The device is intended for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment and indicated for cranial, head and neck and extracranial lesions.

Device Description

RT Elements are computed-based software applications for radiation therapy treatment planning and dose optimization for linac-based conformal radiation treatments, i.e. stereotactic radiosurgery (SRS), fractionated stereotactic radiotherapy (SRT) or stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT) for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

The following applications are included in RT Elements 4.0:

-Multiple Brain Mets SRS
-Cranial SRS
-Spine SRS
Cranial SRS w/ Cones -
-RT QA
-Dose Review
-Retreatment Review

AI/ML Overview

The given FDA 510(k) summary for Brainlab AG's RT Elements 4.0 provides a general overview of the device and its equivalence to a predicate device, but it lacks specific details regarding quantitative acceptance criteria and a structured study to prove these criteria were met.

The document focuses on substantiating equivalence by comparing features and functionality with the predicate device (RT Elements 3.0 K203681). While it mentions "Software Verification," "Bench Testing," "Usability Evaluation," and "Clinical Evaluation," it does not provide the detailed results of these studies in a format that directly addresses specific acceptance criteria with reported device performance metrics.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported performance for the new specific features. It mentions "Dose Calculation Accuracy" as existing criteria from the predicate device that remains the same.

Acceptance Criteria (from Predicate/Existing)	Reported Device Performance (for RT Elements 4.0)
Dose Calculation Accuracy: Pencil Beam/Monte Carlo: better than 3%	Pencil Beam/Monte Carlo: better than 3% (Stated as "the same as in the Predicate Device")
Dose Calculation Accuracy: Circular Cone: 1%/1mm	Circular Cone: 1%/1mm (Stated as "the same as in the Predicate Device")
Software requirements met	Verified through integration tests and unit tests. Incremental test strategies applied for changes with limited scope.
Safety and performance requirements met	Concluded from validation process.
Interoperability for newly added components	Interoperability tests carried out.
Usability for new Retreatment Review Element	Summative and Formative Usability Evaluation carried out.

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

The document does not specify the sample size for any test sets used in the verification or validation activities. It also does not mention the data provenance (country of origin, 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.

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

The document does not mention any adjudication method.

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

The document does not indicate that an MRMC comparative effectiveness study was conducted. The "Clinical Evaluation" is mentioned, but no details of such a study are provided, nor is there any mention of "AI assistance" or its effect size on human readers. The new "Treatment Time Bar" feature is described as "supports the user in decision making" and "gives the user a better overview of different treatment data," but this is not framed as an AI-assisted improvement study.

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

The document does not explicitly describe a standalone algorithm-only performance study. The focus is on the integrated software system for treatment planning.

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

The document does not specify the type of ground truth used for any of the evaluations. For "Dose Calculation Accuracy," the ground truth would typically be a highly accurate physical measurement or a reference dose calculation from a gold-standard system, but this is not explicitly stated.

8. The sample size for the training set

The document does not provide any details about a training set, as this is a software update and verification rather than a de novo AI model development described in typical machine learning submissions. The dose calculation models are well-established.

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

Not applicable based on the available information (no training set mentioned).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a rectangular shape.

March 14, 2023

Brainlab AG % Sadwini Suresh QM Consultant, Regulatory Affairs Olof-Palme-Str. 9 Munchen. BY 81829 GERMANY

Re: K223279/S001

Trade/Device Name: RT Elements (4.0) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: February 13, 2023 Received: February 13, 2023

Dear Sadwini Suresh:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name "Lora D. Weidner -S" in a large font on the left side of the image. On the right side of the image, the text "Digitally signed by Lora D. Weidner -S" is present. Below that, the date "2023.03.14 19:25:04 -04'00'" is displayed.

Lora D. Weidner, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223279

Device Name RT Elements 4.0

Indications for Use (Describe)

The device is intended for radiation treatment planning for use in stereotactic, conformal, computer planned. Linac based radiation treatment and indicated for cranial, head and neck and extracranial lesions.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left and the word "BRAINLAB" in pink capital letters on the right. The symbol appears to be three curved lines stacked on top of each other.

510(k) Summary

March 13, 2023

General Information
Manufacturer	Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany
Establishment Registration	8043933
Trade Names	RT Elements 4.0
Classification Name	Medical charged-particle radiation therapy system
Product Code	MUJ
Regulation Number	892.5050
Regulatory Class	II
Panel	Radiology
Predicate Device	K203681RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS,Cranial SRS, Spine SRS, RT QA, Dose Review
Contact Information
Primary Contact	Sadwini SureshQM ConsultantRegulatory AffairsPhone: +49 89 99 15 68 0Email: regulatory.affairs@brainlab.com
Alternate Contact	Chiara CunicoSenior Manager Regulatory AffairsPhone: +49 89 99 15 68 0Email: chiara.cunico@brainlab.com

1. Indication for Use

2. Device Description

The following applications are included in RT Elements 4.0:

-Multiple Brain Mets SRS
-Cranial SRS
-Spine SRS
Cranial SRS w/ Cones -
-RT QA

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Image /page/4/Picture/0 description: The image shows the word "BRAINLAB" in pink, with a stylized pink symbol to the left of the word. The symbol appears to be a stylized representation of the brain. The text is in all caps and in a sans-serif font.

-Dose Review
-Retreatment Review

3. Substantial Equivalence

The Subject Device has similar intended use and technological features as the predicate device. An overview of the similarities and differences can be found in the tables below:

Topic/ Feature	Predicate Device (RTElements 3.0 K203681)	Subject Device (RTElements 4.0)	Comment
Indications for use	The RT Elements are applicationsfor radiation treatment planning foruse in stereotactic, conformal,computer planned, Linac basedradiation treatment of cranial, headand neck and extracranial lesions.The Cranial SRS w/ Conesapplication as one RT Elementprovides planning and display forfunctional diseases (e.g. trigeminalneuralgia) or cranial lesionradiation treatment.The Multiple Brain Mets SRSapplication as one RT Elementprovides optimized planning anddisplay for cranial multi-metastasesradiation treatment planning.The Cranial SRS application asone RT Element providesoptimized planning and display forcranial radiation treatmentplanning.The Spine SRS application as oneRT Element provides optimizedplanning and display for singlespine metastases.The RT QA application as one RTElement contains features forpatient specific quality assurance.Use RT QA to recalculate patienttreatment plans on a phantom toverify that the patient treatmentplan fulfills the planningrequirements.The Dose Review application asone RT Element contains featuresfor review of isodose lines, reviewof DVHs, dose comparison anddose summation.	The device is intended forradiation treatment planning foruse in stereotactic, conformal,computer planned, Linac basedradiation treatment and indicatedfor cranial, head and neck andextracranial lesions.	The Subject Device hassimilar indications for use asthe Predicate Device. TheSubject Device has a revisedgeneric indications for usestatement.
Topic/ Feature	Predicate Device (RTElements 3.0 K203681)	Subject Device (RTElements 4.0)	Comment
Applications/ElementsIncluded	• Multiple Brain Mets SRS• Cranial SRS• Spine SRS• Cranial SRS w/ Cones• RT QA• Dose Review	• Multiple Brain Mets SRS• Cranial SRS• Spine SRS• Cranial SRS w/ Cones• RT QA• Dose Review• Brain Mets RetreatmentReview	The Subject device has thesame Elements included asthe Predicate Device.Additionally, RT Elements 4.0has the new Brain MetsRetreatment Review Element.
Supported OperatingSystems	• Windows 10 Enterprise 1507• Windows 10 Enterprise 1607• Windows 10 Enterprise 1809• Windows Server 2012 R2 64-bit• Windows Server 2016• Windows Server 2019	• Windows 10 Enterprise 1507• Windows 10 Enterprise 1607• Windows 10 Enterprise 1809• Windows Server 2012 R2 64-bit• Windows Server 2016• Windows Server 2019	The Subject Device supportsthe same operating systemsas the Predicate Device.
SupportedCollimators	• Multileaf Collimators• Circular Conical Collimators	• Multileaf Collimators• Circular Conical Collimators	The Subject Device supportsthe same collimator types asthe Predicate Device.
GUI Technology	• WPF	• WPF• html5	The Subject Device has asimilar GUI technology as thePredicate Device. Parts of thesubject device weretransmitted to html5.
Dose CalculationAccuracy	Pencil Beam/Monte Carlo:better than 3%Circular Cone:1%/1mm	Pencil Beam/Monte Carlo:better than 3%Circular Cone:1%/1mm	The dose calculation in theSubject Device is the sameas in the Predicate Device.
Support of MetalImplants	No support of metal implantsavailable.	It is possible to calculatetreatment plans for targets withmetal implants in the surroundingof the lesion, accounting for aselected material of the implantduring dose calculation.It is also possible to define thematerial of implant objects from agiven list to be used for tissuemodel generation	With the Subject Device it ispossible to consider metalimplants during treatmentplanning especially for spinalmetastasis.
Topic/ Feature	Predicate Device (RTElements 3.0 K203681)	Subject Device (RTElements 4.0)	Comment
Treatment Time Bar	No time bar available.	All objects that are listed in thetime bar are shown on the newestMR in the ACS view and arevisualized in the 3D view. Themetastases are color-coded toprovide an overview of when themetastases were treated.	A new feature coming withthe new Brain MetsRetreatment Element.It supports the user indecision making. No newdata is generated by thisfeature. Instead it gives theuser a better overview ofdifferent treatment data

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Image /page/5/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized symbol on the left and the word "BRAINLAB" on the right. The symbol is a pink abstract design, and the word "BRAINLAB" is also in pink and in all capital letters.

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Image /page/6/Picture/0 description: The image shows the Brainlab logo in pink. The logo consists of a stylized symbol on the left and the word "BRAINLAB" in capital letters on the right. The symbol appears to be a stylized representation of the brain, while the word "BRAINLAB" is written in a bold, sans-serif font.

4. Performance Data

Verification

Software Verification:

Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strategies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid.

Software verification verifies all specifications, including SOUP items and cybersecurity. For newly added components, interoperability tests were carried out, in addition to the individual component verification.

Bench Testina

In addition to the routine software verification, the following tests were carried out:

Usability Evaluation:

Summative and Formative Usability Evaluation was carried out specifically for the Retreatment Review Element which is a new application.

Clinical Evaluation:

Clinical Evaluation was carried out as a part of the design validation process.

Based on the results gathered during the validation process, it was concluded that the device meets the safety and performance requirements and is safe and effective for its intended use as compared to the predicate device.

5. Conclusion

Verification and validation activities carried out established that the set requirements were met and that the device performs as claimed.

The Subject Devices' comparison with the Predicate Device establishes that they have similar functionality, intended use and technological characteristics. Therefore, we believe that the Subject Device can be considered substantially equivalent to the predicate device.

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.