BrainLAB VectorVision Trauma is intended to be a pre- and 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 a patient's pre- or intraoperative image data being processed by a VectorVision workstation. 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 bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy.

Example procedures include but are not limited to:

Spinal Procedures and spinal implant procedures such as pedicle screw placement. Pelvis and acetabular fracture treatment such as screw placement or ilio-sacral screw fixation. Fracture treatment procedures, such as intramedullary nailing or screwing or external fixation procedures in the tubular bones.

Device Description

BrainLAB VectorVision® Trauma is intended to enable operational navigation in spinal, orthopedic and traumatologic surgery, It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on a patients intraoperative image data being processed by a VectorVision workstation.

Vector/sion® Trauma allows navigation of intraopative acquired images considering patients movement in correlation to calibrated surgical instruments. This allows implant positioning, screw placement and bone reduction in different views and reduces the need for treatments under permanent fluoroscopic radiation.

AI/ML Overview

The provided text is a 510(k) summary for the BrainLAB VectorVision Trauma system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the detailed study information required to answer all the posed questions about acceptance criteria and device performance.

Based on the available text, here's what can be extracted and what cannot:

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

The document does not explicitly state acceptance criteria or provide a table of performance metrics. It generally states that "The validation proves the safety and effectiveness of the system," but no specific numerical criteria or performance results are given.

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.

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

The document describes the device as a "pre- and intraoperative image guided localization system" and states it "links a surgical instrument, tracked by flexible passive markers to virtual computer image space on a patients intraoperative image data." This indicates it's an image-guided surgery system, not an AI-assisted diagnostic or interpretive tool that would typically involve human "readers" in the sense of an MRMC study. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device based on its description, and no such study is mentioned.

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

The device is an image-guided navigation system, inherently designed for human-in-the-loop use during surgery. The concept of "standalone" algorithm performance as typically applied to AI diagnostics (e.g., sensitivity/specificity of an algorithm detecting disease) is not directly applicable in the same way to this device. Its performance would be evaluated in terms of accuracy of instrument tracking, registration, and guidance, which are integral to its use by a surgeon. The validation mentioned "proves the safety and effectiveness of the system," implying comprehensive testing, but not a "standalone" algorithm performance in the diagnostic sense.

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

This information is not provided in the document. For an image-guided surgery system, common ground truths might include phantom studies with known fiducial locations, cadaver studies with direct measurements, or intraoperative verification of instrument tip position relative to anatomical landmarks. However, the document does not specify.

8. The sample size for the training set

As this is an image-guided navigation system and not a machine learning-based diagnostic algorithm in the AI sense, there isn't typically a "training set" as understood for deep learning models. The system's "training" refers to its design, calibration, and engineering. This information is not provided in the document.

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

As there isn't a "training set" in the context of supervised machine learning for this device, how its ground truth was established is not applicable/provided in that sense. The system's accuracy and performance are established through validation and verification tests, but these are not for "training" an AI model.

Summary of what is missing:

The provided text from the 510(k) summary focuses on general device description, indications for use, and a statement of substantial equivalence and validation. It lacks specific details regarding any performance study, acceptance criteria, sample sizes, ground truth establishment, or expert involvement for testing the device's accuracy or effectiveness. This level of detail is typically found in the full 510(k) submission, not necessarily in the public summary.

Summary

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MAR 1 4 2002

510 (k) Summary of Safety and Effectiveness for VectorVision® Trauma

Manufacturer:

BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany Phone: +49 89 99 15 68 0 Fax: +49 89 99 15 68 33

Device Name:

Trade Name: Common/Classification Name: Vector Vision® Trauma VectorVision, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Predicate Device:

VectorVision2® (K983831) VectorVision cranial, ENT, spine (K003589)

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

Indications for use:

Example procedures include but are not limited to:

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Device Description:

Substantial equivalence:

VectorVision® Trauma 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 VectorVision2 (K983831),

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle. The text is in a sans-serif font and is evenly spaced around the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2002

Mr. Rainer Birkenbach BrainLab AG Ammerthalstrasse 8 85551 Heimstetten Germany

Re: K012448

Trade/Device Name: VectorVision Trauma Regulation Number: 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: December 20, 2001 Received: December 26, 2001

Dear Mr. Birkenbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regars) and entirent date of the Medical Device Amendments, or to conninered pror to May 20, 1978, as can and with the provisions of the Federal Food. Drug. de necs that have occh recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrore, mailer of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 11 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 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" (21CFR 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,

iriam 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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510(k) Number (if known):

K012448

Device Name:

VectorVision Trauma

Indications For Use:

BrainLAB VectorVision Trauma is intended to be a pre- and 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 a patient's pre- or intraoperative image data being processed by a VectorVision workstation. 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 bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy.

Example procedures include but are not limited to:

Spinal Procedures and spinal implant procedures such as pedicle screw placement. Pelvis and acetabular fracture treatment such as screw placement or illo-sacral screw fixation. Fracture treatment procedures, such as intramedullary nailing or plating or external fixation procedures in the tubular bones.

(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-Countor Use

(Optional Formar 1-2-96)

iriam C. Provost

al. Restorative

510(k) Number K012448

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).