OTP is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

Device Description

The Oncentra Treatment Planning (OTP 1.2) system is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. OTP 1.2 is uses externally acquired medical images and user input. The OTP software is based on a modular client/server design, with the treatment planning functions divided into "Activities". OTP 1.2 contains the following Activities: Anatomy Module: Structure Definition, Target Definition, Image Registration. Beam Module. Connectivity Module. DICOM Import / Export. Dose Module. Evaluation Module: Plan Evaluation, Volume Rendering. In addition, various system utilities are available. The software runs on a Windows XP platform.

AI/ML Overview

This appears to be a 510(k) premarket notification for a radiation therapy planning system (OTP 1.2). The provided document does not contain explicit acceptance criteria or a detailed study proving the device meets such criteria in terms of performance metrics.

The document is a summary of safety and effectiveness information, comparing the device to a predicate device (TheraPlan Plus, K970236) to demonstrate substantial equivalence. It describes the device's intended use and technological considerations but does not present a performance study with detailed acceptance criteria and results in the way a medical device submission often would for novel performance claims.

Therefore, most of the requested information cannot be extracted from this document. I will fill in what can be inferred or explicitly stated, and note where information is missing.

Here's a breakdown based on the provided document:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated or quantified in this document. The submission focuses on substantial equivalence to a predicate device (TheraPlan Plus, K970236) rather than demonstrating specific performance metrics against pre-defined acceptance thresholds for accuracy, sensitivity, or specificity.
Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, precision, dose calculation discrepancies) are reported in this summary. The assessment of equivalence relies on the device having the same intended use and similar technological characteristics to the predicate.

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
(Likely functional and safety criteria implied by being a radiation therapy planning system)	(Performance is implied to be equivalent to the predicate device, TheraPlan Plus, K970236)
(e.g., Dose calculation accuracy within X%)	(No numerical data provided)
(e.g., Image registration accuracy within Y mm)	(No numerical data provided)

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

Sample Size (Test Set): Not mentioned. No specific test set or study validating performance is described.
Data Provenance: Not mentioned, as no specific performance study data is presented.

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)

Number of Experts: Not applicable, as no ground truth establishment for a specific test set is described.
Qualifications of Experts: Not applicable.

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

Adjudication Method: Not applicable, as no performance study with a test set requiring adjudication is 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

MRMC Study: No, this document does not describe an MRMC study or any study involving human readers or AI assistance in that context. The device is a "Radiation Therapy Planning System," not typically an AI-assisted diagnostic or interpretation tool in the sense of an MRMC study.

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

Standalone Performance Study: Not described in this document. The submission focuses on substantial equivalence based on intended use and technological features, rather than a standalone performance evaluation against pre-defined metrics.

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

Type of Ground Truth: Not applicable, as no performance study using ground truth is described.

8. The sample size for the training set

Sample Size (Training Set): Not mentioned. This device is a "Radiation Therapy Planning System" software, which typically involves algorithms for dose calculation, image processing, and 3D rendering. It's not explicitly stated to be an "AI" or machine learning device that would have a traditional "training set" in the common understanding of those terms. If it uses internal parameters or lookup tables, the data used to derive these is not mentioned.

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

Ground Truth Establishment (Training Set): Not applicable, as no training set or its ground truth establishment is described.

Summary

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K031349
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Image /page/0/Picture/2 description: The image shows the word "Nucletron" in a bold, sans-serif font. To the left of the word is a square logo. Inside the square is a black circle with two white circles on opposite sides of it. The logo is simple and modern.

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 Centre of Device and Radiological Health Office of Device Evaluation Special 510(k) section

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)

Submitter of 510(k):

Company name:	Nucletron Corporation
Registration number:	1121753
Address:	7080 Columbia Gateway DriveColumbia, MD 21046-2133
Phone:	410-312-4100
Fax:	410-312-4197
Correspondent:	Lisa DimmickDirector Assurance & Regulatory Affairs

Modified Device Name:

Trade/Proprietary Name:	OTP 1.2
Common/Usual Name:	Radiation Therapy Planning System
Classification Name:	Accessory to Radiotherapy Device
Classification:	21Cfr892.5050 Class II

Legally Marketed Device(s)

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

Manufacturer	of a was well of the first and the commend of the bell the may of the county of the countDevice	510(k)1 #
Nucletron BV	TheraPlan PlusA MARK STATUS CONTRACTORS CONTRACTOR	K970236

Description:

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K031349
Payeref2

OTP 1.2 is uses externally acquired medical images and user input. The OTP software is based on a modular client/server design, with the treatment planning functions divided into "Activities".

OTP 1.2 contains the following Activities:

Anatomy Module: .
- Structure Definition .
- Target Definition .
- Image Registration .
Beam Module ●
Connectivity Module: ●
DICOM Import / Export .
Dose Module .
Evaluation Module: .
- Plan Evaluation .
- Volume Rendering ●

In addition, various system utilities are available.

The software runs on a Windows XP platform.

Intended use:

The modified device has the same intended use as the legally marketed predicate device cited:

OTP is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

Summary of technological considerations:

OTP is substantially equivalent to the cleared predicate device, TheraPlan Plus, 510(k)#: K970236.

T.J. Bt

April 15, 2003

Date

Name: Tim Bateman Title: Business Segment Manager Nucletron B.V. Veenendaal, The Netherlands

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized bird with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES USA'.

radiation therapy system

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 2003

Ms. Lisa Cole Dimmick Director of Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046

Re: K031349 Trade/Device Name: OTP 1.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charge-particle

Regulatory Class: II Product Code: 90 MUJ Dated: July 14, 2003 Received: July 16, 2003

Dear Ms. Dimmick:

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.

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); good manufacturing practice requirements as set 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number

K031349

Device Name

OTP 1.2

Indications for Use

OTP is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

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)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Daniel R. Seymore

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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.