The SURGIVISIO Device is indicated to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized

The SURGIVISIO Device through its freehand navigation feature is indicated as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery.

It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device.

It is indicated to precisely position the Navigated Targeting Needle SPX I during general spinal procedures with a posterior approach.

The SURCIVISIO Device through its robotic guidance feature is indicated for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery.

Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device.

It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.

The SPX1 Instrument and Spine CoBot instruments are designed to be used with the SURGIVISIO Device.

Device Description

The SURGIVISIO Device is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The subject device offers two stereotaxic quidance features: freehand navigation and robotic guidance.

The freehand navigation feature is based on the standard and established technique of navigation systems utilizing optical position determination technology. Like currently marketed optical tracking navigation systems, the operating principle of the freehand navigation feature is based upon the use of a stereoscopic camera emitting infrared light which can determine a 3D position of reflective marker spheres. This allows for real-time tracking of the marker spheres. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and navigation software (3D Spine Universal Workflow software application) and instruments equipped with marker spheres to enable an exact localization in space.

The robotic quidance feature utilizes the same principle of optical position determination technology. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and a navigation software (3D Spine Robotic Workflow software application), a robotic arm (CoBot), and instruments equipped with marker spheres to enable an exact localization in space.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SURGIVISIO Device, focusing on a design modification to the Spine CoBot instruments used with its robotic guidance feature. The core of the submission addresses the device's substantial equivalence to previously cleared versions and predicates.

Here's a breakdown of the acceptance criteria and study information, as much as can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate descriptions)	Reported Device Performance (from cadaveric study)
Device accuracy: < 2 mm	Assessed (result not explicitly stated but implied to meet criteria for substantial equivalence)
Angular error: < 2 degrees	Assessed (result not explicitly stated but implied to meet criteria for substantial equivalence)
Safety of robotic guidance feature	Assessed (implied to meet criteria for substantial equivalence)

Note: The document states that the accuracy and angular error criteria are "Identical" to the predicate, implying these thresholds are the acceptance criteria. The specific numerical results from the cadaveric study are not explicitly provided in the summary, but the conclusion of "substantial equivalence" implies these criteria were met.

2. Sample Size Used for the Test Set and Data Provenance

The text mentions a "cadaveric study" was performed.

Sample Size: Not explicitly stated.
Data Provenance: Cadaveric, implying human anatomical specimens. No country of origin is specified. The study type is effectively prospective in the sense that the new device modification was tested on these cadavers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The cadaveric study assessed accuracy and safety, but it's not clear how "ground truth" for accuracy was established (e.g., gold standard measurements, comparison to expert placement) or how many experts, if any, were involved in these assessments or their qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done?: No, an MRMC study was not conducted. The performance data section explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." The tests performed were nonclinical (sterilization validation, cadaveric study).
Effect size of human readers improve with AI vs without AI assistance?: Not applicable, as no MRMC or clinical study involving human readers and AI assistance was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is a "stereotaxic instrument" with "robotic guidance," intrinsically designed for human-in-the-loop use. The cadaveric study assessed the "accuracy of the robotic guidance feature" and "safety of the robotic guidance feature." While the robotic guidance itself has an algorithm, the performance assessment implies its use in the context of guiding surgical instruments. Therefore, a purely "standalone" algorithm-only performance study, disconnected from its intended use with instruments and human oversight, is not explicitly described or indicated as the primary method of evaluation. The "device accuracy" and "angular error" metrics would represent the precision of the robotic system itself, which is a form of standalone performance for the mechanical guidance aspect.

7. Type of Ground Truth Used

For the accuracy assessment in the cadaveric study, the "ground truth" would likely be:

Instrumented measurements: High-precision measurement devices (e.g., optical trackers, CMM arms) used to determine the actual position and angle of the guided instruments or planned trajectories on the cadaver, against which the device's reported accuracy is compared. This is implied by the quantitative accuracy and angular error metrics.

8. Sample Size for the Training Set

This document describes a premarket notification for a modification to an already cleared device. It does not provide information about the training set used for the original development of the SURGIVISIO device's software or algorithms. The current submission focuses on demonstrating that design modifications to instruments do not negatively impact the device's accuracy and safety, rather than developing new algorithms that would require a new training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document, as it pertains to the original development of the device's algorithms, which is outside the scope of this specific 510(k) submission for a design modification.

Summary

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Image /page/0/Picture/0 description: The image shows the date July 27, 2023. The month is July, the day is 27, and the year is 2023. The date is written in a clear, legible font. The text is black on a white background.

Ecential Robotics Elodie Bouillet Design Process & Regulatory Affaires Manager Zone Mayencin II, Parc Equation - Bâtiment 1

Gieres, 38610 France

tance

Re: K231886

2 avenue de Vignate

Trade/Device Name: SURGIVISIO Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 27, 2023 Received: June 27, 2023

Dear Elodie Bouillet:

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 mediation-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 -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K231886

Device Name SURGIVISIO Device

Indications for Use (Describe)

The SURGIVISIO Device through its freehand navigation feature is indicated as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery.

It is indicated to precisely position the Navigated Targeting Needle SPX I during general spinal procedures with a posterior approach.

Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device.

It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.

The SPX1 Instrument and Spine CoBot instruments are designed to be used with the SURGIVISIO Device.

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter Information

Submitter:	ECENTIAL ROBOTICS2 avenue de VignateZone Mayencin II, Parc Equation – Bâtiment 138610 GièresFrance
Contact Person:	Elodie BOUILLETProject Quality & Regulatory Affairs ManagerPhone : 0033 6 37 82 07 90Email: elodie.bouillet@ecential-robotics.com

Date Summary Prepared: June 27, 2022

Device Information

Trade or proprietaryname	SURGIVISIO Device
Common or usual nameClassification NameRegulation NumberRegulatory classPrimary product code	Orthopedic Stereotaxic InstrumentStereotaxic Instrument21 CFR 882.4560IIOLO
Legally marketed deviceto which equivalence isclaimed	SURGIVISIO Device by ECENTIAL ROBOTICS:- Primary predicate K221028- Other predicateso K202547o K220946o K220627
Scope of thesubmission	The subject device is the SURGIVISIO Device whichenables 2D/3D medical imaging and stereotaxic guidance.The 2D/3D medical imaging feature was cleared originallyvia 510(k) K202547 and via Special 510(k) K220946 andK220627. The stereotaxic guidance including freehandnavigation and robotic guidance feature was cleared via510(k) K221028.The scope of this current submission is limited to the designmodification of the Spine CoBot instruments which are usedfor the Robotic Guidance feature.
Device Description	The SURGIVISIO Device is a medical device that provides2D/3D medical imaging and stereotaxic guidance. The

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subject device offers two stereotaxic quidance features: freehand navigation and robotic guidance.

Indications for use The SURGIVISIO Device is indicated to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis, or articulation structures are visualized.

The SURGIVISIO Device through its freehand navigation feature is indicated as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery. It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device. It is indicated to precisely position the Navigated Targeting Needle SPX1 during general spinal procedures with a posterior approach.

The SURGIVISIO Device through its robotic quidance feature is indicated for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery. Guidance

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is based on an intra-operative plan developed with threedimensional imaging software based on intraoperative 3D images provided by the SURGIVISIO Device. It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.

The SPX1 Instruments and Spine CoBot instruments are designed to be used with the SURGIVISIO Device.

Technology comparison Increase of instruments diameters, modification of the shape of the CoBot, Drill Guide - Sleeve teeth, CoBot, Drill Bit tip and CoBot, Drill Bit connection to power tool. The technology is not impacted by the discussed device change.
Biocompatibility Same as the predicate. The discussed device change, object of this Special 510(K) submission does not require to re-perform Biocompatibility testing as the raw material, manufacturing additives as well as manufacturing processes are not modified following the design change.
Electrical Safety Testing Same as the predicate. The discussed device change, object of this Special 510(K) submission does not impact Electrical Safety.
Performance Testing Same as the predicate. The accuracy and safety assessment (cadaveric study) were redone in order to ensure that the design modification on the Spine CoBot Instruments do not impact the accuracy and the safety of the Robotic Guidance Feature of the SURGIVISIO Device.

Software Testing Same as the predicate

Based upon comparison of devices and performance Conclusion testing results. SURGIVISIO Device is substantially equivalent to the predicate device.

Summary of the technological characteristics of the device compared to the predicate device

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K231886

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Performance Data

For further information about testing, standards, acceptance criteria and results, please refer to section 11 Design Control Activities Summary.

Nonclinical tests: The following nonclinical tests were performed on the SURGIVISIO Device to demonstrate substantial equivalence of safety and efficacy with the predicate device:
- The Sterilization validation part of the reprocessing validation of the Spine CoBot Instruments has been performed.
- A cadaveric study has been performed to assess: -
  - The accuracy of the robotic quidance feature O
  - The safety of the robotic guidance feature o

Clinical tests: No clinical tests were conducted to demonstrate substantial equivalence.

Conclusions drawn from Performance Data

The SURGIVISIO Device is identical in indications for use and technological characteristics as the proposed predicate device. These aspects, along with the performance testing conducted, demonstrate the substantial equivalence SURGIVISIO to the Device (K202547/K220946/K220627/K221028) and that the SURGIVISIO Device does not raise different questions of safety and effectiveness when compared to this predicate.

● ecential robotics

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).

Characteristics	Robotic guidance featureof the SURGIVISIO Device(Subject device)	Robotic guidance featureof the SURGIVISIO Device(K221028)(Predicate device)	Discussion
Indications for use	The SURGIVISIO Devicethrough its robotic guidancefeature is indicated for the	The SURGIVISIO Devicethrough its robotic guidancefeature is intended for the	Similar: word "intended"replaced by "indicated",
Characteristics	Robotic guidance featureof the SURGIVISIO Device(Subject device)	Robotic guidance featureof the SURGIVISIO Device(K221028)(Predicate device)	Discussion
	positioning of instrumentholders or tool guides to beused by surgeons to guidethe Spine CoBot instrumentsduring general spinalsurgery.Guidance is based on anintra-operative plandeveloped with three-dimensional imagingsoftware based on intra-operative 3D imagesprovided by theSURGIVISIO Device.It is indicated for positioningof surgical instruments invertebrae with a posteriorapproach in thethoracolumbar region.The SPX1 instruments andSpine CoBot instrumentsare designed to be usedwith the SURGIVISIODevice.	positioning of instrumentholders or tool guides to beused by surgeons to guidethe Spine CoBot instrumentsduring general spinalsurgery.Guidance is based on anintra-operative plandeveloped with three-dimensional imagingsoftware based on intra-operative 3D imagesprovided by theSURGIVISIO Device.It is indicated for positioningof surgical instruments invertebrae with a posteriorapproach in thethoracolumbar region.The SPX1 instruments andSpine CoBot instrumentsare intended to be used withthe SURGIVISIO Device.	"intended" replaced by"designed" while thestatement of indicationsfor use is the same. Safetyand performance of thesystem are not questioned.
Anatomical site	The SURGIVISIO Devicethrough its robotic guidancefeature is indicated forpositioning of surgicalinstruments in vertebraewith a posterior approach inthe thoracolumbar region.	The SURGIVISIO Devicethrough its robotic guidancefeature is indicated forpositioning of surgicalinstruments in vertebraewith a posterior approach inthe thoracolumbar region.	Identical
Patient population	The SURGIVISIO Devicethrough its robotic guidancefeature is indicated for apopulation with medicalconditions requiring thetreatment of diseases withthe placement of spinalinstruments and for whichthe use of stereotacticsurgery may be consideredto be appropriate and afterconsideration of thecompatibility of patientspinal anatomy withdimensions of the SpineCoBot Instruments anddimensions of virtualimplants proposed by the 3DSpine Robotics workflowsurgical plan.	The SURGIVISIO Devicethrough its robotic guidancefeature is indicated for apopulation with medicalconditions requiring thetreatment of diseases withthe placement of spinalinstruments and for whichthe use of stereotacticsurgery may be consideredto be appropriate and afterconsideration of thecompatibility of patientspinal anatomy withdimensions of the SpineCoBot Instruments anddimensions of virtualimplants proposed by the 3DSpine Robotics workflowsurgical plan.	Identical
Characteristics	Robotic guidance featureof the SURGIVISIO Device(Subject device)	Robotic guidance featureof the SURGIVISIO Device(K221028)(Predicate device)	Discussion
General devicetechnology description	Computer-controlledelectromechanical armguiding neurosurgicalinstruments	Computer-controlledelectromechanical armguiding neurosurgicalinstruments	Identical
Global systemfunctional principal	Stereotactic roboticnavigation guidance of spinesurgical instrument basedon an intra-operative plandeveloped with three-dimensional imagingsoftware which is based onintraoperative 3D imagesusing an optical system(infrared camera)	Stereotactic roboticnavigation guidance of spinesurgical instrument basedon an intra-operative plandeveloped with three-dimensional imagingsoftware which is based onintraoperative 3D imagesusing an optical system(infrared camera)	Identical
Surgical work Flow	1. Patient and deviceinstallation2. Intraoperative imageacquisition3. Registration4. Intraoperative planning5. Spine instrument holderpositioning6. Instrument guidance7. Screw implantation	1. Patient and deviceinstallation2. Intraoperative imageacquisition3. Registration4. Intraoperative planning5. Spine instrument holderpositioning6. Instrument guidance7. Screw implantation	Identical
Graphical UserInterface	System-specific GUI	System-specific GUI	Identical
Surgeon control	- The surgeoncontrols the motionof the robotic armfrom one screwposition to the nextby pressing the footpedal and themanual button.	- The surgeoncontrols the motionof the robotic armfrom one screwposition to the nextby pressing the footpedal and themanual button.	Identical
	The surgeon carries out thefinal positioning through theinstrument guide with atraditional surgicalinstrument.	The surgeon carries out thefinal positioning through theinstrument guide with atraditional surgicalinstrument.
Device accuracy	- Device accuracy: <2mm- Angular error: <2degrees	- Device accuracy: <2mm- Angular error: <2degrees	Identical
SYSTEM COMPONENTS DESIGN

Characteristics	Robotic guidance featureof the SURGIVISIO Device(Subject device)	Robotic guidance featureof the SURGIVISIO Device(K221028)(Predicate device)	Discussion
Overall Device Design	SURGIVISIO DeviceRobotic guidance feature iscomposed of the followingmain components:- Stations- Dedicated software- Robotic arm- Camera pole- Dedicatedinstruments	SURGIVISIO DeviceRobotic guidance feature iscomposed of the followingmain components:- Stations- Dedicated software- Robotic arm- Camera pole- Dedicatedinstruments	Identical
Stations	- Base station(SURGIVISIOStation): two displaymonitors, computerunit, power supply.- Robotic Station(CoBot): roboticarm, control box forthe robotic arm,power supply, footpedal	- Base station(SURGIVISIOStation): two displaymonitors, computerunit, power supply.- Robotic Station(CoBot): roboticarm, control box forthe robotic arm,power supply, footpedal	Identical
Software	- Dedicated spineapplication software	- Dedicated spineapplication software	Identical
Robotic arm	- Guides spineinstruments duringgeneral spinesurgery- Instruments aremounted onto therobot arm's flange- Uses seven degreesof freedomarchitecture to guideinstruments- Uses foot pedaland/or manualbuttons forautomatic alignmentand cooperativemode- Has light indicatorsthat reflect thestatus of the roboticguidance	- Guides spineinstruments duringgeneral spinesurgery- Instruments aremounted onto therobot arm's flange- Uses seven degreesof freedomarchitecture to guideinstruments- Uses foot pedaland/or manualbuttons forautomatic alignmentand cooperativemode- Has light indicatorsthat reflect thestatus of the roboticguidance	Identical
Optical localizer	- An infrared cameradetects reflectivemarkers to track theposition of the	- An infrared cameradetects reflectivemarkers to track theposition of the	Identical
Characteristics	Robotic guidance featureof the SURGIVISIO Device(Subject device)	Robotic guidance featureof the SURGIVISIO Device(K221028)(Predicate device)	Discussion
	robotic arm andinstruments	robotic arm andinstruments
Instruments	- Robotic instruments(Spine CoBotInstruments: CoBot,Tool Holder;Robotic, Tool holder- Tracker; CoBot,Drill Guide - CorticalTip; CoBot, DrillGuide - Sleeve;CoBot, Drill Bit; 3.5mm Hex HeadScrewdriver;Fixation Screws,CoBot SpineInstruments Tray)- Navigationinstruments (SPX1instruments)	- Robotic instruments(Spine CoBotInstruments: CoBot,Tool Holder;Robotic, Tool holder- Tracker; CoBot,Drill Guide - CorticalTip; CoBot, DrillGuide - Sleeve;CoBot, Drill Bit; 3.5mm Hex HeadScrewdriver;Fixation Screws,CoBot SpineInstruments Tray)- Navigationinstruments (SPX1instruments)	Similar: the design ofCoBot, Tool Holder,CoBot, Drill Bit, CoBot,Drill Guide - Sleeve,and CoBot, Drill Guide– Cortical Tip ismodified (scope of thissubmission) howeverthe use of thoseinstruments isunchanged and theperformance and thesafety of the system isnot impacted (seesection 11 - DesignControl ActivitiesSummary).