(86 days)
Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of x-ray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to be or have been applied to a patient, and computing the dose to the patient from the measured radiation fields. This product is to be used as a quality control check for the treatment planning system and delivery system.
Dosimetry Check quality control software uses the radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose and dose distribution using the patient specific CT or other image set or alternately a phantom that is likewise scanned. to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific points as compared to the patient specific radiation treatment plan.
Dosimetry Check does not provide any conclusions regarding the comparisons and does not provide any criteria to be used for interpreting the results. The experienced radiological physicist can reevaluate his patient specific radiation treatment plan in accordance with his clinical judgment.
This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition. the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.
System 2100 for which 510(k) K993530 was cleared by the FDA on December 15, 1999 that is a medical image display system serves as a foundation that provides basic image display functionality for Dosimetry Check.
Dosimetry Check is a software program that will compute the dose and dose distribution to the patient from a measurement of the radiation fields that are applied to the patient. The dose so computed serves as a means to verify the correctness of the radiation treatment and to serve as a final sanity check. The radiation fields are measured with media such as x-ray film or electronic devices that will measure over the area of the field, such as electronic portal imaging devices (EPID), or diode or ion chamber arrays.
To extend Dosmetry Check to support the TomoTherapy machine, the device uses the data measured by the fan beam radiation detector that is part of the TomoTherapy machine. The detectors capture the radiation intensity periodically at predetermined gantry angles and couch positions. known as control points, from the treatment plan. The detector only measures the intensity across the center of the radiation beam in the transverse plane. A prior measured profile in the perpendicular longitudinal direction is then applied to complete the radiation field map. The radiation field map is then applied as a stationary beam at the center gantry angle and couch position for the integration period (between two control points), from which the dose to the patient is computed. The patient dose is then summed up from all such radiation field maps.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the Dosimetry Check version 4 release 1. Instead, it relies on demonstrating equivalence to the predicate device and successful external validation. The performance is reported qualitatively.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions as intended for quality control of TomoTherapy. | "The conclusions of the beta test results submitted demonstrated the safety and performance of the Dosimetry Check software for its intended use and that it can be used by its intended users to compute the dose from the TomoTherapy detector as a quality tool for radiation treatments on that machine." |
| Safety and effectiveness demonstrated. | "The successful non-clinical testing and external validation demonstrates the safety and effectiveness of the Dosimetry Check Version 4 Release 1 when used for the defined indications for use..." |
| Performs as well as or better than the predicate device. | "...and demonstrates that the device for which this 510(k) is submitted performs as well as or better than the legally marketed predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly quantifiable from the provided text in terms of individual patient cases or measurements. The external validation was performed at 2 sites in Europe and 3 sites in the US. The text mentions "All aspects of using Dosimetry Check for quality control for TomoTherapy were tested during the beta testing." This suggests a comprehensive evaluation rather than a fixed number of cases.
- Data Provenance (Retrospective/Prospective, Country of Origin): The external validation involved prospective "beta testing" at 2 sites in Europe and 3 sites in the US. It doesn't specify if the data used for internal testing (modular, regression, verification) was retrospective or prospective, or its origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions that the device is "intended to be used by an experienced radiological physicist for quality control purposes only." It is implied that these "experienced radiological physicists" at the beta test sites would be the ones evaluating the device's output against their clinical judgment or established facility standards, effectively forming the "ground truth" for the device's utility in their context.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1). The "beta testing" implies evaluation by the "intended users" (experienced radiological physicists), but the process of reaching consensus or resolving discrepancies is not described.
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
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a quality control software for dose calculation and comparison, not an AI-assisted diagnostic tool for human readers. It's intended to verify treatment plans, not to assist humans in interpreting images or making diagnoses in the typical MRMC study context. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in essence. Dosimetry Check is described as "standalone software" and its primary function is to "compute the dose and dose distribution" and "compare to the plan dose." While it is used by an "experienced radiological physicist," the software itself performs the calculation and comparison autonomously. The physicist then interprets the results. This aligns with the concept of standalone algorithmic performance in its core function. The "Nonclinical Testing" (modular, regression, verification, installation, performance testing) likely evaluated the algorithm's standalone accuracy in these computations.
7. The Type of Ground Truth Used
The ground truth used for assessing the device appears to be the patient-specific radiation treatment plan (planned dose) against which the device calculates and compares a "reconstructed dose" from measured radiation fields. The text states: "...to calculate the reconstructed dose that is then compared to the plan dose." The overall evaluation of performance during external validation would be based on whether the device's output (the comparison) was deemed acceptable and useful by the "experienced radiological physicist" in their quality control workflow.
8. The Sample Size for the Training Set
The document does not explicitly state a sample size for a training set. Given the nature of this software (dose calculation and comparison based on physical principles), it's more likely developed using well-established physics models and possibly calibrated with phantom measurements, rather than being "trained" on a large dataset in the machine learning sense. The kernel for deconvolution in the predicate device (Dosimetry Check version 3) was derived from "phantom measurements," which might be analogous to a calibration or parameter tuning set, but not a typical "training set" for AI.
9. How the Ground Truth for the Training Set was Established
As there's no explicit "training set" mentioned in the context of machine learning, the question isn't directly applicable. However, if we consider calibration or model parameter derivation:
- For the predicate device, the "kernel" used in the deconvolution process was "derived prior from phantom measurements with the same imaging device or media." This suggests the ground truth for these derivations would be known physical properties of phantoms and direct measurements using established dosimetry techniques.
- For the modified device, the extension to TomoTherapy uses a "fan beam radiation detector" and "a prior measured profile in the perpendicular longitudinal direction is then applied to complete the radiation field map." The establishment of these "prior measured profiles" would similarly rely on physical measurements and known ground truth for radiation fields.
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K132605
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510(k) Summary for Dosimetry Check Version 4 Release 1
| Submitter's Name | Math Resolutions, LLC |
|---|---|
| Address | 5975 Gales LaneColumbia, MD USA 21045 |
| EstablishmentRegistrationNumber | 1833314 |
| Date of Summary | September 17, 2013 |
| TelephoneNumber | (410) 997-9578 |
| WDRenner@MathResolutions.com | |
| Contact Person | Wendel Dean Renner |
| Name of theDevice | Dosimetry Check version 4 release 1 |
| Common or UsualName | Standalone Software Quality Control System |
| ClassificationName | Quality Control for Medical Charged-particle Radiation Therapy Systems. 21 CFR892.5050 |
| Indications forUse | Dosimetry Check is a standalone software product intended to be used by anexperienced radiological physicist for quality control purposes only. DosimetryCheck is intended to check the correctness of x-ray treatment plans delivered fromhigh energy charged-particle radiation therapy treatment machines by using ameasurement of the applied radiation fields that are planned to be or have beenapplied to a patient, and computing the dose to the patient from the measuredradiation fields. This product is to be used as a quality control check for thetreatment planning system and delivery system.Dosimetry Check quality control software uses the radiation fields that aremeasured with media such as x-ray film, electronic portal imaging devices (EPID),diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detectorarray, and provides a theoretical calculation. Dosimetry Check computes the doseand dose distribution using the patient specific CT or other image set or alternatelya phantom that is likewise scanned. to calculate the reconstructed dose that is thencompared to the plan dose. The results reported can include the computed percentdifference at specific points as compared to the patient specific radiation treatmentplan.Dosimetry Check does not provide any conclusions regarding the comparisons anddoes not provide any criteria to be used for interpreting the results. Theexperienced radiological physicist can reevaluate his patient specific radiationtreatment plan in accordance with his clinical judgment. |
| NOV 1 4 2013 |
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Indications for Use This product is not a treatment planning system and is not to be used as onc. cont.
This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition. the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.
| Identification of theLegally MarketedDevice (PredicateDevice) | Dosimetry Check version 3 release 1, K101503 |
|---|---|
| DeviceDescription | System 2100 for which 510(k) K993530 was cleared by the FDA onDecember 15, 1999 that is a medical image display system serves as afoundation that provides basic image display functionality for DosimetryCheck. |
| Dosimetry Check is a software program that will compute the dose anddose distribution to the patient from a measurement of the radiation fieldsthat are applied to the patient. The dose so computed serves as a meansto verify the correctness of the radiation treatment and to serve as a finalsanity check. The radiation fields are measured with media such as x-rayfilm or electronic devices that will measure over the area of the field,such as electronic portal imaging devices (EPID), or diode or ionchamber arrays. |
To extend Dosmetry Check to support the TomoTherapy machine, the device uses the data measured by the fan beam radiation detector that is part of the TomoTherapy machine. The detectors capture the radiation intensity periodically at predetermined gantry angles and couch positions. known as control points, from the treatment plan. The detector only measures the intensity across the center of the radiation beam in the transverse plane. A prior measured profile in the perpendicular longitudinal direction is then applied to complete the radiation field map. The radiation field map is then applied as a stationary beam at the center gantry angle and couch position for the integration period (between two control points), from which the dose to the patient is computed. The patient dose is then summed up from all such radiation field maps.
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Intended Use for Predicate Device: Dosimetry Check version 3 release 1
Dosimetry Check with Exit Dose is a software program intended to provide a means for testing the dosimetry of radiation therapy treatments applied to a patient using high energy x-rays. This test is performed from measurements made during treatment of the patient by measuring the radiation fields after they have passed through the patient with a suitable imaging device such as an electronic portal imaging device or other measuring devices or media. The following software functions are then performed:
- I. The patient's CT scan treatment plan image set is traced to provide the water equivalent path to points on the measured exit dose plane.
-
- A deconvolution process is performed with a kernel that is a function of radius and the thickness transversed to convert the exit images back to x-ray intensity in air fluence prior to patient entry. The kernel is derived prior from phantom measurements with the same imaging device or media.
-
- The derived in air fluence is now the same starting point as when the radiation fields are measured directly prior to patient entry.
Intended Use for Modified Device: Dosimetry Check version 4 release 1
Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of xray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to be or have been applied to a patient, and computing the dose to the patient from the measured radiation fields. This product is to be used as a quality control check for the treatment planning system and delivery system.
Dosimetry Check quality control software uses the radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTheraov, a fan line detector arrav, and provides a theoretical calculation. Dosimetry Check computes the dose and dose distribution using the patient specific CT or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific points as compared to the patient specific radiation treatment plan.
Dosimetry Check does not provide any conclusions regarding the comparisons and does not provide any criteria to be used for interpreting the results. The experienced radiological physicist can reevaluate his patient specific radiation treatment plan in accordance with his clinical judgment.
This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field applied to the patient and provided in an exported file, and a theoretical calculation. This product does not provide any quality assurance that the fields are in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional supportive quality information to the user regarding the correctness of treatment.
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Device Comparison Table
·
| Features | PredicateDosimetry Checkversion 3 release 1K101503 | Modified DeviceDosimetry Checkversion 4 release 1K132605 |
|---|---|---|
| Pre-treatment images | Yes | Yes |
| Exit images | Yes | Yes |
| Compute dose to patient | Yes | Yes |
| Compare to planning system dose | Yes | Yes |
| Used for verifying the correctness of radiation therapytreatments | Yes | Yes |
| Uses a line in the transverse plane through the radiationfield measurement provided to Dosimetry Check. A priormeasured longitudinal profile is applied to each detectorsignal to complete the radiation field. | No | Yes |
| Generates a report as described in the Dosimetry Checkmanual using either the auto-report feature, or the usermay construct their own report using the evaluate tools. | Yes | Yes |
| Installed by downloading the software from the MathResolutions web site athttp://www.mathresolutions.com/downlprg.htm | Yes | Yes |
| Photons (x-ray) | Yes | Yes |
| Electrons | No | No |
| Protons | No | No |
| Ability to use the TomoTherapy detector data measured ina pretreatment dry run without the patient and the detectordata taken during treatment | No | Yes |
| Operating Systems | Microsoft Windows XP.Windows Vista. Windows7. and Ubuntu 9.04(Linux) | Microsoft Windows XP.Windows Vista. Windows7. and Ubuntu 9.04 (Linux) |
| Hardware needed but not provided | Open GL capablegraphics card is requiredwith 24 true color and adepth buffer. For addedstereoscoptic threedimensional displays, anNvidia Quadro fx cardthat supports stereo isneeded with a singlemonitor capable of 120Hertz refresh rate or thePlanar Mirror Systemwith two monitors | Open GL capable graphicscard is required with 24true color and a depthbuffer. For addedstereoscoptic threedimensional displays, anNvidia Quadro fx card thatsupports stereo is neededwith a single monitorcapable of 120 Hertzrefresh rate or the PlanarMirror System with twomonitors |
.
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K132605
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Description and Conclusion of Testing
Nonclinical Testing:
Nonclinical testing included modular testing, regression testing, verification of the risk control measures implemented in the software, verification of successful installation and performance testing.
External Validation:
The external validation was performed at two (2) sites in Europe, three (3) sites in the US. All aspects of using Dosimetry Check for quality control for TomoTherapy were tested during the beta testing. The conclusions of the beta test results submitted demonstrated the safety and performance of the Dosimetry Check software for its intended use and that it can be used by its intended users to compute the dose from the TomoTherapy detector as a quality tool for radiation treatments on that machine.
Conclusion:
The successful non-clinical testing and external validation demonstrates the safety and effectiveness of the Dosimetry Check Version 4 Release 1 when used for the defined indications for use and demonstrates that the device for which this 510(k) is submitted performs as well as or better than the legally marketed predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2013
Math Resolutions, LLC % Mr. Wendel Dean Renner President 5975 Gales Lane COLUMBIA MD 21045
Re: K132605
Trade/Device Name: Dosimetry Check Version 4 Release 1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: Sep. 17, 2013 Received: Sep. 24, 2013
Dear Mr. Renner:
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 cither 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 or any I outlar Bither Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Renner
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/Industrv/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/Satety/ReportalProblem/default.html 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Richard D. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
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Indications for Use
510(k) Number (if known): K132605
Device Name: Dosimetry Check Version 4 Release 1
Indications for Use:
Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of x-ray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to be or have been applied to a patient, and computing the dose to the palient from the measured radiation fields. This product is to be used as a quality control check for the treatment planning system and delivery system.
Dosimetry Check quality control software uses the radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID), diode or ion chamber arrays, or in the case of TomoTherapy, a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose and dose distribution using the patient specific computed tomography (CT) or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific point as compared to the patient specific radiation treatment plan.
This product is not a treatment planning system and is not to be used as one. This product only checks the This produce is not a treatinon planning by each x-ray field applied to the patient and provided in an apported file, and a theoretical calculation. This product does not provide any quality assurance that the caported inc. and a theirenen and correctly aligned with the patient anatomy as planned. In nelds are in and correctly approc to display the above dose on other fused image sets which could addition, the product may be asse to anspire in the user regarding the correctness of treatment.
× Prescription Use (Part 21 CFR 801 Subpart D)
.
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. Oliva
(Division Sign-off)
Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health (OIR) K 132605 210(k)
Page 1 of 1
§ 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.