(178 days)
The Advanced Radiation Therapy Systems, Inc., "Advanced Treatment Planning System" is used to plan patient treatments for radiation therapy with external photons and electrons.
The Advanced Treatment Planning System (ATPS) from Advanced Radiation Therapy Systems, Inc. (ARTS) is a software product that runs on a Silicon Graphics, Inc. UNIX Workstation in conjunction with specified accessory hardware. The ATPS provides the user the tools to easily perform patient treatment planning for the application of electron and photon radiation therapy utilizing input of patient anatomy from Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) devices. Incorporation of 3D visualization software from Advanced Visualization Systems (AVS), combined with X windows and Motif graphics, results in a graphical user interfacc that is both flexible and casy to use. See the User's Manual in Tab 5 for a more detailed description and examples of graphics. The ATPS provides both two dimensional (2D) and three dimensional (3D) dose calculation algorithms for photons and electrons.
The provided text describes a Premarket Notification [510(k)] Summary for a device called "Advanced Treatment Planning System" (ATPS) by Advanced Radiation Therapy Systems, Inc. (ARTS). This document is a regulatory submission to the FDA, asserting substantial equivalence to predicate devices, and as such, it does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical trial detailed report would.
However, based on the information provided, we can infer some aspects related to acceptance criteria and how a "study" (in this context, the 510(k) submission itself and the comparison with predicates) demonstrates compliance.
Here's an attempt to answer your questions based on the provided text, with the understanding that typical detailed study data is not present in this type of summary document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets and then explicitly report "device performance" against those targets in a table format. Instead, the core of a 510(k) submission for a treatment planning system relies on substantial equivalence to predicate devices. This implies that the device's performance, particularly its dose calculation algorithms and user interface, must be comparable or not raise new questions of safety and effectiveness compared to the predicate devices.
The "acceptance criteria" are implicitly the functional and performance benchmarks set by the predicate devices. The "reported device performance" is demonstrated through the "Predicate Comparison Table" (mentioned but not included in the provided text for "Technological Characteristics"). This table would detail how the ATPS's features and performance parameters align with or are similar to the predicate devices.
Implicit Acceptance Criteria (Inferred from 510(k) process):
| Acceptance Criteria Category | Implicit Criteria (Based on Predicate Equivalence) | Reported Device Performance (Inferred from 510(k) approval) |
|---|---|---|
| Dose Calculation Accuracy | Accurate calculation of photon and electron radiation doses for treatment planning, comparable to predicate devices. | Stated to provide "both two dimensional (2D) and three dimensional (3D) dose calculation algorithms for photons and electrons," implying accuracy comparable to predicates for FDA clearance. |
| User Interface & Workflow | Intuitive and efficient user interface for patient treatment planning. | Described as having a "graphical user interface that is both flexible and easy to use" utilizing "3D visualization software" and "X windows and Motif graphics." This suggests a modern and functional UI comparable to or improved over predicates without raising new safety concerns. |
| Input Data Compatibility | Ability to utilize patient anatomy data from standard imaging modalities. | Explicitly states "utilizing input of patient anatomy from Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) devices." |
| Intended Use | Same or similar intended use as predicate devices. | "Used to plan patient treatments for radiation therapy with external photons and electrons," which is consistent with the function of predicate RTPS. |
| Safety & Effectiveness | Does not raise new questions of safety and effectiveness compared to predicate devices. | FDA clearance (K972816) indicates that the device met this fundamental acceptance criterion. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on a specific "test set" sample size or data provenance. In a 510(k) for a treatment planning system, the "test" often involves demonstrating that the dose calculation algorithms produce results consistent with established physics principles and industry standards, and that the software functions as intended across various clinical scenarios. This might involve:
- Benchmarking against publicly available phantom data: Often used to validate dose calculation accuracy.
- Comparison to predicate device outputs: Running the same patient cases on both the new device and the predicate to show comparable treatment plans.
- Internal validation cases: Cases designed by the manufacturer to test specific features and edge cases.
However, the specific numbers of such cases, their origin, or whether they were retrospective or prospective are not mentioned in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not specify the number or qualifications of experts used to establish ground truth. For a device like a treatment planning system, "ground truth" for dose calculations is typically established through:
- Physics principles and accepted dosimetry measurements: E.g., measurements in phantom tanks with ion chambers or film.
- Comparison to other validated algorithms: Using highly accurate research algorithms or established commercial systems as a reference.
- Clinical expert review: Radiation oncologists and medical physicists review generated treatment plans for clinical acceptability and reasonableness.
Given this is a 510(k) summary, these details are usually found in the full submission, not the summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method. This is typically relevant for studies involving human interpretation (e.g., image reading) where disagreement among experts needs to be resolved. For a treatment planning system, the "adjudication" is more about adherence to physical laws and clinical standards, and consistency with predicate device performance.
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
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. MRMC studies are primarily for devices that assist human readers in tasks like diagnosis (e.g., CAD systems for mammography). A Radiation Therapy Treatment Planning System is a tool for physicists and oncologists to create treatment plans, not primarily to "read" or interpret images in a diagnostic sense where AI offers an assistive reading benefit in an MRMC context. Therefore, this type of study would not typically be applicable or described for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The ATPS is inherently a "human-in-the-loop" device. It provides "the user the tools to easily perform patient treatment planning." While the dose calculation algorithms themselves operate "stand-alone" on computed data, the overall "performance" of the system is the combination of the algorithms and the user's ability to create an optimal plan.
Therefore, "standalone" algorithm performance would have been assessed internally (e.g., dose calculation accuracy validation), but the device itself is designed for human interaction. The 510(k) likely focused on validating the accuracy of the underlying algorithms and the usability of the interface, not a "standalone vs. human-in-the-loop" comparison in the same way as AI diagnostic tools.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. For a treatment planning system, the "ground truth" for validation would primarily involve:
- Physics dosimetry measurements: Using phantoms and physical detectors to verify the accuracy of calculated dose distributions.
- Reference calculations: Comparing the ATPS's dose calculations to those from well-validated and accepted algorithms or benchmark software.
- Clinical acceptability by physicists and oncologists: Reviewing treatment plans to ensure they meet clinical standards and safely deliver the prescribed dose to the target while sparing healthy tissue.
The most concrete "ground truth" for the dose calculation algorithms would be based on physical measurements and established physics models, often vetted by expert medical physicists.
8. The sample size for the training set
The document does not mention a "training set" or its sample size. The ATPS is described as a software product providing dose calculation algorithms. Such algorithms, especially those developed in the late 1990s, would typically be based on analytical models of radiation transport (e.g., Clarkson, convolution/superposition for photons; various electron algorithms) derived from fundamental physics, rather than machine learning models that require labeled training data in the modern sense. Therefore, a "training set" as understood in AI/ML contexts would not be applicable here. The algorithms are "trained" by incorporating physics principles and parameters, not by being fed a dataset.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of machine learning, this question is not applicable based on the provided text. The "ground truth" for the underlying physics models would be derived from fundamental scientific principles, experimental measurements in physics labs, and Monte Carlo simulations, all validated by expert physicists over decades.
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Image /page/0/Picture/0 description: The image shows the text "Advanced Radiation Therapy Systems, Inc." The text is arranged in a stacked format, with each word or phrase on a separate line. The font appears to be a bold, serif typeface, and the overall impression is that of a company logo or heading.
430 Jean Way Advanced Radiation The Khy Sun Parassia, PA 19406 610-265-6519 610-354-9226 (Fax)
Ka72816
JAN 23 1998
TAB 10
Premarket Notification |510(k)| Summary
July 25, 1997
Trade Name: Advanced Treatment Planning System
Common Name: Radiation Therapy Treatment Planning System
Medical charged particle radiation therapy system, 90 IYE (per Classification Name: 21 CFR section 892,5050)
Manufacturer's Name: Advanced Radiation Therapy Systems, Inc. 430 Jean Way Address: King of Prussia, Pa 19406
Corresponding Official: Mr. Alexander C. Cheung Chief Executive Officer Title:
Telephone: 610-265-6519 Fax: 610-354-9226
Predicate: Focus RTP: K915691 and Xknifc-3: K953482
Device Description: The Advanced Treatment Planning System (ATPS) from Advanced Radiation Therapy Systems, Inc. (ARTS) is a software product that runs on a Silicon Graphics, Inc. UNIX Workstation in conjunction with specified accessory hardware. The ATPS provides the user the tools to easily perform patient treatment planning for the application of electron and photon radiation therapy utilizing input of patient anatomy from Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) devices. Incorporation of 3D visualization software from Advanced Visualization Systems (AVS), combined with X windows and Motif graphics, results in a graphical user interfacc that is both flexible and casy to use. See the User's Manual in Tab 5 for a more detailed description and examples of graphics. The ATPS provides both two dimensional (2D) and three dimensional (3D) dose calculation algorithms for photons and electrons.
Intended Use: The Advanced Radiation Therapy Systems, Inc., "Advanced Treatment Planning System" is used to plan patient treatments for radiation therapy with external photons and clectrons.
Technological Characteristics: See the attached "Predicate Comparison Table"
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human figures connected at the shoulders, forming a wing-like shape. The figures are rendered in black and appear to be in motion. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 23 1998
Alexander C. Cheung Chief Executive Officer Advanced Radiation Therapy Systems, Inc. 430 Jean Way King of Prussia, PA 19406
K9
Re:
K972816 Radiation Therapy Treatment Planning System Dated: November 11, 1997 Received: November 13, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Cheung:
We have reviewed your Section 510k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 5100k) premarket notification. The FDA finding of substantial equivalence of your device to a legally market predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
h.D.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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TAB 11
510(k) Number (if Known) K972816
Device Name: Advanced Treatment Planning System
Indications for Use:
The Advanced Radiation Therapy Systems, Inc., "Advanced Treatment Planning System" is used to plan patient treatments for radiation therapy with external photons and electrons.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Chistopher de Leon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number
000418
§ 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.