PLATO 3-D Treatment Planning System is used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop plans for external photon and electron therapy. PLATO External Beam Planning RTS V2 and RTS 3D V2 has intended uses equivalent to its predecessor PLATO RTS V1. This device is used for external beam radiation therapy treatment planning for localization and treatment planning of malignant and benign lesions of patients. Treatment of cancer may require use of external radiation beams from an external source. Teletherapy unit coordinates of beam placement including gantry angle, field size, and shape along with accurately calculated predicted dose computation, are necessary in present day planning for radiotherapy. The ability to calculate both coplanar and noncoplanar beams to a highly accurate level is desirable by the industry. PLATO RTS V 2 allows for accuracy and speed to clinically facilitate this need. The recent use of linear accelerator Multileaf Collimators for field shaping is desired and supported by RTS V2.

Device Description

The PLATO 3-D Treatment Planning System described in this submission is a computer-based external beam and brachytherapy treatment planning system for clinical radiation therapy applications. Based on an individual patient's anatomical information obtained from radiographs, CT or MRI scans, a treatment setup or source configuration, including insertion times for brachytherapy, is defined and the resultant dose distribution is calculations rely on physical algorithms describing the radiation transport process which finally leads to dose deposition inside a patient's anatomy. Treatment set-up, or source parameters, are changed until the corresponding dose distribution are clinically acceptable. The operator performing the treatment planning forms part of the PLATO Radiation Treatment Planning System. The prescribed treatment is then administered to the patient, utilizing medical linear accelerators, cobalt units, afterloaders, or manual techniques. The PLATO 3-D Treatment Planning System is modular in structure and consists of the following main features which are depicted in the attached system overview diagram. RTS - A module for External Beam planning EVAL 2.0 - An evaluation module for combination of external and brachytherapy planning using evaluation tools; IPS-CT - Imports images from CT, MRI, radiographs and outlining features; MLC - Multileaf Collimator

AI/ML Overview

The provided text describes the PLATO 3D Radiation Therapy Planning System (K904206) but lacks the detailed information required to fill in all sections of the acceptance criteria and study description. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to manufacturing standards rather than presenting specific performance study results with quantitative metrics.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the PLATO 3D Radiation Therapy Planning System. It emphasizes internal performance standards, adherence to design specifications, and equivalence to predicate devices.

Acceptance Criteria (Quantitative)	Reported Device Performance
Not explicitly stated in the document. The document mentions "standards specified by Nucletron" and "product design specifications" for internal performance standards, and "accuracy" but without quantitative values.	The document states "Function and Dose calculation parameters have been tested" and that the device "allows for accuracy and speed to clinically facilitate this need." However, no specific performance results (e.g., accuracy percentages, error margins, speed metrics) are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text mentions "Function and Dose calculation parameters have been tested," but it does not specify the sample size of the test data (e.g., number of patient cases, number of dose calculations), the type of data used (e.g., phantom studies, patient data), or its provenance (country, retrospective/prospective).

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)

This information is not provided in the document. The document refers to the operator forming part of the system and clinical application specialists, but it does not describe a formal expert panel or their qualifications for establishing ground truth for any testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. There is no mention of an adjudication process for any testing.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The device is a treatment planning system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output. The focus is on the accuracy of dose calculation and treatment plan generation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document states that "the resultant dose distribution is calculations rely on physical algorithms describing the radiation transport process which finally leads to dose deposition inside a patient's anatomy." It also mentions "Function and Dose calculation parameters have been tested." This implies that the dose calculation algorithm, a core standalone component, was tested. However, no specific standalone performance metrics or study details are provided. The system is designed to have a "human-in-the-loop" ("The operator performing the treatment planning forms part of the PLATO Radiation Treatment Planning System."), but testing of the algorithms themselves would be a standalone assessment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not explicitly stated for any testing that may have been performed. For a radiation therapy planning system, ground truth for dose calculation is typically established through:

Physics phantom measurements: Physical measurements of dose distribution in phantoms.
Established analytical or Monte Carlo simulation models: Comparison against highly accurate and validated computational models.
Clinical validation against known outcomes for simplified cases: Less common for initial clearance but could be part of post-market surveillance.

The document mentions "physical algorithms describing the radiation transport process," suggesting a theoretical approach, but how this was validated against a definitive "ground truth" (e.g., specific experimental data) is not detailed.

8. The sample size for the training set

This information is not applicable/provided. The PLATO 3D system described in this 1996 document is a rule-based, algorithm-driven system for dose calculation and treatment planning, not a machine learning or AI system that requires a "training set" in the modern sense. It relies on physical models and algorithms.

9. How the ground truth for the training set was established

This information is not applicable/provided for the same reason as point 8. The device is based on physics algorithms, not learned from a training set.

Summary of Gaps:

The [K904206](https://510k.innolitics.com/search/K904206) document is a 510(k) submission from 1996 for a radiation therapy planning system. It predates many of the rigorous, quantitative performance study requirements and reporting standards common for AI/ML-driven medical devices today. Its primary focus is on establishing substantial equivalence to existing predicate devices based on intended use, manufacturing quality (ISO 9001, GMP), and internal verification/validation processes, rather than presenting detailed prospective clinical efficacy studies with quantitative acceptance criteria. Therefore, most of the specific details requested regarding test sets, ground truth establishment, expert involvement, and MRMC studies are not available in the provided text.

Summary

{0}------------------------------------------------

K904206

SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS DATA PLATO 3D Radiation Therapy Planning System, External Beam Planning RTS V2 and RTS 3D V2

October 17, 1996
Submitter/Contact:	Randolph HemingwayNucletron Corporation7080 Columbia Gateway DriveColumbia, MD 21046-2133Tel: (410) 312-4187 Fax: (410) 312-4199PLATO External Beam Planning RTS V2 and RTS 3D V2
Trade/Proprietary Name:	RTS-2 3-D Radiation Treatment Planning System
Common Name:	3-D Radiation Therapy Planning System
Classification Name:	Medical Charged Particle Radiation Therapy System21 CFR 892.5050 (Class II)
Substantial Equivalence:	Nucletron PLATO Radiation Therapy Planning System510(k) K 921991ADAC Pinnacle 3 APEX510(k) K 951581Siemens Treatment Management System (TMS)510(k) K 953391

Device Description:

The PLATO 3-D Treatment Planning System described in this submission is a computer-based external beam and brachytherapy treatment planning system for clinical radiation therapy applications.

Based on an individual patient's anatomical information obtained from radiographs, CT or MRI scans, a treatment setup or source configuration, including insertion times for brachytherapy, is defined and the resultant dose distribution is calculations rely on physical algorithms describing the radiation transport process which finally leads to dose deposition inside a patient's anatomy.

Treatment set-up, or source parameters, are changed until the corresponding dose distribution are clinically acceptable. The operator performing the treatment planning forms part of the PLATO Radiation Treatment Planning System. The prescribed treatment is then administered to the patient, utilizing medical linear accelerators, cobalt units, afterloaders, or manual techniques.

The PLATO 3-D Treatment Planning System is modular in structure and consists of the following main features which are depicted in the attached system overview diagram.

{1}------------------------------------------------

RTS - A module for External Beam planning

EVAL 2.0 - An evaluation module for combination of external and brachytherapy planning using evaluation tools;

IPS-CT - Imports images from CT, MRI, radiographs and outlining features;

MLC - Multileaf Collimator

Device Intended Use:

As indicated above, the PLATO 3-D Treatment Planning System is used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system can be applied for external photon and electron therapy.

PLATO External Beam Planning RTS V2 and RTS 3D V2 has equivalent intended uses as its predecessor PLATO RTS V1. This device is used for external beam radiation therapy treatment planning for localization and treatment planning of malignant and benign lesions of patients.

Treatment of cancer may require use of external radiation beams from an external source, Teletherapy unit coordinates of beam placement including gantry angle, field size, and shape along with accurately calculated predicted dose computation, are necessary in present day planning for radiotherapy. The ability to calculate both coplanar and noncoplanar beams to a highly accurate level is desirable by the industry. PLATO RTS V 2 allows for the accuracy and speed to clinically facilitate this need. The recent use of linear accelerator Multileaf Collimators for field shaping is desired and supported by RTS V2.

Safety and Effectiveness

The PLATO Treatment Planning System is manufactured by Nucletron B.V. in The Netherlands that is officially registered as an ISO 9001 manufacturer. Accordingly, the system described herein will be manufactured in accordance with the ISO 9001 requirements, GMP regulations, and other applicable European standards.

The operator is provided with a comprehensive User's Manual, accompanied by an Instruction Manual, which provides the operator with a detailed tutorial. Nucletron employs a knowledgeable staff of clinical application specialists to complement the written documentation provided to the user. Such assistance is available during initial start-up and at other times when requested by the user. On-going training programs and seminars for users are conducted by Nucletron on a continual basis.

Nucletron's prior experience with treatment planning systems provides an extensive background in such devices and ensures that all systems are safe and effective as represented.

Software is designed in accordance with prescribed specifications, and detailed test plans ensure software integrity through definitive verification and validation procedures. A concept of "userfriendliness", safe, and effective operation is a top priority in all design and manufacturing efforts by Nucletron.

{2}------------------------------------------------

Conclusion:

: 3

The FDA 510K certification pre-market notification for the RTS 2 product contains adequate information and data to enable the determination of substantial equivalence with the documentation summarized in this submission.

Nucletron's RTS 2 is subject to internal performance standards as defined by product design . specifications.
. The RTS 2 external beam planning software will be developed and ongoing monitored to adhere to standards specified by Nucletron, Good Manufacturing Practices and ISO 9001 requirements.
The information for users contains comprehensive instructions and documentation to ensure ● safe and effective use.
Product Specifications and performance levels are substantially equivalent to other products . currently cleared by FDA for marketing in the U.S. Function and Dose calculation parameters have been tested and will be retested before actual product release.
Close evaluation of other equivalent predicate devices demonstrates that RTS 2 is safe and ● effective for marketing.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a bird in flight or a human figure. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 20 1997

Randolph Hemingway Nucletron Corporation 7080 Columbia Gateway Drive Columbia, MD 21046 --

Re: K964206

Plato RTS-2 3D Radiation Therapy Treatment Planning System Dated: March 30, 1-997………… Received: March 30, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Hemingway:

We have reviewed your Section 510(x) notification of intent to market the device referenced above and we have decemined 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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.

If your device is classified (see above) into either class III (Premater 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. This response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(t) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 yitte diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion 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/cdrtv/dsmamain.html". پر پاک در

Sincerely yours,

William Fox

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

Enclosure

{4}------------------------------------------------

510(k) Number (if known): K964206

Device Name: PLATO External Beam Planning System RTS V2 & RTS 3D V2

Indications For Use;

PLATO External Beam Planning RTS V2 and RTS 3D V2 has intended uses equivalent to its predecessor PLATO RTS V1. This device is used for external beam radiation therapy treatment planning for localization and treatment planning of malignant and benign lesions of patients,

Treatment of cancer may require use of external radiation beams from an external source. Teletherapy unit coordinates of beam placement including gantry angle, field size, and shape along with accurately calculated predicted dose computation, are necessary in present day planning for radiotherapy. The ability to calculate both coplanar and noncoplanar beams to a highly accurate level is desirable by the industry. PLATO RTS V 2 allows for accuracy and speed to clinically facilitate this need. The recent use of linear accelerator Multileaf Collimators for field shaping is desired and supported by RTS V2.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vimill le. Seppem

Division of Reproductive, Abdominal, El and Radiological De 510(k) Number

Prescription Use V (Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.