BrainLAB uni-knee 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 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 knee endoprosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB uni-knee.

Example orthopedic surgical procedures include but are not limited to:

· Unicondylar Knee Replacement
· Ligament Balancing
· Range of Motion Analysis
· Patella Tracking

Device Description

BrainLAB 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. Uni-knee 2.0 uses the registered landmarks to navigate the femoral and tibial cutting quides to the preplanned position.

Uni-knee 2.0 allows 3-dimensional reconstruction of the mechanical axes and alignment of the implants. The uni-knee 2.0 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 uni-knee 2.0 software registers the patient data needed for planning and navigating intra-operatively. No preoperative CT-scanning is necessary.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria or an explicit study proving the device meets those criteria. The document is a 510(k) summary for the BrainLAB uni-knee, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed report of a performance study with acceptance criteria.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes, data provenance, or details of expert involvement for a test set.
Adjudication methods.
Details of a multireader multicase (MRMC) comparative effectiveness study or its effect size.
Confirmation of a standalone performance study.
Type of ground truth used for a test set.
Sample size for the training set or how ground truth was established for it.

The document states:

"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 system."

This indicates that some form of validation was performed, but the specifics of that validation, including acceptance criteria, study design, and results, are not detailed in this 510(k) summary. The summary focuses on showing equivalence to predicate devices (K041899, K021306, K052966) as the basis for regulatory clearance.

Summary

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K080678

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

Manufacturer:

JUN - 6 2008

Address:	BrainLAB AGKapellenstrasse 1285622 FeldkirchenGermany
Phone:	+49 89 99 15 68 0
Fax:	+49 89 99 15 68 33
Contact Person:	Mr. Per Persson
Summary Date:	16 January 2008

Device Name:

Trade name:	Uni-knee 2.0
Common/Classification Name:	BrainLAB uni-knee, BrainLAB Image Guided SurgerySystem / Instrument, Stereotaxic

Predicate Device:

Vector Vision® CT-free Knee (K021306) Ci TKR/UKR (K052966) VectorVision uni-knee (K041899)

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

Intended Use:

BrainLAB uni-knee 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-rav, or MR-based model of the anatomy. The system aids the surgeon in accurately navigating a knee endoprosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB uni-knee.

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Example orthopedic surgical procedures include but are not limited to:

· Unicondylar Knee Replacement
· Ligament Balancing
· Range of Motion Analysis
· Patella Tracking

Device Description:

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 system. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of VectorVision® uni-knee (K041899). VectorVision® CT-free knee (K 021306) and Ci TKR/UKR (K052966).

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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 stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2008

BrainLAB AG % Mr. Per Persson Kapellenstrenstrasse 12 85622 Feldkirchen Germany

Re: K080678 Trade/Device Name: uni-knee Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 6, 2008 Received: March 10, 2008

Dear Mr. Persson:

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 - Mr. Per Persson

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse arents (Medical Device Reporting (MDR)), please contact the Division of Surveillance arvers at (240) 276-3464. 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 yours.

Mark N. Mulhern

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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Indications for Use

510(k) Number (if known):

Device Name: uni-knee

Indications For Use:

BrainLAB uni-knee 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 pationt'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, or MR-based model of the anatomy.

Example orthopedic surgical procedures include but are not limited to:

· Unicondylar Knee Replacement
· Ligament Balancing
· Range of Motion Analysis
· Patella Tracking

Neil R. Osdalen

Division of General, Restorative, and Neurological Devices

510(k) Number K080678

Prescription Use (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)

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).