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 an image guided surgery system for total knee replacement surgery . based on landmark based visualization of the femur and tibia.

AI/ML Overview

The provided 510(k) summary for Brainlab Knee (K102990) describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and the specific study proving the device meets those criteria.

The submission focuses on verification and validation activities at a high level. It generally discusses that the system was verified and validated according to BrainLAB procedures, and that functionality was verified on released platforms with workbench tests on milled model bones. It also mentions validation methods such as comparison to previous products, literature research, real-world testing, usability tests, design reviews, and software validation. Furthermore, it states that validation activities were supported by design reviews with initial design surgeons and a cadaver test.

However, the provided text lacks specific, quantifiable acceptance criteria for performance metrics. It does not report precise device performance values against such criteria. The document describes general validation and verification but does not detail a specific study with defined acceptance criteria and reported outcomes to prove those criteria were met for this particular submission.

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

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

Cannot be provided based on the input. The document does not specify any quantifiable acceptance criteria (e.g., accuracy thresholds, precision ranges) for the Brainlab Knee system. Consequently, it does not report specific device performance values against such criteria. It generally states that "Cut and implant positions have been compared to theoretical values" during workbench tests, but no actual values or criteria are provided.

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

Cannot be fully provided. The document mentions "workbench test have been performed on precisely milled model bones" and "a cadaver test."
- Sample size for test set: Not specified for either the model bones or the cadaver test.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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 mentions "design reviews with many of the initial design surgeons" which "supported" the validation. However, it does not specify the number or qualifications of experts involved in establishing ground truth for any specific test set, nor does it explicitly state their role in ground truth determination.

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

Cannot be provided. The document does not describe any adjudication method for establishing ground truth or resolving discrepancies in test results.

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

No, an MRMC study was not done, or at least not described in this submission. The Brainlab Knee system is an image-guided surgery system, not an AI-assisted diagnostic tool that would typically involve "human readers" in an MRMC study context. The document focuses on the system's ability to aid surgeons in navigating prostheses and performing measurements, not on its impact on diagnostic reader performance. Therefore, an effect size of human readers improving with/without AI assistance is not applicable to the information provided.

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

Yes, implicitly. The "workbench test" performed on precisely milled model bones, where "Cut and implant positions have been compared to theoretical values," represents a form of standalone testing. This indicates that the algorithm's output (planned positions) was evaluated against a known ground truth (theoretical values) without immediate human surgical intervention as part of the evaluation of the algorithm's core functionality.

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

"Theoretical values" and potentially "established history of successful use" and "design surgeons' input."
- For workbench tests on model bones, the ground truth was "theoretical values" for cut and implant positions.
- Validation also included "Comparison of the design to a previous product having an established history of successful use," which implies the ground truth for some aspects might be derived from the proven performance of predicate devices.
- "Design reviews with many of the initial design surgeons" also contributed to validation, suggesting expert input played a role, though not explicitly as "ground truth" for a specific test set.

8. The sample size for the training set

Not applicable / Not provided. The Brainlab Knee is an image-guided surgery system that uses landmarks collected intraoperatively to create a 3D model. It's not an AI/machine learning system in the modern sense that typically has a "training set" of data to learn from in the same way. Its functionality is based on geometric algorithms and image processing, not a trained predictive model that would require a large training dataset to learn patterns.

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

Not applicable / Not provided. As explained above, the concept of a "training set" with established ground truth is not directly applicable to this type of device based on the information given.

Summary

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K102990

APR - 4 2011

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

Manufacturer:

Address:

BrainLAB AG Kapellenstrasse 12 85622 Feldkirchen Germany +49 89 99 15 68 0 Phone: ് +49 89 99 15 68 33 Fax:

Mr. Alexander Schwiersch

Contact Person:

Summary Date:

Device:

Trade name:	Brainlab knee
Common/Classification Name:	Brainlab knee, BrainLAB Image Guided SurgerySystem / Instrument, Stereotaxic
Regulation Number:	21 CFR 852.4560
Product code:	OLO

Predicate Device:

Brainlab knee (K073615) PiGalileo Total Knee Replacement (TKR) System (K061362 )

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

Intended Use:

、

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.

Page 1 of 2

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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 an image guided surgery system for total knee replacement surgery . based on landmark based visualization of the femur and tibia.

Substantial equivalence:

Brainlab knee has been verified and validated according to BrainLAB procedures for product design and development. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device Brainlab knee (K073615) and "PiGalileo Total Knee Replacement (TKR) System (K061362)".

Changes to Predicate Device

Brainlab knee has changed in the following from Predicate Device:

Compatibility to Smith&Nephew's Motorized Cutting Guide (MCG). Which . itself has FDA clearance under PiGalileo Total Knee Replacement (K061362). The MCG is brings the cutting block into the position, which is planned in the software.
Alignment Verification Procedure. A condensed workflow, based entirely on . existing algorithms without the necessity to attach reference arrays to the bone. This procedure allows measurement of the alignment of a static cutting block with patient anatomy.
Disposable Clip-on Remote Control. A facultative enhancement of the existing . pointer. Instead of pivoting the user can press a button on the clip to acquire points. It is also possible to acquire direction with a simple button click instead of holding the pointer still.

Verification/validation summary

To verify the correct functionality of the system Brainlab knee, all relevant test documentation coming from the risk analysis and specifications of each component has been compiled into one system. The system guarantees that all risks and associated tests are traceable and verify that no open risks or untested specifications occur. All inherited modules such as hardware platform, instruments, licenses etc. are taken into account.

The functionality is verified on all released platforms. BrainLAB industrial designers verified compliance of the interface to Brainlab standard. Workbench test have been

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performed on precisely milled model bones. Cut and implant positions have been compared to theoretical values.

The following validation methods were used to validate system Brainlab Knee:

Comparison of the design to a previous product having an established history . of successful use
Literature research and corresponding database search ●
Testing and evaluation under real world conditions .
Usability tests, prototyping and simulations .
Design reviews .
t Software Validation

Validation activities have successfully been performed according to the indications for use. The validation is supported by design reviews with many of the initial design surgeons and a cadaver test.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Food and Drug Administration i 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

BrainLAB AG % Mr. Alexander Schwiersch Kapellenstrasse 12 85622 Feldkirchen. Germany

APR - 4 2511

Re: K102990

Trade/Device Name: Brainlab Knee Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: March 24, 2011 Received: March 28, 2011

Dear Mr. Schwiersch:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 – Mr. Alexander Schwiersch

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ay B. Rh
fr

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): |<| 02990

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 X (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)

NeK.R.P.de/m for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

. 510(k) Number K102990

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).