BrainLAB's VectorVision spine is intended for use as an intraoperative image-quided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is 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, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray or MR-based model of the anatomy. Example procedures include but are not limited to:

· Navigated spinal procedures in support of standard approaches (e.g. anterior, lateral, oblique)
· Spinal implant procedures such as
- · Pedicle screw placement
- · Anterior plating
· Kyphoplasty and vertebroplasty procedures
· Placement of other temporary or permanent devices such as k-wires, needles, catheters or electrodes
· Thoracic spine surgerv
· Tumor surgery on the spinal column and adjacent soft tissue
Placement of acetabular and SI screws on the pelvis

Device Description

VectorVision spine is a device that allows surgical planning and navigation. It links a surgical instrument. (tracked by passive marker sensor system) to a location on a virtual computer image, which is either based ou patient's preoperative 3D information of a CT or MR dataset or based on patient's intraoperative acquired 2D fluoro image(s) of a c-arm.

The device enables the navigation based on 3D data and / or based on acquired fluoro images,

Based on 2D fluoro images, the registration is done automatically by using the exact spatial position informat. of the intra-operatively acquired fluoro images.

Based on 3D data, the procedure of linking the surgical instrument to the virtual computer image is achieved by performing registration methods as paired point matching, surface matching, region matching or CT fluoro matching. The last registration method uses 2D fluoro images to register the previously acquired 3D dataset. Thus, CT fluoro matching combines 2D fluoro imaging with 3D datasets,

After registration, the device assists the surgeon in performing certain surgical procedures as described in the indications for use.

AI/ML Overview

Here’s an analysis of the provided text regarding the acceptance criteria and study for the VectorVision spine device:

The provided 510(k) summary for the BrainLAB VectorVision spine (K053159) does not explicitly state specific acceptance criteria or provide a detailed study report with performance metrics for the device itself.

Instead, the submission primarily focuses on establishing substantial equivalence to predicate devices (BrainLAB VectorVision CT / Fluoro K010968 and BrainLAB Kolibri spine K042721) based on the intended use and device description.

The key statement regarding validation is:
"VectorVision spine 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."

This indicates that internal validation was performed, but the specific details of that validation (e.g., acceptance criteria, test results, statistical analysis) are not presented in this publicly available summary. Such detailed information is typically kept by the manufacturer and is part of the full 510(k) submission, not necessarily released in the abbreviated summary.

Therefore, many of the requested points cannot be answered from the provided text.

Here's an attempt to answer the questions based only on the provided text, noting limitations:

Acceptance Criteria and Study for BrainLAB VectorVision spine (K053159)

This 510(k) summary focuses on demonstrating substantial equivalence by outlining the device's intended use and functionality, rather than presenting a detailed study with explicit acceptance criteria and corresponding performance metrics. The summary states that the device was "verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system." However, the specifics of these validation activities, including numerical acceptance criteria or performance results, are not provided in this document.

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

Acceptance Criteria Category	Specific Acceptance Criteria (Not Explicitly Stated in Document)	Reported Device Performance (Not Explicitly Stated in Document)
Accuracy/Localization	(Likely related to spatial precision of navigated tools)	(Implied to meet internal validation standards, but no numbers)
Safety	(Likely related to system reliability, electrical safety, EMC)	(Implied to meet internal validation standards)
Effectiveness	(Likely related to ability to assist in intended surgical tasks)	(Implied to meet internal validation standards)
Substantial Equivalence	Comparison to predicate device K010968 and K042721	Found substantially equivalent by FDA

2. Sample sized 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 510(k) summary. The internal verification and validation studies are not detailed.

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 510(k) summary. Given the nature of a surgical navigation system, "ground truth" for performance testing would likely involve highly precise measurement tools and potentially expert surgeons in a simulated or cadaveric setting, but no details are given.

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

Not specified in the provided 510(k) summary.

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. This device is a surgical navigation system, not an AI-assisted diagnostic imaging device for "human readers" in the typical sense of MRMC studies. Its purpose is to guide surgeons, not to interpret images or improve human diagnostic accuracy in a reading task.

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

The device is inherently a "human-in-the-loop" system, assisting surgeons. While its underlying algorithms have standalone performance characteristics (e.g., registration accuracy), the overall device performance is always in the context of aiding a surgeon. No details on purely "algorithm only" performance are provided in isolation from the human user.

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

Not specified in the provided 510(k) summary. For a surgical navigation system, ground truth would typically refer to the true anatomical position or the true position of tracked instruments, often established by high-precision physical measurements or imaging techniques.

8. The sample size for the training set

Not applicable. This device, being a system for surgical navigation in 2005, is not described as utilizing machine learning or AI models in the same way modern devices do, which would typically rely on a "training set." Its functionality is based on established image processing, registration algorithms, and passive marker tracking.

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

Not applicable, as there is no mention of a "training set" in the context of contemporary AI/ML.

In summary: The provided 510(k) document is a summary of the device's intended use and design, culminating in the FDA's finding of substantial equivalence to predicate devices. It does not contain the detailed technical data, specific acceptance criteria, or performance study results that would typically be included in the full technical file or detailed clinical study reports.

Summary

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KOS 3159 510 (k) Summary of Safety and Effectiveness for VectorVision spine

Manufacturer:	BrainLAB AG
Address:	Ammerthalstrasse 885551 HeimstettenGermany
Phone:	+49 89 99 15 68 0
Fax:	+49 89 99 15 68 33
Contact Person:	Mr. Rainer Birkenbach
Summary Date:	September 13, 2005
Device Name:
Trade name:	VectorVision spine
Common/Classification Name:	VectorVision spine, BrainLAB Image Guided Surgery System /Instrument, Stereotaxic

Predicate Device:

BrainLAB VectorVision CT / Fluoro (K010968) BrainLAB Kolibri spine (K042721)

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

Intended Use:

BrainLAB's VectorVision spine is intended for use as an intraoperative image-quided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is 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, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray or MR-based model of the anatomy, Example procedures include but are not limited to:

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· Navigated spinal procedures in support of standard approaches (e.g. anterior, lateral, oblique)
· Spinal implant procedures such as
- · Pedicle screw placement
- · Anterior plating
· Kyphoplasty and vertebroplasty procedures
· Placement of other temporary or permanent devices such as k-wires, needles, catheters or electrodes
· Thoracic spine surgerv
· Tumor surgery on the spinal column and adjacent soft tissue
Placement of acetabular and SI screws on the pelvis

Device Description:

The device enables the navigation based on 3D data and / or based on acquired fluoro images,

Based on 2D fluoro images, the registration is done automatically by using the exact spatial position informat. of the intra-operatively acquired fluoro images.

After registration, the device assists the surgeon in performing certain surgical procedures as described in the indications for use.

Substantial equivalence:

VectorVision spine 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 the predicate device BrainLAB VectorVision CT / Fluoro (K010968) and BrainLAB Kolibri spine (K042721).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three abstract human figures intertwined within it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2006

BrainLAB AG % Mr. Martin Ringholz Project Engineer IGS Spine Ammerthalstrasse 8 Heimstetten, Germany 85551

Re: K053159

Trade/Device Name: Vector Vision spine Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulation Class: II Product Code: HAW Dated: May 23, 2006 Received: May 25, 2006

Dear Mr. Ringholz:

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

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Page 2 - Mr. Martin Ringholz

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. 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

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

510(k) Number (if known): K053159

Device Name: Vector Vision spine

Indications For Use:

Example procedures include but are not limited to:

· Navigated spinal procedures in support of standard approaches (e.g. anterior, lateral. oblique)
· Spinal implant procedures such as
- · Pedicle screw placement
- · Anterior plating
· Kyphoplasty and vertebroplasty procedures
· Placement of other temporary or permanent devices such as k-wires, needles, catheters or electrodes
· Thoracic spine surgery
· Tumor surgery on the spinal column and adjacent soft tissue
· Placement of acetabular and SI screws on the pelvis

Prescription Use × (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)
(Division Sign-Off)
Division of General, Restorative,and Neurological Devices
510(k) Number	K053159

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).