iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro), including - image preparation - - image fusion - image segmentation - where the result is used for the creation of treatment plans for Stereotactic Surgery: - Surgery Planning - BrainMAP - Functional Planning In addition iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro) including - image preparation - - image fusion - image segmentation - where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for: Image Guided Surgery BrainLAB's Image Guided Surgery system is intended to be an intraoperative image guided localization system to enable minimally invasive surgery where the image guided surgery system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or verfebra, can be identified relative to a CT, X-ray or MR based model of the anatomy. Example procedures include but are not limited to: - Cranial procedures - -Spine procedures - -ENT procedures Additional Indications For Use: iPlan! FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan! FiberTracking can be used with other iPlan! treatment plans and other BrainLAB medical devices such as VectorVision, where this medical device is used for image guided surgery.

Device Description

iPlan! FiberTracking is developed to enhance functionality of iPlan! Cranial software with the import and planning of diffusion tensor images (DTI). Additional to the basic functions of iPlan! (viewing, drawing, image fusion and planning) this application provides functions for the import and display MRI anisotropic data, image processing of the DTI data and the display of the calculated fiber tracts.

AI/ML Overview

The provided 510(k) summary for iPlan! FiberTracking does not contain explicit acceptance criteria or a detailed study proving the device meets said criteria.

The document states:
"iPlan! has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510(k) application was found to be substantially equivalent with the predicate device iPlan! (K020631)."

This statement indicates that a validation process was undertaken, but it does not specify the acceptance criteria used for the validation or details of the study itself. Without this information, I cannot complete the requested tables and descriptions.

Therefore, the following information cannot be extracted from the provided text:

Table of Acceptance Criteria and Reported Device Performance: This would require specific performance metrics and thresholds, which are not present.
Sample size used for the test set and data provenance: No information on the dataset used for testing.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not specified.
Adjudication method for the test set: Not mentioned.
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: This is a software component of a planning system; such a study is not typically described in this context for this type of device, and no such study is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not specified.
The type of ground truth used: Not specified.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary

{0}------------------------------------------------

04/703

510 (k) Summary of Safety and Effectiveness for iPlan! FiberTracking

OCT 2 2 2004

Manufacturer:

Address:	BrainLAB AGAmmerthalstrasse 885551 HeimstettenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
Contact Person:	Mr. Rainer Birkenbach

Summary Date: May 27, 2004

Device Name: iPlan!

The existent iPlan! Planning System should be amended with the subsystem Fiber Tracking.

iPlan!

Planning System/Stereotaxic Instrument Common/Classification Name:

Predicate Device:

iPlan! (K020631)

Trade name:

Device Classification Name: Instrument, Stereotaxic Requlatory Class: Class II

Intended Use:

iPlan! FiberTracking's indication for use is to prepare and present patient and image data based on MBI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan! FiberTracking can be used with other iPlan! treatment plans and other BrainLAB medical devices such as VectorVision, where his medical device is used for image guided surgery.

Device Description:

Substantial equivalence:

iPlan! has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device iPlan! (K020631).

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2004

Mr. Rainer Birkenbach BrainLAB, AG Ammerthalstrasse 8 85551 Heimstetten Germany

Re: K041703 Trade/Device Name: iPlan! Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: October 8, 2004 Received: October 12, 2004

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 (PMA), 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.

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.

{2}------------------------------------------------

Page 2 - Mr. Rainer Birkenbach

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 (240) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

K041703 510(k) Number (if known):

iPlan! Device Name:

Indications For Use:

iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro), including

image preparation -
image fusion
image segmentation -

where the result is used for the creation of treatment plans for Stereotactic Surgery:

- Surgerv Planning

The Surgery Planning is a tool for pre- and intraoperative stereotactic surgery planning based on stereotactic systems. Multiple graphical display functions and 3-dimensional views of anatomical structures offer effective and efficient means of presenting the anatomical data for diagnostic and surgical planning. Computer-graphic simulation in various views of a chosen probe path can help prevent probe intersections with unwanted, critical structures or vessels.

The surgeon can interactively change a probe path simulation through the image slices in the software with on-line calculation of the accompanying arc settings and graphical manipulation to aid in optimizing his approach.

- BrainMAP

The BrainMAP module is a tool, which defines two and three-dimensional information about anatomical structures of the human brain for pre- and intraoperative planning of stereotactic procedures. These contours are defined and described by

Talairach/Tournoux and/or Schaltenbrand/Wahren based brain atlases.

The user is provided with information about the position of the various functional and anatomical areas of the brain. These positions of the structures have to be correlated with every patients brain data. The correlation is defined by a procedure defined by Talairach/Tournoux. Using their grid system to divide the brain in particular areas, the program will be able to provide matching data for different patient data. BrainMAP may be used alone or in conjunction with neurosurgery.

- Functional Planning

The Functional Planning is based on Surgery Planning, which gives two- and three dimensional online information of a stereotactical surgical instrument (electrodes) for a neurosurqical functional treatment using a stereotactic arc. The user is provided with information by numerical results and by various displays and reconstruction planes based on patient images (CT, MRI, PET, SPECT) about the position and orientation relative to the patient of his surgical instrument to perform stimulation and treatment on brain structures or to a preplanned trajectory .

Page 1 of 3

{4}------------------------------------------------

The software is capable of displaying the trajectory and functional areas of the brain based on BrainMAP online on the screen and recording the stimulations by storing positions of the electrodes.

The Functional Planning is intended to be used with patients where measurement, stimulation and placement of electrodes in the brain (pallidotomy) are part of the treatment. The stereotactic arc system is useful for placing these electrodes or using the instruments during the treatment and in the planning phases of the functional treatment.

In addition iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro) including

image preparation -
image fusion
image segmentation -

where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for:

Image Guided Surgerv

BrainLAB's Image Guided Surgery system is intended to be an intraoperative image guided localization system to enable minimally invasive surgery where the image guided surgery system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or verfebra, can be identified relative to a CT, X-ray or MR based model of the anatomy.

Example procedures include but are not limited to:

Cranial procedures ー
-Spine procedures
-ENT procedures

Additional Indications For Use:

iPlan! FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan! FiberTracking can be used with other iPlan! treatment plans and other BrainLAB medical devices such as VectorVision, where this medical device is used for image guided surgery.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

Muriam C. Provost

Page 2 of 3

(Division Sign-Off) Division of General. Restorative. and Neurological Devices

510(k) Number K041703

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).