For spinal use the CIRQ Robotic Alignment Module is an accessory to the compatible Brainlab IGS Spinal software applications and is intended to be an intraoperative image guided localization system to achieve pre-planned trajectories with surgical instruments.

The medical indications for use of the CIRQ Robotic Alignment Module for spinal use is the treatment of diseases where the placement of spinal screws is indicated.

Device Description

The device is an accessory to the compatible Brainlab IGS Spinal software applications (K183605) and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments.

The device consists of the Cirq Robotic Alignment Module which is connected to the Surgical Base System from Medineering. It serves to align instruments to a pre-planned trajectory during surgical procedures using the Cirq Robotic Application Software together with the Brainlab IGS Spinal software applications.

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

The device is manually pre-aligned roughly to the region of interest by opening the brakes of the Surgical Base System using its 7 degrees of freedom. Following this, the tracking information is used to automatically fine align a tracked guide attached to the Cirq Robotic Alignment Module to achieve a pre-planned trajectory controlled by the CIRQ Robotic Application Software. After finishing the alignment, the device remains in this position and the surgical instruments through the provided guide to perform the surgical steps intended without losing the trajectory.

AI/ML Overview

The provided FDA 510(k) summary for the CIRQ Robotic Alignment Module outlines various tests conducted to demonstrate the device's safety and effectiveness. However, it does not contain specific details regarding acceptance criteria for quantitative performance metrics, nor does it describe a clinical study of the device against a defined ground truth, a multi-reader multi-case (MRMC) study, or statistical analyses of AI performance.

The information provided focuses on engineering and usability verification, with conclusions stating "successful" or "met." It confirms that the device is an accessory for achieving pre-planned surgical trajectories but does not present quantifiable performance data (e.g., accuracy, precision) against specific acceptance criteria for robotic alignment.

Therefore, based on the provided text, I cannot answer sections 1, 2, 3, 5, 6, 7, 8, and 9 of your request as they relate to quantitative device performance, clinical study design, and ground truth establishment in a medical AI context. The document describes a device (hardware/software integration for robotic alignment) rather than a diagnostic AI algorithm.

However, I can extract information relevant to the types of tests performed that would typically lead to acceptance criteria, even if the criteria themselves are not explicitly numeric in this summary:

Summary of Device Performance and Testing (Based on provided 510(k) summary):

The provided document describes engineering verification and validation activities for the CIRQ Robotic Alignment Module. It does not detail a study proving the device meets quantitative performance acceptance criteria in the way one would expect for an AI diagnostic device (e.g., sensitivity, specificity, or AUC). Instead, it focuses on functional, safety, and integration testing.

Here's a breakdown of the relevant information from the document, acknowledging that it doesn't fit the typical "acceptance criteria for an AI study" format:

1. A table of functional/safety criteria and reported device performance (interpreted from the "Test" table):

Acceptance Criteria (Inferred from Test Description)	Reported Device Performance (Conclusion/Result)
Functional: Accurate positioning of surgical instruments to planned trajectory and maintenance of position during procedure. Usefulness in open/percutaneous, minimally invasive approaches.	Verification of general functions successful. All requirements met. (Tested on a MIS Spine Training Model in a simulated clinical environment by spinal surgeons).
Design: Conformance to overall design, layout, and general behavior.	Verification of general design requirements successful.
Safety: Implementation and effectiveness of all specified risk control measures.	Risk control measures are effective and mitigate the associated risks.
Human Factors/Usability: Safe and effective use by surgeons and OR nurses.	System is safe and effective to use. (Usability tests with surgeons and OR nurses performed in a simulated clinical environment covering complete clinical workflow).
Product Safety (Standards Compliance): Compliance with AAMI/ANSI ES60601-1:2005, IEC 60601-1-2, IEC 80601-2-77, AIM standard 7351731.	Compliance with standards requirements demonstrated, no deviations.
Biocompatibility/Reprocessing: Material properties assessed for biocompatibility and response to cleaning/disinfection/sterilization.	Biocompatibility assessment and reprocessing tests successful.
Environmental: Adherence to RoHS, REACH, and WEEE directives.	Environmental tests successful.
Compatibility: Integration into spinal workflow and compatibility with spinal navigation applications and Brainlab navigation platforms.	Integration and compatibility tests successful.
Mechanical: Mechanical stability, lifecycle, and interface of components (e.g., fixating to OR table, holding surgical instruments).	Mechanical tests successful.
Integration (Robotic Application, Surgical Base System, Cirq Robotic Alignment Module, instruments): Tested integration incl. cybersecurity, braking concept, and alignment to desired position.	Integration tests Robotic Application with other components successful.
Software Verification (Surgical Base System firmware & Robotic Application): Compliance with IEC 62304 and FDA Guidance for Premarket Submissions for Software.	Surgical Base System software verification successful.Robotic Application software verification successful.
Sterile Drape Integration: Match in form, fit, function, sterile barrier, and navigation compatibility.	Drape integration tests successful.
Stabilization Brace Integration: Match in form, fit, function with Surgical Base System mechanical dimensions.	Stabilization brace integration tests successful.

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

For the "Verification of general functions" and "Human factors / Usability Testing," the testing involved a "MIS Spine Training Model in a simulated clinical environment." The number of models or simulated cases is not specified.
The "data provenance" is not explicitly mentioned as per country of origin. The tests were simulated clinical environments or engineering tests.

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

For "Verification of general functions," "spinal surgeons" were involved.
For "Human factors / Usability Testing," "surgeons and OR nurses" were involved.
The specific number or detailed qualifications (e.g., years of experience) for these experts are not provided. The "ground truth" here is effective and safe usage in a simulated environment, rather than a clinical diagnosis ground truth.

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

No adjudication method is described for the "test set" as this was not a diagnostic study with ambiguous interpretations requiring adjudication.

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 MRMC or comparative effectiveness study comparing human performance with and without AI assistance is described. This device is a robotic alignment module, an accessory for surgical guidance, not a diagnostic AI tool that assists human readers.

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

The device is designed as a human-in-the-loop system (an accessory supporting the surgeon). Standalone performance in the diagnostic AI sense is not applicable or described. The tests described are on the functionality and safety of the integrated system including the robotic module.

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

For functional and human factors testing, the "ground truth" was operational success and safety as evaluated by the users (spinal surgeons, OR nurses) in a simulated environment (MIS Spine Training Model for functional tests). This is a performance-based ground truth related to task execution and user experience, rather than a diagnostic accuracy ground truth based on pathology or clinical outcomes.

8. The sample size for the training set:

This document describes the verification and validation of a medical device, not the development or training of a machine learning model. Therefore, no "training set" or "sample size for training set" is applicable in the context of an AI model's development.

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

Not applicable, as this is not an AI model requiring a training set with established ground truth.

Summary

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December 23, 2020

Brainlab AG Cunico Chiara Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, 80809 Germany

Re: K202320

Trade/Device Name: CIRQ Robotic Alignment Module, Cirg, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 17, 2020 Received: November 19, 2020

Dear Cunico Chiara:

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.

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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 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,

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) K202320

Device Name

CIRO Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System

Indications for Use (Describe)

The medical indications for use of the CIRQ Robotic Alignment Module for spinal use is the treatment of diseases where the placement of spinal screws is indicated.

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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510(k) Summary

November 17, 2020

General Information
Manufacturer	Brainlab AG
Establishment Registration	8043933
Device Name	CIRQ Robotic Alignment
Trade Name	Cirq, Cirq Robotic Alignment System, Cirq RoboticAlignment Module Spinal, Cirq Robotic AlignmentCranial And Spine, CIRQ Robotic Alignment Cranialand Spine System
Classification Name	Orthopedic Stereotaxic Instrument
Product Code	OLO
Regulation Number	882.4560
Regulatory Class	II
Panel	Orthopedic
Predicate Device and K Number	Spine Trauma 3D - K183605

Contact Information
Primary Contact	Alternate Contact
Chiara Cunico	Regulatory Affairs Brainlab
Manager RA	Phone: +49 89 99 15 68 0
Phone: +49 89 99 15 68 0	Fax: +49 89 99 15 68 5033
Email: chiara.cunico@brainlab.com	Email: regulatory.affairs@brainlab.com

1. Intended Use and Indication for Use

For spinal use the CIRQ Robotic Alignment Module is an accessory to the compatible Brainlab IGS Spinal software applications and is intended to be an intraoperative image guided localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments.

The medical indications for use of the CIRQ Robotic Alignment Module for spinal use is the treatment of diseases where the placement of spinal screws is indicated.

2. Device Description

The device consists of the Cirq Robotic Alignment Module which is connected to the Surgical Base System from Medineering. It serves to align instruments to a pre-planned trajectory during surgical

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procedures using the Cirg Robotic Application Software together with the Brainlab IGS Spinal software applications.

The device is manually pre-aligned roughly to the region of interest by opening the brakes of the Surgical Base System using its 7 degrees of freedom. Following this, the tracking information is used to automatically fine align a tracked quide attached to the Cirg Robotic Alignment Module to achieve a pre-planned trajectory controlled by the CIRQ Robotic Application Software. After finishing the alignment, the device remains in this position and the surgical instruments through the provided guide to perform the surgical steps intended without losing the trajectory.

3. Substantial Equivalence

The subject device has been compared with the predicate device (K183605). The main differences are listed below. Please see Substantial Equivalence Cirq Robotic Alignment Module for full details as well as the demonstration of equivalence.

Topic	Changes included in Subject Device Cirq Robotic AlignmentModule
Platform	• Updated IGS platform with Touchscreen Monitor and StereotacticCamera system
Instruments /HardwareComponents	• Surgical Base System communicates with Navigation platform andattached Cirq Robotic Alignment Module• Cirq Robotic Alignment Module for robotic fine alignment of a trackedguide• Surgical instruments addressing similar use and use cases that can beinserted into above tracked guide
RoboticApplication	• UI with guidance for manual pre-alignment• Communicates with Surgical Base System to provide positioninginformation to attached Cirq Robotic Alignment Module
Compatibility	• Different Drape from 3rd party manufacturer

Both devices are intended as image guided localization systems to position instruments. The intended use of the subject device is limited to achieving pre-planned trajectories which is a subset of the intended use of the predicate device.

The indications for use of the subject device to treat diseases where the placement of spinal screws is indicated is a subset of the indications for use of the predicate device.

The Technological Characteristics are the same as for the predicate device. Both devices

use the same tracking technology, o
consist of a computer workstation, a tracking camera, tracked instruments o
are a combination of software, electrical and non-electrical components O
have motorized components O
communicate over the network O

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Test	Description	Conclusion /Result
Verification ofgeneralfunctions	Tests regarding accurate positioning of surgicalinstruments to planned trajectory as well asmaintenance of a position during the procedure andusefulness of the subject device in open orpercutaneous, minimally invasive approaches have beenconducted on a MIS Spine Training Model in a simulatedclinical environment and where performed by spinalsurgeons.	Verification ofgeneralfunctionssuccessful. Allrequirementsmet.
General designrequirements	Verification of general functions to overall design, layoutand general behavior.	Verification ofgeneral designrequirementssuccessful.
Safety testsregarding riskanalysis	Implementation and effectiveness of all risk controlmeasures specified for the Cirq Robotic AlignmentModule are tested and verified.	Risk controlmeasures areeffective andmitigate theassociated risks.
Human factors /Usability Testing	Usability tests with surgeons and OR nurses wereperformed in a simulated clinical environment coveringthe complete clinical workflow with the Cirq RoboticAlignment Module in combination with the spinenavigation applications and Brainlab navigationplatform.	System is safeand effective touse.
Product safetytests	Compliance of Cirq Robotic Alignment Module includingthe Surgical Base System and the drape has beentested according to the following standards:AAMI/ANSI ES60601 -1:2005/(R)2012 for medicalelectrical equipment - General requirements forbasic safety and essential performance IEC 60601-1-2 General requirements for basicsafety and essential performance - Collateralstandard: Electromagnetic compatibility -Requirements and tests IEC 80601-2-77 Particular requirements for thebasic safety and essential performance of forrobotically assisted surgical equipment AIM standard 7351731 Immunity Test For ExposureTo Radio Frequency Identification Readers	Compliance withstandardsrequirementsdemonstrated,no deviations.
Biocompatibility/ Reprocessing	Material properties in relation to biocompatibility andtheir response to cleaning, disinfectionand sterilization have been assessed and tested.	Biocompatibilityassessment andreprocessingtests successful.
Environmentaltests	Tests regarding adherence to RoHS, REACH andWEEE directives.	Environmentaltests successful.
Compatibilitytests with spinalnavigationapplications andBrainlab	Verification integration of Cirq Robotic Alignment Moduleinto the spinal workflow and compatibility tests with thespinal navigation applications and Brainlab navigationplatforms.	Integration andcompatibilitytests successful.
navigationplatforms
Mechanicaltests	Mechanical stability tests, lifecycle tests and interfacetests of the components of the Cirq Robotic AlignmentModule from fixating the Surgical Base System to theOR table to holding surgical instruments with a definedholding force.	Mechanicaltests successful.
Integration testsRoboticApplication,Surgical BaseSystem, CirqRoboticAlignmentModule andinstruments.	Tested integration of Robotic Application with SurgicalBase System, mounted Cirq Robotic Alignment Moduleand attached instruments including cybersecurity tests,verification tests ensuring that the specified brakingconcept for the Surgical Base System is correctlyimplemented and verification test on aligning to adesired position.	Integration testsRoboticApplication withothercomponentssuccessful.
Surgical BaseSystemfirmwaresoftwareverification	Tested software according to IEC 62304 and "FDAGuidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices"	Surgical BaseSystem softwareverificationsuccessful.
RoboticApplicationsoftwareverification	Tested software according to IEC 62304 and "FDAGuidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices"	RoboticApplicationsoftwareverificationsuccessful.
Integration testsof sterile drape	The Cirq Robotic Alignment Module integrates a drapeto ensure sterile environment to the surgical instruments.Tested that the drape matches in form, fit and functionwith the mechanical dimension onto the components ofthe Cirq Robotic Alignment Module, ensures a sterilebarrier and is compatible with the navigation.	Drapeintegration testssuccessful.
Integration testsof stabilizationbrace	The Cirq Robotic Alignment Module integrates astabilization brace to increase stability to the system.Tested that brace matches in form, fit and function withthe mechanical dimensions of the Surgical BaseSystem.	Stabilizationbraceintegration testssuccessful.

The various tests carried out on the subject device has been listed below:

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Conclusion

The changes described above do not alter intended use or the fundamental scientific technology of the device and these changes do not present any new issues of safety and effectiveness when compared to the predicate device. Therefore, we believe that the Subject Device and the predicate are substantially equivalent.

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).