(262 days)
Open Rib is image analysis software for chest CT images. Open Rib offers a visualization of the unfolded rib cage that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventional multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
Open Rib is image analysis software for chest CT images. The software resides on the Vitrea Advanced Visualization (AV) platform.
Open Rib offers a visualization of the unfolded rib cage called an "unfolded cylindrical projection" (UCP) that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventual multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
The images can be directly exported to PACS and batch saved.
Here's a breakdown of the acceptance criteria and the study details for the Open Rib device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visualization of Unfolded Rib Cage: The device must successfully generate unfolded cylindrical projections of the ribs that are an adjunct to conventional MPR views, and be deemed clinically useful and effective by evaluators. | All three radiologist readers responded "yes" to all questions regarding the clinical utility and effectiveness of the unfolded rib view, measurement tools, and overall application/workflow. This indicated the device met pass criteria for visualization of the rib cage and successfully generates unfolded cylindrical projections of the ribs that are an adjunct to a conventional MPR view. |
| Measurement Tools Functionality: The geometric and HU measurement tools must be functional and considered clinically useful. | All three radiologist readers responded "yes" to all questions regarding the clinical utility and effectiveness of the measurement tools. |
| Overall Application and Workflow: The Open Rib application and its workflow must be considered clinically useful and effective. | All three radiologist readers responded "yes" to all questions regarding the clinical utility and effectiveness of the overall application and workflow. |
| Software Verification and Validation: Software functions must remain consistent with software requirements and achieve all product release criteria. | Software verification and validation activities were completed, and the Open Rib software achieved all product release criteria. |
2. Sample Size and Data Provenance
- Test Set Sample Size: 30 chest CT cases.
- Data Provenance: The cases were acquired with various CT scanners from different manufacturers (Canon: 17, Siemens: 8, GE: 4, Philips: 1). The country of origin for the data is not explicitly stated, but the study evaluators were U.S. board-certified radiologists, implying the study was conducted in the US. The data appears to be retrospective, as it refers to "datasets included" rather than prospectively acquired data for the study.
3. Number of Experts and Qualifications
- Number of Experts: 3.
- Qualifications of Experts: U.S. board-certified radiologists. No specific years of experience are provided, but board certification implies a certain level of expertise.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated as a formal adjudication method. Instead, each evaluator (radiologist) reviewed 10 cases, with cases evenly distributed among them. They were then presented with a list of questions about clinical utility and effectiveness. A "pass" result required positive answers to all questions from all three readers. This suggests a consensus-based evaluation where all experts had to agree on the positive assessment for the device to pass. There was no explicit mention of an adjudicator to resolve disagreements, as "positive answers to all questions" from all three was the criterion.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not performed. The study focused on the standalone performance and perceived utility of the Open Rib visualization and tools when used as an adjunct to conventional views. It did not quantify an improvement in human reader performance directly attributable to the AI.
6. Standalone Performance (Algorithm Only)
- Standalone Performance: Yes, the study essentially describes a standalone performance evaluation of the "Open Rib" software. The evaluators were assessing the generated unfolded rib views and measurement tools themselves. While radiologists were "using" the device, their evaluation was of the output of the algorithm (the UCP view) and its utility, not a comparison of their diagnostic accuracy with and without the device. The prompt asks for "algorithm only without human-in-the loop performance," and while radiologists were in the loop for evaluation, the core function being assessed was the software's ability to generate the UCP view and its perceived utility. The "pass" criteria rely on the radiologists' positive assessment of the device's output.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the presence or absence of abnormalities (e.g., normal vs. abnormal cases like rib fractures, bony lesions, kyphosis) was likely established by the referring physician's diagnosis, prior imaging reports, or a consensus of experts prior to the study, as cases were selected to include both normal (12 cases) and abnormal (18 cases) findings. However, the evaluation for device performance was based on expert consensus (radiologist assessment) of the clinical utility and effectiveness of the device's output (the UCP view, measurement tools, and workflow).
8. Sample Size for the Training Set
- Training Set Sample Size: Not provided in the document. The document describes the validation/test set but does not mention the size or characteristics of any training data used to develop the Open Rib algorithm.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not provided. Since the training set size is not mentioned, how its ground truth was established is also not detailed in this section of the 510(k) summary.
{0}------------------------------------------------
July 13, 2023
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
Canon Medical Informatics, Inc. % Dr. Jay Vaishnav Principal Regulatory Affairs Strategist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343
Re: K223261
Trade/Device Name: Open Rib Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: June 6, 2023 Received: June 6, 2023
Dear Dr. Jay Vaishnav:
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
{1}------------------------------------------------
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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
| Submission Number ( if known ) | |
|---|---|
| --------------------------------------- | -- |
Device Name
Open Rib
Indications for Use (Describe)
Open Rib is image analysis software for chest CT images. Open Rib offers a visualization of the unfolded rib cage that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventional multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
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."
{3}------------------------------------------------
510(k) #: K223261
510(k) Summary
Prepared on: 2023-07-07
Contact Details
Applicant Name
Applicant Address
Applicant Contact
Applicant Contact Email
Correspondent Address
Correspondent Name
21 CFR 807.92(a)(1)
21 CFR 807.92(a)(2)
21 CFR 807.92(a)(4)
Canon Medical Informatics, Inc.
5850 Opus Parkway, Suite 300 Minnetonka MN 55343 United States
(952) 487-9548 Applicant Contact Telephone
Vincent Swenson
vincent.swenson@mi.medical.canon
Jay Vaishnav, PhD, RAC
Canon Medical Informatics, Inc.
5850 Opus Parkway, Suite 300 Minnetonka MN 55343 United States
Correspondent Contact Telephone (952) 487-9769
Correspondent Contact
Correspondent Contact Email
Device Name
Open Rib Device Trade Name Common Name Computed tomography x-ray system Classification Name System, X-Ray, Tomography, Computed Regulation Number 892.1750 Product Code JAK Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate Trade Name (Primary Predicate is listed first) Predicate # Product Code SYNGO, CT BONE READING K123584 JAK
Device Description Summary
Open Rib is image analysis software for chest CT images. The software resides on the Vitrea Advanced Visualization (AV) platform.
Open Rib offers a visualization of the unfolded rib cage called an "unfolded cylindrical projection" (UCP) that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventual multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
The images can be directly exported to PACS and batch saved.
HOW THE DEVICE FUNCTIONS
{4}------------------------------------------------
The device is a software device that operates on chest CT images in order to generate an unfolded cylindrical projection view of the rib The user has the ability to edit the segmentation of the ribs. cage.
SCIENTIFIC CONCEPTS THAT FORM THE BASIS OF THE DEVICE
The main algorithms used to generate the UCP view involve rib cage on standard (non-Al based) segmentation methods, and rib cage unfolding performed by mathematical projection of the rib caresian coordinates into unfolded cylindrical coordinates.
PHYSICAL AND PERFORMANCE CHARACTERISTICS OF THE DEVICE
The device is a software algorithm that operates on thoracic CT images. Device performance was validated on thirty cases, in a qualitative study by three US board-certified radition to this testing, software verification and validation activities were completed to ensure that the Open Rib software functions remained consistent with the software achieved all product release criteria.
Intended Use/Indications for Use
Open Rib is image analysis software for ches. Open Rib offers a visualization of the unfolded rib cage that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventional multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
Indications for Use Comparison
The device has different indications for use in comparison to the predicate device. The differences follow:
• Both the subject and predicate devices offer a visualization of the rib cated only for visualization of the ribs, whereas the predicate device is indication of the rib and spine. Limiting the device indications to ribs only does not constitute a new intended use.
• The subject device uses an unfolded projection instead of curved MPR to generate unfolded rib views. The indications have been modified to reflect the difference. As the device output remains the use of a different method to obtain it does not affect the device's intended use.
ı While the subject device offers similar measurement and visualization capabilities, the IFU is being and brevity. This change does not create a new intended use.
• Any indications related to pathologies or improvements in user workflow have been removed. Reducing the scope of the indications does not create a new intended use.
Technological Comparison
The device has different technological characteristics from the predicate device. The following is a summary comparison:
· Both devices operate on chest CT images and output unfolded views of the algorithms used to generate the unfolded rib views are different. The subject device uses an unfolded cylindrical projection instead of curved MPR to generate unfolded rib views.
v Both devices offer similar visualization tools. All views that the subject device offers are offered by the predicate device offers one additional visualization tool, inverted MIP view, that is not present in the subject device. Inverted MIP view is not necessary for visualization of the rib cage.
• The subject device offer distance line, marker and a pixel lens HU tool. The predicate offers polyline and angle geometric tools and ROI circle, ROI freehand, & VOI sphere HU tools but the subject device does not.
• Both devices offer manual editing capability for the unfolded rib view.
• The predicate device offers inverted MIP view and automated rib labeling. The subject device does not.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(a)(5)
21 CFR 807-92(b)
21 CFR 807.92(a)(5)
{5}------------------------------------------------
Open Rib was tested on 30 chest CT cases with volume ≤ 1mm and reconstructed with a bone kernel. The 30 cases all met the following inclusion criteria:
• CT chest images with most of the ribs
• Slice thickness ≤ 1mm
• Bone reconstruction kernel
with the following excluded:
• Significant motion artifacts from patient breathing present on image
• Severe kyphosis
• Reconstruction kernel other than bone used
The datasets included were representative of most routine chest CT protocols and applied to a variety of clinical including routine diagnostic chest, oncologic chest studies and emergency/trauma studies.
The 30 cases included 12 normal cases (40%) and 18 abnormal cases such as rib fracture(s) and bony lesions and kyphosis (60%). 20 cases were non-contrast images (66.7%) and 10 cases were contrast images (33.3%). 30 cases acquired with various CTs were used. (Canon:17, Siemens:8, GE:4, Philips:1).
The evaluators were U.S. board-certified radiologists. Each evaluator reviewed 10 cases were evenly distributed between evaluators.
The evaluators were subsequently presented a list of questions asking about the clinical utility and effectiveness of the unfolded rib view, the measurement tools, and the overall application and workflow. A "pas" result required positive answers to all guestions.
Al three radiologist readers completed the questionnaire and responded "yes" to each of the device thus met pass criteria for visualization of the rib cage. The results device successfully generates unfolded cylindrical projections of the ribs that are an adjunct to a conventional MPR view.
In addition to this testing, software verification activities were completed to ensure that the Open Rib software functions remained consistent with the software requirements. The software achieved all product release criteria.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.