(204 days)
CollisionCheck is intended to assist radiation treatment planners in predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.
The CollisionCheck device (model RADCO) is software intended to assist users to identify where collisions between the treatment machine and the patient or support structures may occur in a treatment plan. The treatment plans are obtained from the Eclipse Treatment Planning System (also referred to as Eclipse TPS) of Varian Medical Systems. CollisionCheck runs as a dynamic link library (DLL) plugin to Varian Eclipse. It is designed to run on the Windows Operating System. CollisionCheck performs calculations on the plan obtained from Eclipse TPS (Version 12 (K131891), Version 13.5 (K141283), and Version 13.7 (K152393) which is a software used by trained medical professionals to install and simulate radiation therapy treatments for malignant or benign diseases.
The provided text describes the regulatory clearance of CollisionCheck (K171350) and compares it to a predicate device, Mobius3D (K153014). However, it does not contain specific details about acceptance criteria, the study design (e.g., sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods), or MRMC study results. The document states that "no clinical trials were performed for CollisionCheck" and mentions "Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements." This implies that the performance demonstration was likely limited to software verification and validation, rather than a clinical performance study with human-in-the-loop or standalone AI performance metrics.
Therefore, many of the requested details cannot be extracted from the provided text. I will provide what can be inferred or stated as absent based on the document.
Acceptance Criteria and Device Performance
The document does not explicitly list quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, or F1-score for the CollisionCheck device. Instead, the performance demonstration focuses on software verification and validation to ensure the device works as intended and is as safe and effective as the predicate device.
Table of Acceptance Criteria and Reported Device Performance (Inferred/Based on Document Context):
| Acceptance Criterion (Inferred from regulatory context and V&V) | Reported Device Performance (Inferred/Based on V&V Statement) |
|---|---|
| Functionality: Accurately simulate treatment plan and predict gantry collisions with patient or support structures. | Verification tests confirmed the software works as intended, indicating successful simulation and collision prediction. (Pass) |
| Safety: Device operation does not introduce new safety concerns compared to predicate. | Hazard Analysis demonstrated the device is as safe as the Predicate Device. (Pass) |
| Effectiveness: Device effectively assists radiation treatment planners in identifying potential collisions. | Verification tests confirmed the software works as intended, indicating effective assistance in collision identification. (Pass) |
| Algorithm Accuracy (Collision Prediction): Implicitly, the algorithm should correctly identify collision events when they occur and not falsely identify them when they do not. | No specific accuracy metrics (e.g., sensitivity, specificity, precision recall) reported. Performance is based on successful completion of verification tests. |
| Comparison to Predicate: Substantially equivalent to Mobius3D's collision check feature regarding safety and effectiveness. | Minor technological differences do not raise new questions on safety and effectiveness. Deemed substantially equivalent. (Pass) |
Study Details:
Given the statement "no clinical trials were performed for CollisionCheck," and the focus on "Verification tests," most of the questions regarding a typical AI performance study (like those involving test sets, ground truth experts, MRMC studies) cannot be answered with specific data from this document. The performance demonstration appears to have been solely based on internal software verification and validation activities.
-
Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not specified. The document only mentions "verification tests" and "pass/fail criteria."
- Data Provenance: Not specified. It's likely synthetic or internal clinical data used for software testing, rather than a distinct, prospectively collected, or retrospectively curated clinical test set for performance evaluation in a regulatory sense.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. Given that "no clinical trials were performed," it's highly improbable that a formal expert-adjudicated ground truth was established for a test set in the context of an AI performance study. Ground truth in this context would likely be defined by the physics-based simulation of collisions within the software's design.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. No adjudication method is mentioned, consistent with the absence of a clinical performance study involving human readers.
-
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:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states, "no clinical trials were performed." Therefore, no effect size of human reader improvement with AI assistance is reported.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- While the "verification tests" would evaluate the algorithm's standalone functionality, the document does not provide specific performance metrics (e.g., sensitivity, specificity) for its standalone performance that would typically be seen in a standalone AI evaluation. The device assists a human user, so its "standalone" performance wouldn't be in isolation but rather its ability to correctly identify collisions as defined by its internal models.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies a physics-based or computational ground truth. The device performs calculations and simulations. The "ground truth" for its verification and validation would be whether its simulation correctly identifies collisions based on defined geometric and physical parameters. It's not based on expert consensus, pathology, or outcomes data, as it's a planning assistance tool, not a diagnostic one.
-
The sample size for the training set:
- Not applicable/Not specified. The document describes CollisionCheck as software that performs calculations and simulations (modeling the linac as a cylinder, supporting applicators, etc.). It is not described as an AI or machine learning model that requires a "training set" in the conventional sense of supervised learning on a large dataset. Its functionality is likely rule-based or physics-informed, rather than learned from data.
-
How the ground truth for the training set was established:
- Not applicable/Not specified. Since it's not described as an ML model with a training set, the concept of establishing ground truth for a training set does not apply here. The "ground truth" for its development would be the accurate mathematical and physical modeling of collision scenarios.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 29, 2017
RADformation, Inc. % Mr. Kurt Sysock Co-founder/CEO 335 Madison Avenue, 16th Floor NEW YORK NY 10017
Re: K171350
Trade/Device Name: CollisionCheck Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 4, 2017 Received: October 11, 2017
Dear Mr. Sysock:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
K171350/S001
Device Name CollisionCheck
Indications for Use (Describe)
CollisionCheck is intended to assist radiation treatment planners in predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.
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)
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}------------------------------------------------
This 510(k) Summary has been created per the requirements of the Safe Medical Device Act (SMDA) of 1990, and the content is provided in conformance with 21 CFR Part 807.92.
3.1. Submitter's Information
| Table 1 : Submitter's Information | |
|---|---|
| Submitter's Name: | Kurt Sysock |
| Company: | Radformation, Inc. |
| Address: | 335 Madison Avenue, 16th FloorNew York, NY 10017 |
| Contact Person: | Alan NelsonChief Science Officer, Radformation |
| Phone: | 518-888-5727 |
| Fax: | -------- |
| Email: | anelson@radformation.com |
| Date of Summary Preparation | 05/01/2017 |
3.2. Device Information
| Table 2 : Device Information | |
|---|---|
| Trade Name: | CollisionCheck |
| Common Name: | Oncology Information System |
| Classification Name: | Class II |
| Classification: | Medical charged-particle radiation therapy system,dosimetric quality control system |
| Regulation Number: | 892.5050 |
| Product Code: | IYE |
| Classification Panel: | Radiology |
3.3. Predicate Device Information
Mobius3D (K153014)
{4}------------------------------------------------
3.4. Device Description
The CollisionCheck device (model RADCO) is software intended to assist users to identify where collisions between the treatment machine and the patient or support structures may occur in a treatment plan. The treatment plans are obtained from the Eclipse Treatment Planning System (also referred to as Eclipse TPS) of Varian Medical Systems. CollisionCheck runs as a dynamic link library (DLL) plugin to Varian Eclipse.
It is designed to run on the Windows Operating System. CollisionCheck performs calculations on the plan obtained from Eclipse TPS (Version 12 (K131891), Version 13.5 (K141283), and Version 13.7 (K152393) which is a software used by trained medical professionals to install and simulate radiation therapy treatments for malignant or benign diseases.
3.5. Indications for Use
CollisionCheck is intended to assist radiation treatment planners in predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.
3.6. Technological Characteristics
CollisionCheck (Subject Device) makes use of a Predicate Device, Mobius3D (K153014) for substantial equivalence comparison.
3.6.1. CollisionCheck vs. Mobius3D (K153014)
Mobius3D provides the following feature (as described on the manufacturer's website at http://mobiusmed.com/mobius3d/ as of March 27, 2017): "Deliverability Analysis: Confirm Before Your Patient Arrives. Mobius3D performs a virtual delivery of the plan and verifies that no gantry collision or violation of your machine's delivery parameters is predicted."
CollisionCheck likewise simulates the plan and verifies that no gantry (treatment machine) collisions occur. The main difference between the implementation of that feature by Mobius3D and CollisionCheck is that Mobius3D takes DICOM plan data as input in order to perform the virtual delivery while CollisionCheck obtains treatment plan information from the Varian Medical Systems Eclipse Treatment Planning System through its scripting API. Furthermore, CollisionCheck does not have any other features besides the gantry collision check while Mobius3D includes many other features that are not related to the gantry collision check.
From Mobius3D's Intended Use statement: "Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy." CollisionCheck is likewise a quality assurance and treatment plan verification tool, but one with the very specific scope of checking for potential treatment machine collisions that might occur in a treatment plan.
{5}------------------------------------------------
| Table 3: Substantial Equivalence CollisionCheck vs. Mobius3D | |||
|---|---|---|---|
| Parameters | Subject Device: CollisionCheckRadformation | Predicate Device: Mobius3D(K153014) | Equivalence |
| Indications foruse | Used to assist radiationtreatment planners in predictingwhen a treatment plan mightresult in a collision between thetreatment machine and thepatient or support structures | Used for quality assurance,treatment plan verification, andpatient alignment and anatomyanalysis in radiation therapy. | SubjectDevice is asubset of thePredicateDevice |
| Pure software | Yes | Yes | Equivalent |
| Intended users | Trained radiation oncologypersonnel | Trained radiation oncologypersonnel | Equivalent |
| OTC/Rx | Rx | Rx | Equivalent |
| CollisionCheck vs. Mobius3D Deliverability Analysis | |||
| Input | CT, Structure Set, andTreatment Plan data accessedthrough the Eclipse ScriptingAPI | DICOM files containing CT,Structure Set, and TreatmentPlan (including treatment fieldparameters) data | MinorDifferences |
| Functionality | Simulates the plan and predictswhether that no gantry collisionsoccur with patient or supportstructures. | Performs a virtual delivery of theplan and verifies that no gantrycollision is predicted. | Equivalent |
| SimulationDetails | CollisionCheck calculatesgantry clearance by modelingthe linac as a cylinder with auser-configured value fordistance between isocenter andthe face of the gantry.CollisionCheck also supportsadditional applicators:Stereotactic radiosurgery cones(also modeled as a cylinder)and Electron Applicators(modeled as a rectangularprism). | Mobius3D calculates gantryclearance in Plan Checks bymodeling the linac as a cylinderwith a user-configured value fordistance between isocenter andthe face of the gantry. | MinorDifferences |
| Output | CollisionCheck tests thousandsof sample points against CTdata and patient and couchstructures and reports thenumber of sample points thatresulted in a collision.CollisionCheck also displaysthese sample point test results | Mobius3D determines the closestdistance between the treatmenthead and the patient/couch foreach beam and displays awarning if this distance is <= 3cmand an alert if the clearance is<= 0cm. | MinorDifferences |
{6}------------------------------------------------
| with a 3D display and an axial' 2D image plane viewer for theuser to inspect the results. |
|---|
| --------------------------------------------------------------------------------------------------- |
3.7. Differences Discussion
Indications for use
Mobius3D is a quality assurance platform that includes a wide variety of plan checks, including a collision check. CollisionCheck is highly specialized to only perform the collision check function, and therefore CollisionCheck performs only a subset of the uses provided by the predicate device Mobius3D. The fact that CollisionCheck performs only this specialized function does not raise any questions regarding safety and effectiveness in that this specialized function can stand alone and independent of all other functions contained in the Mobius3D predicate device.
Input
Mobius3D requires the CT, Structure Set, and Treatment Plan data to be exported from a treatment planning system in DICOM format. CollisionCheck obtains the same data directly from the Eclipse treatment planning system through Eclipse's Scripting API. This does not raise any new questions regarding safety and effectiveness in that, relative to DICOM export/import, the Eclipse Scripting API layer is closer to the original data and requires less manual user input, therefore exposing fewer issues associated with errors in the DICOM import/export process as well as user error in accidentally exporting or importing the wrong DICOM files.
Simulation Details
Mobius3D and CollisionCheck both simulate the gantry face and head as a cylinder, but CollisionCheck also supports the addition of applicators (which are mounted to the face of the gantry). These are simulated using simple geometries that are no more difficult to simulate than the cylinder used in the gantry face and therefore this difference does not raise new questions regarding safety and effectiveness. The simulation of stereotactic radiosurgery cones and electron applicators increases safety and effectiveness of the device by assisting the treatment planner to predict and avoid collisions with those applicators.
Output
Mobius3D determines the closest distance between the patient and support structures and the simulated gantry head and gives an alert or warning based on the result.
CollisionCheck tests not only patient and support structures for collisions (referred to in CollisionCheck as Structure-based Collisions) but also tests the simulated geometry against the Hounsfield-Unit CT data (referred to in CollisionCheck as HU-based Collisions) to report to the user the number and location of the sample points that resulted in either of those collisions. HU-based collision test adds an extra layer of safety in that the treatment setup, patient geometry, and support structures may not be fully
{7}------------------------------------------------
described by the structure set and by testing the HU values may detect a collision that would otherwise be missed if only the structure set is considered.
In addition to displaying the number of sample point collisions detected, CollisionCheck also displays a 3D model of the simulated treatment unit with the patient and support structure geometry that allows the user to visualize where the treatment unit will be in the treatment. This increases safety significantly in that Mobius3D and CollisionCheck both are limited in the accuracy of their collision check by the data available in the CT and structure set, and where patient anatomy falls outside of the bounds of that data, only manual inspection can determine whether there is a collision risk in those instances. The 3D display provided by CollisionCheck makes it significantly easier and more accurate to manually inspect the treatment geometry for these potential issues.
CollisionCheck also provides an 2D axial slice view of the collision check results which allows the user to see where the treatment machine will be for each treatment field within the actual CT data to assist the user in identifying exactly where the collisions would occur within the patient or support structures.
These differences in output do not raise any questions regarding the safety and effectiveness of CollisionCheck relative to the predicate device Mobius3D.
3.8. Performance Data
As with the Predicate Device, no clinical trials were performed for CollisionCheck. Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements.
3.9. Conclusion
CollisionCheck is deemed substantially equivalent to the Predicate Device, Mobius3D (K153014) due to the similarities with the Mobius3D collision check feature. Verification and Validation testing and Hazard Analysis demonstrate that CollisionCheck is as safe and effective as the Predicate Device. The minor technological differences between CollisionCheck and the Predicate Device with regard to the shared gantry collision check feature do not raise any questions on the safety and effectiveness of the Subject Device.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.