BrainLAB Spine & Trauma iCT is intended as 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 a patient's preoperative or intraoperative 3D image data.

Spine & Trauma ICT enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system.

The software offers screw implant size planning and navigation on rigid bone structures with precalibrated and additional individually-calibrated surgical tools. 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 the acquired CT image.

Device Description

Spine & Trauma iCT 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 based on patient's preoperative or intraoperative 3D information of a CT dataset

The device enables the navigation based on 3D data.

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, region matching or by an automatic registration.

The automatic registration is based on an initial CT- scanner calibration and on the spatial position of CT- scanner and patient at the beginning of the scan. The calibrated volume is scanned and the 3D dataset and registration information is sent to the navigation computer. Thus, automatic registration is available right after patient scanning during surgery. After registration, the device assists the surgeon in performing certain surgical procedures as described in the indications for use.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the way typically found for performance claims in 510(k) summaries. Instead, it states that the device, Spine & Trauma iCT, 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." It concludes that the information provided to the FDA was found to be "substantially equivalent with the predicate device VV Fluoro 3D (K070106)."

This indicates a reliance on the equivalence to a predicate device and internal validation, rather than a detailed report of a new clinical study with specific performance metrics and acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to answer based on the available information:

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

Acceptance Criteria	Reported Device Performance
Not specified in document	"verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system."
Substantial Equivalence to predicate device VV Fluoro 3D (K070106)	Found to be substantially equivalent.

2. Sample sized used for the test set and the data provenance

Sample size for test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "patient's preoperative or intraoperative 3D image data" but not the source or nature of the data used for testing.

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

Not specified.

4. Adjudication method for the test set

Not specified.

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

An MRMC study is not mentioned. The device is an image-guided navigation system, not an AI diagnostic tool primarily focused on improving human reader performance in interpreting images. Its function is to assist in surgical procedures.

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

The device description focuses on its function as an "intraoperative image-guided localization system" that "links a freehand probe... to virtual computer image space." This inherently implies human interaction (a surgeon using a probe). Therefore, a purely standalone algorithm evaluation in the sense of a diagnostic AI is not applicable or described. The validation mentioned refers to the system's overall safety and effectiveness in its intended use with a human operator.

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

Not specified. For a navigation system, ground truth typically relates to the accuracy of probe localization relative to anatomical structures, which would likely be established through physical measurements and imaging.

8. The sample size for the training set

Not applicable/specified. This is not an AI/machine learning device that typically requires a separate training set in the conventional sense for a 510(k) submission of this type. The "automatic registration" mentioned is based on initial CT-scanner calibration rather than a trained machine learning model.

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

Not applicable/specified as there's no mention of a traditional machine learning "training set" for ground truth establishment.

Summary

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K083310.

510 (k) Summary of Safety and Effectiveness for Spine & Trauma iCT

Manufacturer:

Address:	BrainLAB AGKapellenstrasse 1285622 FeldkirchenGermany
	Phone:Fax:	+49 89 99 15 68 0+49 89 99 15 68 33
Contact Person:	Mr. Per Persson
Summary Date:	March 09, 2008

Device Name:

Trade name:	Spine & Trauma ICT
Common/Classification Name:	BrainLAB Image Guided Surgery System / Instrument,Stereotaxic

Predicate Device:

VV Fluoro 3D (K 070106)

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

Intended Use:

BrainLAB Spine & Trauma iCT is intended as an intraoperative image-quided 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 preoperative or intraoperative 3D image data.

Spine & Trauma iCT enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system.

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Device Description:

The device enables the navigation based on 3D data.

Substantial equivalence:

Spine & Trauma iCT Module 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 VV Fluoro 3D (K070106).

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge to form the shape of a bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

BrainLAB AG % Mr. Per Persson Kapellenstrasse 12 85622 Feldkirchen Germany

APR -1 2009

Re: K083310

Trade/Device Name: Spine & Trauma iCT Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO Dated: March 17, 2009 Received: March 19, 2009

Dear Mr. Persson:

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. Per Persson

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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510(k) Number (if known): K083310

Device Name: Spine & Trauma iCT

Indications For Use:

Spine & Trauma ICT enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system.

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)

Daniel Knore for MKH 3/26/09

(Division Sign-G Division of General, Restorative, and Neurological Devices

510(k) Number K083310

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).