(78 days)
Not Found
Yes
The summary explicitly states that the device implements artificial intelligence including nonadaptive machine learning for image segmentation and describes the training data used for the AI-based ankle algorithm.
No
The device is a software interface for planning total ankle arthroplasty, and its intended use is for visualization, modification, validation of planning, and communication of treatment options, not for directly treating a medical condition.
No
The "Intended Use / Indications for Use" section explicitly states "Customize is not intended to be used for... diagnostic purposes."
Yes
The device description explicitly states it consists of a "single software user interface" and describes its functions as software-based operations on digital data (DICOM, CAD files). While it interacts with external hardware (CT scanner, X-ray), the device itself is presented as a software application for planning and visualization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a software interface to assist in the planning of total ankle arthroplasty. It focuses on visualization, modification, validation, communication, segmentation, 3D model generation, and managing timelines/cases. It explicitly states it is not intended for diagnostic purposes.
- Device Description: The description reinforces the planning aspect, detailing how it visualizes surgical options, allows for review and modification of 3D objects, includes an implant library for positioning and sizing, and saves the treatment plan for reference during surgery or further processing.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. This device does not perform any of these functions on specimens taken from the body. It processes medical images (CT and X-ray) and assists in surgical planning.
While the device uses medical imaging data and includes image processing and AI for segmentation, its primary function is to aid in the surgical planning process, not to diagnose a condition or provide information based on in vitro analysis of biological samples.
No
The letter explicitly states "Not Found" under "Control Plan Authorized (PCCP) and relevant text," which means there is no language indicating FDA review or clearance of a PCCP for this specific device.
Intended Use / Indications for Use
Customize for ankle arthroplasty is intended to be used as a software interface to assist in:
- Visualization, modification, validation of the planning of total ankle arthroplasty
- Communication of treatment options
- Segmentation of CT-scan data
- 3D CAD models generation
- use x-ray scan information to enhance the planning of ankle arthroplasty
- Managing timeline and cases
Customize is not intended to be used for
- Spine surgeries
- Implant and instrument design
Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
Product codes (comma separated list FDA assigned to the subject device)
QIH
Device Description
Customize is intended to be used during the preparation of ankle arthroplasties. It visualizes surgical treatment options that were previously created based on 3D CAD files generated from multi-slice DICOM data from a CT scanner. It consists of a single software user interface where the physician can review the CAD files in 3D, CT and X-Ray images in 2D and modify the position and orientation of the different 3D objects. Customize includes an implant library with 3D digital representations of various implant models so that the right implant positioning and sizing can be achieved based on the physician's input. After approval by the physician, the treatment plan is saved on the server and can be used as a reference during surgery. It is also possible to export the treatment plan for further processing such as designing and manufacturing of patient specific devices (the design of those later is done using an external software).
Customize is prescription use only.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT-scan data, x-ray scan information, x-ray images
Anatomical Site
Ankle
Indicated Patient Age Range
Adult patients only
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
The AI-based ankle algorithm is based on a machine that has been trained to identify bones using a dataset of 126 medical images (CT scans) and their corresponding segmentation. A proportion of 30% of the cases are eligible for ankle arthroplasty surgery, 70% are cadaveric cases. No confounder is available in the dataset. The population consists of 32% of women, and 68% of man, with an average age of 62 years old.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance data was included in the 510(k)-submission demonstrating Customize has been validated for its intended use and substantial equivalence to the predicate device.
Software verification and validation were performed, and documentation was included in this submission in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This includes verification against defined requirements, and validation against user needs. In addition, performance testing included 1) segmentation validation of the Customize software, 2) Repeatability and Reproducibility (R&R) study on the segmentation of ankle anatomies and 3) accuracy study on 3D model generation for tibia and talus.
Key results: Nonclinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
3D-Side SA % Mieke Janssen Regulatory Affairs Consultant OrthoGrow NV Davincilaan 1 Zaventem, Vlaams-Brabant 1930 BELGIUM
Re: K221432
Trade/Device Name: Customize Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, Dated: July 8, 2022 Received: July 11, 2022
August 3, 2022
Dear Mieke Janssen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221432
Device Name Customize
Indications for Use (Describe)
Customize for ankle arthroplasty is intended to be used as a software interface to assist in:
- Visualization, modification, validation of the planning of total ankle arthroplasty
- Communication of treatment options
- Segmentation of CT-scan data
- 3D CAD models generation
- use x-ray scan information to enhance the planning of ankle arthroplasty
- Managing timeline and cases
Customize is not intended to be used for
- Spine surgeries
- Implant and instrument design
Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY (21CFR807.92)
SUBMITTER
Company Name: Establishment registration number: Address:
Phone number: Principal contact person: Principal contact e-mail address Additional contact person: Additional contact e-mail address Summary date:
DEVICE
Name & trade name: Classification name:
Classification product code Regulation number
3D-Side 3013561205 Rue André Dumont 5 1435 Mont-Saint-Guibert, BE +32 (0) 10 81 35 48 Mieke Janssen mieke@ortho-grow.com Laurent Paul lp@3dside.eu
Customize Automated Radiological Image Processing Software ੀਮ 21 CFR 892.2050
PREDICATE AND REFERENCE DEVICES
The predicate device to which substantial equivalence is claimed:
| Item | Description |
|---|---|
| Device Classification Name | Automated Radiological Image Processing Software |
| 510(k) number | K213779 |
| Trade or proprietary or | |
| model name | Customize |
| Original Applicant | 3D-Side SA |
| Regulation Number | 21 CFR 892.2050 |
| Decision date | March 16, 2022 |
| Classification product code | QIH |
| 510(k) Review Panel | Radiology |
DESCRIPTION AND FUNCTIONING OF THE DEVICE
Customize is intended to be used during the preparation of ankle arthroplasties. It visualizes surgical treatment options that were previously created based on 3D CAD files generated from multi-slice DICOM data from a CT scanner. It consists of a single software user interface where the physician can review the CAD files in 3D, CT and X-Ray images in 2D and modify the position
K221432
4
and orientation of the different 3D objects. Customize includes an implant library with 3D digital representations of various implant models so that the right implant positioning and sizing can be achieved based on the physician's input. After approval by the physician, the treatment plan is saved on the server and can be used as a reference during surgery. It is also possible to export the treatment plan for further processing such as designing and manufacturing of patient specific devices (the design of those later is done using an external software).
Customize is prescription use only.
INTENDED USE
Customize for ankle arthroplasty is intended to be used as a software interface to assist in:
- Visualization, modification, validation of the planning of ankle arthroplasty -
- -Communication of treatment options
- Segmentation of CT-scan data -
- -3D CAD models generation
- Use X-Ray images to enhance the planning of ankle arthroplasty -
- -Managing timeline and cases
Customize is not intended to be used for
- Spine surgeries -
- Implant, instrument or patient-specific devices design -
Experience in usage and clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
Comparison of Technological Characteristics with the Predicate Device Following similarities exist between the subject device Customize and the predicate device (Customize, K213779):
- Intended use/indications for use: both the subject and the predicate device share the same intended use
- Device functionality: -
- Both devices read and visualize medical images compliant with the DICOM O standard, and visualize 3D objects.
- Both devices implement artificial intelligence including nonadaptive machine o learning, followed by human supervision.
- Both devices use 3D rendering to visualize the treatment options, and allow preview o of the implant replacement components intraoperatively.
Following technological difference exists between the subject device and the predicate device:
5
- -Next to CT imaging data as input for the generation of 3D CAD models, the subject device also uses information from x-ray images as input for the pre-operative planning.
Since the fundamental technologies are similar, no new or different questions of safety or effectiveness are raised. Bot the subject as well as predicate device visualize x-ray images, therefore the use of landmark information to calculate parameters for the preoperative planning does not raise different questions of safety and effectiveness.
SUMMARY OF PERFORMANCE DATA
Non-clinical performance data was included in the 510(k)-submission demonstrating Customize has been validated for its intended use and substantial equivalence to the predicate device.
Software verification and validation were performed, and documentation was included in this submission in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This includes verification against defined requirements, and validation against user needs. In addition, performance testing included 1) segmentation validation of the Customize software, 2) Repeatability and Reproducibility (R&R) study on the segmentation of ankle anatomies and 3) accuracy study on 3D model generation for tibia and talus.
For image segmentation, the device includes artificial intelligence including nonadaptive machine learning followed by human supervision by a 3D-Side engineer. The AI-based ankle algorithm is based on a machine that has been trained to identify bones using a dataset of 126 medical images (CT scans) and their corresponding segmentation. A proportion of 30% of the cases are eligible for ankle arthroplasty surgery, 70% are cadaveric cases. No confounder is available in the dataset. The population consists of 32% of women, and 68% of man, with an average age of 62 years old. The machine produces a temporary label to the user which should be seen as an initialization to the segmentation which requires manual editions.
CONCLUSION
The characteristics that determine the functionality and performance of Customize, the subject device, are substantially equivalent to the predicate device cleared under K213779. The nonclinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicate.