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
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-rav(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 vertebra, 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
Hip procedures
Knee procedures

Device Description

iPlan! is a software tool running on a standard, standalone computer workstation or being accessable via the intranet connection for pre- or intraoperative planning of treatments based on stereotactic systems or image quided surgery systems.
The system provides e.g. tools for the automatic or manual segmentation of anatomical structures which helps the user such as the radiologist or the surgeon to quickly achieve the desired segmentation results through an unlimited number of automatic and/or manual re-segementations. Additionally anatomical and functional structures and segmentations of the human brain as defined and described by Talairach/Tournoux and/or Schaltenbrand/Wahren brain atlases can be correlated with the patient´s brain data.
The created treatment plans of iPlan! can be used on its own or in conjunction with other Brainl.AB medical devices such as VectorVision for performing the planned treatment.

AI/ML Overview

The provided 510(k) summary for the iPlan! device focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use and general description. It does not contain specific information about formal acceptance criteria, a dedicated study proving performance against those criteria, or details regarding ground truth establishment and expert adjudication for either test or training sets.

Therefore, much of the requested information cannot be extracted from this document. The sections below will indicate where information is missing.

Acceptance Criteria and Reported Device Performance

Not explicitly defined in the provided document. The 510(k) summary 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 system." However, it does not specify quantitative acceptance criteria (e.g., accuracy thresholds, precision values) or report specific performance metrics against such criteria in a table format. The primary "performance" mentioned is the device's ability to be "substantially equivalent" to predicate devices.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Study Proving Device Meets Acceptance Criteria

As specific acceptance criteria are not detailed, a formal study explicitly demonstrating the device meets those criteria is not described in this document. The document primarily focuses on demonstrating substantial equivalence to predicate devices.

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

Not provided. The document does not mention the sample size or provenance of any test set used for validation.

2. 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)

Not provided. Details regarding ground truth establishment for a test set, including the number and qualifications of experts, are absent.

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

Not provided. The document does not describe any adjudication method.

4. 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

Not provided. The document does not mention an MRMC study or any results related to human reader improvement with or without AI assistance. The iPlan! device itself is a planning software, not specifically an AI-driven image interpretation tool in the modern sense. Its function is to prepare and present data, and assist in planning, rather than to make diagnostic interpretations that would be compared with human readers.

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

Not explicitly detailed as a standalone performance study. The device is described as a "software tool" that provides "e.g. tools for the automatic or manual segmentation." While automatic segmentation implies an algorithm's performance, no standalone performance metrics (e.g., accuracy of segmentation without human interaction) are reported. The device is designed to be used by radiologists or surgeons, implying a human-in-the-loop context.

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

Not provided for any formal validation study. The document mentions the use of "Talairach/Tournoux and/or Schaltenbrand/Wahren based brain atlases" for the BrainMAP module to define anatomical and functional structures. This would serve as a form of anatomical ground truth for positional information within the software, but it's not described as part of a formal validation study with patient-specific ground truth.

7. The sample size for the training set

Not provided. The document does not typically discuss training sets for this type of software in this era (2002), as it's not described as a machine learning/AI product in the contemporary sense. It's a planning tool with segmentation and atlas-correlation capabilities.

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

Not provided. As no training set is mentioned in the context of machine learning, ground truth establishment for such a set is not applicable or described. Any embedded anatomical knowledge in the software would likely be derived from established anatomical atlases and medical literature, such as the Talairach/Tournoux and Schaltenbrand/Wahren atlases mentioned.

Summary

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

9 2002 SEP

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

Manufacturer:	BrainLAB AG
Address:	Ammerthalstrasse 885551 HeimstettenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
Contact Person:	Mr. Rainer Birkenbach
Summary Date:	September 4, 2002
Device Name:
Trade name:	iPlanl
Common/Classification Name:	Planning System/Stereotaxic Instrument

이 대한민국 대학교 사업

Prodicate Dovices:

Vector Vision® 2 Cranial, Spine, ENT	(K 003589)
Vector Vision® 2 Hip	(K 010602)
Vector Vision® 2 Knee	(K 010612)
@target®	(K 983410)

Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II and the comments of the count :

. 1

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

Intended Use:

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

image preparation i
image fusion ﺴ
image segmentation -

where the result is used for the creation of treatment plans for

Stereotactic Surgery:

- Surgery 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 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 neurosurgical 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 .

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.

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

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-rav(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:

lmage 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 vertebra, 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 ﺖ
ENT procedures -
ﺳ Hip procedures
--Knee procedures

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

Device Description:

The system provides e.g. tools for the automatic or manual segmentation of anatomical structures which helps the user such as the radiologist or the surgeon to quickly achieve the desired segmentation results through an unlimited number of automatic and/or manual re-segementations. Additionally anatomical and functional structures and segmentations of the human brain as defined and described by Talairach/Tournoux and/or Schaltenbrand/Wahren brain atlases can be correlated with the patient´s brain data.

The created treatment plans of iPlan! can be used on its own or in conjunction with other Brainl.AB medical devices such as VectorVision for performing the planned treatment.

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 system. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate devices @target® (K 983410), Vector Vision® 2 Cranial, Spine, ENT (K 003589), Vector Vision® 2 Hip (K 010601) and Vector Vision®2 Knee (K 010612),

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 9 2002

Mr. Rainer Birkenbach Executive Vice President BrainLab AG Ammerthalstrasse 8 85551 Heimstetten Germany

Re: K020631 Trade/Device Name: iPlan Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 14, 2002 Received: June 19, 2002

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 mav 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 Fedcral 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.

{5}------------------------------------------------

Page 2 - Mr. Rainer Birkenbach

11 11:4

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Stypt Rlurdu

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

{6}------------------------------------------------

510(k) Number (if known):

K020631

Device Name:
--------------	--

iPlan!

Indications For Use:

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

image preparation -

image fusion
image segmentation

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

- Surgery 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.

- 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. BrainNAP may be used alone or in coniunction with neurosurgery.

· Functional Planning

The Functional Planning is based on Surgery Planning, which gives two- and three dimensional online information of a stereotactical instrument (electrodes) for a neurosurgical 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, MRL PET, SPECT) about the position and orientation relative to the patient of his surgical instrument to perform stimulation and treatment on to a preplanned traiectory .

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	✓
------------------------------------------	-----------------------------------------

	(Division Sign-Off) Division of General, Restorative and Neurological Devices	Over-The-Counter Use(Optional Format I-2-96)
--	----------------------------------------------------------------------------------------------------------------	--------------------------------------------------

510(k) Number K020631

{7}------------------------------------------------

510(k) Number (if known):

K020631

Device Name:
Comments of the program and the state of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution

iPlan!

In addition iPlan!'s indications for use is to prepare and present patient and image data based on CT MR. X-rav(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

Example procedures include but are not limited to:

Cranial procedures ﺖ
Spine procedures เ
ENT procedures -
Hip procedures -
Knee procedures

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Division Sig Division of General, Restorative

(Optional Format 1-2-96)

Neurological Devices

510(k) Number K620631

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).