iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

Device Description

iPlan RT is a software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy. The system is the evolutionary successor of the predicate devices iPlan RT Image (K080886) and iPlan RT Dose (K080888). It is specialized for stereotactic procedures for cranial as well as extracranial lesions. It includes functions for all relevant steps from outer contour detection to quality assurance. It combines most of its predecessor's functionality iPlan RT Image and iPlan RT Dose together with additional improvements. Therefore, the new version shall be called "iPlan RT".

The device incorporates conformal beams, conformal IMRT beams, circular arcs, and both static and dynamic arc treatments. Moreover, a combination of optimized dynamic arc treatments together with IMRT beams was added to the treatment modalities.

The system calculates dose using a convolution algorithm as the previous version. Alternatively, a Monte Carlo method based calculation algorithm can be used as in iPlan RT Dose (K080888). The documentation & export function facilitates printouts of all parameters and results for the creation of DICOM RT (RT Plan and RT Image) files.

Adapting existing treatment plans during fractionated radiotherapy treatments is facilitated using an elastic deformation algorithm. Existing structures are morphed from an existing treatment plan onto a new follow-up scan. If necessary, these structures can be adapted by the physician and can be used to update the current treatment plan accordingly.

AI/ML Overview

The provided document, a 510(k) summary for Brainlab AG's iPlan RT, does not contain a study that proves the device meets specific acceptance criteria in the manner typically seen for novel medical device algorithms or AI. Instead, it demonstrates substantial equivalence to predicate devices (iPlan RT Image K080886 and iPlan RT Dose K080888) through non-clinical testing.

Here's an analysis based on the provided text, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. The summary of non-clinical testing only states that the device "has met its specifications" and is "substantially equivalent to the predicate devices" and "safe and effective for its intended use." These are general conclusions rather than detailed performance metrics.

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

The document does not mention the use of a "test set" in the context of clinical data for performance evaluation. The evaluation was based on non-clinical testing and comparison to predicate devices. Therefore, there is no information on sample size or data provenance.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Since no clinical test set was used to establish performance against a ground truth, this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

As no clinical test set requiring ground truth establishment was used, there is no mention of an adjudication method.

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

The document explicitly states: "Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness." Therefore, an MRMC comparative effectiveness study was not performed.

6. Standalone (Algorithm Only) Performance Study

The document describes non-clinical "Verification and Validation tests" which confirmed the device "met its specifications." This implicitly refers to the algorithm's performance in generating treatment plans. However, no specific metrics like sensitivity, specificity, accuracy, or a detailed study design for standalone performance are provided beyond the general statement of meeting specifications. The focus is on functionality and equivalence to predicate devices.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would likely have been the expected computational output based on known physics and engineering principles for radiation dose calculation and planning. This is inferred from the statement that the device "has met its specifications." There is no mention of external clinical ground truth (e.g., pathology, outcomes data, or expert consensus on clinical cases) for this 510(k) submission.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI models with data-driven training. The iPlan RT is described as an "evolutionary successor" of previous devices, suggesting a development and refinement process rather than a machine learning training paradigm. The core dose calculation uses a convolution algorithm or Monte Carlo method, which are physics-based models rather than models trained on large datasets.

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

As no explicit training set for a machine learning model is mentioned, this question is not applicable based on the provided text.

In summary, the 510(k) for iPlan RT focuses on demonstrating substantial equivalence to existing predicate devices through non-clinical verification and validation, rather than extensive clinical studies with specific acceptance criteria tables and ground truth evaluations typically associated with novel AI/ML devices.

Summary

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K103246

MAR 1 6 2011

510 (k) Summary of Safety and Effectiveness for iPlan RT

Manufacturer

Address	Brainlab AGKapellenstr. 1285622 FeldkirchenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
Contact Person	Mr. Alexander Schwiersch
Summary Date	January 19, 2011

Device Name

Device Name
Common Name
Classification Name

Classification Number Regulatory Class FDA Establishment Registration Number

iPlan RT System, Planning, Radiation Therapy Treatment Medical charged-particle radiation therapy system 21 CFR 892.5050 Class II 8043933

Predicate Device

Predicate Device: iPlan RT Image K080886 510 (k):

Predicate Device: iPlan RT Dose K080888 510 (k):

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ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા

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Intended Use

Device Description

Summary of Non-Clinical Testing

The performed hazard analysis shows that all relevant hazards have been taken into consideration and the corresponding measures are effective. The Verification and Validation tests were completed according to Brainlab's procedures and show that iPlan RT

has met its specifications,
is substantially equivalent to the predicate devices and

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is safe and effective for its intended use.

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Summary of Clinical Testing

Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness.

Conclusion `

The detailed comparison table (see "Experiences from previous product") shows substantial equivalence to the compared predicated devices.

iPlan RT has been verified and validated according to Brainlab's procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by Brainlab in this 510 (k) application was found to be substantially equivalent with the predicate devices iPlan RT Image (K080886) and iPlan RT Dose (K080888).

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Image /page/3/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes the department's emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The emblem is a stylized representation of a human figure.

Public Health Service

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

Mr. Alexander Schwiersch
Regulatory Affairs Manager
Brainlab AG
Kapellenstrasse 12
85622 Feldkirchen
GERMANY	MAR 16 2011

Re: K103246

Trade/Device Name: iPlan RT Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: February 11, 2011 Received: February 14, 2011

Dear Mr. Schwiersch:

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 includions for use stated in the enclosure) to legally marketed predicate devices marketed in intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendonsats, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or to 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 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 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 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 (1 - 1 (1 ) 701 and 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 tiblin the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. 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): K103246

Device Name: iPlan RT

Indications For Use:

Mary Satti
(Division Sign-Off)

Divisi Office of In Vitro Diagnostic I

510K K103241

Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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.