iPlan's indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, atlas assisted visualization and segmentation, intraoperative functional planning where the output can be used e.g. with stereotactic image guided surgery or other devices for further processing and visualization.

Example procedures include but are not limited to:

Planning and simulation of cranial surgical procedures such as tumor resection, shunt placement, minimal-invasive stereotactic interventions, biopsy, trajectory planning for stimulation and electrode recording
ENT procedures such as sinus surgery, tumor surgery -
Spine procedures such as tumor surgery, pedicle screw planning, vertebroplasty planning
iPlan View is an application which is intended to be used for reviewing existing treatment plans

Device Description

Following planning sub-modules are available in the functional applications: Load and Import, View and Adjustment, Registration Points, ACPC Localization, Localization, Image Fusion, Object Creation, Advanced Object Planning, BOLD MRI mapping, Fiber Tracking, Trajectory planning, Stereotactic planning, Electrode recording, Save and Export.

AI/ML Overview

The provided text describes the 510(k) summary for the iPlan device (K101627). However, it does not contain specific details about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, or any formal study results (like MRMC comparative effectiveness studies or standalone performance studies) that prove the device meets acceptance criteria.

The document states that:

"On different levels of development (module, subsystem, system) specific bench and integration tests were conducted."
"Internal standards were tested and documented as conformance report, environment compatibility and interfaces."
"Compatibility with previous version and comparable workflows to predicate devices were documented in corresponding review protocols."
"Side-by-side comparison testing of the new version of iPlan with its predicate device was conducted to determine substantial equivalences of the new version of iPlan with its predicate version."

This indicates that testing was performed, but the results, specific acceptance criteria, and detailed methodology are not included in this summary. The FDA's letter states a "substantial equivalence determination" to a legally marketed predicate device (iPlan K053127) was made, which is the basis for clearance, rather than a detailed performance study against specific acceptance criteria.

Therefore, I cannot populate the requested table and sections with the information provided. The document outlines:

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

Not provided. The document generally states "specific bench and integration tests were conducted" and "Internal standards were tested," but no specific criteria or performance metrics are detailed.

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

Not provided.

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):

Not provided.

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

Not provided.

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:

Not explicitly mentioned or detailed. The device description focuses on planning and visualization tools, not necessarily AI-assisted interpretation to improve human reader performance in a diagnostic context. "Side-by-side comparison testing" was done with the predicate device to determine substantial equivalence, not typically an MRMC study demonstrating human performance improvement.

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

Not explicitly mentioned or detailed. The device is described as a "Planning System, Stereotactic Instrument" used by "medical professionals," implying human interaction.

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

Not provided.

8. The sample size for the training set:

Not applicable/Not provided. The document describes a medical device software for planning and visualization, not typically an AI/ML model that would have a distinct training set in the conventional sense of deep learning. The testing described focuses on functional equivalence to a predicate device.

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

Not applicable/Not provided. (See point 8)

Summary

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K101627

JUN - 3 2011

510 (k) Summary of Safety and Effectiveness for iPlan

Manufacturer:

Address:	Brainlab AGKapellenstrasse 1285622 FeldkirchenGermany
	Phone: +49 89 99 15 68 0
	Fax: +49 89 99 15 68 33
Submitter:	Mr. Rainer Birkenbach

Contact Person: Mr. Alexander Schwiersch

Summary Date: April 21, 2011

Device Name:

Trade name:	iPlan Cranial, iPlan StereotaxyiPlan ENT, iPlan Spine, iPlan View
Common/Classification Name:	Planning System, Stereotactic Instrument

Predicate Device:

iPlan (K053127)

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

Indications For Use:

iPlan's indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, atlas assisted · visualization and segmentation, intraoperative functional planning where the output can be used e.g. with stereotactic image guided surgery or other devices for further processing and visualization.

Example procedures include but are not limited to:

Planning and simulation of cranial surgical procedures such as tumor resection, shunt placement, minimal-invasive stereotactic interventions, biopsy, trajectory planning for stimulation and electrode recording
ENT procedures such as sinus surgery, tumor surgery -
Spine procedures such as tumor surgery, pedicle screw planning, vertebroplasty planning
iPlan View is an application which is intended to be used for reviewing existing treatment plans

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Typical users of iPlan are medical professionals, including but not limited to surgeons and radiologists.

Device Description

Following planning sub-modules are available in the functional applications:

#	Sub-module	Changed*)	iPlanCranial	iPlanENT	iPlanStereotaxy	iPlanSpine	iPlanView
1	Load and Import	yes	X	X	X	X	X
2	View and Adjustment	yes	X	X		X	X
3	Registration Points	yes	X	X	X	X
4	ACPC Localization	yes			X
5	Localization	yes			X
6	Image Fusion	yes	X	X	X	X	X
7	Object Creation	yes	X	X	X	X
8	Advanced ObjectPlanning	yes	X	X
9	BOLD MRI mapping	yes	X		X
10	Fiber Tracking	yes	X		X
11	Trajectory planning	yes	X	X		X
12	Stereotactic planning	yes			X
13	Electrode recording	yes			X
14	Save and Export	yes	X	X	X	X

*) changed compared to previous iPlan version

Description of sub-modules:

#	Sub-module	Description
1	Load and Import	Load existing treatment data from different data sources, Import patient data from DICOM or other archive types, manage (delete/copy/move) patient folders
2	View and Adjustment	Review patient data in various reconstructions or overlay, side-by-side comparison of different modalities, aligning the data set orientation, import or export screenshot images
3	Registration Points	Automatic detection of CT or MR registration markers for navigation, manual placement of markers and anatomical landmarks
4	ACPC Localization	This planning task allows the definition of AC/PC coordinate system
5	Localization	Assign a localizer frame for CT or MRI localizationPerform automatic detection of localizer rods
6	Image Fusion	Align available image sets automatically, manually orusing landmarks for various combinations of images setsand modalities such as CT, MRI, PET and SPECT.Visual verification of alignment.
7	Object Creation	Outline anatomical structures using manual or automaticsegmentation methods. Advanced manipulation for 3Dobjects with scaling, logical operations and objectsplitting.Volumetric measurements based on the created 3Dobjects
8	Advanced Object Planning	Mirror and split segmented structures
9	BOLD MRI mapping	Processing of blood oxygen level dependent (BOLD) MRIdataDefinition of block design functional task, calculation ofactivation areas based on BOLD MRI data, time seriesview for activation signal, creation of 3D objects fromactivation areas
10	Fiber Tracking	Processing of diffusion tensor imaging (DTI) using variousways to define and combine seed regions of interest.Definition of multiple fiber bundles and creation of 3Dobjects from fiber bundles.Volumetric measurements and detailed fiber information
11	Trajectory planning	Plan pathways for surgical instruments or resection,definition of entry, target points and diameter fortrajectories
12	Stereotactic planning	Planning of stereotactic trajectoriesUsage of AC/PC coordinates and Schaltenbrandt-WahrenatlasCalculation of stereotactic arc settings for plannedtrajectories
13	Electrode recording	Planning of parallel electrode tracksEnter and display microelectrode recording andstimulation results, display information stepwise alongtracks
14	Save and Export	Save the current treatment plan to the patient folderExport the results to the navigation, as DICOM or STLformat

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The iPlan software can be used on a dedicated Brainlab system or other platforms with defined minimum requirements.

The iPlan software can be mainly used in combination with the Brainlab devices: iPlan Net, Digital Lightbox, VectorVision navigation, Kolibri navigation.

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K101627

Application performance testing

On different levels of development (module, subsystem, system) specific bench and integration tests were conducted. Internal standards were tested and documented as conformance report, environment compatibility and interfaces. Compatibility with previous version and comparable workflows to predicate devices were documented in corresponding review protocols.

Side-by-side comparison testing of the new version of iPlan with it's predicate device was conducted to determine substantial equivalences of the new version of iPlan with it's predicate version.

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

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. In the center of the seal is a stylized image of a bird, possibly an eagle, with its wings spread. The bird is composed of three curved lines, and below it are three wavy lines, possibly representing water.

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

JUN - 3 2011

BrainLab AG c/o Mr. Alexander Schwiersch Regulatory Affairs Manager Kapellenstrasse 12 Feldkirchen Germany 85622

Re: K101627

Trade/Device Name: iPlan Cranial, iPlan Stereotaxy, iPlan ENT, iPlan Spine, iPlan View Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 13, 2011 Received: May 25, 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 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. Iisting 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 801); medical device reporting (reporting of medical

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

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Q. Ci. Tim, m/

Malvina B. Evdelman. M.E Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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K101627

Indications for Use

510(k) Number (if known):

Device Name: iPlan

Indications For Use:

Example procedures include but are not limited to:

Planning and simulation of cranial surgical procedures such as tumor resection, " shunt placement, minimal-invasive stereotactic interventions, biopsy, planning and simulation of trajectories for stimulation and electrode recording
ENT procedures such as sinus surgery, tumor surgery -
Spine procedures such as tumor surgery, pedicle screw planning, vertebroplasty planning
iPlan View is an application which is intended to be used for reviewing existing treatment plans

Typical users of iPlan are medical professionals, including but not limited to surgeons and radiologists.

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)

tion Use

er 21 CFR 801.109)

(Division/Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Throat Devices

Division of
Nose and Throat Devices

510(k) Number

Page

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).