Spine & Trauma 3D 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 2D or 3D image data.

Spine & Trauma 3D 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 image (CT, MR, 2D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

Device Description

This navigation system consists of software and hardware components and is an image guided surgery system for navigated treatments in the fields of spine and trauma surgery, whereas the user may use 3D data based on CT, MR or XT. The Software may be installed on a fixed (e.g. Buzz Navigation (CM)) or mobile (e.g. Kick, Curve) navigation platform and supports the surgeon in clinical procedures by displaying tracked instruments in patient's image data. Such instruments can be held by a surgeon or by a mechatronic arm, which passively keeps the instrument in the position. (Mechatronic Vario Guide, "Cirq").

AI/ML Overview

Based on the provided text, the documentation does not describe a study involving an AI/Machine Learning device that requires a test set with ground truth established by experts, an adjudication method, or a multi-reader, multi-case comparative effectiveness study. The device, "Spine & Trauma Navigation," is a stereotaxic instrument for image-guided localization in surgery, linking a freehand probe to virtual computer image space on patient data. It is not an AI/ML diagnostic or predictive device.

Therefore, many of the requested details about acceptance criteria and study proving the device meets them, especially those related to AI/ML performance metrics, are not applicable or extractable from this document. The document focuses on the verification of the navigational system's functionalities, accuracy, safety, and compliance with standards rather than AI/ML performance.

Here's an attempt to answer the questions based on the available information, noting where information is not present or not applicable to an AI/ML context:

1. Table of acceptance criteria and the reported device performance

The document broadly states that "The essential performance characteristic for this product is the overall registration and navigation accuracy of the system to ensure the safe and effective use according to the intended use." Specific quantitative acceptance criteria for navigation accuracy (e.g., in mm) or the reported numerical performance are not explicitly provided in the summary.

Instead, the document details various verification tests and their conclusions:

Acceptance Criteria Category (Derived from "Verification Summary")	Reported Device Performance / Conclusion
Verification of general functions (accurate positioning, robust alignment of surgical instrument with Mechatronic Vario Guide)	"Verification of general functions successful. All requirements met."
General design requirements (overall design, layout, general behavior)	"Verification of general design requirements successful."
Safety tests regarding risk analysis (effectiveness of risk control measures)	"Risk control measures are effective and mitigate the associated risks."
Human factors / Usability Testing (clinical workflow with Mechatronic Vario Guide)	"System is safe and effective to use."
Product safety tests (compliance with AAMI/ANSI ES60601-1:2005/(R)2012 for medical electrical equipment)	"Compliance with standards requirements demonstrated, no deviations."
Biocompatibility / Reprocessing (material properties, response to cleaning/disinfection/sterilization)	"Biocompatibility assessment and reprocessing tests successful."
Environmental tests (adherence to RoHS, REACH, WEEE directives)	"Environmental tests successful."
Integration tests with spine navigation applications and Brainlab navigation platforms	"Integration and compatibility tests successful."
Mechanical tests (stability, interface tests, holding force)	"Mechanical tests successful."
Integration tests of Surgical Base System (braking concept, visual indicators, holding forces)	"Surgical Base System integration tests successful."
Surgical Base System firmware software verification (compliance with IEC 62304 and FDA Guidance)	"Surgical Base System software verification successful."
Integration tests of sterile drape (form, fit, function, sterile barrier, navigation compatibility)	"Drape integration tests successful."

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

Test Sample Size: Not specified quantitatively. For "Verification of general functions," tests were conducted "on an MIS Spine Training Model." For "Human factors / Usability Testing," tests involved "surgeons and OR nurses." The number of models, cases, or participants is not given.
Data Provenance: Not explicitly stated. The tests were performed in a "simulated clinical environment." There is no mention of country of origin for any data or whether it was retrospective or prospective patient data, as the tests involved models and simulated environments, not real patient data in a traditional clinical study sense.

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

Number of Experts: Not specified. For "Verification of general functions," tests were "performed by spinal surgeons." For "Human factors / Usability Testing," tests were performed "with surgeons and OR nurses." The exact number or qualifications (e.g., years of experience) beyond their titles are not provided.
Ground Truth Establishment: For a navigation system, "ground truth" would typically refer to the true anatomical position or trajectory. The document does not describe a method for establishing such ground truth by experts in a review process, as might be done for diagnostic image interpretation. Instead, the "accuracy" is verified as part of the system's function (e.g., "accurate positioning").

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

Not applicable / No information provided. The nature of the device (a surgical navigation system, not a diagnostic AI/ML algorithm) and the described verification tests do not suggest a need for, or implementation of, an adjudication method for establishing ground truth from multiple human readers.

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

No, not specified. This device is a surgical navigation system, not an AI-assisted image interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable and was not reported. The focus is on the system's ability to guide surgical instruments, not to enhance human interpretation of images.

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

Not applicable. The device is inherently a "human-in-the-loop" system, designed to assist surgeons during procedures by displaying tracked instruments in patient image data. Its performance is evaluated in the context of its intended use in guiding a human operator. There is no "algorithm-only" performance that would be separate from its interactive nature. The "software verification" and "mechanical tests" ensure the underlying components function correctly, but the overall "performance" is tied to its use by an operator.

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

The document implies ground truth is established by the system's design specifications and verified through functional testing against these specifications. For parameters like "accurate positioning," it would presumably be measured directly against known coordinates or physical measurements on a phantom model. Ground truth is therefore based on engineering specifications and measurements on physical models/phantoms rather than medical expert consensus, pathology, or outcomes data, as this is a navigation device and not a diagnostic tool.

8. The sample size for the training set

Not applicable / Not provided. This is a traditional image-guided surgical navigation system, not an AI/ML system that undergoes a training phase with a "training set" in the context of deep learning models. The software components are developed and verified through standard software engineering practices.

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

Not applicable. As this is not an AI/ML system that utilizes a training set in the conventional sense, the concept of establishing ground truth for a training set does not apply.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Brainlab AG Hugo Morales Senior QM Consultant - Regulatory Affairs Olof-Palme-Str. 9 Munich, 81829 DE

Re: K183605

Trade/Device Name: Spine & Trauma Navigation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 24, 2019 Received: May 31, 2019

August 29, 2019

Dear Hugo Morales:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For, Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name Spine & Trauma Navigation

Indications for Use (Describe)

INDICATIONS FOR USE

Spine & Trauma 3D is intended as an intraoperative image-guided localization system to enable mimimally 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 2D or 3D image data.

Spine & Trauma 3D enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system.

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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K183605

510 (K) SUMMARY SPINE & TRAUMA NAVIGATION SYSTEM

IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92

General Information
Manufacturer	Brainlab AG
Establishment Registration #	8043933
Device name:	Spine and Trauma Navigation System
Trade name:	Spine and Trauma 3D Navigation
Classification name:	Stereotaxic instrument_21 CFR 882.4560
Review Panel	Orthopedic
Product Code:	OLO
Device Class:	Class II
Predicate Device:	K083310, Spine and Trauma iCT
Date of preparation	December 20, 2018

Contact Information
Primary contact person	Alternate contact person
Chiara Cunico	Regulatory Affairs Brainlab
Manager RA	Email: regulatory.affairs@brainlab.com
phone: +49 89 99 15 68 1738	phone: +49 89 99 15 68 0
Email: Chiara.cunico@brainlab.com	fax: +49 89 99 15 68 5033

INTENDED USE: 1

The intended use of the Spine & Trauma Navigation System is to support the surgeon in an operating theater for spinal and trauma cases. The System enables the user to navigate different instruments and / or implants in 3D datasets.

Indications for Use

Spine & Trauma 3D enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or inter-operatively by an appropriate image acquisition system.

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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 sterectactic 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 image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

2 DEVICE DESCRIPTION:

This navigation system consists of software and hardware components and is an image quided surgery system for navigated treatments in the fields of spine and trauma surgery, whereas the user may use 3D data based on CT, MR or XT. The Software may be installed on a fixed (e.g. Buzz Navigation (CM)) or mobile (e.g. Kick, Curve) navigation platform and supports the surgeon in clinical procedures by displaying tracked instruments in patient's image data. Such instruments can be held by a surgeon or by a mechatronic arm, which passively keeps the instrument in the position. (Mechatronic Vario Guide, "Cirq").

Operator profile

The operator's profile for this devices are surgeons or their assistants having a 3D image acquisition system (such as CT or 3D C-arm) in combination with a Brainlab navigation system. All operators are performing surgeries with this system on bony structures (e.g. spine), independent of their original discipline. Therefore different kind of surgeons may perform such procedures, which also includes Orthopedic, Spinal, Trauma and Neuro surgeons.

Patient population

The patient population includes 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 image (CT, 3D fluoroscopic image reconstruction).

Intended use environment

The application shall be used in an operating room / suite.

Operating principle

Infrared passive marker based tracking as provided by the optical tracking camera unit of the navigation station is used to determine the instrument's and patient's position between the patient and the reference attached to the patient is realized with a registration (manually or automatic).

Use scenarios

The system is placed in a way that the surgeon can easily watch the screen(s) and interact with the system during the procedure, but sterility is not compromised. The camera is positioned in a way that it has an unobstructed view on the surgical field.

The patient is positioned and draped in the usual manner, taking in to account that the reference geometry has to be attached to the relevant anatomical structure in a way that it is not disturbing the latter workflow. The surgical approach is performed. A reference array is attached to the relevant bony structure using conventional surgical techniques (either under sight or minimally invasive). The 3D dataset is either acquired or loaded and subsequently registered.

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After the scan has been transmitted to the navigation system or the registration computation has been performed, the surgeon is asked to verify the success of the registration with a general instrument or a dedicated pointer.

After successful verification the surgeon is able to access pre-planned objects, to plan or re-plan screws / trajectories and to visualize manually or pre-calibrated surgical instruments.

Intended part of the body or type of tissue applied to or interacted with

This system has different components, whereas most of them are software. Therefore, only instruments may get in contact with a patient, some instruments are included to perform the surgery. All Instruments are used temporarily for orientation within the situs or for preparations to be able to implant 3ºd party devices, which are not part of this system.

Such instruments can be used at rigid bony structures, such as a long bone or vertebra, where the user wants to use this navigation software according to the indications for use.

Essential performance characteristics

The essential performance characteristic for this product is the overall registration and navigation accuracy of the system to ensure the safe and effective use according to the intended use.

VERIFICATION SUMMARY 8

The verification of the Spine & Trauma Navigation System has been carried out thoroughly both at the top level and on underlying modules according to the verification plan and following internal processes. The verification was done to demonstrate that the design specifications are met.

In general, verification includes different kinds of tests within the software, GUI based automatic software tests and explorative testing. Results are documented in corresponding test reports and summarized in the Verification Summary document. For hardware parts, mechanical or biocompatibility tests were performed and filed accordingly.

For the integration of the Mechatronic Vario Guide, hardware and software related tests were performed regarding the following aspects:

Test	Description	Conclusion / Result
Verification ofgeneralfunctions	Tests regarding accurate positioning as well as robustalignment of a surgical instrument with the Mechatronic VarioGuide have been conducted on an MIS Spine Training Modelin a simulated clinical environment and were performed byspinal surgeons.	Verification of generalfunctions successful.All requirements met.
General designrequirements	Verification of general functions to overall design, layout andgeneral behavior.	Verification of generaldesign requirementssuccessful.
Safety testsregarding riskanalysis	Implementation and effectiveness of all risk control measuresspecified for the Mechatronic Vario Guide are tested andverified.	Risk control measuresare effective andmitigate theassociated risks.
Human factors/ UsabilityTesting	Usability tests with surgeons and OR nurses were performedin a simulated clinical environment covering the completeclinical workflow with the Mechatronic Vario Guide in	System is safe andeffective to use.

Product safety tests	combination with the spine navigation applications andBrainlab navigation platform.Compliance of Mechatronic Vario Guide including theSurgical Base System and the drape with AAMI/ANSIES60601 -1:2005/(R)2012 for medical electrical equipmenthas been tested.Part 1: General requirements for basic safety and essentialperformancePart 1-2: General requirements for basic safety and essentialperformance - Collateral standard: Electromagneticcompatibility - Requirements and tests	Compliance withstandardsrequirementsdemonstrated, nodeviations.
Biocompatibility / Reprocessing	Material properties in relation to biocompatibility and theirresponse to cleaning, disinfectionand sterilization have been assessed and tested.	Biocompatibilityassessment andreprocessing testssuccessful.
Environmental tests	Tests regarding adherence to RoHS, REACH and WEEEdirectives.	Environmental testssuccessful.
Integration tests with thespinenavigationapplicationsand Brainlabnavigationplatforms	Verification integration of Mechatronic Vario Guide into thespinal workflow and compatibility tests with the spinalnavigation applications and Brainlab navigation platform.	Integration andcompatibility testssuccessful.
Mechanical tests	Mechanical stability tests and interface tests of thecomponents of the Mechatronic Vario Guide from fixating themechatronic arm to the OR table to holding a drill guide witha defined holding force.	Mechanical testssuccessful.
Integration tests ofSurgical BaseSystem	The Mechatronic Vario Guide integrates the MedineeringSurgical Base System.Tested integration of surgical base system into theMechatronic Vario Guide including verification tests ensuringthat the specified braking concept and visual indicators arecorrectly implemented and that in any position the expectedholding forces are met.	Surgical Base Systemintegration testssuccessful.
Surgical BaseSystemfirmwaresoftwareverification	Tested software according to IEC 62304 and "FDA Guidancefor the Content of Premarket Submissions for SoftwareContained in Medical Devices"	Surgical Base Systemsoftware verificationsuccessful.
Integrationtests of steriledrape	The Mechatronic Vario Guide integrates a drape to ensuresterile environment to the surgical instruments.Tested that the drape matches in form, fit and function withthe mechanical dimension onto the components of theMechatronic Vario Guide, ensures a sterile barrier and iscompatible with the navigation.	Drape integration testssuccessful.

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All tests successfully passed demonstrating that the subject device performs as safely and effectively as the predicate device and supporting substantial equivalence.

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SUBSTANTIAL EQUIVALENCE ব

The Spine & Trauma Navigation System has similar functionality, intended use, technological characteristics and typical users as the predicate device.

Additionally, the Mechatronic Vario Guide ("Cirq") has been included as a holding arm for Drill Guides to support the surgeon in pedicle screw placement procedures.

Other included minor changes do not affect the fundamental scientific technology of the device.

CONCLUSION 5

The comparison of the Spine & Trauma Navigation System with the predicate device shows that the Spine & Trauma Navigation System has similar functionality, intended use, technological characteristics, and typical users as the predicate device. Verification activities ensure that the design specifications are met and that the Spine & Trauma Navigation System does not introduce new issues concerning safety and effectiveness. Hence the Spine & Trauma Navigation System is a substantial equivalent to the predicate device.

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).