Oncentra is a radiation therapy 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.

Device Description

Oncentra Brachy 4.4 is a radiation therapy 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.

Oncentra Brachy 4.4 is a brachytherapy treatment planning only version of the Oncentra treatment planning system (Oncentra 4.2- K121448) and does not include Oncentra external beam treatment planning capabilities. Oncentra Brachy 4.4 includes all Oncentra software that is required for brachytherapy treatment planning which includes

Anatomy Module: The Anatomy Modeling (AM) module is an advanced contouring package for defining structures (ROIs) 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.
Connectivity Module: The Connectivity Module (CM) module handles all forms of DICOM data input to the Oncentra Brachy system from external sources, and data output from the system to external sources.
Brachy Planning Module: The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations. The software allows reconstruction of the implant from external images, identification of the radioactive sources, optimization methods, displayed dose distributions and output of treatment times.
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 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.
Collapsed Cone Algorithm (ACE): Is a model based dose calculation that has been implemented in accordance with the AAPM TG-186 recommendations for brachytherapy uniformity. This algorithm takes into account the effects of tissue heterogeneities (normal tissue, air and bone), shields and applicators within finite patient dimensions.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Oncentra Brachy 4.4), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and a comprehensive study report in the way a clinical trial might. It describes non-clinical and clinical "testing" at a high level.

Here's an attempt to extract and present the information based on the typical requirements for acceptance criteria and study descriptions, interpreting "testing" as "study" where appropriate:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format as one would expect from a rigorous clinical study. The "acceptance criteria" are implied by the summary statements regarding verification, validation, and clinical agreement.

Acceptance Criterion (Implied)	Reported Device Performance
Meet Nucletron verification and validation requirements for medical device software.	"Oncentra Brachy 4.4 met Nucletron verification and validation requirements for medical device software. This included traceable test cases for each requirement, identified risk, clinical scenarios and usability issues. All test cases were well documented with the results demonstrating all acceptance criteria were met and the software is determined to be safe and effective for clinical use."
Implementation of AAPM TG 186 meets clinical requirements and user expectations.	"Oncentra Brachy 4.4 includes AAPM TG 186 as an evaluation method, which was clinically tested to ensure the implementation met clinical requirements and user expectations. All sites were in agreement that Oncentra Brachy 4.4 (including AAPM TG 186) was safe, effective and met clinical requirements."
Overall safety and effectiveness for clinical use.	"Based on the technical characteristics and comprehensive testing it is determined that Oncentra Brachy 4.4 is safe, effective and meets clinical, requirements."

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

Test Set Sample Size: Not explicitly stated. The document refers to "test cases for each requirement, identified risk, clinical scenarios and usability issues" for non-clinical testing and "All sites" for clinical testing. No specific number of cases or patients is provided for either.
Data Provenance: The document does not specify the country of origin for any data. Given that Nucletron B.V. is based in The Netherlands, it is possible some data could originate from there, but this is not confirmed. The nature of the studies (retrospective or prospective) is not explicitly stated. The "clinical scenarios" could imply retrospective data or simulated prospective cases.

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

Number of Experts: Not specified. The document mentions "All sites were in agreement," implying multiple clinical sites and potentially multiple clinicians/experts, but no specific number or roles are provided.
Qualifications of Experts: Not specified beyond the implication that they would be "qualified medical personnel" as mentioned in the "Indications for Use" for reviewing and approving treatment plans. There is no mention of their specific experience (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

Not specified. The statement "All sites were in agreement" suggests a consensus was reached, but the process (e.g., 2+1, 3+1, none) is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No. The document does not describe a comparative effectiveness study involving human readers with and without AI (or in this case, the new calculation algorithm). The study focuses on verifying the software's functionality and alignment with clinical requirements and user expectations.
Effect size of human readers with AI vs. without AI assistance: Not applicable, as no such study was performed or reported. The device itself is a planning software, not an AI assistance tool for human reading in the typical sense. The "AI" aspect here refers to the advanced dose calculation algorithm (ACE), not an interpretative AI.

6. Standalone (Algorithm Only) Performance Study

Was it done? Yes, implicitly for the dose calculation algorithm. The document states, "A collapsed cone algorithm has been implemented to meet the AAPM TG 186 recommendations for brachytherapy uniformity; ACE (Advanced Dose calculation Engine) accounts for tissue heterogeneities, backscatter, attenuation, shielding and provides the user with a comparison of AAPM TG-43 and AAPM TG-186 based calculations." This suggests the algorithm's performance was evaluated against the AAPM TG 186 recommendations, which are a standard for standalone dose calculation accuracy. The non-clinical verification and validation would have assessed the algorithm's output independently.

7. Type of Ground Truth Used

Non-clinical testing: Likely based on simulated data, phantom data, and known input-output relationships for software function verification and dose calculation accuracy based on physics principles and established standards (like AAPM TG 186).
Clinical testing: "Clinical requirements and user expectations" likely imply a subjective assessment of the reasonableness and utility of the treatment plans generated by the software when applied to real or realistic patient cases, with "agreement" among sites/experts serving as a form of expert consensus or validation against clinical practice. It doesn't appear to be based on pathology, or long-term patient outcomes data.

8. Sample Size for the Training Set

Not applicable. This device is a treatment planning software that implements a specific dose calculation algorithm (ACE/AAPM TG 186). It is not described as a machine learning or AI-driven diagnostic system that typically requires a "training set" in the context of supervised learning. The algorithm is based on established physics models.

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

Not applicable, as there is no mention of a training set for a machine learning model. The algorithm's "ground truth" would be the underlying physics principles and the AAPM TG 186 recommendations it was designed to adhere to.

Summary

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K132816
Page 1 of 3

Traditional (510k) Oncentra Brachy 4.4

Image /page/0/Picture/2 description: The image shows the logo for Nucletron, an Elekta company. The logo consists of a stylized atom symbol on the left, with the word "Nucletron" in bold, sans-serif font to the right. Below "Nucletron" is the text "AN ELEKTA COMPANY" in a smaller font size.

JUN 1 3 2014

Page 1 May 2014

Nucletron B.V. Waargelder 1 3905 TH Veenendaal The Netherlands

Phone:(+31) 318-557-133 Fax: (+31) 629-031-313

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

Submitter of 510(k):
Company name:	Nucletron B.V.
Establishment Registration number:	9611894
Address:	Nucletron B.V.Waargelder 13905 TH VeenendaalThe Netherlands
Phone:	(+31) 318-557-133
Fax:	(+31) 629-031-313
Correspondent:	Leo HovestadtQuality Assurance and Regulatory Affairsleo.hovestadt@elekta.com
Device Name:
Trade/Proprietary Name:	Oncentra Brachy 4.4
Common/Usual Name:	Radiation therapy planning system
Classification	Class II
Classification Name:	System, planning, radiation therapy treatment
	21 CFR 892.5050
	Product Code: MUJ

Legally Marketed Device(s)

Our device is a modification of the legally marketed device:

Manufacturer	DeviceALLARIA ALEA A STATUS A STATUS STATE OF THE FE' TETHER	CANDIJAVAI.
and and and the more of the first for the comments of the comments of the comments of the comments ofNucletron B.VComments of the comments of the commended the desires of the comments of the comments of the comments of	A Property LA A Pick of A continued Channel Clause Claud Charge Claudi Children A PhJncentra 4------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	K121448

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Traditional (510k) Oncentra Brachy 4.4

Page 2 May 2014

Device description:

Anatomy Module: The Anatomy Modeling (AM) module is an advanced contouring package for defining structures (ROIs) 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.
Connectivity Module: The Connectivity Module (CM) module handles all forms of DICOM data input to the Oncentra Brachy system from external sources, and data output from the system to external sources.
Brachy Planning Module: The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations. The software allows reconstruction of the implant from external images, identification of the radioactive sources, optimization methods, displayed dose distributions and output of treatment times.
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 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.
Collapsed Cone Algorithm (ACE): Is a model based dose calculation that has been implemented in accordance with the AAPM TG-186 recommendations for brachytherapy uniformity. This algorithm takes into account the effects of tissue heterogeneities (normal tissue, air and bone), shields and applicators within finite patient dimensions.

Intended Use:

Oncentra is radiation therapy 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.

Summary of the Technical Characteristics

Oncentra Brachy 4.4 has the same technical characteristics as the legally marketed device (Oncentra 4.2) with the exclusion of external beam treatment planning software. There is no difference between the devices in the handling of images, planning brachytherapy treatments, analysis of the dose distribution or treatment plan output. A collapsed cone algorithm has been implemented to meet the AAPM TG 186 recommendations for brachytherapy uniformity; ACE (Advanced Dose calculation Engine) accounts for tissue heterogeneities, backscatter, attenuation, shielding and provides the user with a comparison of AAPM TG-43 and AAPM TG-186 based calculations.

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KB2816
Page 3 of 3

Page 3 May 2014

Traditional (510k) Oncentra Brachy 4.4

Summary of Non-clinical testing

Oncentra Brachy 4.4 met Nucletron verification and validation requirements for medical device software. This included traceable test cases for each requirement, identified risk, clinical scenarios and usability issues. All test cases were well documented with the results demonstrating all acceptance criteria were met and the software is determined to be safe and effective for clinical use.

Summary of Clinical testing

Oncentra Brachy 4.4 includes AAPM TG 186 as an evaluation method, which was clinically tested to ensure the implementation met clinical requirements and user expectations. All sites were in agreement that Oncentra Brachy 4.4 (including AAPM TG 186) was safe, effective and met clinical requirements.

Conclusion

Based on the technical characteristics and comprehensive testing it is determined that Oncentra Brachy 4.4 is safe, effective and meets clinical, requirements.

Labels	Values
Name	John Lapre
Title	President
	Nucletron B.V.

May 20, 2014

 Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three diagonal lines that curve at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

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

June 13, 2014

Nucletron B. V. % Ms. Lu Anne Johnson President Capamed, Inc. 1917 29 % Avenue RICE LAKE WI 54868

Re: K132816

Trade/Device Name: Oncentra Brachy 4.4 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 20, 2014 Received: May 22, 2014

Dear Ms. Johnson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Ms. Lu Anne Johnson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

. *

Sincerely yours,

Robert A Ochs

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

K132816 510(k) Number (if known):

Device Name: Oncentra Brachy 4.4

Indications for Use:

Prescription Use X (Part 21 CFR 801 subpart D) AND/OR

Over-The-Counter Use (Part 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 Diagnostics and Radiological Health (OIR)

Robert A Ochs

(Division Sign-Off) Division of Radiological Health Office of In Viro Diagnostics and Radiological Health 510(k)_K132816

Page 1 of 1

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.