(56 days)
ThinkQA is a radiation therapy dosimetry Quality Assurance (QA) device consisting of a software framework intended to contain a suite of modules to verify that radiation dose actually delivered to the patient is as intended.
The Epibeam module contained in ThinkQA is intended to be used as follows:
Epibeam is a standalone software tool independent of the linear accelerator, the TPS and the Record-and-Verify system. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery. It is to be used by a radiation oncology medical professional as a guide to provide pretreatment plan delivery verification.
The software is to be used for the purposes of detecting errors in the delivery of radiation therapy prior to treatment, like corruption of the transferred plan data to the treatment unit, inappropriate multileaf collimator sequence or beam output malfunctioning. The software acquires data from the Electronic Portal Imaging Device (EPID) during a blank fraction dedicated to the pretreatment verification without the patient and subsequently processes it. The processed data is compared with data calculated by the Epibeam system. The comparison is derived on one hand, from the application of dose conversion to the EPID data and on the other hand, from the computation of a predicted dose image under ideal conditions of functioning. A gamma-index analysis is then performed according to the dose difference and distance-to-agreement criteria provided by the user.
Epibeam is not a treatment planning system and cannot be used to generate radiotherapy treatment plans. It provides an independent means of checking the reliability of the dose delivery for each beam in reference to TPS data.
Epibeam therefore provides an added level of treatment quality assurance, thus giving clinicians confidence especially when complex treatment techniques are employed (gantry-fixed and rotational intensity modulated radiation therapy).
Epibeam is intended to support decision making in relation to the delivery of treatment plan to the patient with every clinical linear accelerators equipped with an EPID, but does not alter the existing Indications for Use of the treatment unit.
ThinkQA is a modular software suite composed of the module Epibeam which is a quality assurance tool dedicated to Patient Specific QA for pretreatment verification of irradiation beams.
The EPIbeam verification module integrated to the ThinkOA software platform is a Quality Assurance tool in external beam radiation therapy, used in combination with the electronic portal imaging device (EPID) and dedicated to the irradiation beam pre-treatment verifications, particularly for IMRT and VMAT techniques.
EPIbeam principle is based on the comparison of two images expressed in terms of absolute dose: on the one hand, a RT Plan defined in the TPS is used for the acquisition of a real portal image (test image) with the EPID directly irradiated (without attenuating medium); on the same RT Plan is used to compute a theoretical portal image (reference image). Specific models and algorithms are applied to express both images in the same absolute dose terms.
The dose images obtained from the same RT Plan, one by the conversion model of the acquired raw EPID images and the other by the prediction model, can be quantitatively compared through dose difference mappings or 2D gamma-index. Both models are based on dosimetric data provided from the TPS.
Here's a summary of the acceptance criteria and study details for the ThinkQA Epibeam device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria. Instead, it describes functional requirements and states that "acceptance criteria were met." The performance is generally framed as demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria (Implied / Functional) | Reported Device Performance |
|---|---|
| Pretreatment check functionality | Yes |
| Independent software operation | Yes |
| Ability to acquire pretreatment images | Yes |
| Algorithm for computing predicted reference dose image | Yes |
| Algorithm for converting acquired portal image into dose image | Yes |
| Comparison of measured and reference dose images via gamma-index analysis | Yes |
| Generation of reviewer reports | Yes |
| Inclusion of gamma agreement index per beam | Yes |
| Inclusion of significant statistic gamma index values per beam | Yes |
| Ability to view test and reference images | Yes |
| Ability to view superimposed test/reference dose profiles | Yes |
| Ability to view 2D gamma index distribution | Yes |
| Patient control database integration | Yes |
| User-defined Alert Criteria for out-of-tolerance analysis | Yes |
| Import Approved Plan data from Treatment Planning System | Yes |
| Import Portal Images from pretreatment fraction | Yes |
| Automatic offline analysis | Yes |
| Support for multiple treatment techniques (Static, IMRT, VMAT) | Yes |
| Requirement for EPID panel Calibration for commissioning | Yes |
| Use of TPS results for dose data reference | Yes |
| Demonstration of substantial equivalence to predicate device (K133572) | Achieved through performance, functional, and algorithmic testing. |
| Conformance to applicable technical design specification | Met |
| Achievement of safety and effectiveness | Achieved |
| Meeting device requirements under normal conditions of use | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" with a particular sample size from real patient data. The validation seems to be based on "clinically representative conditions" and "test cases" rather than a specific patient cohort for a validation study.
- Sample Size for Test Set: Not explicitly stated as a separate patient-based test set. The testing involved "unit, integration and system tests" and "validation of the system under clinically representative conditions."
- Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a software release, it's likely synthetic or internally generated test cases reflecting various clinical scenarios, and potentially retrospective clinical data for "clinically representative conditions."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of external experts to establish a "ground truth" for a specific test set. The ground truth for the device's function appears to be established through:
- Comparison of acquired EPID data with data calculated by the Epibeam system itself, based on TPS plans and prediction models.
- The assumption that the TPS data and the device's prediction model represent the "ideal conditions of functioning" or "reference."
4. Adjudication Method for the Test Set
Not applicable/not mentioned. There's no indication of an adjudication method involving multiple human readers for establishing a ground truth or resolving discrepancies in a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The document focuses on the standalone performance and substantial equivalence of the software tool.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, a standalone study was done. The entire premise of the "Performance Testing - Bench" section describes the testing of the ThinkQA software's functionalities and algorithms independently. The Epibeam module is described as a "standalone software tool independent of the linear accelerator, the TPS and the Record-and-Verify system." The performance testing demonstrates that the software itself "meets the requirements of the device."
7. Type of Ground Truth Used
The ground truth for the comparison performed by the Epibeam module is based on:
- Predicted dose image: Calculated by the Epibeam system under ideal conditions, derived from the RT Plan defined in the Treatment Planning System (TPS).
- Dose conversion of acquired EPID data: The software converts raw EPID images into dose terms.
- TPS data: The models and algorithms used by Epibeam are based on dosimetric data provided by the TPS, which serves as a reference for the planned dose.
Essentially, the "ground truth" for the device's internal comparison is the expected dose distribution as calculated by the validated Treatment Planning System and through the device's own prediction models.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" or its size. As a "software framework" and a "Quality Assurance tool," its development likely involved conventional software engineering practices, potentially including internal data for model development and calibration, but a specific "training set" like in deep learning models is not detailed.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" is not explicitly mentioned, the method for establishing its ground truth is also not described. The device's foundational data relies on the principles of radiation dosimetry and verified TPS data.
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March 13, 2018
Image /page/0/Picture/1 description: The image shows 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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
DOSIsoft S.A. % Mr. Luc DIOT Quality Director 45/47, avenue Carnot 94230 Cachan FRANCE
Re: K180106
Trade/Device Name: ThinkOA Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 29, 2017 Received: January 16, 2018
Dear Mr. Diot:
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.
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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 mediation-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,
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180106
Device Name ThinkQA
Indications for Use (Describe)
ThinkQA is a radiation therapy dosimetry Quality Assurance (QA) device consisting of a software framework intended to contain a suite of modules to verify that radiation dose actually delivered to the patient is as intended.
The Epibeam module contained in ThinkQA is intended to be used as follows:
Epibeam is a standalone software tool independent of the linear accelerator, the TPS and the Record-and-Verify system. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery. It is to be used by a radiation oncology medical professional as a guide to provide pretreatment plan delivery verification.
The software is to be used for the purposes of detecting errors in the delivery of radiation therapy prior to treatment, like corruption of the transferred plan data to the treatment unit, inappropriate multileaf collimator sequence or beam output malfunctioning. The software acquires data from the Electronic Portal Imaging Device (EPID) during a blank fraction dedicated to the pretreatment verification without the patient and subsequently processes it. The processed data is compared with data calculated by the Epibeam system. The comparison is derived on one hand, from the application of dose conversion to the EPID data and on the other hand, from the computation of a predicted dose image under ideal conditions of functioning. A gamma-index analysis is then performed according to the dose difference and distance-to-agreement criteria provided by the user.
Epibeam is not a treatment planning system and cannot be used to generate radiotherapy treatment plans. It provides an independent means of checking the reliability of the dose delivery for each beam in reference to TPS data.
Epibeam therefore provides an added level of treatment quality assurance, thus giving clinicians confidence especially when complex treatment techniques are employed (gantry-fixed and rotational intensity modulated radiation therapy).
Epibeam is intended to support decision making in relation to the delivery of treatment plan to the patient with every clinical linear accelerators equipped with an EPID, but does not alter the existing Indications for Use of the treatment unit.
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.
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Image /page/4/Picture/0 description: The image shows the word "DOSI" in a bold, serif font, followed by a blue butterfly logo, and the word "soft" in a thin, sans-serif font. The word "DOSI" is in black, and the word "soft" is in gray. The butterfly logo is blue with red arrows pointing towards it.
Image /page/4/Picture/1 description: The image is a blue circular seal that says "CERTIFIED" at the top and has the number "73485" at the bottom. The letters "iSO" are in the center of the seal in a sans-serif font. There are two red arrows on either side of the letters "iSO".
Premarket Notification 510(k) Summary
[as required bv 21 CFR 807.92]
510(k) Summary
1. Date the Summary was prepared: 2017-12-08
2. Submitter:
| Company Name: | DOSIsoft SA |
|---|---|
| Address: | 45-47, Avenue Carnot94230 CACHAN - France |
| Phone No.: | +33 1 41 24 26 26 |
| Fax No.: | +33 1 41 24 26 28 |
| Contact Name: | Mr. Marc USZYNSKI |
3. Device Information:
| Proprietary Name: | ThinkQA |
|---|---|
| Trade Names: | ThinkQA, EPIbeam |
| Common Name: | Standalone software quality control system |
| Classification Name: | Medical charged-particle radiation therapy system(Class II, 21 CFR 892.5050, Product Code IYF) |
4. Predicate Device:
K133572 - ARIA Radiation Therapy Management - "Enhanced Portal Dosimetry gamma evaluation" feature - Varian Medical Systems, Inc.
Executive Summary
5. Product Description:
ThinkQA is a modular software suite composed of the module Epibeam which is a quality assurance tool dedicated to Patient Specific QA for pretreatment verification of irradiation beams.
The EPIbeam verification module integrated to the ThinkOA software platform is a Quality Assurance tool in external beam radiation therapy, used in combination with the electronic portal imaging device (EPID) and dedicated to the irradiation beam pre-treatment verifications, particularly for IMRT and VMAT techniques.
EPIbeam principle is based on the comparison of two images expressed in terms of absolute dose: on the one hand, a RT Plan defined in the TPS is used for the acquisition of a real portal image (test image) with the EPID directly irradiated (without attenuating medium); on the same RT Plan is used to compute a theoretical portal image (reference image). Specific models and algorithms are applied to express both images in the same absolute dose terms.
The dose images obtained from the same RT Plan, one by the conversion model of the acquired raw EPID images and the other by the prediction model, can be quantitatively compared through dose difference mappings or 2D gamma-index. Both models are based on dosimetric data provided from the TPS.
6. Intended Use and User profiles:
ThinkQA is a modular software suite composed of the module EPIbeam which is a quality assurance tool dedicated to Patient Specific QA for pretreatment verification of irradiation beams.
The intended Use for the EPIbeam module contained in ThinkQA product is as follows:
EPIbeam is a standalone software tool independent of the linear accelerator, the TPS and the Record-and-Verify system. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery. It is to be used by a radiation oncology medical professional as a guide to provide pretreatment plan delivery verification.
4230 Cachan - France
+33 (0)1 41 24 26 26
+33 (0)1 41 24 26 28
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Image /page/5/Picture/0 description: The image shows the word "DOSI" in a bold, serif font, followed by a blue butterfly outline, and then the word "soft" in a thin, sans-serif font. The butterfly is positioned between the two words, acting as a visual element that connects them. The overall design is clean and modern, with a focus on typography and a simple color palette.
Image /page/5/Picture/1 description: The image is a blue and white circular logo that says "CERTIFIED" at the top and has the letters "ISO" in the center. There are two arrows on either side of the letters "ISO". At the bottom of the logo is the number "73485" with a dot on either side of the number.
The software is to be used for the purposes of detecting errors in the delivery of radiation therapy prior to treatment, like corruption of the transferred plan data to the treatment unit, inappropriate multileaf collimator sequence or beam output malfunctioning. The software acquires data from the Electronic Portal Imaging Device (EPID) during a blank fraction dedicated to the pretreatment verification without the presence of the patient and subsequently processed data is compared with data calculated by the EPIbeam system. The comparison is derived on one hand, from the application of dose conversion to the EPID data and on the other hand, from the computation of a predicted dose image under ideal conditions of functioning. A gamma-index analysis is then performed according to the dose difference and distance-to-agreement criteria provided by the user.
EPlbeam is not a treatment planning system and cannot be used to generate radiotherapy treatment plans. It provides an independent means of checking the reliability of the dose delivery for each beam in reference to TPS data.
EPIbeam therefore provides an added level of treatment quality assurance, thus giving clinicians confidence especially when complex treatment techniques are employed (gantry-fixed and rotational intensity modulated radiation therapy).
EPIbeam is intended to support decision making in relation to the delivery of treatment plan to the patient with every clinical linear accelerators equipped with an EPID, but does not alter the existing Indications for Use of the treatment unit.
7. Technological Characteristics Summary:
The detailed technological characteristics and the substantial equivalence discussion as included in the body of the 510(k) submission support the claim that ThinkQA and its EPIbeam module technological characteristics and indication for use are substantially equivalent to that of its predicate device ARIA Radiation Therapy Management – "Enhanced Portal Dosimetry gamma evaluation" feature – K133572.
The table below compares the device functionalities of ThinkOA / EPIbeam and Portal Dosimetry component of ARIA Radiation Therapy Management product (K133572).
| Functionality | Think QAEPIbeamDOSIsoft SA(this submission) | Portal DosimetryVarian Medical Systems |
|---|---|---|
| FDA Control Number | - | K133572 |
| CE Marked | Yes | Yes |
| Pretreatment check | Yes | Yes |
| Independent software | Yes | Only compatible with Varianhardware and software |
| Pretreatment images | Yes | Yes |
| Algorithm for computing predicted referencedose image | Yes | Yes (Eclipse TPS - PDIP) |
| Algorithm for converting acquired portalimage into dose image | Yes | Yes |
| Compares measured dose image to thereference dose image according to gamma-index analysis | Yes | Yes |
| Generates a report for the reviewer | Yes | Yes |
| Results include gamma agreement indexper beam | Yes | Yes |
| Results include significant statistic gammaindex values per beam | Yes | Yes |
| Ability to view test and reference images | Yes | Yes |
| Ability to view superimposed test/referencedose profiles | Yes | Yes |
| Ability to view 2D gamma index distribution | Yes | Yes |
| Patient control database | Yes | Yes (ARIA database) |
| User defined Alert Criteria for out oftolerance analysis | Yes | Yes |
4230 Cachan - France
- +33 (0)1 41 24 26 26 | +33 (0)1 41 24 26 28 |
info@dosisoft.com www.dosisoft.com
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Image /page/6/Picture/0 description: The image shows the word "DOSIsoft" with a butterfly image in between the two words. The word "DOSI" is in a bold, serif font, while the word "soft" is in a thinner, sans-serif font. The butterfly image is a simple outline of a butterfly, with a blue fill and a darker blue outline.
Image /page/6/Picture/1 description: The image is a blue and white circular logo that says "CERTIFIED ISO" in a circular pattern. The word "ISO" is in the center of the circle in a sans-serif font. There are two red arrows on either side of the word "ISO". The number "73485" is at the bottom of the circle.
| Import Approved Plan data from TreatmentPlanning System | Yes | Yes (ARIA database) |
|---|---|---|
| Import Portal Images from pretreatmentfraction | Yes | Yes |
| Analysis performed automatically offline | Yes | Yes |
| Multiple treatment techniques | Static, IMRT, VMAT | IMRT, VMAT (RapidARC) |
| EPID panel Calibration required forcommissioning | Yes | Yes |
| TPS results for dose data reference | Yes | Yes |
The substantial equivalence discussion sustains the claim that ThinkQA software and its EPIbeam module intended use, clinical, technical (principles of operation, functionalities and critical performances) and biological characteristics are the same as for the predicate device Portal Dosimetry component of ARIA Radiation Therapy Management product CE marked and legally marketed in the U.S. (K133572).
In summary, DOSIsoft therefore considers that, in its opinion, ThinkOA / EPIbeam is substantially equivalent and is as safe and effective as the predicate device.
8. Performance Testing - Bench:
ThinkQA software was submitted to performance, functional and algorithmic testing.
The results of performance, functional and algorithmic testing demonstrate that ThinkOA meets the requirements of the device, which are demonstrated to be substantially equivalent to those of the predicate device.
ThinkQA software underwent unit, integration and system tests. All test cases were documented with the results showing that acceptance criteria were met.
Validation of the system under clinically representative conditions has been performed. Results from verification and validation testing demonstrate that conformance to applicable technical design specification has been met and that safety and effectiveness have been achieved.
Regression testing was also successfully performed.
All product requirements can be traced to the test results.
Performance Testing Conclusions:
The conclusions of the verification and validation activities are that the safety, performances and benefit / risk ratio under normal conditions of use met device requirements.
The substantial equivalence discussion and the performance testing conclusions demonstrate that ThinkQA is substantially equivalent to and performs at least as safely and effectively as its predicate device.
+33 (0)1 41 24 26 26 | (0)1 41 24 26 28
§ 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.