(56 days)
The OrthoNext ™ Platform system is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. 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 OrthoNext ™ Platform system is not to be used for mammography.
The OrthoNextTM Platform is a web-based platform module system, to allow surgeons to evaluate digital images while performing various pre-operative treatment planning, evaluation of images and post-operative treatment planning. This software application enables surgeons to import radiological images, display various 2D views of the images, overlays the positioning of the Orthofix devices template and simulate the treatment options, generate parameters and/or measurements to be verified or adjusted by the surgeons based on their clinical judgment.
The provided document is a 510(k) summary for the OrthoNext™ Platform System. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with specific acceptance criteria and detailed performance metrics as would be found in a PMA or de novo submission.
Based on the document, here's what can be extracted and what is not explicitly provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. Instead, it relies on demonstrating equivalence to the predicate device and successful non-clinical testing. The "Performance Analysis" section states: "Subject device has similar configuration, and operating principle as the predicate device. Non-clinical software testing on operative treatment planning of orthopedic surgery using OrthoNext ™ Platform system produces results comparable to planning using acetate overlays but with the additional advantages of digital planning and simulations including ease of use, library, case documentation, access to a wider arrange of tools, and secure accessibility."
The "Conclusion" section indirectly describes the "performance" by stating that "The successful non-clinical testing demonstrates the safety and effectiveness of the OrthoNext ™ Platform system when used for the defined indications for use and demonstrates that the subject device, for which this Traditional 510(k) is submitted, performs as well as or better than the legally marketed predicate devices."
The types of testing performed are listed: "Unit, System/Integration and Acceptance test levels. Testing included also security, negative testing, error message handling, stress testing, platform testing, workflow testing, functional testing, multi-user/external access testing, data integrity testing, compatibility testing, load testing, regression testing, and hazard mitigation testing." However, specific acceptance criteria for each of these tests are not provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing focuses on non-clinical software testing: "Non-clinical software testing on operative treatment planning of orthopedic surgery using OrthoNext ™ Platform system produces results comparable to planning using acetate overlays..." The nature of this "testing" doesn't seem to involve a "test set" of patient data in the typical sense of a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The document mentions that the device is "indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery" and that "Clinical judgments and experience are required to properly use the software." However, it does not detail any expert review process for a test set or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
5. 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
An MRMC comparative effectiveness study was not performed or at least not reported in this 510(k) summary. The document states: "The review of clinical literatures on similar devices support the clinical performance of the Subject device with no additional clinical data." This indicates that no new clinical study (like an MRMC) was conducted for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of the algorithm alone (without human-in-the-loop) was not explicitly described with specific performance metrics. The nature of the device, which "assists healthcare professionals" and requires "clinical judgments and experience," implies a human-in-the-loop interaction as its primary mode of use. The software testing mentioned is "non-clinical software testing," which would assess the software's functionality and accuracy in performing its intended tasks (e.g., measurements, template overlay) rather than a diagnostic standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical software testing, the document suggests the "ground truth" or reference for comparison was "planning using acetate overlays." This implies that the accuracy of the software's measurements and template positioning was compared against established practices using physical overlays. No mention of expert consensus, pathology, or outcomes data for establishing ground truth is made for the device's performance evaluation in this document.
8. The sample size for the training set
This information is not provided. The document describes "non-clinical software testing," and given the nature of the device (a planning and measurement tool, not an AI for diagnosis), a "training set" in the context of machine learning model development is most likely not applicable or not disclosed. The device performs functions like overlaying templates and performing measurements, which are rule-based software operations rather than typically requiring a "training set" in the AI sense.
9. How the ground truth for the training set was established
As a training set is likely not applicable or not disclosed, the method for establishing its ground truth is also not provided.
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October 27, 2020
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Orthofix Srl % Ms. Cheryl Wagoner Consultant Wagoner Consulting LLC P O Box 15729 WILMINGTON NC 28408
Re: K202519
Trade/Device Name: OrthoNext™ Platform System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 25, 2020 Received: September 1, 2020
Dear Ms. Wagoner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202519
Device Name OrthoNext TM Platform system
Indications for Use (Describe)
The OrthoNext ™ Platform system is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. 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 OrthoNext ™ Platform system is not to be used for mammography.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape above the word "ORTHOFIX" in black, with a registered trademark symbol next to it. The abstract shape is a curved, geometric design.
510(k) Summary (21 CFR 807.92) K202519 Submitter information Submitter Name Orthofix Srl Via delle Nazioni, 9 | 37012 Bussolengo (VR) - Italy Address Telephone + 39 045 6719.000 Fax + 39 045 6719.380
| Contact Person | Gianluca RicadonaSr. Quality & Regulatory Affairs Manager |
|---|---|
| Address | Via delle Nazioni, 937012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719 000 |
| Fax | + 39 045 6719 380 |
| Email address | GianlucaRicadona@orthofix.it |
| Date of submission | October 22, 2020 |
Trade Name, Common Name, Classification
| Trade Name | OrthoNext ™ Platform system |
|---|---|
| Device Classification name | Image Processing System Radiological |
| Product code | LLZ |
| Panel Code | Radiology |
| Class | Class II |
| Classification Regulation Number | 21 CFR § 892.2050 |
Predicate devices
| Primary Predicate Device | 510(k) Number | Manufacturer |
|---|---|---|
| TraumaCad Mobile 1.0 | K142923 | ORTHOCRAT,LTD.291Hillside AvenueSomerset, MA 02726 |
| Additional Predicate Device | ||
| TraumaCAD Version 2.0 | K073714 | ORTHOCRAT,LTD.291Hillside AvenueSomerset, MA 02726 |
| Device description | The OrthoNextTM Platform is a web-based platform module system, toallow surgeons to evaluate digital images while performing various pre-operative treatment planning, evaluation of images and post-operativetreatment planning.This software application enables surgeons to import radiologicalimages, display various 2D views of the images, overlays thepositioning of the Orthofix devices template and simulate the treatmentoptions, generate parameters and/or measurements to be verified oradjusted by the surgeons based on their clinical judgment. |
|---|---|
| Indications for use | The OrthoNextTM Platform system is indicated for assisting healthcareprofessionals in preoperative planning of orthopedic surgery. Thedevice allows for overlaying of Orthofix Product templates onradiological images, and includes tools for performing measurementson the image and for positioning the template. Clinical judgments andexperience are required to properly use the software.The OrthoNextTM Platform system is not to be used for mammography. |
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| TechnologicalCharacteristics andIntended Use | The OrthoNext™ Platform operating principles and technological characteristic, including the intended use and users are the same as, or similar to, the chosen predicate devices.Summary of the equivalence in technological characteristics and Intended Use:✓ Intended use: identical.✓ Operating principles, technological characteristics and conditions of use are substantially equivalent to predicates:the OrthoNext ™ Platform system is a web-based software executed on a common web browser (Chrome, Internet Explorer, Safari), intended to run on a PC, MAC by Windows and Mac OS package , accessible in a secure environment by a license activation code and password provided by the manufacturer.Principle of operation includes:• Importation medical images format (x-ray images)• Processing tools• Measurements and parameters analysis tools• Surgical planning tools• Enable SW Modules (operative treatment planning) for overlaying template for simulation. | |
|---|---|---|
| PerformanceAnalysis | Subject device has similar configuration, and operating principle as the predicate device. Non-clinical software testing on operative treatment planning of orthopedic surgery using OrthoNext ™ Platform system produces results comparable to planning using acetate overlays but with the additional advantages of digital planning and simulations including ease of use, library, case documentation, access to a wider arrange of tools, and secure accessibility. Any potential hazards have been evaluated and controlled through Risk Management activities.The review of clinical literatures on similar devices support the clinical performance of the Subject device with no additional clinical data. Usability testing have been performed by simulating a clinical environment requiring the test participants to perform treatment |
Basis for Substantial Equivalence
| SUBJECT DEVICE | PRIMARYPREDICATE DEVICE | |
|---|---|---|
| SystemFeatures | OrthoNext ™ Platform | TraumaCad Mobile 1.0 |
| Product Code | LLZ | Identical |
| Indications for Use | The OrthoNext ™ Platform system isindicated for assisting healthcareprofessionals in preoperative planning oforthopedic surgery. The device allows foroverlaying of Orthofix Product templateson radiological images, and includes toolsfor performing measurements on theimage and for positioning the template.Clinical judgments and experience arerequired to properly use the software. TheOrthoNext ™ Platform system is not to beused for mammography | Identical |
| Intended Enviroment | Hospital | Identical |
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| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | |
|---|---|---|
| Specialties Sites | Easy-to-use solutions for various orthopedic subspecialties for skeletal appendicular trauma and deformity analysis | Identical |
| Configuration | Web- based | Identical |
| Image Input | Can receive digital images | Identical |
| Run on server | YES | Identical |
| Digital Device Template | YES | Identical |
| Interactive Template positioning | YES | Identical |
| Automatic scaling | YES | Identical |
| Template support from the manufacturer | YES | Identical |
| Permits template rotation | YES | Identical |
| Treatment operative planning | YES | Identical |
| Patient contacting | NO | Identical |
| Control of Life-Saving Devices | NO | Identical |
| HCP intervention for interpretation and manipulation of images | YES | Identical |
| Conclusion | The successful non-clinical testing demonstrates the safety and effectiveness of the OrthoNext ™ Platform system when used for the defined indications for use and demonstrates that the subject device, for which this Traditional 510(k) is submitted, performs as well as or better than the legally marketed predicate devices. OrthoNext ™ Platform contains a subset of the same features and algorithms as those that are in the predicate devices. The testing for each release consisted of Unit, System/Integration and Acceptance test levels. Testing included also security, negative testing, error message handling, stress testing, platform testing, workflow testing, functional testing, multi-user/external access testing, data integrity testing, compatibility testing, load testing, regression testing, and hazard mitigation testing. In case a test was failed any necessary corrections were made, the relevant test was executed and repeated again until all passed. |
|---|---|
| ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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).