The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software.
The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic EEG, laser tissue ablation, etc.).
The Midas Rex™ Legend™ depth stop attachment and tools are incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

Device Description

Stealth Autoguide™ System: The Stealth Autoguide System is a robotic positioning and guidance system intended to interpret navigation tracker coordinates and surgical plan coordinates from the StealthStation to robotically position and orient instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments to pre-defined plans.
Midas Rex™ Legend™ Depth Stop System: The Midas Rex™ Legend™ Depth Stop System consists of a Depth Stop Attachment and specific surgical dissecting tools that will be used in conjunction with the Stealth Autoguide System to create cranial access holes for neurosurgical procedures.

AI/ML Overview

The provided text describes the Medtronic Stealth Autoguide System and Midas Rex Legend Depth Stop System. It includes information on performance testing for the Stealth Autoguide System, but lacks specific details on acceptance criteria and a study to prove the device meets all acceptance criteria in a comprehensive format. It also doesn't contain the requested information about training sets, expert ground truth development, MRMC studies, or standalone performance.

However, based on the provided text, I can extract the following information concerning the performance testing for the Stealth Autoguide System's accuracy:

Acceptance Criteria and Reported Device Performance for Stealth Autoguide™ System

Acceptance Criterion	Reported Device Performance (Mean)	Standard Deviation	99% CI* Upper
3D Positional Accuracy: Mean error ≤ 2.0 mm
Biopsy Needle Accuracy Validation - StealthStation S7	0.92 mm	0.47 mm	3.03 mm
Biopsy Needle Accuracy Validation - StealthStation S8	0.97 mm	0.26 mm	1.70 mm
sEEG bolts/Visualase Accuracy Validation - StealthStation S7	1.50 mm	0.68 mm	3.08 mm
sEEG bolts/Visualase Accuracy Validation - StealthStation S8	1.48 mm	0.48 mm	2.60 mm
Trajectory Angle Accuracy: Mean error ≤ 2.0 degrees
Biopsy Needle Accuracy Validation - StealthStation S7	1.22 degrees	0.51 degrees	2.41 degrees
Biopsy Needle Accuracy Validation - StealthStation S8	0.59 degrees	0.23 degrees	1.11 degrees
sEEG bolts/Visualase Accuracy Validation - StealthStation S7	1.04 degrees	0.76 degrees	2.81 degrees
sEEG bolts/Visualase Accuracy Validation - StealthStation S8	0.42 degrees	0.17 degrees	0.82 degrees

Details of the Accuracy Study:

Sample size used for the test set and the data provenance: The document states that performance was determined using "overall end-to-end worst-case system level accuracy testing which incorporated clinically relevant anatomical phantoms." Further specifics about the sample size (e.g., number of phantoms, number of measurement points per phantom) and data provenance (e.g., country of origin, retrospective or prospective) are not provided in this document.
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 document. The accuracy testing seems to be based on direct physical measurements against defined targets on phantoms rather than expert interpretation of images.
Adjudication method for the test set: This information is not provided. Given the nature of the accuracy testing (physical measurements), traditional adjudication methods for image interpretation would likely not apply.
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: This information is not provided. The assessment described is a technical accuracy validation of the device's navigation and positioning capabilities, not a study involving human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Stealth Autoguide™ System" is described as a "robotic positioning and guidance system" and the accuracy validation focuses on its "performance in 3D positional accuracy" and "trajectory angle accuracy." This implies standalone technical performance testing of the system's ability to achieve planned trajectories, before a human surgeon uses it to guide instruments. The system is designed to "robotically position and orient instrument holders or tool guides," suggesting its core function is algorithm-driven positioning. However, the evaluation here focuses on the accuracy of the guidance provided, which would then be utilized by a surgeon.
The type of ground truth used: The ground truth for the accuracy study was established by defining "clinically relevant anatomical phantoms" and measuring the device's "performance in 3D positional accuracy" and "trajectory angle accuracy" against the known positions and trajectories on these phantoms. This is a phantom-based measurement ground truth.
The sample size for the training set: This information is not provided. The document describes an accuracy validation study, not the development or training of an AI algorithm.
How the ground truth for the training set was established: This information is not provided, as details about a training set are not included in the document.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

November 1, 2019

Medtronic Navigation, Inc. Jason Woehrle Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K191597

Trade/Device Name: Stealth Autoguide System, Midas Rex Legend Depth Stop System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, HBC, HBB, HBE Dated: September 27, 2019 Received: October 2, 2019

Dear Jason Woehrle:

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

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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,

Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K191597

Device Name Stealth Autoguide™ System

Indications for Use (Describe)

The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic EEG, laser tissue ablation, etc.).

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Indications for Use

510(k) Number (if known) K191597

Device Name Midas Rex™ Legend™ Depth Stop System

Indications for Use (Describe)

The Midas Rex™ Legend™ depth stop attachment and tools are incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary June 14, 2019

I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200
Medtronic Powered Surgical Systems 4620 N Beach Street Ft Worth, TX 76137 USA
Contact: Jason Woehrle (Primary) Senior Regulatory Affairs Specialist Telephone Number: 949-399-1509 Fax Number: 720-890-3500
K. Elizabeth Waite (Alternate) Principal Regulatory Affairs Specialist Telephone: (720)-890-2182 Fax: 720-890-3500
II.
Proprietary Trade Name:
Stealth Autoguide™System
Midas Rex " Legend" "Depth Stop System

III. Common Name:

Stealth Autoguide™ System: Stereotaxic Instrument Midas Rex " Legend " Depth Stop System: Motor, Drill, Electric, Motor, Drill, Pneumatic, Powered simple cranial drills, burrs, trephines, and their accessories

IV. Classification Name:

Stealth Autoguide " System: Stereotaxic Instrument (21 CFR 882.4560) Midas Rex™ Legend™ Depth Stop System: Electric cranial drill motor (21 CFR 882.4360) Pneumatic cranial drill motor (21 CFR 882.4370) Powered simple cranial drills, burrs, trephines, and their accessories (21 CFR 882.4310)

V. Classification: Stealth Autoguide™ System: Class II Midas Rex " Legend " Depth Stop System: Class II
VI. Product Code: Stealth Autoguide™ System: HAW Midas Rex 1 Legend " Depth Stop System: HBC, HBB, HBE

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VII. Product Description:

Midas Rex™ Legend™ Depth Stop System: The Midas Rex™ Legend™ Depth Stop System consists of a Depth Stop Attachment and specific surgical dissecting tools that will be used in conjunction with the Stealth Autoguide System to create cranial access holes for neurosurgical procedures.

Indications for Use: VIII.

Stealth Autoguide "" System: The Stealth Autoguide System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (e.g., stereotactic biopsy, stereotactic EEG, laser tissue ablation, etc.).

Midas Rex "" Legend"" Depth Stop System: The Midas Rex "" Legend" depth stop attachment and tools are indicated for the incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

IX. Identification of Legally Marketed Devices (Predicate Devices): Stealth Autoguide "System:

Predicate: K151359 – ROSA Brain, manufactured by MEDTECH S.A Reference Devices: K131433 - iSYS1, manufactured by ISYS Reference Devices: K162309 - StealthStation S8 Cranial, manufactured by Medtronic Navigation, Inc. Reference Devices: K162604 - Cranial Reducing Tubes, manufactured by Medtronic Navigation, Inc.

Midas Rex "" Legend "" Depth Stop System:

Predicate: K170312. K163182 – Midas Rex Legend Electric and Pneumatic Drill Systems, manufactured by Medtronic Powered Surgical Systems.

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X. Summary of the Technological Characteristics:

Stealth AutoguideTM System
Item	Subject Device	Predicate Devices
General Description	Computer controlledelectromechanical multi-jointed arm for use as astereotactic instrument	Predicate: ROSA Brain(K151359)Computer controlledelectromechanical multi-jointed arm for use as astereotactic instrument
Product Code	HAW	Predicate: ROSA Brain(K151359) HAW
Intended Use/Indications for Use	The Stealth AutoguideTMSystem is a positioning andguidance system intended forthe spatial positioning andorientation of instrumentholders or tool guides to beused by neurosurgeons toguide standard neurosurgicalinstruments, based on a pre-operative plan and feedbackfrom an image-guidednavigation system with three-dimensional imaging software.The Stealth AutoguideTMSystem is a remotely-operatedpositioning and guidancesystem, indicated for anyneurological condition inwhich the use of stereotacticsurgery may be appropriate(for example, stereotacticbiopsy, stereotactic EEG, lasertissue ablation, etc.).	Predicate: ROSA Brain(K151359)Intended for the spatialpositioning and orientation ofinstrument holders or toolguides to be used byneurosurgeons to guidestandard neurosurgicalinstruments (biopsy needle,stimulation or recordingelectrode, endoscope). Thedevice is indicated for anyneurosurgical procedure inwhich the use of stereotacticsurgery may be appropriate.Reference Device: iSYS1 (K131433)The iSYS 1 device is intendedto assist the surgeon in thepositioning of a needle orelectrode where bothcomputed tomography (CT)and fluoroscopic imaging can
Item	Subject Device	Predicate Devices
		be used for target trajectoryplanning and intraoperativetracking. The needle orelectrode is then manuallyadvanced by the surgeon.Trajectory planning is madewith software that is not partof the iSYS device.
Operating Principle	Preoperative images(StealthStation)Surgical planning(StealthStation)Patient registrationGuidance of instruments	Reference Device: iSYS1 (K131433)Preoperative images (thirdparty)Surgical planning (third party)Patient registrationGuidance of instruments
Localization Means	Optical markers on tool holder	Reference Device:Stealth S8 Cranial (K162309)Optical markers on tool holder
Image-Guided	Yes (on StealthStation)	Reference Device: iSYS1 (K131433)Yes
Planning Software	Compatible with:S8 Cranial v1.1Synergy Cranial v.3.1	Reference Device:Stealth S8 Cranial (K162309)S8 Cranial v1.2
System AccuracyRequirement	Under representative worst-case configuration, theStealthStation® System withCranial Software used withStealth AutoguideTM System,has demonstrated performancein 3D positional accuracy witha mean error ≤ 2.0 mm and intrajectory angle accuracy witha mean error ≤ 2.0 degrees.	Reference Device:Stealth S8 Cranial (K162309)Under representative worst-case configuration, theStealthStation® System S8with StealthStationTM Cranialv1.0.0 Software, hasdemonstrated performance in3D positional accuracy with amean error ≤ 2.0 mm and intrajectory angle accuracy witha mean error ≤ 2.0 degrees.
Instrumentation	Navigated Trajectory GuideTool Holders (Drill Guides,Reducing Tubes)Height GuidesTapping Tube	Reference Device:Cranial Reducing Tubes(K162604)Navigated Trajectory GuideTool Holders (Drill Guides,Reducing Tubes
Item	Subject Device	Predicate Devices
Instrument Fixation	Special tool holders for different applications mounted to the Stealth Autoguide	Height GuidesTapping TubeReference Device: iSYS1 (K131433)Special tool holders for different applications mounted to the device
Guide PositionAdjustment	Robotic movement	Predicate: ROSA Brain(K151359)Automatic (Robotized)
Accessories	Sterile DrapesHead Frame AdapterCable Sets	Reference Device: iSYS1 (K131433)Sterile DrapesTable AdaptersCable Sets
Real-Time InstrumentPosition	Yes (on StealthStation)	Reference Device: iSYS1 (K131433)Yes
Patient Registration	Optical Registration Device(via StealthStation)	Reference Device:Stealth S8 Cranial (K162309)Optical Registration Device(via StealthStation)
Surgeon Performs FinalInstrument Deliverythrough InstrumentGuide	Yes	Reference Device: iSYS1 (K131433)Yes

Stealth Autoguide TM System

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Feature/Attribute	SubjectDevicesMidasRex™Legend™DepthStop	Electric DrillExpanded Indications(K170312)	Pneumatic DrillExpanded Indications(K163182)
Product Code	HBC, HBB,HBE	HBE, HBC, HRX,HWE, EQJ, ERL, KFK	KFK, HBB, ERL, EQJ, HSZ,GET, KFK, HBE, DWH
Intended Use	Incision,cutting,removing,and drillingof soft andhard tissue	Incision/ cutting,removal, drilling, andsawing of soft and hardtissue, bone, andbiomaterials.	Incision/ cutting, removal,drilling, and sawing of soft andhard tissue, bone, andbiomaterials.
Indicationsfor use	The MidasRex LegendDepth Stopattachmentand toolsareindicatedfor theincision,cutting,removing,and drillingof soft andhard tissueduringcranialsurgicalprocedureswith theintent tocreate a holethrough thecranium toallowsurgeonsaccess todesiredsurgicallocationsand/or to	The Medtronic ElectricDrill System is indicatedfor the incision/cutting,removal, drilling, andsawing of soft and hardtissue, bone, andbiomaterials inNeurosurgical (Cranial,Craniofacial) includingcraniotomy; as well asEar, Nose and Throat(ENT), Orthopedic,Arthroscopic, Spinal,and General SurgicalProcedures includingMaxillofacial,Craniofacial andSternotomy Surgeries.Additionally, theElectric Drill System isindicated for theincision / cutting,removal, drilling, andsawing of soft and hardtissue, bone, andbiomaterials duringopen and minimallyinvasive spineprocedures, which mayincorporate application	The Medtronic Pneumatic DrillSystem is indicated for theincision/cutting, removal,drilling, and sawing of soft andhard tissue, bone, andbiomaterials in Neurosurgical(Cranial, Craniofacial)including craniotomy; as wellas Ear, Nose and Throat (ENT),Orthopedic, Arthroscopic,Spinal, and General SurgicalProcedures includingMaxillofacial, Craniofacial andSternotomy Surgeries.Additionally, the PneumaticDrill System is indicated for theincision / cutting, removal,drilling, and sawing of soft andhard tissue, bone, andbiomaterials during open andminimally invasive spineprocedures, which mayincorporate application ofvarious surgical techniquesduring the following lumbarspinal procedures:• Lumbar Microdiscectomy• LumbarStenosis
Feature/Attribute	SubjectDevicesMidasRex™Legend™DepthStop	Electric DrillExpanded Indications(K170312)	Pneumatic DrillExpanded Indications(K163182)
	facilitateinsertion,placementof othersurgicaldevicesduring suchprocedures.	of various surgicaltechniques during thefollowing lumbar spinalprocedures:• LumbarMicrodiscectomy• LumbarStenosisDecompression• PosteriorLumbarInterbodyFusion (PLIF)• TransforaminalLumbarInterbodyFusion (TLIF)	• Posterior LumbarInterbody Fusion (PLIF)• TransforaminalLumbar InterbodyFusion (TLIF)• Anterior LumbarInterbody Fusion (ALIF)• Direct LateralInterbody Fusion(DLIF)
GeneralSystemComponents	Attachment,SurgicalDissectingTool	Electric Handpiece,Attachments, SurgicalDissecting Tools,System Accessories	Pneumatic Handpiece,Attachments, SurgicalDissecting Tools, SystemAccessories
PatientContactingComponents	Attachmentand SurgicalDissectingTools	Attachments andSurgical DissectingTools	Attachments and SurgicalDissecting Tools
Materials ofPatientContactingComponents	Attachment- StainlessSteel,Phenolic,Chevron	Attachments - StainlessSteel, Aluminum,Ceramic, Phenolic,Epoxy, Chrome CoatedBrass, Torlon 4301	Attachments - Stainless Steel,Aluminum, Ceramic, Phenolic,Epoxy, Chrome Coated Brass,Polymeric
	SRI Grease2SurgicalDissectingTools -ToolSteel	Dissecting Tools:Stainless Steel, ToolSteel, Alloy Steel,Carbide, TDC Coating,Diamond Coating in	Dissecting Tools: StainlessSteel, Tool Steel, Alloy Steel,Carbide, TDC Coating,Diamond Coating in NickelSubstrate, Titanium Nitride
Feature/Attribute	SubjectDevicesMidasRex™Legend™DepthStop	Electric DrillExpanded Indications(K170312)	Pneumatic DrillExpanded Indications(K163182)
		Nickel Substrate,Titanium Nitride
SurgicalDissectingTools - TipStyle	Twist Drill	Round/Acorn, MatchHead, Ball, Cylinder,Oval, Tapered/SideCutting, MetalCutting, Twist Drill,Hole Maker/Saw,	Round/Acorn, Match Head,Ball, Cylinder, Oval,Tapered/Side Cutting, MetalCutting, Twist Drill, HoleMaker/Saw, Reverse Tapered
SurgicalDissectingTool -OverallLength	SurgicalDissectingTool:6.7-8.7cm	Surgical DissectingTool:3-42cm	Surgical Dissecting Tool:3-42cm
SurgicalDissectingTool - HeadDiameter	SurgicalDissectingTool:2.5 - 7.5mm	Surgical DissectingTool:0.5-25mm	Surgical Dissecting Tool:0.5-25mm
AttachmentConfiguration	Depth Stop	Straight, Angled,Footed, Contra Angled,Right Angled, MetalCutting, Depth limitingDrill Guides, Perforator,Jacob ChuckAttachments, Wire/PinCollet Attachments	Straight, Angled, Footed,Contra Angled, Right Angled,Metal Cutting, Depth limitingDrill Guides, Perforator, JacobChuck Attachments, Wire/PinCollet Attachments
AttachmentLength	ASDS0113.7cm -14.8cm in1mmincrements	2-40cm	2-40cm
Drill SystemOperatingPrinciple	Electricpowered byIPC andPneumaticpowered byPneumaticPressure	Electric powered by IPC	Pneumatic powered byPneumatic Pressure
Feature/Attribute	SubjectDevicesMidasRexTMLegend™DepthStop	Electric DrillExpanded Indications(K170312)	Pneumatic DrillExpanded Indications(K163182)
Packaging -Single UseDissectingTools	TheSurgicalDissectingTools areindividuallypackaged ina Propionatecellulosicplasticcapped tubeand sealedwithin a 4mil PET-Nylon-HDPE Co-Ex (PeelSeal)/4 milPET-Nylon-EVA Pouch.	The Surgical DissectingTools are individuallypackaged in aPropionate cellulosicplastic capped tube andsealed within a 4 milPET-Nylon-HDPE Co-Ex (Peel Seal)/4 milPET-Nylon-EVAPouch.	The Surgical Dissecting Toolsare individually packaged in aPropionate cellulosic plasticcapped tube and sealed within a4 mil PET-Nylon-HDPE Co-Ex(Peel Seal)/4 mil PET-Nylon-EVA Pouch.
Sterilization	SurgicalDissectingTools aresuppliedGammaSterilizedNon-sterile,Attachments	Surgical DissectingTools are suppliedGamma Sterilized;- Electric Handpieces,and Attachments aresupplied Non-Sterileand require cleaning andsterilization prior toeach surgical use:- Electric Foot ControlUnit, and SystemAccessories are suppliedNon-Sterile.	Surgical Dissecting Tools aresupplied Gamma Sterilized;- Pneumatic Handpieces, andAttachments are supplied Non-Sterile and require cleaning andsterilization prior to eachsurgical use;- Pneumatic Foot Control Unit,and System Accessories aresupplied Non-Sterile.
Shelf Life	5 years forSurgicalDissectingTools	5 years for SurgicalDissecting Tools	5 years for Surgical DissectingTool

Midas Rex™ Legend™ Depth Stop System:

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XI. Discussion of the Performance Testing:

Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the Stealth Autoguide TM System and Midas Rex TM Legend TM Depth Stop System to establish substantial equivalence of the system and verify that the device will perform as intended meeting all the design inputs:

AAMI/ANSI ES 60601-1:2012 Medical Electrical Equipment Part 1:General . Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General . requirements for safety; Electromagnetic Compatibility - Requirements andTests
Software Verification and Validation testing verifying the operating system ● software requirements are met and software performs as intended
Hardware Verification testing ensuring the hardware requirements identified for ● the system are met and hardware performs as intended
Usability Testing was conducted in accordance to IEC 62366 demonstrating that . the usability and human factors requirements were adequately met.

The following table summarizes the testing conducted on the Stealth Autoguide™ System when used with the StealthStation 100 System and Stealth Cranial Software

Description

Under representative worst-case configuration, the Stealth Autoguide™ System when used with the StealthStation™ System utilizing Stealth Cranial Software, has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error < 2.0 degrees. The performance was determined using overall end-to-end worst-case system level accuracy testing which incorporated clinically relevant anatomical phantoms.

To exercise the performance and impact of the Stealth Autoguide™ System utilizing Stealth Cranial software, four distinct end-to-end worst-case configuration pathways were identified. The following table summarizes the performance of the Stealth Autoguide™ System when used with the StealthStation™ System (S7 and S8) utilizing Stealth Cranial Software with Biopsy and sEEG bolts/Visualase.

Performance Validation	Positional Error (mm)			Trajectory Angle Error (degrees)
	Mean	Standard Deviation	99% CI* Upper	Mean	Standard Deviation	99% CI* Upper
Biopsy Needle Accuracy Validation-StealthStation S7	0.92	0.47	3.03	1.22	0.51	2.41
Biopsy Needle Accuracy Validation-StealthStation	0.97	0.26	1.70	0.59	0.23	1.11

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S8
sEEGbolts/VisualaseAccuracyValidation-StealthStationS7	1.50	0.68	3.08	1.04	0.76	2.81
sEEG bolts/VisualaseAccuracyValidation-StealthStationS8	1.48	0.48	2.60	0.42	0.17	0.82
*CI (confidence interval)

The following tables summarize the biocompatibility studies Medtronic sponsored on the Midas Rex Legend Depth Stop System and Stealth Autoguide Surgical Instruments.

Cytotoxicity, sensitization, intracutaneous reactivity and material-mediated pyrogenicity studies were conducted on the extractables and leachables (E&L) of representative Midas Rex Legend Depth Stop System Attachment and Tools (ASDS01 and DS1TD75), as well as Stealth Autoguide Surgical Instruments (28324). A toxicological risk assessment was also performed. The Midas Rex Legend Depth Stop Attachment (ASDS01) is the only attachment for the Midas Rex Legend Depth Stop System and thus, does not represent any other devices. The 7.5mm Depth Stop Twist Drill Tool (DS1TD75) is representative of all Midas Rex Legend Depth Stop Tools. The Visualase Drill Guide (28324) is representative of all Stealth Autoguide Surgical Instruments.

Test	Results	Conclusions
Chemical characterization –Extractables and Leachables(polar and nonpolar)Toxicological RiskAssessment	All MOS > 1.0,All HI < 1.0	Non-toxic
Cytotoxicity – ISO MEMElution	% Rounding – 0;% w/o IntracytoplasmicGranules – 0;% Lysis – 0;Grade – 0Reactivity – None.	Non-cytotoxic
Sensitization – 2 solvents	Dermal Reaction Scores 24-hr control, test; 48-hrcontrol, test)SC Extract: 0, 0;SO Extract: 0, 0	Non-sensitizing
Intracutaneous Reactivity/Irritation – 2 solvents	Overall Erythema & EdemaMean Difference (Test -Control)SC Extract = 0;SO Extract = 0	Non-irritating

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Material-mediatedPyrogenicity	DS1TD75Individual Rise (°C): 0.3,0.0, 0.0Total Rise (°C): 0.3	Non-pyrogenic
	ASDS01Individual Rise (°C): 0.2,0.3, 0.1Total Rise (°C): 0.6
	28324Individual Rise (°C): 0.1,0.2, 0.1Total Rise (°C): 0.4

Material-mediated pyrogenicity testing and an additional hemolysis characterization test were sponsored on the Stealth Autoguide Burr Hole Reducing Tube (28334). The Stealth Autoguide Burr Hole Reducing Tube (28334) is representative for all Stealth Autoguide Reducing Tubes.

Test	Results	Conclusions
Material-mediatedPyrogenicity	Temp., °C, Rise (1, 1.5, 2,2.5, 3 hr)0, 0.1, 0, 0, 0.2	Non-pyrogenic
Hemolysis (extract)	Diluted blood Abs: 0.380 –0.397;Direct Contact HemolyticIndex: 1.2%;Extract - Hemolytic Index:0.2%	Non-hemolytic

ХП. Conclusions:

The Stealth Autoguide™ System, Instrumentation and Midas Rex™ Legend™ Depth Stop System have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.

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).