Intuition Image's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including

image preparation -
image localization -
image fusion -
image segmentation -
isocenter handling -
plan review and approval where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.

Device Description

Intuition Image is a software tool running on a standard, standalone computer workstation or being accessible via the intranet connection for pre-planning of treatments based on stereotactic 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 neurosurgeon to quickly achieve the desired segmentation results through a variety of automatic and/or manual re-segmentations. 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 Intuition Image can be used on its own or in conjunction with other BrainLAB treatment planning systems such as Intuition Dose (to be developed) or BrainSCAN (K994413) for further planning of parameters, which are relevant for Radiotherapy/Radiosurgery. Intuition Image may also serve as a pre-planning station for various third party treatment planning systems.

AI/ML Overview

The provided 510(k) summary for Intuition Image (K032511) does not contain detailed information about specific acceptance criteria or an explicit study proving the device meets these criteria in the way a modern AI/ML device submission would.

The approval is based on "substantial equivalence" to predicate devices (K020631 and K994413), and the provided text highlights general validation and verification according to BrainLAB's procedures. This pre-dates the current rigorous expectations for AI/ML device performance validation.

Therefore, many of the requested details cannot be extracted from the given text. Below is an attempt to answer what can be inferred or explicitly stated, with clear indications where information is missing.

Acceptance Criteria and Device Performance

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

The document does not provide a table of specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or segmentation precision) or quantified performance metrics for Intuition Image. The primary "performance" reported is that the device "has been verified and validated according to BrainLAB's procedures for product design and development" and that this "validation proves the safety and effectiveness of the system."

Metric / Feature	Acceptance Criteria (Not explicitly stated)	Reported Device Performance	Comments / Interpretation
Overall Functionality	Device performs intended functions for image preparation, localization, fusion, segmentation, isocenter handling, and plan review/approval.	"Verified and validated according to BrainLAB's procedures for product design and development."	Implies software functions as designed and fulfills its stated intended use.
Safety	No undue risk to patients or users.	"validation proves the safety and effectiveness of the system."	General assurance of safety.
Effectiveness	Device achieves intended clinical purpose.	"validation proves the safety and effectiveness of the system."	General assurance of effectiveness.
Segmentation Accuracy	(Not specified)	Tools for "automatic or manual segmentation of anatomical structures, which helps the user such as the radiologist or the neurosurgeon to quickly achieve the desired segmentation results through a variety of automatic and/or manual re-segmentations."	Implies the tool facilitates accurate segmentation by the user, but no inherent automated accuracy metric is provided for the device itself.
Equivalence to Predicates	Functionally similar and equally safe/effective as iPlan! (K020631) and BrainSCAN (K994413).	"found to be substantially equivalent with the predicate devices."	The core of the 510(k) approval process for this device.

Study Details (Based on available information)

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

Sample Size: Not specified.
Data Provenance: Not specified. The document states BrainLAB AG is in Germany, but this does not confirm the origin of any test data.
Retrospective or Prospective: Not specified.

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):

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It mentions the "user such as the radiologist or the neurosurgeon" for segmentation, implying these are the intended experts for using the tool, but not necessarily for establishing ground truth in a formal test.

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

Not specified.

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 described or implied in the provided text. The device is a "pre-planning station" and software tool, not an AI-assisted diagnostic aid in the modern sense that would typically require such a study for its primary claim (though the "automatic segmentation" could be seen as an early form of AI-assistance).

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

The device description states it provides "tools for the automatic or manual segmentation." While "automatic segmentation" implies a standalone algorithmic component, no specific standalone performance metrics for this automatic function are reported. The focus is on the user leveraging these tools to achieve results.

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

Not specified. Given the nature of a planning system, it's likely that ground truth for segmentation or localization would involve expert anatomical delineation on imaging, potentially with cross-validation from multiple modalities or surgical confirmation contextually, but this is not detailed.

8. The sample size for the training set:

This device predates the common terminology and strict requirements for "training sets" as understood in modern AI/ML submissions. Therefore, a training set size is not mentioned, as the validation would have focused on a more traditional software verification and validation approach rather than an AI model training and testing paradigm.

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

As no training set is mentioned, the method for establishing its ground truth is also not specified.

Summary of Missing Information:

The provided 510(k) summary is typical for its era (2003) and for device types that are primarily software tools aiding clinicians, rather than standalone diagnostic AI algorithms. It emphasizes "substantial equivalence" to predicate devices and general verification/validation of software functionality. The granular details now expected for AI/ML device submissions, such as specific performance metrics, detailed study designs, ground truth establishment methods, and training/test set sizes, are largely absent.

Summary

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

K$\phi$32511

510 (k) Summary of Safety and Effectiveness for Intuition Image

Manufacturer:	BrainLAB AG
Address:	Ammerthalstrasse 885551 HeimstettenGermany
Phone:	+49 89 99 15 68 0
Fax:	+49 89 99 15 68 33
Contact Person:	Mr. Rainer Birkenbach
Summary Date:	August 1, 2003
Device Name:Trade name:	Intuition Image

Common/Classification Name:

Planning System/X-ray radiation therapy system

Predicate Device: iPlan! (K020631) BrainSCAN (K994413)

Device Classification Name: X-ray radiation therapy system Regulatory Class: Class II

Intended Use:

Intuition Image's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including

image preparation -
image localization -
image fusion -
image segmentation -
isocenter handling -
plan review and approval ﯩ

plan forlow and applied. where in roomputer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.

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

K$\emptyset$32511

Device Description:

Intuition Image is a software tool running on a standard, standalone computer workstation or being accessible via the intranet connection for pre-planning of treatments based on stereotactic 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 neurosurgeon to quickly achieve the desired segmentation results through a variety of automatic and/or manual re-segmentations. 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 Intuition Image can be used on its own or in conjunction with other BrainLAB treatment planning systems such as Intuition Dose (to be developed) or BrainSCAN (K994413) for further planning of parameters, which are relevant for Radiotherapy/Radiosurgery. Intuition Image may also serve as a pre-planning station for various third party treatment planning systems.

Substantial equivalence:

Intuition Image 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 iPlan! (K020631) and BrainSCAN (K994413).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2004

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

Re: K032511

Trade/Device Name: Intuition Image Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 LHN, and MUJ Dated: December 5, 2003 Received: December 10, 2003

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 10 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 111 (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.

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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 the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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) you may obtain. 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,

Nancy C. Brogdon

Nancy C. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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510(k) Number (if known): K$\phi$32511

Device Name:

Intuition Image

Indications For Use:

Intuition Image's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including

image preparation -
image localization -
image fusion
image segmentation -
isocenter handling .
plan review and approval -

where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use __

(Optional Formal I-2-96)

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

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.