Brainlab 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, scapula, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy. In addition to the image guided navigation, Brainlab trauma also enables image-free navigation of trajectories for trauma procedures.

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 iliosacral screw fixation.
Fracture treatment procedures such as intramedullary nailing or plating or screwing, or external fixation procedures in the tubular bones.
Retrograde drilling of osteochondral lesions.

Device Description

Brainlab trauma is intended to enable operational navigation in spinal, traumatologic surgery. It links surgical instruments tracked by passive markers to a virtual computer image space.

In Brainlab trauma this virtual computer image space refers either to intraoperatively acquired and registered x-ray images of the individual patient's bone structure or to a landmark, which is intraoperatively defined by the surgeon using the tip of a tracked instrument.

Brainlab trauma allows surgical navigation considering patient movement in correlation to calibrated surgical instruments. This allows implant positioning, screw placement and bone fracture reduction in different views and reduces the need for treatments under permanent fluoroscopic radiation.

AI/ML Overview

The provided text describes modifications to an existing image-guided surgery system (Brainlab trauma) and the verification and validation activities conducted to demonstrate its safety and effectiveness. However, it does not explicitly define acceptance criteria in terms of specific performance metrics with numerical thresholds for accuracy, sensitivity, or specificity. Instead, it states that "All tests have been successfully completed" and "All relevant hazards have been taken into consideration and the corresponding measures are effective," implying that the device met internal specifications without providing those specifications.

Therefore, many of the requested sections regarding acceptance criteria and performance metrics cannot be directly answered from the provided text.

Here's an attempt to answer based on the available information, with caveats where data is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Not explicitly stated with numerical thresholds in the provided text, but implied as "correct functionality" and "accuracy")	Reported Device Performance
Accuracy of image registration using xSpot	Implied: Must be accurate for surgical navigation.	Tested in a "non-clinical setup using both plastic bones (sawbone) and cadavers." Validated in cadaver sessions and clinical sites. All tests successfully completed; features proven safe and effective. (Specific accuracy values are not reported).
Accuracy of x-ray image free trajectory placement	Implied: Must be accurate for depth and placement.	Verified regarding "accuracy of depth and placement." All tests successfully completed. (Specific accuracy values are not reported).
Accuracy of implant calibration/navigation	Implied: Must be accurate for implant navigation.	Verified to "ensure the accurate implant navigation." Validated in cadaver sessions and clinical sites. All tests successfully completed; features proven safe and effective. (Specific accuracy values are not reported).
Workflow Functionality	Implied: Correct behavior of software and user interface.	Verified through "testing of the workflow," "detailed verification of the signed specifications covering the detailed functionality of the buttons," and "workflow based concept for the graphical user interface." Validated in sawbone environments, cadavers, and clinical sites. All tests successfully completed.
Safety and Effectiveness	Implied: Device must be safe and effective for its intended use.	"All tests have been successfully completed." "All relevant hazards have been taken into consideration and the corresponding measures are effective." "All system features could be proven to be safe and effective in a clinical environment." (This is a qualitative statement, not a quantitative metric).
Spherical drill limitation	Implied: Correctly enable warnings to prevent breaking out/into spherical anatomical regions.	Verified and validated as part of the overall system. Clinically validated as part of the "screw workflow in combination with the spherical drill limitation." All tests successfully completed.
Semi-automatic segmentation of bone shaft fragments	Implied: Correct segmentation functionality.	Clinically validated. All tests successfully completed.
Drill angle cone	Implied: Correct functionality.	Validated in sawbone environment and clinically. All tests successfully completed.

While the document states that tests were successfully completed and the device was proven safe and effective, it does not provide numerical results or specific quantifiable acceptance criteria for these claims within the provided extract.

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

Sample Size: Not explicitly stated. The document mentions "plastic bones (sawbone)" and "cadavers" for non-clinical testing, and "Three clinical sites" for clinical validation. The exact number of sawbones, cadavers, or patient cases at the clinical sites is not provided.
Data Provenance:
- Non-clinical: Sawbone (plastic bone) and cadaver models. Origin not specified (e.g., country of origin for cadavers).
- Clinical: Data from "Three clinical sites." The country of origin for these clinical sites is not specified, but the manufacturer is based in Germany, and the FDA submission is for the USA, so sites could be in either or both.
- Retrospective/Prospective: The clinical validation appears to be prospective in nature, as it describes the "features clinically validated" in a clinical environment, implying active testing.

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

This information is not provided in the given text. It is stated that "Three clinical sites have been validating Brainlab trauma as well as new and changed features regarding a user friendly and correct functionality," which implies expert users (surgeons, clinical staff) were involved, but their specific number or qualifications for establishing ground truth are not detailed.

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

This information is not provided in the given text.

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

MRMC Comparative Effectiveness Study: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance. The Brainlab trauma system is an image-guided navigation system, not an AI diagnostic aid for "human readers." Its purpose is to assist surgeons during procedures.
Effect Size: Therefore, no effect size related to human reader improvement with AI assistance is mentioned.

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

The context of Brainlab trauma is an "image guided localization system" that "links a freehand probe... to virtual computer image space" and "allows surgical navigation." It is inherently a system designed to be used with a human surgeon in the loop. The verification and validation activities include testing hardware (xSpot, instruments), software functionalities, and workflows in both non-clinical and clinical settings, all implying human interaction.

It's highly unlikely that a "standalone" or "algorithm-only" performance would be assessed for such a device, as its utility is defined by its interaction with a surgeon during a procedure. The closest analogue would be the accuracy measurements (e.g., image registration, trajectory placement, implant calibration) performed on sawbones and cadavers, which represent the algorithmic performance in a controlled environment before clinical human interaction, but these are components of the human-in-the-loop system.

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

The type of ground truth used is implied through the nature of the tests:

Non-clinical (sawbones, cadavers): Ground truth for accuracy tests (e.g., image registration, trajectory placement, implant accuracy) would likely involve precise physical measurements (e.g., using a coordinate measuring machine or similar high-precision instruments) on the models or anatomical structures to compare against the system's generated coordinates or paths.
Clinical sites: For clinical validation, the ground truth for "user friendly and correct functionality" could be a combination of:
- Surgeon assessment and feedback: Through direct observation and qualitative reporting.
- Intraoperative imaging: Comparing the navigated position/trajectory with subsequent intraoperative fluoroscopy or other imaging to confirm accuracy.
- Clinical outcomes (short-term): While not explicitly stated, successful completion of procedures, correct implant placement, and lack of complications in the short term would contribute to "proven to be safe and effective."

8. The sample size for the training set

The document does not mention a "training set" or "training data" in the context of machine learning. The Brainlab trauma system described predates widespread deep learning applications in medical devices (2011). It's an image-guided surgery system relying on image processing, registration algorithms, and a database of implants, rather than a machine learning model that requires a discrete "training set" in the modern sense.

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

Since no "training set" for a machine learning model is mentioned, this question is not applicable based on the provided text. The "ground truth" for the development of its algorithms (e.g., for registration, trajectory planning, spherical drill limitation) would have been established through engineering principles, mathematical modeling, and rigorous bench testing against known physical standards.

Summary

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510 (k) Summary of Safety and Effectiveness for Brainlab trauma

AUG - 5 2011

Manufacturer:

Address:	Brainlab AGKapellenstrasse 1285622 FeldkirchenGermany
	Phone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
Contact Person:	Mr. Alexander Schwiersch

Summary Date: April 18, 2011

Device:

Trade name:	Brainlab trauma
Common/Classification Name:	Brainlab Trauma, trauma 3.0, Brainlab ImageGuided Surgery System / Instrument, Stereotaxic
Regulation Number:	21 CFR 882.4560
Product Code:	OLO, HAW

Predicate Device:

Modification to VectorVision Trauma (K062358) VectorVision hip 5.1 unlimited (K083483)

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

Intended Use:

Indications For Use:

Brainlab 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 preor 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, scapula, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy. In addition to the image guided navigation, Brainlab trauma also enables image-free navigation of trajectories for trauma procedures.

Example procedures include but are not limited to:

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Spinal procedures and spinal implant procedures such as pedicle screw placement.
· Pelvis and acetabular fracture treatment such as screw placement or iliosacral screw fixation.
Fracture treatment procedures such as intramedullary nailing or plating or . screwing, or external fixation procedures in the tubular bones.
Retrograde drilling of osteochondral lesions .

Device Description:

Brainlab trauma is intended to enable operational navigation in spinal, traumatologic surgery. It links surgical instruments tracked by passive markers to a virtual computer image space.

Modifications to Predicated Device:

Besides other minor changes Brainlab trauma has changed in the following from its Predicate Devices:

Introduction of a new x-ray image registration device (xSpot), which allows a . free handed handling of the registration device to ensure good visibility of the device for the tracking camera.
Introduction of trauma implant navigation on fluoro images based on an . implant database for the placement of trauma implants without the need of permanent x-ray radiation.
Multiple screw planning and navigation .
Introduction of screw fixation with the usage of a spherical drill limitation, . which enables warnings of breaking out or breaking into spherical anatomical regions (e.q. acetabulofemoral joint) to prevent this breaking.
Introduction of a x-ray image free workflow for screw fixation .
Workflow based concept for the graphical user interface including a . procedure selection based on the anatomical region of interest

Verification and Validation summery

To proof conformance to the predefined specifications of Brainlab trauma and its integrated components various verification and validation tests have been performed.

Completed verification activities:

Non-clinical bench tests have been performed to ensure the correct system functionality according to its specification.

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The accuracy of the image registration using the new image registration device (xSpot) has been tested in a non-clinical setup using both plastic bones (sawbone) and cadavers.
The x-ray image free trajectory placement has been verified regarding . accuracy of depth and placement.
. The accuracy of the implant calibration has been verified to ensure the accurate implant navigation.

Moreover the complete functionalities of the system including application. subsequent subsystems and modules have been verified regarding correct behavior guided by Brainlab's design, verification and risk management process. This includes:

· Part of the verification includes the testing of the workflow to ensure the correct behavior of the software.
· Detailed verification of the signed specifications covering the detailed functionality of the buttons and other was performed.
· Additionally, the measures against the defined risks of the Risk Analysis have been tested.

This strategy ensures the verification of the software algorithm, the combination of the software with the instrumentation, and the safety of the defined measures of the Risk Analysis. All tests have been successfully completed.

Completed verification activities:

Non-clinical and clinical validation have been performing to prove the usability and functionality of the overall system and certain features:

· The non-clinical validation was performed within a sawbone environment at the following features: interlocking, drill angle cone, image free workflow and the xSpot.
Cadaver sessions have been performed to validate the workflows and the following features:
- o Image registration using the new image registration device (xSpot)
- o Implant navigation

Three clinical sites have been validating Brainlab trauma as well as new and changed features regarding a user friendly and correct functionality. Besides the clinical/software workflow all system features could be proven to be safe and effective in a clinical environment.

The features clinically validated are: .
- o The new image registration device (xSpot) in combination with the changed image acquisition functionalities including image verification
- o the x-ray image free workflow
- o The screw workflow in combination with the spherical drill limitation
- o The implant navigation ·
- o The semi-automatic segmentation of bone shaft fragments
- o The drill angle cone.

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The verification and validation has been successfully performed. All relevant hazards have been taken into consideration and the corresponding measures are effective.

Substantial equivalence:

Brainlab trauma has been verified and validated according to Brainlab's procedures for product design and development. The information provided by Brainlab in this 510(k) application was found to be substantially equivalent with the predicate devices Modification to VectorVision® trauma (K062358) and (K042721), VectorVision hip 5.1 unlimited (K083483).

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "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 form the wings and body of the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Brainlab AG % Mr. Alexander Schwiersch Kapellenstrasse 12 85622 Feldkirchen Germany

Re: K110204

Trade/Device Name: Brainlab Trauma Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW Dated: July 07, 2011 Received: July 14, 2011

AUG - 5 2011

Dear Mr. Schwiersch:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Alexander Schwiersch

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark A Millan

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (K110204):

Device Name: Brainlab trauma

Indications For Use:

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 plating or . screwing, or external fixation procedures in the tubular bones.
Retrograde drilling of osteochondral lesions ●

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)

Neil R.P. deyle Firman

(Division Sign (Division Sign-on), Orthopedic, Avision or and Restorative Devices

510(k) Number K110204

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).