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 to assist a surgeon to perform one (open wedge) or two (closed wedge) cuts to achieve a leg angle correction.
Example orthopedic surgical procedures include but are not limited to:
Open wedge osteotomy for the lower limb
Closed wedge osteotomy for the lower limb

Device Description

BrainLAB VectorVision®Osteotomy is intended to enable 3 dimensional correction planning and navigation for lower limb osteotomies. The SW links a surgical instrument tracked by passive markers to a model of the patient's bone geometry, which is generated by acquiring multiple landmarks on the bone surface. VectorVision® Osteotomy uses the registered landmarks tonavigate the tibial cutting guides to the preplanned position. Leg geometry correction can be tracked continuously until osteosynthesis.

AI/ML Overview

The provided document is a 510(k) summary for the BrainLAB VectorVision® Osteotomy system. This document focuses on establishing substantial equivalence to a predicate device and does not contain detailed acceptance criteria, device performance studies, or the specific information required to complete all parts of your request.

However, based on the information provided, here's what can be extracted and inferred:

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

The document states: "The VectorVision® CT-free knee software calculates all planning values based on the same registered landmark and parameters equally to the VectorVision® osteotomy software. The initial geometry of the registered including in same way. For the knee software the registered leg geometry is used to calculate position and size of the used implants. In the osteotomy software the leg geometry itself is used to create the plan of treatment, as the geometry correction is the task. In summary it can be stated the both applications use the same calculation, th output of the VectorVision® CT-free knee software contains several continuative steps until planning result is completed."

This implies that the acceptance criteria are related to the accuracy and reliability of the planning values, registered landmarks, and leg geometry calculations, which are considered to be equivalent to the predicate device (VectorVision® CT-free knee, K021306). However, specific numerical acceptance criteria (e.g., error margins in mm or degrees) are not provided in this document.

Acceptance Criteria Category (Inferred)	Stated Device Performance (Inferred)
Planning Value Calculation Accuracy	"calculates all planning values based on the same registered landmark and parameters equally to the VectorVision® osteotomy software." (Implies performance equivalent to predicate)
Registered Landmark Accuracy	"based on the same registered landmark" (Implies performance equivalent to predicate)
Leg Geometry Calculation Accuracy	"The initial geometry of the registered including in same way." and "the leg geometry itself is used to create the plan of treatment, as the geometry correction is the task." (Implies performance equivalent to predicate in generating and using leg geometry for planning and correction.)
Overall System Safety and Effectiveness	"The validation proves the safety and effectiveness of the system." (General statement, specific metrics not provided.)

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

This information is not provided in the document. The filing is a 510(k) summary for substantial equivalence, which often relies on demonstrating that the new device uses the same fundamental technology and principles as a predicate. It does not detail specific clinical or non-clinical test sets used for validation in the same way a PMA or a full clinical study report would.

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):

This information is not provided in the document.

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

This information is not provided in the document.

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:

This information is not provided in the document, as the device described is an image-guided surgery system, not an AI-assisted diagnostic or interpretation tool that would typically involve human "readers." The system assists surgeons with planning and navigation.

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

The document describes the device as an "intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe...to virtual computer image space on an individual 3D-model of the patient's bone." This implies a human-in-the-loop system where the surgeon uses the navigation for guidance. There is no information provided to suggest a standalone algorithm-only performance assessment was conducted or is relevant to this device's intended use.

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

This information is not specified in the document. Given the description, ground truth for an image-guided surgery system would typically involve precise measurements of alignment, accuracy of probe localization relative to planned targets (e.g., in a phantom or cadaver study), or intraoperative verification of cut planes. However, the document does not detail how "ground truth" was established for any validation testing.

8. The sample size for the training set:

This information is not provided in the document. The device uses "multiple landmarks on the bone surface" to generate a 3D model, implying it's a model-building and navigation system rather than a machine learning system that requires a "training set" in the typical AI sense.

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

This information is not provided in the document, and as noted above, the concept of a "training set" in the context of this device's description is not clearly applicable.

Summary

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FEB 1 0 2005

KOUS 513 510 (k) Summary of Safety and Effectiveness for VectorVision® Osteotomy

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:	26th August 2004
Device Name:Trade name:	VectorVision® Osteotomy
Common/Classification Name:	VectorVision, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Predicate Device: Vector Vision® ct free knee (K 021306)

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

Intended Use:

ന്നാമിയെ മാഠ:
BrainLAB VectorVision is intended to be an intraoperative image guided localization system to enable DramLAD Vocor volon former in monitor to treehand probe, tracked by a passive marker sensor system to virtual mininally invaor o ourger fri «nite dual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface.

acquiring mailible lanamarke on the beneon to perform one (open wedge) or two (closed wedge) cuts to achieve a leq angle correction.

Example orthopedic surgical procedures include but are not limited to:

Open wedge osteotomy for the lower limb Closed wedge osteotomy for the lower limb

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Device Description:

High Tibial Osteotomy is like total and unicondylar knee arthroplasty a common therapy for osteoarthritis. Actually it obtains its relevance it seems more sensible to preserve nermal articular annuit.". long as possible instead of early joint replacement.

Two different kinds of operational procedure are in use. Open wedge osteotomy and closed wedge osteotomy. Open wedge osteotomy: One cut is performed on a planned level of the tibia and when spreadingt this cut open the leg geometry is changed. For the treatment of more common medial gonarthrosis the open wedge on is performed on the medial side of the tibia. The opened cut is fixed with a special plate designed for this treatment.

The open wedge technique provides an easier surgical approach, less vulnerable structures can interfere. But with great correction angles (>10°) the opened bone wedge gets unstable.

Closed wedge osteotomy: Two cuts with a certain angulation are peformed on the tibia. When the wedge, resulting from these two cuts, is removed a gap occurs which is closed by bringing both vutting hanes together. The fixation of this situation is less difficult as the situation bone on bone provides certain stability. The medial gonarthrosis is treated from the lateral side.

For greater correction angels the lateral closing wedge technique gives more stability. But the approach is more difficult and in most of the cases the fibular bone must be cut too.

The whole procedure can be performed without any additional imaging technique.

Substantial equivalence:

VectorVision® Osteotomy has been verified and validated according to BrainLAB's procedures for product desig 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 the 510(k)clearance of VectorVision® CT-free knee (K 021306).

The VectorVision® CT-free knee software calculates all planning values based on the same registered landmark and parameters equally to the VectorVision® osteotomy software. The initial geometry of the legisted including in same way. For the knee software the registered leg geometry is used to calculate position and size of the used implants. In the osteotomy software the leg geometry itself is used to create the plan of treatment, as the geometry correction is the task. In summary it can be stated the both applications use the same calculation, th output of the VectorVision® CT-free knee software contains several continuative steps until planning result is completed.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2005

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

Re: K042513

Trade/Device Name: VectorVision Osteotomy Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 19, 2005 Received: January 24, 2005

Dear Mr. Birkenbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have reviewed 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 for use bated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to econimer to from to rial as in accordance with the provisions of the Federal Food, Drug, de rioss marina ve over require approval of a premarket approval application (PMA). and Oosmeter For (110) respect 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 rr your device 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 or any I 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 Of It fart 6077; adoling (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) This letter whilanow you to begin manisting of substantial equivalence of your device to a legally premaired notification. "The Privating sification 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 If you ucsire specific acrite for Joan acc) 276-0115. Also, please note the regulation entitled, Comics the Office of Compilance an (21 t notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/industry/support/index.html.

Sincerely yours,
Mark A. Millan

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):	K042513
Device Name:	VectorVision Osteotomy

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 to assist a surgeon to perform one (open wedge) or two (closed wedge) cuts to achieve a leg angle correction.
Example orthopedic surgical procedures include but are not limited to:
Open wedge osteotomy for the lower limb
Closed wedge osteotomy for the lower limb

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)

Mark N. Milkenson

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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).