VECTORVISION UNI-KNEE by BRAINLAB AG

BrainLAB VectorVision is intended to be an intraoperative image quided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system 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. The system is indicated for any medical condition in which the use of stereotactic surgery may 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, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee endoprothesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by VectorVision® uni-knee.

Example orthopedic surgical procedures include but are not limited to:

Knee Procedures: Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Patella Tracking

Device Description

BrainLAB VectorVision®uni-knee is intended to enable 3 dimensional implant planning and navigation for unicompartimental orthopedic knee surgery. The SW links a surgical instrument tracked by passive markers to a 3D-model of the patient's bone, which is generated by acquiring multiple landmarks on the bone surface. Vector/ision® uni-knee uses the registered landmarks to navigate the femoral and tibial cutting guides to the pre-planned position.

VectorVision® uni-knee allows 3-dimensional reconstruction of the mechanical axes and alignment of the implants. The VectorVision® uni-knee software has been designed to read in implant data and tool data from different manufacturers and offers to individually choose the prosthesis during each surgery. The VectorVision® uni-knee software registers the patient data needed for planning and navigating intraoperatively. No preoperative CT-scanning is necessary.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the BrainLAB VectorVision® uni-knee system, dated October 5, 2004. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain the specific information requested about acceptance criteria, device performance results, sample sizes, ground truth establishment, or study methodologies.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

No Acceptance Criteria or Performance Data: The document states that the device "has been verified and validated according to BrainLAB's procedures for product design and development" and that "The validation proves the safety and effectiveness." However, it does not detail what those specific acceptance criteria were (e.g., accuracy thresholds, precision measurements) nor does it report the actual device performance against any such criteria.
No Study Details: There is no mention of specific studies conducted to prove the device meets acceptance criteria. Information regarding test set sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample sizes, or how training set ground truth was established is entirely absent.

In summary, the provided document is a regulatory submission claiming safety and effectiveness based on internal validation, but it does not provide the details of that validation or the performance data against defined acceptance criteria, as an engineering or clinical study report would.

Therefore, I cannot populate the requested table or answer the specific questions below it. The entire response would be "Not provided in the given text."

Summary

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4i899

OCT 6 - 2004

510 (k) Summary of Safety and Effectiveness for VectorVision® uni-knee

Manufacturer:	BrainLAB AG
Address:	Ammerthalstrasse 885551 HeimstettenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
Contact Person:	Mr. Rainer Birkenbach
Summary Date:	October 5, 2004
Device Name:
Trade name:	VectorVision® uni-knee
Common/Classification Name:	VV uni-knee; BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Predicate Device: Vector Vision® CT-free Knee (K021306) Ci TKR/UKR (K031770)

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

Intended Use:

Example orthopedic surgical procedures include but are not limited to:

Knee Procedures: Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Patella Tracking Device Description:

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Substantial equivalence:

VectorVision® uni-knee 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 includes the Accuris Tibiofemoral Cutting Block Adapter and was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of VectorVision® CT-free knee (K 021306) and Ci TKR/UKR (K031770).

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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 features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 - 2004

Mr. Rainer Birkenbach BrainLab AG Ammerthalstrasse 8 85551 Heimstetten Germany

Re: K041899

Trade/Device Name: VectorVision Uni-Knee Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: September 3, 2004 Received: September 8, 2004

Dear Mr. Birkenbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your beeermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreaty to regists of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, do noos har ha re oo.h require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may , arover rovisions 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 rr your de rior 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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Page 2 - Mr. Rainer Birkenbach

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to organ maniemag your and equivalence of your device to a legally prematics notification: "The promotion of ryour 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 If you desire specific arrice 10-10-10-10-115. Also, please note the regulation entitled, Connect the Office of Company of Company (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormation on Job 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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K041899

Device Name:

VectorVision uni-knee

Indications For Use:

BrainLAB VectorVision is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system 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. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a ngid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee mr buou more of the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by VectorVision® uni-knee.

Example orthopedic surgical procedures include but are not limited to:

Knee Procedures: Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Patella Tracking

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Optional Format I-2-96)

al. Restorative. and Neurological De

510(k) Number K041899

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).