PLATO ITP is intended to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT) prior to final dosimetry planning on PLATO RTS external beam planning.

Once the optimization is complete, the dose distribution and dose-volume histogram curves are displayed for the user to evaluate. The optimized plan can be saved for final dose calculation and plan output using PLATO RTS.

Device Description

PLATO ITP as described in this submission is a software package which is used to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). ITP is installed and runs on a PLATO radiation therapy planning system workstation.

Nucletron's PLATO ITP software uses previously defined anatomical structures and beams from the PLATO database to construct a 3D patient model used in the optimization process. The 3D patient model is based on CT images and is displayed in single or multiple image windows. The software also uses the treatment machine beam data from the PLATO radiation therapy planning system database.

The user defines the desired dose to be delivered to the target and the maximum dose to be delivered to the surrounding structures. Priority values are entered to weight the optimization calculations according to the importance of reaching the dose objectives for the target and other structures. After the user starts the optimization, the software calculates the required MLC or partial attenuation block shapes needed to achieve the dose objectives. This is done for each beam simultaneously and the resulting dose distribution and DVH are displayed in real-time. Once the optimization is complete, the dose distribution and DVH curves are displayed for the user to evaluate. If the user is not satisfied with the results of the optimization, the input parameters can be modified (dose constraints and priority values) and the optimization repeated.

The optimized plan can be saved for final dose calculation using PLATO RTS. Plans that have not been recalculated using PLATO radiation therapy planning system cannot be used for patient treatment. After final dose calculation thereforming system cannot be exported to a DICOM RT Plan compatible system for treatment delivery.

AI/ML Overview

The provided text does not contain specific acceptance criteria or an explicit study describing how the Nucletron Inverse Treatment Planning (ITP) device meets such criteria. The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria.

However, based on the information provided, we can infer some aspects related to the device's intended function and the general approach to its evaluation for regulatory clearance. Since detailed study data is absent, the following table and subsequent sections highlight what would typically be expected in such a study, along with what can be partially inferred from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria and corresponding performance metrics are not explicitly stated in the document, this table outlines the implied functional acceptance criteria based on the device's description and its intended use, and the reported device performance (as inferred from the 510(k) summary).

Acceptance Criteria (Inferred from Intended Use)	Reported Device Performance (Inferred from 510(k) Submission)
Accuracy of Optimization: Ability to calculate MLC/block shapes to achieve user-defined dose objectives for targets and maximum dose to surrounding structures.	"After the user starts the optimization, the software calculates the required MLC or partial attenuation block shapes needed to achieve the dose objectives." "This is done for each beam simultaneously and the resulting dose distribution and DVH are displayed in real-time." Implied Performance: The system successfully computes MLC/block shapes that correspond to the user's dose objectives.
Consistency with User Input: Capability to modify input parameters (dose constraints, priority values) and re-optimize.	"If the user is not satisfied with the results of the optimization, the input parameters can be modified (dose constraints and priority values) and the optimization repeated." Implied Performance: The system responds to user input modifications by re-optimizing the plan accordingly.
Integration with PLATO RTS: Ability to save optimized plans for final dose calculation and export.	"The optimized plan can be saved for final dose calculation using PLATO RTS." "After final dose calculation thereforming system cannot be exported to a DICOM RT Plan compatible system for treatment delivery." Implied Performance: The system successfully integrates with PLATO RTS for subsequent steps and supports DICOM RT output.
Substantial Equivalence: Functional equivalence to predicate devices (Nomos Peacock Plan, GE Target Series 2, Nucletron PLATO RTS) for IMRT optimization.	"The PLATO ITP software is substantially equivalent to the predicate devices." (K940663, K841997, K964206). Implied Performance: The device performs the core function of IMRT optimization in a manner comparable to the established predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective). The 510(k) summary primarily focuses on the device's description and its substantial equivalence to predicate devices. For a software device like this, testing typically involves various phantom cases and potentially clinical cases, but these details are not present.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The provided text does not mention the use of experts to establish ground truth for a test set, nor does it specify their number or qualifications. In the context of a treatment planning system, ground truth might involve comparing the system's output (dose distributions, fluences) against established physics principles, dose measurement phantoms, or expert-generated plans. However, these details are absent.

4. Adjudication Method for the Test Set

The provided text does not describe any adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The provided text does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor does it mention any effect size for human readers improving with or without AI assistance. This type of study is more common for diagnostic imaging AI rather than a treatment planning optimization tool like PLATO ITP.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The 510(k) summary does not explicitly state if a standalone performance evaluation of the algorithm was conducted. However, given that it's a treatment planning optimization software, its core function is to generate optimal MLC/block shapes based on user-defined objectives. The "user evaluates" the results and can "modify input parameters," indicating that human interaction is an inherent part of its intended use. A standalone evaluation would likely involve analyzing the conformity of the generated plans to dose constraints on a set of reference cases, which is implicitly part of demonstrating its functionality.

7. The Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used for any testing. For a radiation therapy planning system, ground truth could involve:

Physics-based calculations: Comparison of the optimized dose distributions against known physical models and algorithms.
Phantom measurements: Verifying dose distributions with physical phantoms and dosimeters.
Clinical expert consensus: In the absence of a "true" physical optimum, expert-generated ideal plans might serve as a benchmark.

The substantial equivalence claim suggests that the device's output and functionality were deemed comparable to systems already cleared, implying their outputs served as an indirect form of ground truth or benchmark for functionality.

8. The Sample Size for the Training Set

The provided text does not mention a training set sample size. PLATO ITP is described as a software package that "uses previously defined anatomical structures and beams from the PLATO database" and "treatment machine beam data from the PLATO radiation therapy planning system database." This suggests a rule-based or optimization algorithm that relies on pre-existing data and physics models rather than a machine learning model that requires a dedicated "training set" in the modern AI sense.

9. How the Ground Truth for the Training Set Was Established

Since the document does not indicate the existence of a "training set" in the context of machine learning, it does not describe how ground truth for such a set was established. The system's functionality is based on physics algorithms and optimization techniques, not on learning from labeled data in the way an AI diagnostic tool would.

Summary

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K99 2434

Premarket Notification Nucletron Inverse Treatment Planning (ITP) Date: July 7, 1999

JAN 1 3 2000

Image /page/0/Picture/3 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square logo. The logo contains a black circle with two white circles inside.

NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O.Box 930 The Netherlands Phone +31 318 557133 Fax +31 318 550485

Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by section 807.92(c)

Submitter of 510(k) a.

Company name:	Nucletron Corporation
Registration #	1121753
Address:	7080 Columbia Gateway Drive
	Columbia, MD 21046-2133
Contact Person:	Ralph E. Shuping
	Regulatory Affairs Manager
Phone:	410-312-4100
Fax:	410-312-4197

Device Name: b.

Trade/Proprietary Name:	PLATO ITP
Common/Usual Name:	Radiation therapy treatment planning system
Classification Name:	Radiation Therapy Simulation System, accessory to

Legally Marketed Predicate Device(s) C.

Our device is substantially equivalent to the legally marketed predicate devices cited in the table below.

Manufacturer	Device	510(k) #
NOMOS Corp.	Peacock Plan	K940663
General Electric	Target Series 2	K841997
Nucletron	PLATO RTS	K964206

Appendix 5, page 2

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Premarket Notification Nucletron Inverse Treatment Planning (ITP) Date: July 7, 1999

K992434

d. Description

Intended use e.

f. Summary of technological considerations

The PLATO ITP software is substantially equivalent to the predicate devices. It allows optimization of beam intensity for muli-leaf collimators and partial attenuation blocks.

.J. RZ

Name: T. J. Bateman Title: Product Manager Nucletron BV Veenendaal, The Netherlands

7/7/99
Date

Date

Appendix 5, page 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 17 2000

Ralph Shuping, Sc.D. Regulatory Affairs Manager Nucletron Corporation 7080 Columbia Gateway Drive Columbia, MD 21046

Re: K992434 PLATO ITP (Inverse Treatment Planning) Regulatory Class: II /21 CFR 82.5700 Product Code: 90 MUJ Dated: October 14, 1999 Received: October 15, 1999

Dear Dr. Shuping:

This letter corrects our substantially equivalent letter of January 13, 2000 regarding the PLATO ITB (Inverse Treatment Planning).

We have reviewed your Section 510(k) 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 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). 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 II (Special Controls) or class III (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 Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic OS inspections. FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to continue marketing your device as described in your 510(k) promarket 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.

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Page 2 - Ralph Shuping, Sc.D.

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 questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Nucletron Inverse Treatment Planning (ITP) Date: July 7, 1999

Image /page/4/Picture/1 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square containing a black circle with two white circles inside. The white circles are positioned on opposite sides of the black circle.

NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 Fax +31 318 550485

Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section

Statement of intended use

Device Name: PLATO ITP

Intended use

PLATO ITP is intended to optimize multi-leaf collimator (MLC) positions or partial r attenuation block shapes for intensity modulated external beam redialion or partial
prior to final dosimetry planning on PLATO DISCOLL bear radiation therapy (IMRT) prior to final dosimetry planning on PLATO RTS external beam radiation.
Ones the sating on PLATO RTS external beam planning.

Once the optimization is complete, the dose distribution and dose-volume histogram curves and the user to evaluate. The optimized plan can be saved for final dose-volume histogram o
calculation and plan outsut using PLATO Dian can be saved for final dose calculation and plan output using PLATO RTS.

Prescription use

The PLATO ITP is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.

.J. Btz

Name: T. J. Bateman Title: Product Manager Nucletron BV Veenendaal, The Netherlands

7/7/99

Date

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K992434

Prescription Use . (Per 21 CFR 801.109)

Appendix 5, page 4

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.