BrainLAB 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, MR-based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB knee.

Example orthopedic surgical procedures include but are not limited to:

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

Device Description

BrainLAB knee is intended to enable operational planning and/navigation in orthopedic surgery. It links a surqical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is gegerated through acquiring multiple landmarks on the bone surface. BrainLAB knee uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.

BrainLAB knee allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. BrainLAB knee software registers the, patient data needed for planning and navigating the surgery intraoperatively. No preoperative CT-scanning is necessary.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from the given text.

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

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

Acceptance Criteria: Not specified in the provided text.
Reported Device Performance: Not detailed in the provided text as specific quantitative performance metrics. The document broadly states that "The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application."

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

Not specified in the provided text.

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 specified in the provided text.

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

Not specified in the provided text.

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 specified in the provided text. The device is a surgical navigation system, not an AI-assisted diagnostic device, so an MRMC study with "human readers" is unlikely to be relevant in this context.

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

The device is described as an "intraoperative image guided localization system" that "aids the surgeon." This implies a human-in-the-loop system, so a standalone algorithm-only performance study as typically understood for diagnostic AI might not be directly applicable or detailed here. The text does not provide information about such a study.

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

Not specified in the provided text. The system generates a "3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface." Performance would likely be evaluated against the accuracy of navigation to planned positions, but the method for establishing this "ground truth" for validation is not described.

8. The sample size for the training set:

Not specified in the provided text. The device relies on an "individual 3D-model of the patient's bone" generated intraoperatively, rather than a pre-trained AI model in the typical sense that would require a "training set."

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

Not applicable/Not specified. As noted in point 8, the system's operation doesn't suggest a "training set" in the context of machine learning model development.

Summary

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K073615

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

Manufacturer:	BrainLAB AG
Address:	Kapellenstrasse 1285622 FeldkirchenGermany
Phone:	+49 89 99 15 68 0
Fax:	+49 89 99 15 68 33
Contact Person:	Mr. Per Persson
Summary Date:	December 5, 2007

SSEP-520008

Device Name:
Trade name:	BrainLAB knee essential, BrainLAB knee unlimitedCi™ knee, Ci™ knee unlimited
Common/Classification Name:	BrainLAB Image Guided Surgery System / Instrument,Stereotaxic

Predicate Devices:
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:
Brainl AB/knee is intended to be an intraoperative image guided localization system to eBrainLAB/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, MR-based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by BrainLAB knee.

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Example orthopedic surgical procedures include but are not limited to:

· Total Knee Replacement
Smeenter Knee Replacement
· Ligament Balancing
· Range of Motion Analysis
Cruciate Ligamoni Sargers
· Patella Tracking

Device Description:

Substantial equivalence:

BrainLAB 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 was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of VectorVision® CT-free knee (K021306), VectorVision® Uni-Knee (K041899) and of Ci TKR/UKR (K052966).

Page 2 of 2

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

SEP - 5 2008

Re: K073615

Trade/Device Name: BrainLab knee Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: August 25, 2008 Received: September 2, 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 (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. 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 events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems 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 M. Mullean

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

K073615 510(k) Number (if known):

Device Name: BrainLAB knee

Indications For Use:

Example orthopedic surgical procedures include but are not limited to:

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

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

510(k) Number	16073618
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Page

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).