BrainLAB's VectorVision® hip SR is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a VectorVision® navigation station. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's bone, which is generated by acquiring multiple landmarks on the bone surface. The 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. The system aids the surgeon in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

· Partial/hemi-hip resurfacing

Device Description

BrainLAB's VectorVision® hip SR is intended to enable operational planning and navigation in orthopedic hemi resurfacing surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. VectorVision® hip SR uses the registered landmarks to navigate the initial pin insertion into the femur with a pre-calibrated drillguide to the planned position.

VectorVision® hip SR allows 3-dimensional reconstruction of the relevant anatomical axes and planes of the femur and alignment of the implants. The VectorVision® hip SR software has been designed to read in data of implants and tools if provided by the implant manufacturer and offers to individually choose the prosthesis during each surgery. If no implant data is available it is possible to provide information in order to achieve a generally targeted alignment relative to the bone orientation as defined by the operating surgeon. The VectorVision® hip SR software registers the patient data needed for planning and navigating the surgery intraoperatively without CT-based imaging. The system can be used to generally align tool orientations according to the anatomy described and defined by the landmarks acquired by the surgeon.

AI/ML Overview

The provided document is a 510(k) Summary of Safety and Effectiveness for the BrainLAB VectorVision® hip SR device. It details the device's intended use, description, and states that it has been verified and validated according to BrainLAB's procedures for product design and development, proving its safety and effectiveness. However, the document does not contain explicit acceptance criteria or a detailed study report with performance metrics, sample sizes, ground truth establishment, or expert qualifications as requested. It primarily focuses on demonstrating substantial equivalence to predicate devices (VectorVision® hip K040368 and VectorVision® osteotomy K042513) for regulatory clearance.

Therefore, much of the requested information cannot be extracted from this document.

Here's what can be addressed based on the provided text:

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

Not available in the document. The document states: "The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device Vector Vision® hip (K 040368) and Vector Vision® osteotomy (K042513)." This indicates that validation was performed, but the specific acceptance criteria and detailed performance metrics (e.g., accuracy, precision) are not included in this summary.

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

Not available in the document. The document does not provide details on sample sizes for any test sets or the provenance of data used for validation.

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 available in the document. The document does not describe the establishment of ground truth for any test sets or the involvement or qualifications of experts.

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

Not available in the document. The document does not mention any adjudication methods.

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 available in the document. This document describes an image-guided navigation system for surgery, not an AI-assisted diagnostic device typically evaluated with MRMC studies. There is no mention of human reader studies or AI assistance for diagnostic interpretation.

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

The device itself is an "intraoperative image-guided localization system" that aids a surgeon. While the "algorithm only" performance (e.g., system accuracy) would be part of its validation, the document does not provide details or results of such a standalone performance study. It only states that the device was "verified and validated."

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

Not available in the document. The document does not specify the type of ground truth used for any validation. Given it's a navigation system, ground truth would likely relate to accuracy of tool positioning relative to planned positions or anatomical landmarks, but this is not detailed.

8. The sample size for the training set

This device is described as an image-guided surgery system that uses either "preoperatively-acquired patient images" or an "individual 3D model... generated by acquiring multiple landmarks on the bone surface." It does not explicitly describe a machine learning model that would require a "training set" in the conventional sense for deep learning. If there are underlying algorithms, the training set size for those is not available in the document.

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

As a "training set" is not explicitly mentioned in the context of machine learning, the establishment of its ground truth is not available in the document. If this refers to the data used to develop the system's underlying algorithms, those details are not provided.

Summary

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® BrainLAB

BrainLAB AG Kapellenstraße 12 · 85622 Feidkirchen · Germany

phone: · 49 89 99 15 68 - 0 • 49 89 99 15 68 - 33

brainlab.com

OEC 1 2 2006

510 (k) Summary of Safety and Effectiveness for VectorVision® hip SR

KO63028

Manufacturer:	BrainLAB AG
Address:	Kapellenstrasse 1285622 FeldkirchenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
Contact Person:	Mr. Per Persson
Summary Date:	September 26th, 2006
Device Name:
Trade name:	VectorVision® hip SR

Common/Classification Name:

VectorVision®, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Predicate Device: VectorVision® hip (K 040368) VectorVision® osteotomy (K042513)

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

Intended Use:

BrainLAB's VectorVision® hip SR is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a VectorVision® navigation station. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's generated by acquiring multiole landmarks on the bone surface. The 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. The system aids the surgeon in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

· Partial/hemi-hip resurfacing

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Image /page/1/Picture/0 description: The image shows the logo for BrainLAB. The logo consists of a caduceus symbol on the left, followed by the word "Brain" in bold, and then the word "LAB" with a striped pattern. The logo is in black and white.

14063098

Device Description:

VectorVision® hip SR allows 3-dimensional reconstruction of the relevant anatomical axes and planes of the femur and alignment of the implants. The Vector/sion® hip SR software has been designed to read in data of implants and tools if provided by the implant manufacturer and offers to individually choose the prosthesis during each surgery. If no implant data is available it is possible to provide information in order to achieve a generally targeted alignment relative to the bone orientation as defined by the operating surgeon. The VectorVision® hip SR software registers the patient data needed for planning and navigating the surgery intraoperatively without CT-based imaging. The system can be used to generally align tool orientations according to the anatomy described and defined by the landmarks acquired by the surgeon.

Substantial equivalence:

VectorVision® hip SR has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device Vector Vision® hip (K 040368) and Vector Vision® osteotomy (K042513).

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Public Health Service

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BrainLAB AG % Rainer Birkenbach Executive Vice President Kapellenstrasse 12 85622 Feldkirchen Germany

DEC 1 2 2006

Re: K063028 Trade/Device Name: VectorVision® hip SR Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: September 28, 2006 Received: October 2, 2006

Dear Rainer 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 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 (OS) 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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Page 2 - Rainer Birkenbach

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vo

for Pedro V
Mark N. Melkerson
DEPUTY
DIRECTOR

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

Enclosure

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Indications for Use

510(k) Number (if known): KO6 3028

Device Name: VectorVision® hip SR

Indications For Use:

Example orthopedic surgical procedures include but are not limited to:

· Partial/hemi-hip resurfacing

Prescription Use(Per 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number K063028

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).