The Oncentra system is a 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. The system is intended for use by qualified medical personnel in radiotherapy clinics, suitably trained by Nucletron staff (or other competent people) in using the system. The Oncentra system should be configured locally and maintained by radiation physicists. It is a requirement that the person responsible for the local configuration has been suitably trained in configuring and maintaining the system. Oncentra 4.2 uses externally acquired medical images and user input. The Oncentra 4.2 software is based on a modular client/server design, with the treatment planning functions divided into "Activities".

AI/ML Overview

This document describes the Oncentra 4.2 radiation treatment planning software. However, the provided text does not contain sufficiently detailed information about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Oncentra MasterPlan 3.1, K081281) for regulatory purposes. It mentions "dosimetric validation" for brachytherapy and external beam calculations, which are relevant to performance, but it does not specify quantitative acceptance criteria or a formal study design that would typically be expected for a detailed evaluation of device performance against specific targets.

Here's an analysis based on the available information, highlighting what is and is not present:

Missing Information:
The document does not provide:

A table of quantitative acceptance criteria with corresponding device performance metrics.
Sample sizes for a dedicated test set.
Data provenance for a test set (country of origin, retrospective/prospective).
Number of experts or their qualifications for establishing ground truth for a test set.
Adjudication method for a test set.
Any information about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
Details about a standalone (algorithm only) performance study against specific, pre-defined metrics.
The sample size for a training set (as this is not an AI/ML device in the modern sense, but rather a treatment planning software).
How the ground truth for a training set was established.

Information on "Acceptance Criteria" and "Study" (based on interpretation of "Dosimetric Validation"):

The closest the document comes to describing an "acceptance criterion" and a "study" is in sections 5.1 and 5.2 regarding Dosimetric Validation.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Brachytherapy: "Results well within expectable error margins" and "dose calculations are deemed good for clinical use" compared to:	Brachytherapy:
* Earlier Oncentra Brachy releases	* Comparisons made between Oncentra Brachy releases and Plato version 14.3.5.
* Plato version 14.3.5	* Accuracy of applicator shielding calculations validated by comparisons with the established Plato planning system.
* Phantom measurements	* No specific quantitative results provided, but stated: "No changes have been made to the brachytherapy dose calculations, therefore only a comparison with the previous version has been performed to verify consistency. The results are well within expectable error margins and the dose calculations are deemed good for clinical use."
* Data published in the TG-43 report (AAPM Task Group No. 43 report update for brachytherapy dose calculations)
External Beam: "Results well within expectable error margins" and "dose calculations are deemed good for clinical use" compared to:	External Beam:
* Earlier versions of Oncentra (to ensure no unexpected changes, as base algorithms have not been updated)	* Comparison of results with those from earlier versions has been made to ensure that no unexpected changes have taken place.
	* No specific quantitative results provided, but stated: "The results are well within expectable error margins and the dose calculations are deemed good for clinical use."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a "test set" in the context of a formal study with specific case counts. The validation refers to comparisons (with other software, phantom measurements, and published data).
Data Provenance: Not specified for a particular test set. The validation is internal ("evaluated by the physics team").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Experts: "Evaluated by the physics team." Specific number and qualifications are not detailed beyond "physics team."
Qualifications: Not specified.

4. Adjudication method for the test set:

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 MRMC comparative effectiveness study was done as this is a radiation treatment planning software, not an AI diagnostic aid for human readers. The document predates widespread discussion of "human readers improve with AI."

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

The "dosimetric validation" described for both brachytherapy and external beam calculations focuses on the algorithms' output (dose calculations). This can be considered a standalone assessment of the algorithms' accuracy in generating dose distributions. However, it's not presented as a standalone study against a defined ground truth in the way a modern AI/ML device might be evaluated for a specific diagnostic task. It's more of a verification of calculation consistency and agreement with established methods.

7. The type of ground truth used:

Brachytherapy: Comparisons were made against:
- Results from the Plato version 14.3.5 planning system (another dose calculation algorithm).
- Phantom measurements (physical validation data).
- Data published in the TG-43 report (consensus-based physics model for brachytherapy dose calculations).
External Beam: Comparisons were made against results from earlier versions of Oncentra (verifying consistency, implying the previous version's calculations served as a reference).

8. The sample size for the training set:

This is not an AI/ML device in the context of machine learning training data. Therefore, a "training set" in that sense is not applicable or discussed. The software is based on physics models and algorithms, not data-driven machine learning.

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

Not applicable for the reasons stated above.

In summary, the provided document offers a high-level overview of dosimetric validation performed to support the substantial equivalence claim for Oncentra 4.2. It emphasizes consistency with prior versions and established methods, rather than presenting a detailed performance study against explicit quantitative acceptance criteria for a novel AI/ML device.

Summary

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K121449

JUL 2 2012

Image /page/0/Picture/2 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square containing a black shape with two white circles. The black shape appears to be two overlapping circles with a portion cut out, creating a unique design within the square. The logo is simple and professional.

NUCLETRON B.V.

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

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92

1. SUBSCRIBERS NAME & ADDRESS

Company name:	Elekta Inc. D/B/A Nucletron Corporation
Registration number:	1121753
Address:	7 St. Paul Street, Suite 1660Baltimore, Maryland 21202
Phone:	770-670-2548
Fax:	770-729-1585
Correspondent:	Thomas ValentineVP QA/RA, Elekta Inc. D/B/A Nucletron Corporation
Date:	May 1, 2012

2. MODIFIED DEVICE NAME- CLASSIFICATION:

Oncentra 4.2 Trade/Proprietary Name: Common/Usual Name: Radiation Therapy Planning System Classification Name: System,Planning,Radiation Therapy Treatment 21Cfr892.5050 Class II Classification:

3. PREDICATE DEVICE IDENTIFICAITON

Our modified device is based on the legally marketed device cited in the table below:

. Sul a se affer si for a send and and and services and super and super	12 - Device Device - Device - Torre - Torrest -Manufacturer. Ing	1510(k) # .
Nucletron BV	Oncentra MasterPlan 3.	K081281
Nucletron BV	םI ATO Brachvtherapy 14.0	. K98334?

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4. OVERALL DESCRIPTION OF ONCENTRA 4.2

Oncentra 4.2 is an update of Oncentra MasterPlan 3.1- they are the same product with same technological characteristics. The technical described below is part of both Oncentra 4.2 and Oncentra MasterPlan 3.1.

1. Overview

The system is intended for use by qualified medical personnel in radiotherapy clinics, suitably trained by Nucletron staff (or other competent people) in using the system. In addition to radiotherapy, the users must be trained in general Windows usage -- Nucletron does not provide specific training or documentation conceming standard Windows functionality.

The Oncentra system should be configured locally and maintained by radiation physicists. It is a requirement that the person responsible for the local configuration has been suitably trained in configuring and maintaining the system.

2. Primary Operating Functions

The following table shows the general Primary Operating Functions (POF) for the system, respectively workflow descriptions and which actor that is most probably to perform the workflow. The POF have been identified in the Action Error Analysis (AEA) for Oncentra. Changes to this table must be motivated by the changes or additions to the AEA.

POF	Workflow Description	Actor
A. System Installation	The system (server/client) is installed or upgradedto a new version.	Medical Engineers
B. Manage Treatment Unitand Physics Data	The treatment unit parameters and data areinstalled, configured, updated and checked.	Physicists
C. Prescription	Dose is prescribed; fractionation and treatmentprotocol are decided.	Physicians
D. Define anatomy	Target and risk structures are defined on theplanning CT images. Structures (ROI) arecontoured based on the information from thephysician.	PhysiciansRadiation therapistsPhysicists
E. Approve structures	The defined structure set is approved.	Physicians
F. Create plan	The prescription is interpreted and a treatment plandeveloped.	Radiation therapistsPhysicists
G. Evaluate plan	The plan is evaluated according to the prescribeddose for the contoured structures.	Physicians
H. Approve plan	The physicians approve a plan for treatment.	Physicians

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I. Export plan	The plan is exported to the treatment unitverification system	External beam:PhysiciansBrachy:Radiation therapistsPhysicists
J. Validate plan	The treatment plan is validated before treatmentdelivery through independent calculations andmeasurements.	Physicists

3. Activities

Oncentra 4.2 uses externally acquired medical images and user input. The Oncentra 4.2 software is based on a modular client/server design, with the treatment planning functions divided into "Activities".

Oncentra 4.2 contains the following Activities:

· Anatomy Module:

The Anatomy Modeling (AM) module is an advanced contouring package for defining structures (ROls) related to the patient anatomy and target volumes for treatment planning. The AM allows the user to create and edit image registration between image series so that image fusion tools can be utilized.

·Beam Module

The Beam Modeling (BM) module handles specification of the beam shapes and other manipulation of the treatment plan.

·Plan Manager

The Plan Manager activity allows the user to create a new, or modify an existing, external beam treatment plan for photon beams. The activity provides tools for manual, and, if applicable, automatic, manipulation of beam geometries and modifiers

· Connectivity Module:

The Connectivity Module (CM) module handles all forms of DICOM data input to the Oncentra MasterPian system from external sources, and data output from the system to extemal sources.

·Dose Module

The Dose Modelling (DM) module handles execution of External Beam dose calculations.

· Optimizer Module

The Oncentra Optimizer (OM) module handles execution of treatment plan optimization. This activity will result in an optimized treatment plan for which the final dose calculation must be performed by DM.

· Brachy Planning Module

The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations.

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· Evaluation Module:

The Evaluation Module (EM) handles the necessary tools for evaluating one treatment plan that has a calculated Dose result. EM supports the same tools as BM but in a readonly mode. Tools that are not read-only like new/delete beams, field shaping, edit MLC, apply/remove wedges, etc. are not supported in EM.

· Evaluator Module

The Oncentra Evaluator (EVAL) handles the necessary tools for evaluating and comparing multiple treatment plans and dose summation of two or more plans for a selected case. The user may also select a candidate plan and approve the plan for treatment. The EVAL is a read-only activity with the exception of the plan approval function.

· Volume Rendering

The Volume Rendering (VR) module handles visualization of plans and their corresponding dose in 3D. No plan related data is modified in this module.

In addition, various system utilities are available. The software runs on a Windows 7 and XP platform.

5. SUBSTANTIAL EQUIVALENCE

The functionality for the Oncentra 4.2 is equivalent to its predicate device K081281 in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 (k) submission.

5.1 Dosimetric validation - Brachy

The dosimetric accuracy for brachy dose calculations has for earlier releases been evaluated by the physics team. Comparisons have been made between Oncentra Brachy releases and Plato version 14.3.5. phantom measurements, and data published in the TG-43 report [[1] AAPM TG-43 Rivard MJ, Coursey BM, DeWerd LA, Hanson WF, Huq MS, Ibbott GS, Mitch MG, Nath R and Williamson JF. (2004). Update of AAPM task group no. 43 report: a revised AAPM protocol for brachytherapy dose calculations. Med. Phys. 31, pp.633-674.]

The accuracy of applicator shielding calculations was validated by comparisons with the established Plato planning system

No changes have been made to the brachytherapy dose calculations, therefore only a comparison with the previous version has been performed to verify consistency.

The results are well within expectable error margins and the dose calculations are deemed good for clinical use.

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5.2 Dosimetric validation - External Beam

The base dose calculation algorithms of Oncentra have not been updated for this version. Comparison of results with those from earlier versions has been made to ensure that no unexpected changes have taken place.

The results are well within expectable error margins and the dose calculations are deemed good for clinical use.

6. INTENDED USE:

The legally marked predicate device Oncentra MasterPlan 3.1 (K081281) has the same intended use as the modified device cited:

Oncentra 4.2

is a 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.

7. CLINICAL USAGE OF ONCENTRA 4.2

Oncentra 4.2 is to be used in radiotherapy. Most patients are cancer patients who will receive radiotherapy treatment. There are also other conditions which can be-treated with radiotherapy such as AVM Arteriovenus Malformations, Keloids (scars), and after removal of osteophytes (bone spurs) among others. - Patient population > all ages and genders.

Name: John Lapre
Title: Vice President Research & Development

May 30, 2012
Date

Title: Vice President Research & Development Nucletron B.V. Veenendaal, The Netheflands

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

7 2012 JUL

Mr. Thomas Valentine Vice President, Quality and Regulatory Affairs Elekta Inc. D/B/A Nucletron Corporation 7 St. Paul Street, Suite 1660 BALTIMORE MD 21202

Re: K121448

Trade/Device Name: Oncentra 4.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 11, 2012 Received: May 15, 2012

Dear Mr. Valentine:

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 for use barba in the energeansy is toge 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 r ou may, alorested, mains of the Act include requirements for annual registration, listing of general on the profice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 your dovice to to loving major regulations affecting your device can be found in Title 21, additional controls: Entraing may 10 895. 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 i teast of actised that I Dr a vise in that your device complies with other requirements of the Act that I Dri has made a actorized by other Federal agencies. You must or any 1 ouvral statuates and including, but not limited to: registration and listing (21 comply with and the rev 021 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/Safety/ReportaProblem/default.htm 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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 11121448

Device Name:

Oncentra 4.2

Indications for Use:

Prescription Use X (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 Diagnostic Devices (OIVD)

	Page 1 of ______
	(Division Sign-Off)
	Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K	K121448

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.