(266 days)
The SOFTDISO system is a standalone software solution designed to be used by medical physicists, radiation oncologists, and dosimetrists to have an overview of the treatment plans delivered from Treatment Systems (LINAC Systems using high energy x-rays) to the patient. This solution is to be used as a quality control check purposes only.
SOFTDISO does not provide any conclusions or policy for interpretation of the results based on the comparison results data. The output from SOFTDISO cannot be and must not be used for changing the planning or treatment strategy or as a means of proving the effectiveness of the quality control process/chain during treatment. It is the physician's responsibility to verify the working of the quality control process/chain and the correctness of the dose delivered.
SOFTDISO software permit an IN-VIVO dosimetric analysis (IVD) in patient for 3DCRT, IMRT and VMAT beams using a Si-EPID portal systems.
The dosimetric analysis consists of two tests elaboration, dose reconstruction in the isocenter point and EPID images y-analysis. In case of out of tolerance levels, the system is capable of underline the right type of quality control useful to remove the causes of discrepancy.
SOFTDISO software is based on the usage of generalized correlation factors between transit signals measured by EPID and doses measured in water equivalent solid phantom, along the beam central axis.
SOFTDISO software uses generalized functions taken from measurements of 70 beams of Varian, Elekta and Siemens linacs. So only a small set of dosimetric measurements must be performed by the user for the software commissioning, and some of those measurements are already performed during the linac's beams calibration. In particular some of the measurements that the user performs include calculating the beam dose in cGy/UM in reference conditions (field 10.10 cm2 at drif =10 cm depth), the beam quality indicator (TPR20, 10) and the attenuation factor WF for wedged beams. The user also performs a measure of the EPID signal in reference condition (field 10.10 cm2 at SED distance) for EPID calibration.
SOFTDISO software can use information coming from record and verify systems through DICOM and DICOM-RT protocols. DICOM protocol is used for transferring images from CT and from EPID and the DICOM-RT protocol is used for transferring information related to the TPS system.
The provided document describes the K170345 510(k) submission for the SOFTDISO device. Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| R ratios for 3DCRT within ± 5% | All 192 tests for 3DCRT were within ± 5% |
| Gamma analysis (y%) for 3DCRT ≥ 95% | All 192 tests for 3DCRT were ≥ 95% |
| Gamma analysis (ymean) for 3DCRT ≤ 0.3 | All 192 tests for 3DCRT were ≤ 0.3 |
| R ratios for IMRT within ± 5% | All 48 tests for IMRT were within ± 5% |
| Gamma analysis (y%) for IMRT ≥ 95% | All 48 tests for IMRT were ≥ 95% |
| Gamma analysis (ymean) for IMRT ≤ 0.3 | All 48 tests for IMRT were ≤ 0.3 |
| R ratios for VMAT within ± 5% | All 60 tests for VMAT were within ± 5% |
| Gamma analysis (y%) for VMAT ≥ 95% | All 60 tests for VMAT were ≥ 95% |
| Gamma analysis (ymean) for VMAT ≤ 0.3 | All 60 tests for VMAT were ≤ 0.3 |
| Ease of setup and use | Indicated SOFTDISO was easy to setup and use |
| Average analysis time per patient | Approximately 2.5 minutes per patient |
| Ability to identify errors during treatment (e.g., patient setup, laser misalignment, TPS beam-implementation, patient morphological changes) | Was able to identify errors that occur during treatment (e.g., patient setup, laser misalignment, TPS beam-implementation) and patient morphological changes (e.g., tumor shrinkage, gas pockets, loss of patient weight) |
Study Details
2. Sample size used for the test set and the data provenance
- External Validation (Dosimetry Accuracy):
- 3DCRT: 192 tests
- IMRT: 48 tests
- VMAT: 60 tests
- Data Provenance: Conducted at "three different clinical sites" for 3DCRT and IMRT, and "two different clinical sites" for VMAT. The document does not specify the country of origin, but "clinical sites" suggests real-world patient or phantom data. This appears to be prospective data collection as part of validation, though the exact nature (e.g., real patient treatments vs. carefully controlled phantom experiments) is not fully detailed.
- Clinical Validation (Usability and Error Detection):
- Usability: 1287 treatments
- Error Detection: 823 patient data (340 3DCRT, 483 VMAT treatments)
- Data Provenance: The document states "Clinical validation was performed by applying in-vivo dosimetry checks on 1287 treatments" and "performed on 823 patient data." This strongly suggests retrospective or prospective use of real patient data from clinical settings. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications for the test set. The Indications for Use state that "It is the physician's responsibility to verify the working of the quality control process/chain and the correctness of the dose delivered," implying that medical physicists, radiation oncologists, and dosimetrists are involved in the overall quality control process. However, for the validation studies themselves, the method for establishing ground truth and the experts involved are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for the test set.
5. 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not described. The validation focused on the performance of the device itself against established dosimetric tolerances and its ability to identify errors, rather than directly comparing human reader performance with and without the device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was performed as part of the "External validation to validate the accuracy of dosimetry procedure." This involved evaluating the R ratios and gamma analysis indexes of the SOFTDISO software against preset tolerance levels (e.g., ± 5% for R ratios, ≥ 95% for γ%, ≤ 0.3 for γmean). This directly assesses the algorithm's accuracy in comparing planned and measured doses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth appears to be based on dosimetric comparison against established tolerance levels.
- For the R ratios, the implicit ground truth is the "planned dose" from the Treatment Planning System (TPS) and the "measured dose" from the EPID, with the expectation that these should match within a certain tolerance.
- For the gamma analysis, the ground truth is again the comparison between a "reference EPID image" (likely related to the planned dose distribution) and a "current one," with deviation measured against industry-standard gamma criteria.
- For the clinical validation identifying errors, the ground truth for "errors" (patient setup, laser misalignment, TPS beam-implementation, patient morphological changes) would likely be established through independent clinical assessment or follow-up by the medical physicists and oncologists at the sites. The document doesn't detail how these "errors" were definitively confirmed as ground truth for the study.
8. The sample size for the training set
The document states, "SOFTDISO software uses generalized functions taken from measurements of 70 beams of Varian, Elekta and Siemens linacs." This indicates that these 70 beams likely formed part of the training or commissioning data used to develop these generalized functions within the software, which then allows for site-specific commissioning with a smaller dataset. The exact nature of this "training set" for a machine learning context is not detailed, but the 70 beams are the most relevant number provided for the model's underlying data.
9. How the ground truth for the training set was established
For the "generalized functions taken from measurements of 70 beams," the ground truth was established through direct physical measurements. The text mentions:
- "measurements of 70 beams of Varian, Elekta and Siemens linacs."
- "Small set of dosimetric measurements must be performed by the user for the software commissioning, and some of those measurements are already performed during the linac's beams calibration."
- Specifically highlights measurements for "calculating the beam dose in cGy/UM in reference conditions (field 10.10 cm2 at drif =10 cm depth), the beam quality indicator (TPR20, 10) and the attenuation factor WF for wedged beams," and "a measure of the EPID signal in reference condition (field 10.10 cm2 at SED distance) for EPID calibration."
This indicates that the ground truth for the "training" data (the 70 beams and
user-performed commissioning measurements) was established through physical dosimetric measurements performed by qualified personnel (likely medical physicists) in a controlled environment.
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October 27, 2017
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Best NOMOS % Vineet Gupta, Ph.D. Director-R&D One Best Drive PITTSBURGH PA 15202
Re: K170345
Trade/Device Name: SOFTDISO Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 5, 2017 Received: October 10, 2017
Dear Dr. Gupta:
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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Robert Oaks
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) K170345
Device Name
SOFTDISO
Indications for Use (Describe)
The SOFTDISO system is a standalone software solution designed to be used by medical physicists, radiation oncologists, and dosimetrists to have an overview of the treatment plans delivered from Treatment Systems using high energy x-rays) to the patient. This solution is to be used as a quality control check purposes only.
SOFTDISO does not provide any conclusions or policy for interpretation of the results based on the comparison results data. The output from SOFTDISO cannot be and must not be used for changing the planning or treatment strategy or as a means of proving the effectiveness of the quality control process/chain during treatment. It is the physician's responsibility to verify the working of the quality control process/chain and the correctness of the dose delivered.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
x | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) Summary
A. SUBMITTERS NAME
Best NOMOS
B. ADDRESS
One Best Drive Pittsburgh, PA 15202
C. CONTACT
| Name: | Vineet Gupta, Ph.D. |
|---|---|
| Phone: | (412) 312-6819 |
| Fax: | (412) 312-6701 |
| Email: | vineet.gupta@nomos.com |
D. DATE PREPARED
Date: 5-Oct-2017
E. ESTABLISHMENT REGISTRATION NUMBER
Corporate Office Registration Number: 2434141 Manufacturing and Packaging Registration Number: 2434141
F. DEVICE NAME
Device Trade Name: SOFTDISO Standalone Software Quality Control System Common Name: Medical Charged Particle Radiation Therapy System (21 CFR Classification Name: 892.5050)
G. DEVICE CLASS
Class II Panel: Radiology Product Code: IYE Regulation Number: 21CFR 892.5050
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H. STATEMENT OF INDICATIONS FOR USE
The SOFTDISO system is a standalone software solution designed to be used by medical physicists, radiation oncologists, and dosimetrists to have an overview of the treatment plans delivered from Treatment Systems (LINAC Systems using high energy x-rays) to the patient. This solution is intended to be used as a quality control check purposes only.
SOFTDISO checks the correctness of the treatment by comparing the planned dose (from a treatment planning system) with the applied dose measured from the Electronic Portal Imaging Device (EPID) during treatment delivery and presents the results. SOFTDISO does not provide any conclusions or policy for interpretation of the results based on the comparison results data. The output from SOFTDISO cannot be and must not be used for changing the planning or treatment strategy or as a means of proving the effectiveness of the quality control process/chain during treatment. It is the physician's responsibility to verify the working of the quality control process/chain and the correctness of the dose delivered.
DEVICE DESCRIPTION I.
SOFTDISO software permit an IN-VIVO dosimetric analysis (IVD) in patient for 3DCRT, IMRT and VMAT beams using a Si-EPID portal systems.
The dosimetric analysis consists of two tests elaboration, dose reconstruction in the isocenter point and EPID images y-analysis. In case of out of tolerance levels, the system is capable of underline the right type of quality control useful to remove the causes of discrepancy.
SOFTDISO software is based on the usage of generalized correlation factors between transit signals measured by EPID and doses measured in water equivalent solid phantom, along the beam central axis.
SOFTDISO software uses generalized functions taken from measurements of 70 beams of Varian, Elekta and Siemens linacs. So only a small set of dosimetric measurements must be performed by the user for the software commissioning, and some of those measurements are already performed during the linac's beams calibration. In particular some of the measurements that the user performs include calculating the beam dose in cGy/UM in reference conditions (field 10.10 cm2 at drif =10 cm depth), the beam quality indicator (TPR20, 10) and the attenuation factor WF for wedged beams. The user also performs a measure of the EPID signal in reference condition (field 10.10 cm2 at SED distance) for EPID calibration.
SOFTDISO software can use information coming from record and verify systems through DICOM and DICOM-RT protocols. DICOM protocol is used for transferring images from CT and from EPID and the DICOM-RT protocol is used for transferring information related to the TPS system.
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As soon as the treatment plan and the EPID images (fraction images for each day) are imported into the system, the user is able to visualize the comparison results.
At the end of fraction SOFTDISO provides result for two tests:
- Calculation of R ratio between in patient reconstructed dose and the one planned by the TPS
- Gamma analysis between a reference EPID image and a current one with Py<1 € Ymean . indexes
SOFTDISO can print the tests results and once signed by a Medical Physicist it can become part of the patient's clinical folder. The patient images and the comparison results are stored in the system's internal database for easy access at any time.
J. PREDICATE DEVICE INFORMATION
The predicate devices identified within this submission are as follows:
- a. Math Resolution, LL, Dosimetry Check with Exit Dose (510(K) No. K101503 (Decision Date: 04-August-2010)).
K. COMPARISON TO THE PREDICATE DEVICE
This section provides the summary of comparison of SOFTDISO to the predicate device.
| Proposed DeviceSOFTDISO | Predicate DeviceDosimetry Check with Exit Dose(K101503) | |
|---|---|---|
| Indications forUse | The SOFTDISO system is astandalone software solution designedto be used by medical physicists,radiation oncologists, and dosimetriststo have an overview of the treatmentplans delivered from TreatmentSystems (LINAC Systems using highenergy x-rays) to the patient. Thissolution is to be used as a qualitycontrol check purposes only.SOFTDISO does not provide anyconclusions or policy forinterpretation of the results based onthe comparison results data. Theoutput from SOFTDISO cannot be | The product is to be used by radiationoncologist, dosimetrist, and radiationtherapy physicist to check thecorrectness of the x-ray treatmentfields from high energy treatmentmachines that are planned to be orhave been applied to a patient. Thisproduct is to be used in addition tothe treatment planning system toprovide a means for additional andredundant verification that the plan isin fact successfully accomplished.This product is not a treatmentplanning system and is not to be usedas one. This product only checks theapplied dose based on the |
Table 1 Indications for Use & Intended Use Comparison
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| and must not be used for changingthe planning or treatment strategy oras a means of proving theeffectiveness of the quality controlprocess/chain during treatment. It isthe physician's responsibility toverify the working of the qualitycontrol process/chain and thecorrectness of the dose delivered. | measurement of each x-ray field anda theoretical calculation. This productdoes not provide any qualityassurance that the fields are. in factcorrectly applied to and correctlyaligned with the patient anatomy asplanned. In addition, the product maybe used to display the above dose onother fused image sets which couldprovide additional clinicalinformation to the radiationoncologist regarding the treatment. |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Comparison Item | Proposed DeviceSOFTDISO | Predicate DeviceDosimetry Check with ExitDose (K101503) |
|---|---|---|
| Classification Name | Quality Control For MedicalCharged Particle RadiationTherapy System | Quality Control For MedicalCharged Particle RadiationTherapy System |
| Product Code | IYE | IYE |
| Class | II | II |
| Regulation Number | 892.5050 | 892.5050 |
Table 2 General Comparison
The indications for use for both the proposed device (SOFTDISO) and the Predicate Device (Dosimetry Check with Exit Dose) are similar. Both the devices are intended to be used as QA check to determine the correctness of the dose delivery by using the planned dose and delivered dose as input to the software to generate the report of differences. Both the devices use the planning images and exit images, and are designed to work only on photons (x-rays). Since the target population, indications for use, intended use, and the technical features of the proposed device (SOFTDISO) are similar to that of the predicate device, any minor difference in features do not raise any concerns for safety, performance, or effectiveness of the device; thus indicating that the proposed device is substantially equivalent to its predicate device. The characteristics/features of SOFTDISO with respect to the predicate device is described in detail the comparison chart in the submission. The similarities and differences are discussed in detail as part of this submission.
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L. SUMMARY OF TESTING
Design verification and validation testing was performed to ensure that the device functionality works as per its intended use, all risks are mitigated, and the product conforms to the required standards. The details of the design verification and validation activities are explained in the submission.
Non-Clinical Testing:
Non-clinical testing included functional testing, performance testing, verification of risk control measures implemented in the software, and installation testing.
Validation:
External validation to validate the accuracy of dosimetry procedure for 3DCRT was performed at three different clinical sites. The results of R ratios for all 192 tests performed were within the acceptable tolerance of ± 5%. The y% and ymean indexes for all tests were ≥ 95% and ≤ 0.3 respectively.
To validate the accuracy of dosimetry procedure for IMRT and VMAT, external validation was performed at three and two different clinical sites respectively. The results of the R ratios for 48 tests for IMRT was well within the acceptable tolerance of ± 5%. The results of the R ratios for 60 tests for VMAT were well within the acceptable tolerance of ± 5%. The y% and Ymean indexes for all tests for IMRT and VMAT were ≥ 95% and ≤ 0.3 respectively.
Clinical validation was performed by applying in-vivo dosimetry checks on 1287 treatments. The results of the in-vivo dosimetry check indicated that SOFTDISO was easy to setup and use. The average analysis time was about 2.5 mins per patient (2 hours for an average of 50 patients/day).
Clinical validation was performed on 823 patient data who underwent 3DCRT (340) and VMAT (483) treatments. The results of the study indicated that the SOFTDISO system was able to identify errors that occur during treatment that were a result of inadequate quality controls (for example: patient setup, laser misalignment. TPS beam-implementation) and patient morphological changes (for example: tumor shrinkage, gas pockets, loss of patient weight).
Conclusion:
Detailed results of these tests are included as part of this submission. The verification and validation results demonstrate that the SOFTDISO system met its design requirements and specifications, is safe and effective to use for its intended purpose, and conforms to the applicable sections of standards that includes IEC 63204:2006: Medical device software - Software life cycle processes, BS EN 62366:2008: Medical devices -Application of usability engineering to medical devices.
§ 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.