iPlan Flow is designed as a planning system for pre- and intraoperative planning of stereotactic or image guided surgery treatments. It is specially designed to display anatomical images of a patient acquired with MR and/or CT as well as images derived from DTI-data acquired with Magnetic Resonance Imaging (MRI).

iPlan Flow is a dedicated tool for planning trajectories of intra-cranial catheters. Guidelines for the catheter placement e.g. from catheter suppliers can be visualized and displayed to support the surgeon in improving catheter placement planning. The guidelines, in combination with anatomical information, can be used to suggest areas that are compliant with the guidelines. iPlan Flow does not generate or create rules for the placement of intracranial catheters by any means. iPlan Flow uses MR-DTI and T2weighted MR images to suggest likely volumes of fluid distribution.

The Primary mode of action for iPlan Flow is a device for creating treatment plans for stereotactic or image guided surgical treatment, especially for the creation of plans for the placement of intra-cranial catheters.

The treatment plans can be used in conjunction with other BrainLAB medical devices such as VectorVision for image guided surgical treatment.

Device Description

Like iPlan!FLOW (K041330), iPlan Flow is a software tool running on a standard, standalone computer (PC or Laptop) or being accessible via the intranet connection for pre- or intraoperative planning of treatments based on stereotactic systems or image guided surgery systems.

Unchanged to iPlan!FLOW (K041330) iPlan Flow provides e.q. tools for the automatic or manual segmentation of anatomical structures which enables the user such as radiologists or neurosurgeons to quickly achieve the desired seamentation results through an unlimited number of automatic and/or manual re-segmentations. Like the predicate device iPlan!FLOW (K041330) iPlan Flow can be used for the planning of intracranial catheters, with image guided surgery. Guidelines provided e.g. by the catheter suppliers for the exact placements of intracranial catheters can be visualized. These quidelines comprise the minimal depth of the catheter tip in the brain tissue, the minimal distance of the catheter tip from intra-cranial surfaces and the minimal distance between different catheter tips. In addition to the predicate device the depth guideline can be calculated from the flow rate and the catheter diameter and warnings will be displayed if the trajectory of a planned catheter is likely to cross an intra-cranial surface. iPlan Flow is able to calculate a likely fluid distribution from the planned catheter positions to support the physician in his decision about appropriate catheter positions.

These features enable the surgeon to better plan and place intra-cranial catheters.

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

AI/ML Overview

The provided text is a 510(k) summary for the iPlan Flow device. It states that "The validation proves the safety and effectiveness of the system," and that the device was found "substantially equivalent" to its predicate device, iPlan!FLOW (K041330). However, the document does not describe any specific acceptance criteria for performance metrics or any detailed study demonstrating that the device meets such criteria.

Therefore, many sections of your request cannot be fulfilled based on the given document.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

Cannot be provided. The document states that the device was "verified and validated according to BrainLAB's procedures for product design and development" and was found "substantially equivalent" to the predicate device. However, it does not specify any quantitative acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) or report specific performance metrics for the iPlan Flow device.

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

Cannot be provided. The document does not mention any specific test set, its sample size, or data provenance.

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)

Cannot be provided. The document does not describe any specific test set or the establishment of ground truth for such a set. It mentions that the software enables users like "radiologists or neurosurgeons to quickly achieve the desired segmentation results through an unlimited number of automatic and/or manual re-segmentations," but this refers to the use of the device, not the process of establishing ground truth for a validation study.

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

Cannot be provided. No information about a test set or adjudication methods is present.

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

Cannot be provided. The document does not describe an MRMC study or any results related to human reader improvement with or without AI assistance. The device is a "planning system" and an "aid" for surgeons in planning, not directly an AI for improving human reader diagnostic performance in a typical MRMC study context.

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

Cannot be provided. While iPlan Flow is a software tool, the document doesn't detail a standalone performance study in the way this question implies (e.g., algorithmic accuracy without human interaction on a test dataset). Its functionality is inherently tied to assisting human planning.

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

Cannot be provided. The document does not describe the specific ground truth used for any validation studies.

8. The sample size for the training set

Cannot be provided. The document does not mention a training set or its sample size.

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

Cannot be provided. The document does not mention a training set or how its ground truth was established.

Summary based on the provided text:

The 510(k) summary for iPlan Flow (K053164) focuses on demonstrating substantial equivalence to its predicate device, iPlan!FLOW (K041330). It states that the device was "verified and validated according to BrainLAB's procedures for product design and development" and that "The validation proves the safety and effectiveness of the system." However, it does not provide the detailed study results, acceptance criteria, sample sizes, ground truth establishment methods, or expert qualifications that would be required to answer your specific questions about performance metrics and validation studies. Such detailed information is typically found in the full 510(k) submission, which is more extensive than the summary provided.

Summary

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MAR 23 2006

K053164

Page 1 of 2

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

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:	March 21, 2006
Device Name:
Trade name:	iPlan Flow

Common/Classification Name:

Plan Flow

Stimulant Classification Name.

Planning System/Stereotactic Instrument

Predicate Device: iPlan!FLOW (K 041330)

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

Intended Use:

The treatment plans can be used in conjunction with other BrainLAB medical devices such as VectorVision for image guided surgical treatment.

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K05-3164

Page 2 of 2

Device Description:

These features enable the surgeon to better plan and place intra-cranial catheters.

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

Substantial equivalence:

iPlan Flow 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 device iPlan!FLOW (K041330).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads or faces.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2006

BrainLAB AG c/o Mr. Rainer Birkenbach Ammerthalstrasse 8 85551 Heimstetten Germany

Re: K053164

Trade/Device Name: iPlan Flow Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 8, 2006 Received: March 10. 2006

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 cither 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

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Page 2 - Mr. Rainer Birkenbach

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. 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,

J. Hubert Lemmer wo

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kos-3164

Indications for Use

510(k) Number (if known):

Device Name: iPlan Flow

Indications For Use:

iPlan Flow is designed as a planning system for pre- and intraoperative planning of stereotactic or image quided surgery treatments. It is specially designed to display anatomical images of a patient acquired with MR and/or CT as well as images derived from DTI-data acquired with Magnetic Resonance Imaging (MRI).

iPlan Flow is a dedicated tool for planning trajectories of intra-cranial catheters. Guidelines for the catheter placement e.g. from catheter suppliers can be visualized and displayed to support the surgeon in improving catheter placement planning. The quidelines, in combination with anatomical information, can be used to suggest areas that are compliant with the guidelines. iPlan Flow does not generate or create rules for the placement of intracranial catheters by any means. iPlan Flow uses MR-DTI and T2weighted MR images to suggest likely volumes of fluid distribution.

The treatment plans can be used in conjunction with other BrainLAB medical devices such as VectorVision for image guided surgical treatment.

Prescription Use × (Per 21 CFR 801 Subpart D)

(10(k) Nimber

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
K053164

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).