result PDF Report. The software does not perform any functions that could not be accomplished by a trained user with manual tracing methods; the purpose of the software is to save time and automate the tedious manual task of segmentation and distance measurement.

ScanDiags Ortho L-Spine MR-Q software is an adjunct tool and is not intended to replace a radiologist's review of the MRI study, nor is it intended to replace his or her clinical judgment, and it does not detect, diagnose or identify any abnormalities. Radiologists must not use the generated output as a primary interpretation.

# 4. Indications for Use

ScanDiags Ortho L-Spine MR-Q software is an image-processing and measurement software tool that provides quantitative 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, and documenting area and distance measurements of relevant anatomical structures (vertebral body, intervertebral disc, neuroforamina, thecal sac) of the lumbar spine:

- . Feature segmentation:
- . Feature measurement; and
- Export of measurement results to a PDF report containing measurement results and overlay ● images for user's review, revise and approval.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for ScanDiags, a company that specializes in AI interpreting orthopaedic MRI. The logo consists of a blue square made up of smaller squares, followed by the company name in blue, bold letters. Below the logo, it says "AI INTERPRETING ORTHOPAEDIC MRI" in smaller, gray letters. At the bottom right of the image, it says "ScanDiags AG Page 3 of 7" in gray letters.

ScanDiags Ortho L-Spine MR-Q software does not produce or recommend any type of medical diagnosis or treatment. Instead, it simply helps users to more easily identify and classify features in lumbar MR images and compile a report. The user is responsible for reviewing and verifying the software-generated 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 22 and above are considered to be valid input. ScanDiags Ortho L-Spine MR-Q software does not support DICOM images of patients that are pregnant, undergo MRI scan with contrast media, have post-operational complications or infections.

# 5. Summary of technological characteristics

The following table compares the key technological feature of the subject device (ScanDiags Ortho L-Spine MR-Q) to the predicate device (CoLumbo, K220497).

| | Subject Device:<br>ScanDiags Ortho L-Spine MR-Q | Predicate Device:<br>CoLumbo |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | TBD | K220497 |
| Applicant | ScanDiags AG | Smart Soft Healthcare AD |
| Device Name | ScanDiags Ortho L-Spine MR-Q | CoLumbo |
| Regulation<br>Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Product Code | QIH | QIH |
| Class | II | II |
| Image Modality | Radiological images: MRI<br>(Standardized images used as input) | Radiological images: MRI<br>(Standardized images used as input) |
| Study Type<br>(anatomical area<br>of interest) | Lumbar spine | Lumbar spine |
| Segmentation<br>and quantitative<br>analysis | Lumbar spine vertebral body area Lumbar spine intervertebral disc area Foraminal area segmentation Spinal canal area For all segmented areas the area in mm2<br>is calculated | Vertebral body area Intervertebral disc area Foraminal stenosis clearance size Dural sac area and stenotic ratio |
| Measurements | Vertebral body heights (anterior, middle, posterior) Vertebral body derived measurements: Height ratios | Vertebral body height (anterior, middle, posterior) Disc height (anterior, middle, posterior) Spinal canal anteroposterior diameter |
| | Angle Biconcave height losses Intervertebral disc heights<br>(anterior, middle, posterior) Spinal canal anteroposterior and mediolateral diameters | |
| Provided output | Report:<br>A Measurement Result PDF-report sent back to the PACS, which is reviewed, revised and approved by radiologist and contains cropped versions of the original MRI images, with an overlay on top of the cropped images to highlight the segmented anatomic structures and applied measurements and tables displaying quantitative data of the anatomic areas of interest. | Report:<br>Export of measurement results to a written report for user's review, revise and approval. |
| Human<br>Intervention for<br>Interpretation | Required | Required |
| Privacy | The ScanDiags Ortho L-Spine MR-Q Software is HIPAA Compliant by preventing unauthorized access (only authenticated and authorized users can access DICOM data and preliminary Measurement Results in built-in ScanDiags DICOM Viewer), encrypting data in transfer (both DICOM-TLS, SSL certificates in use). The DICOM data transferred to and processed by ScanDiags Ortho L-Spine MR-Q Software only temporarily stores the data until it is either approved or rejected by the intended user. The vulnerability assessment and penetration testing demonstrates satisfactory security performance. | Smart Soft Healthcare 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. The vulnerability assessment and penetration testing demonstrates satisfactory security performance. |
| SaMD | Yes | Yes |
| Supported<br>Modality | MR | MR |
| Patient<br>Population | Adult ≥ 22 years of age | Patients aged ≥ 18 are considered to be valid input. |
| Intended User | Clinicians | Clinicians |
| Machine<br>Learning<br>Methodology | Supervised Deep Convolutional Neural Network (DCNN), both for classification (image-to-class) to and segmentation (image-to-image) model architectures | Deep Convolutional Image-to-Image Neural Network |
| Performance<br>Testing | Machine Learning validation study<br>(standalone performance assessment):<br>100 individual patient MRI studies<br>of different age, gender, racial<br>groups, collected from two<br>hospital groups, one in Missouri<br>(18 patients served by a rural<br>hospital group) and one in North<br>Carolina (82 patients served by<br>urban and rural hospital groups). Ground truth annotated by 3 US<br>board certified MSK radiologist.<br>Consent ground truth for anatomic<br>structure segmentation<br>determined by pixel-based<br>majority opinion between the<br>three radiologists. Consent<br>ground truth for area and distance<br>measurements determined by<br>averaging the measurements of<br>all three readers. The 100 studies were acquired<br>from GE, Siemens Healthineers<br>and Philips systems: Siemens: 42 GE: 40 Philips: 18 | Performance data based standalone<br>software performance assessment study<br>conducted in the U.S.:<br>101 MRI image studies for 101<br>patients of different ages and racial<br>groups, collected from seven sites<br>across the U.S. Ground truth defined by 3<br>radiologists on segmentations and<br>measurements (per-pixel majority<br>opinion of the three radiologists<br>established the ground truth for the<br>segmented tissue) The 101 study images were<br>acquired on MRI imaging systems<br>made by five manufacturers<br>(Toshiba 1.5T/3T: 65, Siemens<br>1.5T: 17, Philips 1.5T: 1, Hitachi<br>1.5T: 1, GE 1.5T: 17) |

{7}------------------------------------------------

{8}------------------------------------------------

Both subject and predicate devices have similar technological characteristics and principles of operation. Any differences do not raise new concerns of safety and efficacy.

# 6. Performance Data Substantial Equivalent Discussion

The subject device was developed and tested in accordance with ScanDiags' Design Control processes and has been subjected to extensive safety and performance testing. Verification and validation testing was conducted to demonstrate the substantial equivalence of the subject device to the predicate. The primary success criterion was that the subject device would produce segmentations within acceptable measurement range as well as Dice score above a set threshold compared to the consensus annotation of three radiologists.

Extensive algorithm development and software verification testing, assessed the performance characteristics of the algorithm, including accuracy and overall functional performance. Images and cases used for verification and validation testing were separate and carefully segregated from training datasets. Non-clinical verification and validation test results established that the device meets its design requirements and intended use.

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for ScanDiags, a company that specializes in AI interpreting orthopaedic MRI. The logo consists of a blue square with a smaller blue square inside, followed by the word "SCANDIAGS" in large, bold, blue letters. Below the logo, the text "AI INTERPRETING ORTHOPAEDIC MRI" is written in a smaller font. The text "ScanDiags AG Page 6 of 7" is located on the bottom right of the image.

# 7. Machine Learning Performance Evaluation Summary

A retrospective, multicenter study was designed to evaluate the capability of the machine learning model in calculating the quantified values. A variety of imaging equipment manufacturers included Philips, GE and Siemens were used for the input data.

### 7.1 Intraclass Correlation Coefficient (ICC)

The device successfully passed the primary ICC acceptance criteria across all structures.

| Mean intraclass correlation coefficient (ICC) of measurements (heights, diameters and areas) for<br>lumbar vertebrae, discs, neuroforamina and the thecal sac. | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------|
| Body Region | Measurement | ICC [95% CI] |
| Vertebra | Area | 0.95 [0.94 - 0.96] |
| | Anterior Height | 0.85 [0.30 - 0.94] |
| | Middle Height | 0.91 [0.63 - 0.96] |
| | Posterior Height | 0.89 [0.87 - 0.91] |
| Neuroforamen | Area | 0.90 [0.86 - 0.93] |
| Intervertebral Disc | Area | 0.92 [0.87 - 0.94] |
| | Anterior Height | 0.78 [0.73 - 0.82] |
| | Middle Height | 0.85 [0.18 - 0.95] |
| | Posterior Height | 0.74 [0.68 - 0.78] |
| Thecal Sac | Area | 0.94 [0.91 - 0.96] |
| | Anteroposterior Diameter | 0.92 [0.90 - 0.94] |
| | Mediolateral Diameter | 0.86 [0.83 - 0.88] |

### 7.2 Dice Similarity Coefficient (DSC)

The device successfully passes the secondary DICE acceptance criteria across all structures.

| Table 8: Mean DICE scores for lumbar vertebrae, discs, neuroforamina and the thecal sac. | Measurement |
|------------------------------------------------------------------------------------------|--------------------|
| | DICE [95% CI] |
| Vertebra | 0.95 [0.95 - 0.96] |
| Neuroforamen | 0.86 [0.85 - 0.86] |
| Intervertebral Disc | 0.89 [0.89 - 0.90] |
| Thecal Sac | 0.89 [0.89 - 0.90] |

### 7.3 Mean Absolute Error (MAE)

The device successfully passes the co-secondary MAE acceptance criteria across all structures.

| Table 9: Mean absolute error (MAE) of measurements (heights, diameters and areas) for lumbar vertebrae, discs, neuroforamina and the thecal sac. | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------|
| Body Region | Measurement | MAE |
| Vertebra | Anterior Height [mm] | 1.17 |

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the logo for ScanDiags, a company that specializes in AI interpreting orthopaedic MRI. The logo features a blue square design followed by the company name in bold, blue letters. Below the logo, it says "ScanDiags AG Page 7 of 7" in a smaller, grey font.

| | Middle Height [mm] | 0.86 |
|---------------------|-------------------------------|------|
| | Posterior Height [mm] | 0.79 |
| Intervertebral Disc | Anterior Height [mm] | 1.1 |
| | Middle Height [mm] | 1.19 |
| | Posterior Height [mm] | 0.96 |
| Thecal Sac | Anteroposterior Diameter [mm] | 0.81 |
| | Mediolateral Diameter [mm] | 1.26 |

Bland Altman as well as subgroup analysis based on age, sex, ethnicity, body weight, and MRI manufacturer, MR imaging parameters, underlying disease conditions, and clinical sites were also conducted with detailed results reported in the labeling.

# 8. Conclusions

Performance testing demonstrated that the subject device is substantially equivalent to the predicate device. The device has the same intended use, and similar indications for use, principles of operation and technological characteristics as the predicate device. The differences do not raise new concerns of safety and effectiveness, therefore the subject device is considered substantially equivalent to the predicate device.