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, 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
Planning and simulation of cranio-maxillofacial procedures

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

Device Description

iPlan is a software based treatment planning application providing functionalities like viewing, processing and documentation of medical data including different modules for image preparation, image fusion, image segmentation where the result is a treatment plan that can be used e.g. for stereotactic and/or image guided surgery.

AI/ML Overview

The provided 510(k) summary for iPlan focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and non-clinical performance data. It does not provide detailed acceptance criteria or a specific study proving the device meets those criteria in the format typically associated with AI/ML device performance evaluations (e.g., sensitivity, specificity, AUC).

However, I can extract the information related to non-clinical performance data and application performance testing which served as the basis for the FDA's substantial equivalence determination for this software planning application.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity, specificity, accuracy) for the device's performance. Instead, it relies on demonstrating equivalence to predicate devices and adherence to internal standards and specifications.

Acceptance Criterion (Implicit)	Reported Device Performance
Usability Validation: The device is usable and meets user needs.	"Usability workshops were performed with prototype versions of the software which has no relevant user interface differences to the final version and is therefore equivalent to the final version in respect to the usability validation. Moreover an Expert Group Review has worked with Brainlab in order to tailor the existing iPlan planning functionalities to the specific needs of CMF surgeons."
Functional Equivalence: The software performs its intended functions correctly and reliably.	"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."
Clinical Relevance/Safety: The device's output is safe and effective for its indicated uses.	"The clinical evaluation has been based on literature studies." (This suggests reliance on existing clinical knowledge and predicate device performance rather than a new clinical trial for iPlan itself).
Substantial Equivalence: The device is as safe and effective as legally marketed predicate devices.	The overall conclusion of the 510(k) summary is that the submitted information... is complete and supports a substantial equivalence decision. The FDA's letter concurs with this, stating that the device is "substantially equivalent... to legally marketed predicate devices."

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of a dataset for a performance study.

For Usability Workshops: The sample size (number of participants) is not mentioned. The workshops were likely conducted on prototypes.
For Application Performance Testing: The sample size of test cases or data used during bench and integration tests is not specified.
Data Provenance: Not applicable in the context of a dataset for a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not directly applicable as there isn't a traditional "test set" with ground truth established by experts in the context of a performance study for this type of device described.

For the Expert Group Review in usability: The number of experts is not specified, but they are described as working with Brainlab "to tailor the existing iPlan planning functionalities to the specific needs of CMF surgeons." Their qualifications are implicitly that they are CMF (Cranio-Maxillofacial) surgeons.

4. Adjudication method for the test set

Not applicable, as a dedicated "test set" for performance evaluation with an adjudication process is not described.

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

No MRMC comparative effectiveness study is mentioned. The device is a planning application, and the evaluation focuses on its functional correctness, usability, and equivalence to predicates, not on AI-assisted diagnostic improvement for human readers.

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

This refers to the software performing its functions without human interaction. The "Application performance testing" ("bench and integration tests") would implicitly cover the standalone performance of the algorithms and modules within iPlan to ensure they meet internal standards. However, specific metrics are not provided. iPlan is described as a "software based treatment planning application," implying it's a tool for medical professionals, not a fully autonomous diagnostic or therapeutic AI.

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

For the "Application performance testing," the ground truth would be the expected output or behavior of the software modules based on their specifications and internal standards. This is typically established through:

Functional Specifications: Defining what each module (e.g., Image Fusion, Object Creation) is supposed to do.
Reference Data/Known Inputs: Using synthetic or previously validated medical data where the "correct" output of a segmentation, fusion, or trajectory calculation is known or can be analytically derived.
Comparison to Predicate Devices: Ensuring that functionally similar modules perform comparably to predicate devices.

8. The sample size for the training set

This document does not describe the development of an AI/ML model that would typically have a "training set." iPlan is presented as a software application with various processing and visualization functionalities.

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

Not applicable, as a "training set" for an AI/ML model is not mentioned in this context.

Summary

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

510(k) Summarv iPlan

MAY - 7 2012

K113732

510(k) Summary- iPlan

1. Manufacturer

Address:	Brainlab AG
	Kapellenstrasse 12
	85622 Feldkirchen
	Germany
Phone:	+49 89 99 15 68 0
Fax:	+49 89 99 15 68 33

Contact Person: Mr. Alexander Schwiersch

November 17, 2011 Summary Date:

2. Device Name

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

3. Predicate Devices iPlan (K101627) Maxilim (K052424)

4. Device Description

5. Intended use

Example procedures include but are not limited to:

Planning and simulation of cranial surgical procedures such as tumor resection, l shunt placement, minimal-invasive stereotactic interventions, biopsy, planning and simulation of trajectories for stimulation and electrode recording

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

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
Planning and simulation of cranio-maxillofacial procedures -

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

#	Sub-module	Changed*)	iPlanCMF	iPlanCranial	iPlanENT	iPlanStereotaxy	iPlanSpine	iPlanView
1	Load and Import	No	X	X	X	X	X	X
2	View and Adjustment	No	X	X	X		X	X
3	Registration Points	No	X	X	X	X	X
4	ACPC Localization	No				X
5	Localization	No				X
6	Image Fusion	No	X	X	X	X	X	X
7	Object Creation	No	X	X	X	X	X
8	Advanced Object Planning	No	X	X	X
9	BOLD MRI mapping	No		X		X
10	Fiber Tracking	No		X		X
11	Trajectory planning	No	X	X	X		X
12	Stereotactic planning	No				X
13	Electrode recording	No				X
14	Save and Export	No	X	X	X	X	X
15	3D Functionalities	Yes	X	X	X	X	X	X

6. Technological Characteristics

*) changed compared to iPlan K101627

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, aligningthe data set orientation, import or export screenshotimages
3	Registration Points	Automatic detection of CT or MR registration markers fornavigation, manual placement of markers and anatomicallandmarks
4	ACPC Localization	This planning task allows the definition of AC/PCcoordinate 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 ObjectPlanning	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) usingvarious ways to define and combine seed regions ofinterest.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
15	3D Functionalities	Three-dimensional volume based rendering for differentimage modalities and planning data.Extension of standard view types and options withstructure specific view types

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

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

7. Assessment of non-clinical performance data: non clinical tests

Usability workshops were performed with prototype versions of the software which has no relevant user interface differences to the final version and is therefore equivalent to the final version in respect to the usability validation.

Moreover an Expert Group Review has worked with Brainlab in order to tailor the existing iPlan planning functionalities to the specific needs of CMF surgeons.

8. Clinical Evaluation/Validation

The clinical evaluation has been based on literature studies.

9. 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.

10. Conclusions

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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

Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAY - 7 2012

Mr. Alexander Schwiersch Regulatory Affairs Manager Brainlab AG Kapellenstrasse 2 85622 Feldkirchen GERMANY

Re: K113732

Trade/Device Name: iPlan Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, LLZ Dated: April 30, 2012 Received: May 4, 2012

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, 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

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

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 and Safety at (301) 796-5450. 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/ReportalProblem/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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): にいる732

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
Planning and simulation of cranio-maxillofacial procedures

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

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)

Marlon D. Kirk

Division Sign-Off Division of Radiological Devices Office of In Vitro Division of Raciologics Evaluation and Safety

K113732
510K

Page

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.