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 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® CT-free knee.

Example orthopedic surgical procedures include but are not limited to:

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

Device Description

BrainLAB VectorVision® CT-free knee is intended to enable operational planning and navigation in orthopedic 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® CT-free knee uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.

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

AI/ML Overview

This 510(k) submission for the VectorVision® CT-free knee does not contain the information requested regarding acceptance criteria or a study that specifically proves the device meets such criteria in a quantitative manner as typically expected in modern medical device submissions.

Instead, the submission focuses on establishing substantial equivalence to a predicate device (VectorVision® Knee K 010612) through a general statement of verification and validation. There are no detailed performance metrics, test sets, ground truth establishment, or sample sizes provided for a formal clinical or technical study.

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

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

Missing: The document states that the device "has been verified and validated according to BrainLAB's procedures for product design and development" and that this "validation proves the safety and effectiveness." However, no specific acceptance criteria or quantitative performance measures are reported. For example, there's no mention of accuracy in degrees, millimeters, or any other measurable outcome for navigation, ligament balancing, or bone alignment.

2. Sample size used for the test set and the data provenance:

Missing: There is no mention of a specific "test set" or studies conducted with a defined sample size. The submission relies on a general statement of verification and validation without providing details on the number of cases or data origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Missing: Since no specific test set or study is described, there's no information on expert involvement for ground truth establishment.

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

Missing: No specific test set or adjudication method is mentioned.

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 Applicable / Missing: This device is a surgical navigation system, not an imaging interpretation AI. Therefore, an MRMC study with "human readers" is not relevant in the usual sense. There's no AI component for image interpretation that would be assisted by human readers. The text only mentions the system aids the surgeon in navigation.

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

Not Applicable / Missing: Similar to the above, this is a human-in-the-loop navigation system. Its "performance" is inherently tied to the surgeon's interaction with the system. There's no "algorithm only" performance to evaluate in isolation from its intended use in surgery.

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

Missing: Given the lack of a detailed study description, the type of ground truth used for validation is not specified. The validation is described generally as proving "safety and effectiveness."

8. The sample size for the training set:

Missing: As a non-AI device (in the modern sense of machine learning), the concept of a "training set" for an algorithm like this is not explicitly discussed. The system uses "registered landmarks" from the patient's bone, which is a real-time data acquisition process, not a pre-trained model in the typical sense of AI.

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

Missing: (See point 8).

Summary of what is present:

The submission confirms that the VectorVision® CT-free knee:

Intended Use: An intraoperative image-guided localization system to enable minimally invasive surgery, specifically for knee procedures like Total Knee Replacement, Unicondylar Knee Replacement, Ligament Balancing, etc., without the need for pre-operative CT scanning.
Predicate Device: VectorVision® Knee (K 010612).
Substantial Equivalence: Claimed based on verification and validation according to BrainLAB's internal procedures, which "proves the safety and effectiveness," making it substantially equivalent to the predicate device.
Regulatory Clearance: Received 510(k) clearance from the FDA, indicating that the FDA found it substantially equivalent to a legally marketed predicate device.

Conclusion:

The provided 510(k) summary is typical for medical devices cleared around 2002, where explicit, quantitative acceptance criteria and detailed study results (especially for AI/algorithm performance) were not always required or presented in the same comprehensive format as they might be today. The focus was heavily on demonstrating substantial equivalence to a predicate device through a general statement of verification and validation, rather than providing specific performance metrics from a dedicated study.

Summary

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K021306

OCT 2 5 2002

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

Manufacturer:

Address:	BrainLAB AG
	Ammerthalstrasse 8
	85551 Heimstetten
	Germany
	Phone: +49 89 99 15 68 0
	Fax: +49 89 99 15 68 33
Contact Person:	Mr. Rainer Birkenbach
Summary Date:	October 22, 2002

Device Name:

Trade name:

VectorVision® CT-free knee

Common/Classification Name:

VectorVision® CT-free knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

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Predicate Device: Vector Vision® Knee (K 010612)

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

Intended Use:

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Example orthopedic surgical procedures include but are not limited to:

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

Device Description:

Substantial equivalence:

VectorVision® CT-free 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® knee (K 010612).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BrainLAB AG Rainer Birkenbach Executive Vice President Ammerthalstrasse 8 85551 Heimstetten Germany

Re: K021306

Trade/Device Name: VectorVision CT-Free Knee Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: July 25, 2002 Received: August 1, 2002

Dear Mr. 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 (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) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and 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,

Muriam C. Provost

for 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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Page 1 of 1

510(k) Number (if known):

Device Name:

Vector Vision® CT-free knee

Indications For Use:

BrainLAB VectorVision is intended to be an intrapperative 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 endoprothesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by VectorVision® CT-free Knee.

Example orthopedic surgical procedures include but are not limited to:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format I-2-96)

miriam

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K021306

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).