(95 days)
Not Found
Yes
The document explicitly states that the device uses an "artificial intelligence algorithm" for 3D model reconstruction and analysis of X-ray scans.
No
The device is a software tool used for 3D reconstruction of bones from radiographs to assist in preoperative planning, not to directly treat or diagnose a medical condition.
No
The device is a software tool for 3D reconstruction of bones from 2D radiographs, intended for assisting clinicians in the preoperative planning of knee orthopedic surgical procedures by providing a 3D model and anatomical landmarks. It does not provide a diagnosis itself.
Yes
The device description explicitly states "Zebra's HealthJOINT device is a software product". The entire description focuses on the software's function, algorithms, and integration via API, with no mention of accompanying hardware components provided by the manufacturer.
Based on the provided information, the Zebra Health.JOINT device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens derived from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The Health.JOINT device analyzes 2D radiographs (X-rays), which are medical images, not biological samples.
- Its purpose is image processing and reconstruction: The device's primary function is to reconstruct a 3D model of bones from 2D images and identify anatomical landmarks. This is an image processing and analysis task, not a diagnostic test performed on a biological sample.
- Its intended use is for surgical planning: The device is intended to assist clinicians in the preoperative planning of knee orthopedic surgical procedures. This is a clinical workflow support tool, not a diagnostic test to identify a disease or condition based on a biological sample.
Therefore, while it is a medical device that uses AI and image processing, it does not fit the definition of an In Vitro Diagnostic.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Zebra Health.JOINT device is a software tool for 3D reconstruction of bones from a set of 2D radiographs. The device is intended for assisting clinicians in the preoperative planning of knee orthopedic surgical procedures. Zebra's HealthJOINT analyzes cases using an artificial intelligence algorithm for the 3D model reconstruction. In addition to the model, the software provides a list of anatomical landmarks with their position on the 3D model. The result is made available via a 3rd parties' software interface for further display and analysis of the 3D bone model. Clinical judgement and experience are required to properly use the models produced by this software.
Product codes
LLZ
Device Description
Zebra's HealthJOINT device is a software product that uses an artificial intelligence algorithm to analyze X-ray scans. The HealthJOINT is indicated for the analysis of X-rays scans. The device receives a set of 2D radiographs and automatically provides a 3D model of the bones together with a list of anatomical landmarks with their position on the 3D model may be used by physicians for pre-operative planning of knee orthopedic surgeries. The HealthJoint supports 3D reconstructions of healthy bones, and osteoarthritis patients graded 1 to 4 based on the Kellgren-Lawrence grading system.
The HealthJOINT device functions as a component that can be used by 3rd parties via an API to generate the 3D models and provides a list of anatomical landmarks with their position on the 3D model. The software communicates with the API only, and is not user-facing. The software does not recommend clinical decisions or treatment.
The software is intended for use by clinicians in conjunction with additional patient information and professional judgment.
The following modules compose the HealthJoint software:
Data input and validation: performs validation of the input, X-ray DICOM images, assesses the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm.
HealthJoint algorithm: Once the study has been validated the algorithm analyzes the AP (anteriorposterior) along with the LAT (lateral) knee X-ray study in order to provide 3D bone models and locations of anatomic landmarks.
IMA Integration feature: provides the capability to post studies for processing, get the study analysis status and the results of successful study analysis via a Web API.
Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the calling 3rd party via the Web API.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
X-ray
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians, physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The data set for the 3D model accuracy included 67 pairs of a Knee X Ray and a CT scan of the same patient within a maximum time frame of 6 months. Performance accuracy of the HealthJOINT software was compared to an established Ground Truth by an experienced US Board-Certified radiologist.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The HealthJOINT device performance was evaluated in a stand-alone retrospective study for accuracy of the 3D model of the Femur, Tibia, and Fibula (RMSE) and the accuracy of the three-dimensional positioning of the anatomic landmarks on the Femur and Tibia. The 3D model accuracy and the anatomical landmark positioning were evaluated comparing to the pre-defined success criteria. The data set for the 3D model accuracy included 67 pairs of a Knee X Ray and a CT scan of the same patient within a maximum time frame of 6 months. Performance accuracy of the HealthJOINT software was compared to an established Ground Truth by an experienced US Board-Certified radiologist.
The HealthJOINT software performance accuracy was determined by measuring the RMSE (Root Mean Square Error), versus the ground truth. The HealthJOINT device performance for the Femur was an RMSE of 1.14 (95% CI: [1.097,1.187]), for the Tibia an RMSE of 1.05 (95% CI: [1.005,1.087]), and for the Fibula an RMSE of 0.94 (95% CI: [0.891, 0.986]). The device performance met the pre-defined success criteria.
Additionally, HealthJOINT performance accuracy in the identification of the anatomic landmark positioning versus the ground truth was determined by measuring the distance between the software landmarks positioning and the ground truth in mm, in terms of the standard deviation of the distance. The HealthJOINT software device precision met the performance goal. In conclusion, this study demonstrated the HealthJOINT safety and effectiveness and meets its intended use statement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
RMSE, distance between anatomical landmarks
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Zebra Medical Vision Ltd. % Flair Bar VP Operations Shefayim Commercial Center PO Box 25 Shefayim, 6099000 ISRAEL
December 4, 2020
Re: K202487
Trade/Device Name: HealthJOINT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 3, 2020 Received: November 6, 2020
Dear Flair Bar:
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 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 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
2
Indications for Use
510(k) Number (if known) K202487
Device Name HealthJOINT
Indications for Use (Describe)
The Zebra Health.JOINT device is a software tool for 3D reconstruction of bones from a set of 2D radiographs. The device is intended for assisting clinicians in the preoperative planning of knee orthopedic surgical procedures. Zebra's HealthJOINT analyzes cases using an artificial intelligence algorithm for the 3D model reconstruction. In addition to the model, the software provides a list of anatomical landmarks with their position on the 3D model. The result is made available via a 3rd parties' software interface for further display and analysis of the 3D bone model. Clinical judgement and experience are required to properly use the models produced by this software.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image contains the logo for Zebra Medical Vision. The logo consists of a yellow horizontal line on the left, followed by a stylized black and white icon resembling a 'Z', and the word 'zebra' in black, with 'MEDICAL.VISION' in smaller black letters underneath. The 'TM' symbol is also present next to the word 'zebra'.
5. 510 (k) Summary
510(K) Summary - HealthJOINT Zebra Medical Vision Ltd.
510(k) Number – K202487
| Applicant's Name: | Zebra Medical Vision Ltd.
Shefayim Commercial Center
PO Box 25
Shefayim, 6099000
ISRAEL
Telephone: +972-9-8827795
Fax: +972-9-8827795 |
| ------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- November 03, 2020 Date Prepared:
- Trade Name: HealthJOINT
Classification Name:
LLZ - Picture Archiving and Communication System
Classification:
Class II, Radiology
Predicate Device:
The HealthJOINT device is substantially equivalent to the following device:
| Proprietary Name | Efficient Care 3D Planning |
|---|---|
| Premarket Notification | K183544 |
| Classification Name | Picture Archiving and Communication System |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food,
Drug, and Cosmetic Act.
Intended Use/Indication for Use:
The Zebra HealthJOINT device is a software tool for 3D reconstruction of bones from a set of 2D radiographs. The device is intended for assisting clinicians in the preoperative planning of knee orthopedic
4
Image /page/4/Picture/0 description: The image shows the logo for Zebra Medical Vision. The logo consists of a stylized letter Z on the left and the word "zebra" on the right. Below the word "zebra" is the text "MEDICAL.VISION".
surgical procedures. Zebra's HealthJOINT analyzes cases using an artificial intelligence algorithm for the 3D model reconstruction. In addition to the model, the software provides a list of anatomical landmarks with their position on the 3D model.
The result is made available via a 3rd parties' software interface for further display and analysis of the 3D bone model.
Clinical judgement and experience are required to properly use the models produced by this software.
Device Description:
Zebra's HealthJOINT device is a software product that uses an artificial intelligence algorithm to analyze X-ray scans. The HealthJOINT is indicated for the analysis of X-rays scans. The device receives a set of 2D radiographs and automatically provides a 3D model of the bones together with a list of anatomical landmarks with their position on the 3D model may be used by physicians for pre-operative planning of knee orthopedic surgeries. The HealthJoint supports 3D reconstructions of healthy bones, and osteoarthritis patients graded 1 to 4 based on the Kellgren-Lawrence grading system.
The HealthJOINT device functions as a component that can be used by 3rd parties via an API to generate the 3D models and provides a list of anatomical landmarks with their position on the 3D model. The software communicates with the API only, and is not user-facing. The software does not recommend clinical decisions or treatment.
The software is intended for use by clinicians in conjunction with additional patient information and professional judgment.
The following modules compose the HealthJoint software:
Data input and validation: performs validation of the input, X-ray DICOM images, assesses the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm.
HealthJoint algorithm: Once the study has been validated the algorithm analyzes the AP (anteriorposterior) along with the LAT (lateral) knee X-ray study in order to provide 3D bone models and locations of anatomic landmarks.
IMA Integration feature: provides the capability to post studies for processing, get the study analysis status and the results of successful study analysis via a Web API.
Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the calling 3rd party via the Web API.
Performance Data:
Safety and performance of HealthJOINT has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation & Verification Process to ensure performance according to specifications, User Requirements and Federal Regulations and Guidance documents. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The HealthJOINT device performance was evaluated in a stand-alone retrospective study for accuracy of the 3D model of the Femur, Tibia, and Fibula (RMSE) and the accuracy of the three-dimensional positioning of the anatomic landmarks on the Femur and Tibia. The 3D model accuracy and the anatomical landmark positioning were evaluated comparing to the pre-defined success criteria. The data set for the 3D model accuracy included 67 pairs of a Knee X Ray and a CT scan of the same patient within a maximum
5
Image /page/5/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a yellow horizontal line on the left, followed by a stylized black and white "Z" symbol. To the right of the symbol is the word "zebra" in black, with the words "MEDICAL.VISION" in smaller font below it.
time frame of 6 months. Performance accuracy of the HealthJOINT software was compared to an established Ground Truth by an experienced US Board-Certified radiologist.
The HealthJOINT software performance accuracy was determined by measuring the RMSE (Root Mean Square Error), versus the ground truth. The HealthJOINT device performance for the Femur was an RMSE of 1.14 (95% CI: [1.097,1.187]), for the Tibia an RMSE of 1.05 (95% CI: [1.005,1.087]), and for the Fibula an RMSE of 0.94 (95% CI: [0.891, 0.986]). The device performance met the pre-defined success criteria.
Additionally, HealthJOINT performance accuracy in the identification of the anatomic landmark positioning versus the ground truth was determined by measuring the distance between the software landmarks positioning and the ground truth in mm, in terms of the standard deviation of the distance. The HealthJOINT software device precision met the performance goal. In conclusion, this study demonstrated the HealthJOINT safety and effectiveness and meets its intended use statement.
Technological Characteristics Compared to Predicate Device:
The technological characteristics, e.g., overall design, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the HealthJOINT device are substantially equivalent to the predicate device cited above.
A comparison of the technological characteristics with the predicate device is summarized below.
| Technological | Proposed Device: | Predicate Device: | Summary |
|---|---|---|---|
| Characteristics | HealthJoint | Efficient Care 3D Planning | |
| (K183544) | |||
| Intended | |||
| Use/Indications for | |||
| Use | The Zebra HealthJOINT device is | ||
| a software tool for 3D | |||
| reconstruction of bones from a set | |||
| of 2D radiographs. The device is | |||
| intended for assisting clinicians | |||
| in the preoperative planning of | |||
| knee orthopedic surgical | |||
| procedures. Zebra's | Efficient Care 3D Planning is | ||
| software indicated for assisting | |||
| orthopedic surgeons in preoperative | |||
| planning of knee orthopedic | |||
| surgeries. The software allows for | |||
| the overlaying of 3D/2D implant | |||
| models and for the visualization of | |||
| the radiological images and 3D | Similar. In | ||
| addition to the 3D | |||
| reconstruction and | |||
| 3D/2D overlay for | |||
| the visualization | |||
| of radiological | |||
| images, the | |||
| predicate device | |||
| HealthJOINT analyzes cases | |||
| using an artificial intelligence | |||
| algorithm for the 3D model | |||
| reconstruction. In addition to the | |||
| model, the software provides a list | |||
| of anatomical landmarks with | |||
| their position on the 3D model. | |||
| The result is made available via a | |||
| 3rd parties' software interface for | reconstruction of bones, and | ||
| includes tools for performing | |||
| measurements on the images or 3D | |||
| model of bones, and for selecting | |||
| and positioning the implant model. | |||
| Clinical judgments and experience | |||
| are required to properly use the | |||
| software. | also provide tools | ||
| for performing | |||
| measurements and | |||
| for selecting the | |||
| implant model. | |||
| further display and analysis of the | |||
| 3D bone model. | |||
| Clinical judgement and | |||
| experience are required to | |||
| properly use the models produced | |||
| by this software. | Efficient Care 3D Planning is to be | ||
| used with the following fixed | |||
| bearing knee replacement systems | |||
| in accordance with their indications | |||
| and contraindications: NexGen® | |||
| CR, NexGen CR-Flex, NexGen | |||
| CR-Flex Gender, NexGen LPS, | |||
| NexGen LPS-Flex, NexGen | |||
| LPSFlex Gender, Persona® CR, |
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Image /page/6/Picture/0 description: The image shows the logo for Zebra Medical Vision. The logo consists of a stylized "Z" symbol on the left, followed by the word "zebra" in a lowercase, sans-serif font. Below the word "zebra" are the words "MEDICAL.VISION" in a smaller font size. The logo is simple and modern, and the use of the "Z" symbol and the word "zebra" suggests a connection to medical imaging and diagnostics.
| | | Persona PS, Vanguard® CR, and
Vanguard PS. | |
|-----------------------------|---------------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------|
| Classification/Product code | 21 CFR 892.2050/LLZ | 21 CFR 892.2050/LLZ | Same |
| User | Prespecified clinical users
(clinicians) | Prespecified clinical users
(clinicians) | Same |
| Radiological images format | DICOM | DICOM | Same |
| Modality | X-ray | X-ray | Same |
| Body part | Knee | Knee | Same |
| Software processing | Image segmentation and
processing | Image segmentation and processing | Same |
| Output | 3D bone reconstruction | 3D bone reconstruction | Same |
| 2D/3D Overlay | Yes | Yes | Same |
| Anatomic Landmarks | Yes | Yes | Same |
| Measurement Tools | No | Yes | Different, but do
not raise
questions of
safety and
effectiveness. |
| Implant Predictability | No | Yes | Different, but do
not raise
questions of
safety and
effectiveness. |
Substantial Equivalence:
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, HealthJoint device raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety and effectiveness. The subject device has the same intended use, similar indications for use, and technological characteristics as the predicate device.
The results of the performance comparison study demonstrated that the HealthJoint device performs as intended, in the specified use conditions, and thus demonstrates the safety and effectiveness of the subject device.
The HealthJoint device is therefore substantially equivalent to the predicate device and share the same intended use and technological characteristics.