(140 days)
The OrthoNext™ Platform System is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery and post-operative planning of orthopedic treatment. The device allows for overlaying of Orthofix Product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.
The subject OrthoNext™ Platform System is a web-based modular software system, indicated for assisting healthcare professionals in planning of orthopedic surgery and treatment both preoperatively and postoperatively, including deformity analysis and correction with several Orthofix products.
The subject software system is intended for use by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures, in the operating theatre only.
The subject software functions are intended to inform the HCP on orthopedic procedure treatment planning when the Orthofix external or internal fixation systems are used. These functions are evidence-based tools that support HCP when considering treatment digital planning options for a patient. The software functions do not treat a patient or determine a patient's treatment.
The software enables the HCP to import radiological images, display 2D views (frontal and lateral) of the radiological images, overlay the positioning of the template and simulate the treatment plan option, and to generate parameters and/or measurements to be verified or adjusted by the HCP based on their clinical judgment.
Here's a breakdown of the acceptance criteria and the study details for the OrthoNext Platform System, based on the provided document:
Acceptance Criteria and Device Performance
The OrthoNext Platform System was evaluated for measurement accuracy and an AI/ML algorithm's performance for automatic marker detection.
Table of Acceptance Criteria and Reported Device Performance
| Feature / Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measurement Accuracy | Overall accuracy verified under a representative worst-case scenario. | For measurements made using anatomical axes:- Mean error: 0.1 mm for linear measurements, 0.05 degrees for angular measurements.- Mean percentage error: 0.24% (threshold 0.27% within 95th percentile) for linear measurements, 0.08% (threshold 1% within 95th percentile) for angular measurements.For measurements made using mechanical axes:- Mean error: 0.4 mm for linear measurements, 0.06 degrees for angular measurements.- Mean percentage error: 1.73% (threshold 16.67% within 95th percentile) for linear measurements, 0.28% (threshold 1.27% within 95th percentile) for angular measurements. |
| Sensitivity of Measurements | Not explicitly stated as a separate acceptance criterion, but device performance reported. | 1 mm for linear measurements, 1 degree for angular measurements. |
| Specificity of Measurements | Not explicitly applicable as a direct acceptance criterion due to manual nature. | The device requires active user involvement for each measurement, relying on user expertise. |
| AI/ML Algorithm Accuracy | Not explicitly stated as an isolated acceptance criterion, but reported. | 0.8 |
| AI/ML Algorithm Specificity | Goal: zero false positives in the test set, resulting in a precision of 1. | 1 (Precision) |
| AI/ML Algorithm Sensitivity | Not explicitly stated as an isolated acceptance criterion, but reported. | 0.75 (TPR/Recall) |
| AI/ML Algorithm FPR | Not explicitly stated as an isolated acceptance criterion, but reported. | 0 |
| AI/ML Algorithm F1 Score | Not explicitly stated as an isolated acceptance criterion, but reported. | 0.86 |
| AI/ML Algorithm Intersection over Union (IoU) | Not explicitly stated as a direct acceptance criterion, but reported. | 79% |
| AI/ML Algorithm Center MAE | Not explicitly stated as a direct acceptance criterion, but reported. | 4.83 px |
| AI/ML Algorithm Center MAPE | Not explicitly stated as a direct acceptance criterion, but reported. | 0.38% |
| AI/ML Algorithm Radius MAE | Not explicitly stated as a direct acceptance criterion, but reported. | 1.29 px |
| AI/ML Algorithm Radius MAPE | Satisfying 3% Radius MAPE. | 3% Radius MAPE, contributing to an error of less than 1 mm. |
Study Details: Magnification Marker Detection Algorithm
The document focuses on the performance testing for the magnification marker detection algorithm, which is an AI/ML component of the OrthoNext Platform System.
-
Sample size used for the test set and the data provenance:
- Sample Size: 1000 X-ray images. Of these, 800 images depicted a magnification marker, and 200 images did not.
- Data Provenance: The test set consisted of real X-ray images. The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that these images were "not used during training, ensuring independence."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. The document mentions "qualified personnel" were used for the truthing process.
- Qualifications of Experts: "Qualified personnel" are mentioned, but specific qualifications (e.g., radiologist with X years of experience) are not provided.
-
Adjudication method for the test set:
- The document describes a "review and discard process" implemented to ensure the quality of the annotations, but it does not specify an adjudication method like "2+1" or "3+1". This suggests a quality control step for annotations rather than a formal consensus process among multiple readers for ground truth establishment.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done or reported in this document. The study evaluates the standalone performance of the AI/ML algorithm for magnification marker detection, not its impact on human reader performance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation of the AI/ML algorithm for magnification marker detection was explicitly done and reported. The performance metrics (Precision, Accuracy, TPR/Recall, FPR, F1 Score, IoU, MAE, MAPE) are all indicative of standalone algorithm performance.
-
The type of ground truth used:
- Expert Consensus (Annotation): The ground truth was established through a "truthing process... conducted by qualified personnel, who carefully overlaid a circular shape on each magnification marker using annotation software."
-
The sample size for the training set:
- Training Set Composition: 1500 X-ray images with random areas depicting magnification markers.
- These 1500 magnification markers were randomly overlaid on top of 4000 X-ray images.
- Image augmentation techniques (random rotations, brightness adjustments) generated 24,000 unique X-ray images for training.
-
How the ground truth for the training set was established:
- The training set involved synthetic images. Specifically, "1500 X-ray images with random areas depicting magnification markers" were created, and these markers were "randomly overlaid on top of 4000 X-ray images." Image augmentation was then applied. This suggests that the ground truth for the training set markers was generated as part of the synthetic image creation process (i.e., the location and characteristics of the overlaid markers were known by design). A "hash check" was used to ensure the uniqueness of these synthetic images.
{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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Orthofix Srl Elvira Taccarelli Regulatory Affairs Manager Via delle Nazioni, 9 Bussolengo, VR 37012 Italy
December 19, 2024
Re: K242270
Trade/Device Name: OrthoNext Platform System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: November 19, 2024 Received: November 19, 2024
Dear Elvira Taccarelli:
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.
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"
{1}------------------------------------------------
(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 (OS) 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.
For comprehensive regulatory information about medical devices and radiation-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
{2}------------------------------------------------
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 Assistant Director Imaging Software Team DHT8B: Division of Radiologic 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
510(k) Number (if known) K242270
Device Name OrthoNext™ Platform System
Indications for Use (Describe)
The OrthoNext™ Platform System is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery and post-operative planning of orthopedic treatment. The device allows for overlaying of Orthofix Product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. A registered trademark symbol is located to the upper right of the "X" in "ORTHOFIX".
ORTHONEXT™ PLATFORM SYSTEM
510(k) SUMMARY
Submitter information
| Company Name: | Orthofix S.r.l. |
|---|---|
| Address | Via Delle Nazioni, 937012 Bussolengo (VR) - Italy |
| Telephone | +39 045 6719000 |
| Fax | +39 045 6719380 |
| Contact Person | Elvira Taccarelli |
|---|---|
| Regulatory Affairs Manager | |
| Address | Via Delle Nazioni, 9 |
| 37012 Bussolengo (VR) - Italy | |
| Telephone | +39 045 6719000 |
| Fax | +39 045 6719380 |
| Email address | elvirataccarelli@orthofix.it |
| Date prepared | 2024, November 19th |
Trade Name, Common Name, Classification
| Trade Name: | OrthoNext™ Platform System |
|---|---|
| Classification Regulation Number: | 21 CFR 892.2050 |
| Regulation name: | Medical image management and processing system |
| Review Panel: | Radiology |
| Product Code: | QIH |
| Device Class: | Class II |
| Device Classification Name: | Automated radiological image processing software |
Primary Predicate
| Primary Predicate | 510(k) Number | Manufacturer |
|---|---|---|
| OrthoNextTM Platform System | K202519 | Orthofix S.r.l. |
Reference device
| Reference Device | 510(k) Number | Manufacturer |
|---|---|---|
| Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | K170650 | Orthofix S.r.l. |
ල Orthofix Srl | Via delle Nazioni, 9 | 37012 Bussolengo (VR) Italy 1 2 +39 045 6719380 @ orthofix.com
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
SEDE LEGAL: VA VITOR RIAN 16 LE. P. P. A89766050 CEE VI INMERT (1997600150 Meriston Meriston (1.E. M 127769 Cap.So. E.u. 1.560.00 in. ves.
SED SECONDAIL: VA DELLE MAZON, 9 37
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black capital letters. A registered trademark symbol is present to the right of the "X" in "ORTHOFIX".
| Device description | The subject OrthoNext™ Platform System is a web-based modular software system, indicated for assisting healthcare professionals in planning of orthopedic surgery and treatment both preoperatively and postoperatively, including deformity analysis and correction with several Orthofix products.The subject software system is intended for use by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures, in the operating theatre only.The subject software functions are intended to inform the HCP on orthopedic procedure treatment planning when the Orthofix external or internal fixation systems are used. These functions are evidence-based tools that support HCP when considering treatment digital planning options for a patient. The software functions do not treat a patient or determine a patient's treatment.The software enables the HCP to import radiological images, display 2D views (frontal and lateral) of the radiological images, overlay the positioning of the template and simulate the treatment plan option, and to generate parameters and/or measurements to be verified or adjusted by the HCP based on their clinical judgment. |
|---|---|
| Indications for use | The OrthoNext™ Platform System is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery and post-operative planning of orthopedic treatment. The device allows for overlaying of Orthofix Product templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgments and experience are required to properly use the software. |
| Comparison ofTechnologicalCharacteristics with thePredicate Device | The following table provides a comparison of technological characteristics of the subject and the primary predicate device. Any differences have been demonstrated to not raise different questions of safety and effectiveness by virtue of objective evidence. |
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue, curved shape on the left, followed by the word "ORTHOFIX" in black, bold letters. A small "®" symbol is located to the right of the "X" in "ORTHOFIX".
| Technological Characteristics | Subject DeviceOrthoNext™ Platform System | Primary Predicate DeviceOrthoNext™ Platform System(K202519) | |
|---|---|---|---|
| 1. | Indications for use | The OrthoNext™ Platform system isindicated for assisting healthcareprofessionals in preoperative planningof orthopedic surgery and post-operative planning of orthopedictreatment. The device allows foroverlaying of Orthofix Producttemplates on radiological images, andincludes tools for performingmeasurements on the image and forpositioning the template. Clinicaljudgments and experience arerequired to properly use the software. | The OrthoNext™ Platform system isindicated for assisting healthcareprofessionals in preoperativeplanning of orthopedic surgery. Thedevice allows for overlaying ofOrthofix Product templates onradiological images, and includestools for performing measurementson the image and for positioning thetemplate. Clinical judgments andexperience are required to properlyuse the software.The OrthoNext™ Platform system isnot to be used for mammography. |
| Assessment: The subject indications for use include "post-operative planning of orthopedic treatment", afeature already included in the scope of the reference device, without substantially changing the intendeduse of the device, which remains intended for assisting healthcare professionals in orthopedic procedure(surgery and treatment) planning. The difference in the type of treatment planning does not constitute anew intended use. The statement "The OrthoNext™ Platform system is not to be used for mammography"included in the original Indications for Use of the primary predicate device was not incorporated in theIndications for Use of the subject device because it was specifically addressed in a dedicated section of theInstructions for Use; as the primary predicate device, the subject device is not to be used formammography.Equivalent - no significant new questions have been raised. | |||
| 2. | Population to be treated | OrthoNext™ Platform System doesnot directly interact with patients.Software planning functionalities areapplicable to patients that need pre-operative orthopedic surgery planningorpost-operative orthopedictreatment planning. | OrthoNext™ Platform System doesnot directly interact with patients.Software planning functionalities areapplicable to patients that need pre-operative orthopedic surgeryplanning. |
| Assessment: in comparison to the predicate device, the subject patient population explicitly includespatients needing postoperative orthopedic treatment planning, as in the reference device. The populationthat undergoes postoperative treatment is the same (or a subgroup) of the population needingpreoperative planning, thus it can be considered already included in the patient population of the primarypredicate device.Equivalent - no significant new questions have been raised. | |||
| 3. | Principle of Operation | Principle of operation:• Importation medical images format(x-ray images)• Processing tools• Measurements and parametersanalysis tools• Surgical planning tools• Enable software modules(preoperative and postoperative) for | Principle of operation:• Importation medical images format(x-ray images)• Processing tools• Measurements and parametersanalysis tools• Surgical planning tools• Enable software modules(preoperative and postoperative) for |
| Assessment: The subject device has the same principle of operation of the primary predicate. Equivalent - no significant new questions have been raised. | |||
| 4. | Configuration and mode of access | Web-based: login is possible through access to a website by username and password licensed by the manufacturer.The device is not incorporated into IT-Networks. | Web-based: login is possible through access to a website by username and password licensed by the manufacturer.The device is not incorporated into IT-Networks. |
| Assessment: The configuration and mode of access of the subject device is the same as the predicate device.Equivalent - no significant new questions have been raised. | |||
| 5. | Supported devices | PC/Mac/Tablet | PC/Mac |
| Assessment: the main supported platforms are PC/Mac, as the primary predicate device. The subject device is also validated for use on a tablet: since the software is web-based, access is allowed via a login to the same web portal, independently from the platform used.Equivalent - no significant new questions have been raised. | |||
| 6. | Operating Systems | Windows (Microsoft) - Minimum Windows 10; macOS (Apple) - Minimum macOS Big Sur (version 11); iPad (Apple) - Minimum 15.8 | Windows (Microsoft) - Minimum Windows 10; macOS (Apple) - Minimum macOS Big Sur (version 11) |
| Assessment: the supported operating systems are the same (Windows, macOS) in comparison to the primary predicate. The subject device is also validated for use on a tablet, thus also a dedicated operating system is included.Equivalent - no significant new questions have been raised. | |||
| 7. | Supported browsers | Google Chrome v120 or higher (Windows) Microsoft Edge v121 or higher (Windows) Firefox v122 or higher (Windows) Safari 17.2 or higher (macOS) Mobile Safari 15.8 or higher (iPadOS) Web Graphics Library (WebGL) enabledNOTE: Web Graphics Library (WebGL) availability and minimum screen resolution are checked at login time in order to provide access to the SW. | Google Chrome Browser Version 83 or higher (Windows) Microsoft Edge Version 44 or higher (Windows) Mozilla Firefox Version 77 or higher (Windows) Safari Version 13 or higher (macOS) - Web Graphics Library (WebGL) enabledNOTE: Web Graphics Library (WebGL) availability and minimum screen resolution are checked at login time in order to provide access to the SW. |
| Assessment: The supported browsers are the same in comparison with the primary predicate, with updated versions. The subject device is also validated for use on a tablet, thus also a dedicated browser is included.Equivalent - no significant new questions have been raised. | |||
| 8. | System requirements | Computer System RequirementsDisplay Settings: Screen Resolution of1280 x 768 pixels or higher.Internet Connection:Minimum required internetconnectivity speed of 512 kbpsRecommended internet connectivityspeed of 3 mbps or higher | Computer System RequirementsDisplay Settings: Screen Resolution of1280 x 768 pixels or higher.Internet Connection:Minimum required internetconnectivity speed of 512 kbpsRecommended internet connectivityspeed of 3 mbps or higher |
| Assessment: The subject device system requirements are identical to the primary predicate device.Equivalent - no significant new questions have been raised. | |||
| 9. | Image input | Can receive digital images in .png or.jpg format | Can receive digital images in .png or.jpg format |
| Assessment: Subject device image input management is identical to the primary predicate device.Equivalent - no significant new questions have been raised. |
() Orthofix Srl | Via delle Nazioni, 9 | 37012 Bussolengo (VR) Italy ↑ 2 +39 045 6719380 ® orthofix.com
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
SEDE LEGAL: VA VITOR PIANI (E.) - P.NA 0897660150 CE VAT NUMER (1097660150 Registo Millio O9768001) R.E. M 125769 Cap. So. E.o. 1.56.000 in. ves.
SED E. SEDS SECNOMIA: VA DEL
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the Orthofix logo. The logo consists of a blue, stylized "O" shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. A registered trademark symbol is present to the upper right of the "X" in "ORTHOFIX".
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the Orthofix logo. The logo consists of a blue abstract shape on the left and the word "ORTHOFIX" in black, bold letters on the right. A registered trademark symbol is located to the right of the "X" in "ORTHOFIX".
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. A registered trademark symbol is located to the right of the word "ORTHOFIX".
| Performance Data | The following performance data were provided in support of substantial equivalence determination. |
|---|---|
| Accuracy, Sensitivity and SpecificityOrthoNext Platform System software provides users with a set of tools that allow for manual linear and angular measurements on X-ray images. The information derived from the software must be clinically reviewed regarding its plausibility before use in treating patients. | |
| Accuracy : the overall accuracy of the system's measurements was verified under a representative worst-case scenario. The following acceptance criteria have been met.For measurements made using anatomical axes:The mean error is 0.1 mm for linear measurements and 0.05 degrees for angular measurements.The mean percentage error is 0.24% with a threshold of 0.27% (within the 95th percentile) for linear measurements and 0.08% with a threshold of 1% (within the 95th percentile) for angular measurements.For measurements made using mechanical axes:The mean error is 0.4 mm for linear measurements and 0.06 degrees for angular measurements.The mean percentage error is 1.73% with a threshold of 16.67% (within the 95th percentile) for linear measurements and 0.28% with a threshold of 1.27% (within the 95th percentile) for angular measurements. | |
| Sensitivity : the sensitivity of the subject device is 1 mm for linear measurements and 1 degree for angular measurements. | |
| Specificity : since the device does not perform automated measurements, specificity is not directly applicable in this context. The subject device requires active user involvement for each measurement, and the ability to perform accurate measurements relies entirely on the user's expertise and clinical interpretation. | |
| In addition, considerations on accuracy, specificity and sensitivity of the AI/ML algorithm for the automatic marker detection have been included in the submission:AI/ML Algorithm Accuracy: 0.8AI/ML Algorithm Specificity (Precision): 1AI/ML Algorithm Sensitivity (TPR): 0.75 | |
| Validation of Machine Learning derived outputsPerformance testing for the magnification marker detection algorithm was conducted using 1000 X-ray images (see table below). | |
| Acceptance Criteria : The goal was to achieve zero false positives in the test set of 1000 X-ray images, resulting in a precision of 1. | |
| Training Set Composition : The training set included 1500 X-ray images with random areas depicting magnification markers. The 1500 magnification marker have been randomly overlaid on top of 4000 x-Ray images. Image augmentation techniques, such as random rotations and brightness adjustments, generated 24000 unique X-ray images.Each synthetic image is unique, validated by a hash check, where if the hash of two images shows a similarity > 90%, the image is discarded. |
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the text "Page 7 of 9". This text likely indicates the page number within a document. The document has at least 9 pages, and this image represents the seventh page.
Image /page/10/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. A registered trademark symbol is located to the right of the word "ORTHOFIX".
Testing and Training Independence: The model was trained using synthetic images, while the test set consisted of real X-ray images that were not used during training, ensuring independence.
Equipment and Protocols: A study on the distribution of magnification marker intensities produced the following results (0 = black; 255 = white).
| N° of Samples | Mean value [0-255] | Median Value [0-255] |
|---|---|---|
| 24000 | 190 | 193 |
Clinical Subgroups Information: The focus of this model is solely on the magnification marker; therefore, a statistical analysis and distribution of characteristics such as age, sex, gender, and ethnicity are not applicable. Below is the data regarding the geometrical properties of the magnification marker for both the training and test sets.
Training Set, Sample size = 24000.
| Statistic | Value |
|---|---|
| Mean Diameter [px] | 70 |
| Median Diameter [px] | 71 |
| Mean Area [px2] | 4105 |
| Median Area [px2] | 3959 |
| Mean Brightness | 190 |
| Median Brightness | 193 |
Test Set, Sample size = 800; 200 images of the Test set didn't depict a magnification marker
| Statistic | Value |
|---|---|
| Mean Diameter [px] | 40.37 |
| Median Diameter [px] | 42.23 |
| Diameter Std. Deviation [px] | 11.16 |
| Mean Area [px²] | 1377.48 |
| Median Area [px²] | 1400.69 |
| Area Std. Deviation [px²] | 692.44 |
| Mean Brightness | 192 |
| Median Brightness | 194 |
Performance Testing Summary:
| Candidate Model - Threshold Value = 0.96 | |
|---|---|
| Precision | 1 |
| Accuracy | 0.8 |
| TPR/Recall | 0.75 |
| FPR | 0 |
| F1 Score | 0.86 |
(1) Orthofix Srl | Via delle Nazioni, 9 | 37012 Bussolengo (VR) Italy 12 +39 045 6719380 @ orthofix.com
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
SEDE LEGALE: VA VITOR PSANI 16 2012 MILANO ITALIA C.F. P. IN NUMBERTO99660150 Registo Inprese di Miano 0997660050 I R.E.A.M 125769 Cap. Eu. 1.560.00 in. ves SEDE SECONDARIA: VIA DELLE NAZIONI, 9137012 BUSSOLENGO (VERONA) | ITALIA | Registro Imprese di Verona | R.E.A. VR 215209
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. A small registered trademark symbol is located to the right of the "X" in "ORTHOFIX".
The candidate model produced the following statistics when evaluated on the ground truth values of the Test Set:
| Intersection | Center MAE | Center MAPE | Radius MAE | Radius MAPE |
|---|---|---|---|---|
| over Union (%) | (px) | (%) | (px) | (%) |
| 79 | 4.83 | 0.38 | 1.29 | 3 |
The 3% Radius MAPE (Mean Absolute Percentage Error), when evaluated on the mean value and mean ± 1 standard deviation of the test set distribution, contributes to an error of less than 1 mm.
Ground Truth Annotation Process: The truthing process was conducted by qualified personnel, who carefully overlaid a circular shape on each magnification marker using annotation software. A review and discard process has been implemented to ensure the quality of the annotations.
Software Verification and Validation Testing
Software verification and validation testing of the subject device OrthoNext™ Platform System have been performed as outlined below to demonstrate equivalence in function and safety in respect to its primary predicate device (K202519).
The subject device was developed following the requirements of international standard ANSI AAMI IEC 62304:2006 + A1:2016 "Medical device software — Software life cycle processes", as the primary predicate device.
During the development of the subject device, the manufacturer performed software verification testing according to the relevant FDA Guidances "Content of Premarket Submissions for Device Software Functions", issued on June 14, 2023, and "General Principles of Software Validation", issued in January 2002, to ensure that the software design output meets input of the subject OrthoNext™ Platform System and mitigates the associated risks in the scope of its intended use.
A link between software Product Requirements (Customer requirements), Software Requirements Specifications (SRS), identified hazard and mitigations, and Software verification and validations testing is provided for the subject device within the Traceability Matrix of OrthoNext™ Platform System, as evidence of the correct and complete implementation of the Software Requirements Specifications (SRS) and Product Requirements.
Design validation activities for the subject OrthoNext™ Platform System were performed in accordance with the Design Validation Plan and Design Validation Protocol, to establish that the software specifications conform to user needs and intended use, confirming proper operation of the software in its actual or simulated use environment.
Validation activities consisted of two different validation scenarios: the software validation during the software testing activities and the "surgeons validation" to confirm the fulfillment of the product to investigate use errors during simulated use, according to standard IEC 62366-1 "Medical devices- Application of usability engineering to medical devices".
For software validation, each product requirement was related to the relevant Software Requirements Specifications (SRS) / User story, to verify if users performed each task. Based on the results presented, all the requirements defined as eligible for user design validation have been satisfactorily tested.
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
SOE EGALE: VA VITOR PSAN1 6 / 2012 MILANO ITALA C.F. P. P. NAMBR IT097660150 Registo Inpress di Mino 0997660150 R.E.A.M 125769 Cap. E.c. . . 560.00 in. ves SEDE SECONDARIA: VIA DELLE NAZIONI, 9 | 37012 BUSSOLENGO (VERONA) | ITALIA | Registro Imprese di Verona | R.E.A. VR 215209
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue circular shape on the left, followed by the word "ORTHOFIX" in black, bold letters. The "®" symbol is located to the right of the word "ORTHOFIX".
| Software usability activities have been conducted at the same time, asking surgeonsto perform some specified tasks, answer to some questions in written form, navigatethrough the software and inviting them to describe ease of use or concerns regardingtasks they are invited to perform. Feedback has been collected in written formtogether with the answers rating and was analyzed in the Summative Usability Report.Given the overall analysis, Orthofix concluded that the design verification andvalidation results are acceptable, and that the usability test gave objective evidencethat the device usability requirements are met as far as safety of the user interface ofthe subject OrthoNext™ Platform System is concerned. | |
|---|---|
| Conclusions | Based upon: intended use, conditions of use, patient population, basic softwaredesign, operating principle, and non-clinical performance data, the subjectOrthoNext™ Platform System has been shown to be substantially equivalent to thelegally marketed primary predicate device (K202519). |
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
§ 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).