iPlan RT Dose is a stereotactic 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 Dose 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 device BrainSCAN (K994413). It is specialized for stereotactic procedures for cranial as well as extracranial lesions. It includes functions for all relevant steps from outer contract detection to quality assurance.

iPlan RT Dose incorporates most capabilities of the predicate device BrainSCAN. The device incorporates conformal beams, conformal IMRT beams, both static and dynamic arc treatments. The system calculates dose using a convolution algorithm similar to the predicate device BrainSCAN. The documentation & export allows producing printouts of all parameters and results for the creation of DICOM RT (RT Plan and RT Image) files.

AI/ML Overview

This document is a 510(k) summary for the iPlan RT Dose system, a radiation treatment planning system. It establishes substantial equivalence to a predicate device (BrainSCAN, K994413). It does not contain information regarding acceptance criteria, device performance metrics, or details of specific studies conducted to establish performance characteristics in the way you've outlined.

The document states: "iPlan RT Dose 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." However, it does not provide the specifics of these verification and validation studies, including acceptance criteria or performance results.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The other requested information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is also not present in this 510(k) summary.

In summary, the provided text does not contain the information needed to fill out your request.

Summary

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K053584/

JUL 1 2 2006

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

Manufacturer

Address	BrainLAB AGAmmerthalstrasse 885551 HeimstettenGermany
	Phone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
Contact Person	Mr. Rainer Birkenbach
Summary Date	December 21, 2005

Device Name

Device Name
Common Name
Classification Name
Classification Number
Regulatory Class
FDA Establishment Registration Number

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

Predicate Device

BrainSCAN (K994413)

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Intended Use

Device Description

Substantial Equivalence

iPlan RT Dose 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 device BrainSCAN (K994413).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of an eagle or other bird-like figure, with its wings spread and tail feathers flowing.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL I 2 2006

Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstraße 8, 85551 Heimstetten GEMANY

Re: K053584

Trade/Device Name: iPlan RT Dose Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: June 14, 2006 Received: June 16, 2006

Dear Mr. Birkenbach:

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 (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows a logo with the text "1906-2006 FDA Centennial" in a circular design. The logo is for the Food and Drug Administration (FDA) and commemorates its centennial anniversary. The text "Protecting and Promoting Public Health" is written in a decorative font below the logo. The image appears to be a scan or reproduction of an older document or emblem.

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Page 2 -

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.

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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

510(k) Number (if known): K053584

Device Name: iPlan RT Dose

Indications For Use:

iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planning system that is intended in
eropial, bood and post cranial, head and neck, and extracranial lesions.

David R. Syverson

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

Prescription Use X (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)

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.