(252 days)
Not Found
Yes
The "Mentions AI, DNN, or ML" section explicitly states that the software utilizes machine learning algorithms trained on medical images.
No.
The device is image processing software designed to aid in the measurement and assessment of radiographic abnormalities, not to provide therapy or treatment.
Yes
The device aids medical professionals in the measurement of minimum joint space width, assessment of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria, and the presence or absence of radiographic knee OA based on Kellgren-Lawrence grading. These functions directly contribute to identifying a medical condition or disease, which is the definition of a diagnostic device.
Yes
The device description explicitly states that RBknee is a "fully-automated image processing stand-alone software" and a "software device". It takes digital radiographs as input and provides visual and text reports as output. There is no mention of any accompanying hardware component that is part of the medical device itself. While it can be integrated with PACS and operates in a Linux environment compatible with Docker, these are infrastructure components, not part of the regulated medical device hardware.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- RBknee's function: RBknee processes radiological images (CR and DX) of the knee. It analyzes these images to measure joint space width and assess the presence of certain features based on established criteria.
- No specimen analysis: The device does not interact with or analyze any biological specimens from the patient. Its input is image data.
Therefore, RBknee falls under the category of medical image processing software, not In Vitro Diagnostics.
No
The letter does not state that the FDA has reviewed and approved or cleared the PCCP for this specific device.
Intended Use / Indications for Use
RBknee is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on the Kellgren-Lawrence (KL) score.
It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.
Product codes
LLZ, JAK
Device Description
RBknee is a fully-automated image processing stand-alone software designed to assist clinicians in analyzing and measuring radiographic abnormalities during review of posterior-anterior (PA) and anterior-posterior (AP) radiographs. RBknee takes digital radiographs (AP/PA) as input and as output provides: 1. A visual report with a copy of regions of interest from the original radiographs with overlays that mark the minimum Joint Space Width (JSW), and a table with the measurement of the minimum JSW in millimeters (mm), information on the presence or absence of joint space narrowing, osteophytes, and sclerosis based on OARSI gradings, and information on the presence or absence of radiographic knee osteoarthritis (OA) based on the Kellgren-Lawrence (KL) score. 2. A text report with a textual summary of the presence or absence of joint space narrowing, osteophytes, and sclerosis based on OARSI gradings (called findings), and a textual summary of the presence or absence of radiographic knee osteoarthritis (OA) based on the Kellgren-Lawrence score (called impression). RBknee is not interpreting any results but makes an objective measurement and providing an output based on a well established scale (OARSI/KL). RBknee can be integrated to a PACS and the outputs of RBknee can be reviewed in a DICOM viewer. RBknee operates in a Linux environment and can be compatible with any operating system supporting the third-party software Docker.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
computed (CR) or directly digital (DX) images, digital radiographs (AP/PA)
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals including, but not limited to, radiologists, orthopedics, physicians and medical technicians.
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
A standalone clinical performance validation of RBknee was performed using the open-access database from the Osteoarthritis Initiative (OAI), a large U.S. prospective multicenter observational study conducted over a period of 12 years. Ground truth grading for Kellgren Lawrence grades, as well as osteophyte, sclerosis and joint space narrowing grades according to the OARSI (Osteoarthritis Research Society International) guidelines, and measurements of the minimum joint space width was established by two physicians following adjudication procedures with a third reviewer for discrepancies.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected. A standalone clinical performance validation of RBknee was performed using the open-access database from the Osteoarthritis Initiative (OAI). The performance of RBknee for the status indicators of the radiographic findings (Kellgren-Lawrence status, Joint Space Narrowing Status, Osteophytosis status, Subchondral Sclerosis status) was evaluated, showing sensitivities ranging from 0.82 to 0.89 and specificities ranging from 0.78 to 0.87. The accuracy of the measurements of the minimum Joint Space Width by RBknee was quantified using orthogonal linear regression by comparing the measurements by RBknee with equivalent measurements from the OAI, resulting in slopes of 1.00 and intercepts of -0.07 (Medial) and -0.10 (Lateral), and 95% CIs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| RBknee | |||
|---|---|---|---|
| Data Support | |||
| (images/ unique subjects) | Sensitivity | Specificity | |
| Kellgren-Lawrence status* | 4279/421 | 0.88 | 0.87 |
| 95% CI | 0.85 0.91 | 0.84 0.89 | |
| Joint Space Narrowing Status# | 4279 / 421 | 0.82 | 0.87 |
| 95% CI | 0.79 0.86 | 0.84 0.90 | |
| Osteophytosis status# | 2427/289 | 0.89 | 0.78 |
| 95% CI | 0.87 0.91 | 0.72 0.84 | |
| Subchondral Sclerosis status# | 2329/272 | 0.84 | 0.87 |
| 95% CI | 0.80 0.87 | 0.84 0.90 |
Minimum Joint Space Width Measurement Accuracy:
| RBknee | ||
|---|---|---|
| Slope | Intercept | |
| Medial | 1.00 | -0.07 |
| Medial, 95%CI | 0.98 1.02 | -0.17 0.03 |
| Lateral | 1.00 | -0.10 |
| Lateral, 95%CI | 0.97 1.03 | -0.27 0.06 |
Predicate Device(s)
IB Lab GmbH, KOALA (K192109)
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
September 20, 2021
Image /page/0/Picture/1 description: The image contains 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" in blue, with "ADMINISTRATION" written below in a smaller font.
Radiobotics ApS % John Smith Partner Hogan Lovells US LLP 555 13th Street. NW Washington, District of Columbia 20004
Re: K203696
Trade/Device Name: RBknee Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ, JAK
Dear John Smith:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 27th, 2021. Specifically, FDA is updating this SE Letter due to the SE package containing the wrong version of the 510(k) Summary and Indications for Use statement.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Thalia Mills, OHT7: Office of In Vitro Diagnostics and Radiological Health by email (Thalia.Mills(@fda.hhs.gov) or phone (301-796-6641).
Sincerely,
Image /page/0/Figure/9 description: The image shows a digital signature. The signature is for Laurel M. Burk -S. The date of the signature is 2021.09.20, and the time is 09:15:35 -04'00'.
Laurel Burk Chief 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
1
August 27, 2021
Image /page/1/Picture/1 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 blue square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Radiobotics ApS % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC 20004
Re: K203696
Trade/Device Name: RBknee Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ, JAK Dated: June 1, 2021 Received: June 1, 2021
Dear Dr. Smith:
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
2
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,
Michael D. O'Hara
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
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known) K203696
Device Name RBknee
Indications for Use (Describe)
RBknee is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence of radiographic knee OA based on Kellgren-Lawrence grading of standing. fixed-flexion radiographs of the knee.
It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.
The system is to be used by trained professionals including, but not limited to, radiologists, orthopedics, physicians and medical technicians.
Type of Use (Select one or both, as applicable)
区 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:
Health Department of 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
510(k) SUMMARY Radiobotics Aps's RBknee
Submitter
Radiobotics ApS
Esplanaden 8C, 1-tv, 1263 Copenhagen, Denmark
Phone: +45 26 14 61 84
Contact Person: Martin Christian Axelsen, PhD; Co-founder & CSO
Date Prepared: June 1, 2021
Name of Device: RBknee
Trade/proprietary name of device: RBknee
Common or Usual Name: System, Image Processing, Radiological
Classification Name: Medical Image Management and Processing System (892.2050)
Regulatory Class: Class II
Product Codes: LLZ, JAK
Classification Advisory Committee: Radiology
Predicate Device: IB Lab GmbH, KOALA (K192109)
Intended Use / Indications for Use
RBknee is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren-Lawrence grading of standing, fixed-flexion radiographs of the knee.
It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.
The system is to be used by trained professionals including, but not limited to, radiologists, orthopedics, physicians and medical technicians.
Technological Characteristics
In general, the technological characteristics of the RBknee is directly comparable to the predicate device, KOALA.
5
Similar to KOALA, RBknee as a fully-automated image processing stand-alone software is a software device designed to assist clinicians in analyzing and measuring radiographic abnormalities during review of posterior-anterior (PA) and anterior-posterior (AP) radiographs.
The predicate and subject software utilize computer vision and machine learning algorithms trained on medical images. The machine-learning algorithms allow for high accuracy in the detection and measurement of OA related symptoms visible on knee radiographs.
In brief, RBknee takes digital radiographs (AP/PA) as input and as output provides:
-
- A visual report with
- a. A copy of regions of interest from the original radiographs with overlays that mark the minimum Joint Space Width (JSW)
- A table with the measurement of the minimum JSW in millimeters (mm), information ﻒ on the presence or absence of joint space narrowing, osteophytes, and sclerosis based on OARSI gradings, and information on the presence or absence of radiographic knee osteoarthritis (OA) based on the Kellgren-Lawrence (KL) score.
-
- A text report with
- a. A textual summary of the presence or absence of joint space narrowing, osteophytes, and sclerosis based on OARSI gradings (called findings), and a textual summary of the presence or absence of radiographic knee osteoarthritis (OA) based on the Kellgren-Lawrence score (called impression).
RBknee is not interpreting any results but makes an objective measurement and providing an output based on a well established scale (OARSI/KL).
RBknee can be integrated to a PACS and the outputs of RBknee can be reviewed in a DICOM viewer.
RBknee operates in a Linux environment and can be compatible with any operating system supporting the third-party software Docker. The integration environment has to support RBknee data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
Performance Data
Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected.
A standalone clinical performance validation of RBknee was performed using the open-access database from the Osteoarthritis Initiative (OAI), a large U.S. prospective multicenter observational study conducted over a period of 12 years. Ground truth grading for Kellgren Lawrence grades, as well as osteophyte, sclerosis and joint space narrowing grades according to the OARSI (Osteoarthritis Research Society International) guidelines, and measurements of the minimum joint space width was established by two physicians following adjudication procedures with a third reviewer for discrepancies.
The performance of RBknee for the status indicators of the radiographic findings are listed in the table below.
6
| RBknee | |||
|---|---|---|---|
| Data Support | |||
| (images/ unique subjects) | Sensitivity | Specificity | |
| Kellgren-Lawrence status* | 4279/421 | 0.88 | 0.87 |
| 95% CI | 0.85 0.91 | 0.84 0.89 | |
| Joint Space Narrowing Status# | 4279 / 421 | 0.82 | 0.87 |
| 95% CI | 0.79 0.86 | 0.84 0.90 | |
| Osteophytosis status# | 2427/289 | 0.89 | 0.78 |
| 95% CI | 0.87 0.91 | 0.72 0.84 | |
| Subchondral Sclerosis status# | 2329/272 | 0.84 | 0.87 |
| 95% CI | 0.80 0.87 | 0.84 0.90 | |
| * KL-grade ≥ 2 |
OARSI-grade > 0 | | | |
The accuracy of the measurements of the minimum Joint Space Width by RBknee was quantified using orthogonal linear regression by comparing the measurements by RBknee with equivalent measurements from the OAI. The slope and intercept can be seen in the table below.
7
| RBknee | ||
|---|---|---|
| Slope | Intercept | |
| Medial | 1.00 | -0.07 |
| Medial, 95%CI | 0.98 1.02 | -0.17 0.03 |
| Lateral | 1.00 | -0.10 |
| Lateral, 95%CI | 0.97 1.03 | -0.27 0.06 |
Summary
- Software verification and validation testing was completed for the subject device. The -RBknee functioned in all instances as intended and all results observed were as expected.
- RBknee is an effective image processing device that provides reliable measurements and accurate indicators for presence/absence of radiographic features relevant for the analysis of radiographic knee osteoarthritis. Thus, the device performs as intended and is substantially equivalent to the predicate device.
Substantial Equivalence
The RBknee is as safe and effective as the KOALA. The RBknee has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Performance data demonstrates that the RBknee is as safe and effective as KOALA. Thus, the RBknee is substantially equivalent.
Conclusions
In conclusion, RBknee is as safe, as effective, and performs as well as the predicate device, KOALA. The RBknee has a similar intended use, indication, technological characteristics, and principles of operation as KOALA. The differences between RBknee and KOALA do not alter the intended use of the device and do not raise new or different questions regarding its safety and effectiveness when used as labelled. Performance data demonstrates that the device performs as intended. Thus, RBknee is substantially equivalent.