(226 days)
The StealthStation™ System, with Station™ Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures ):
- · Tumor resections
- · General ventricular catheter placement
- · Pediatric ventricular catheter placement
- · Depth electrode, lead, and probe placement
- · Cranial biopsies
The user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
The StealthStation™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The StealthStation™ S8 System, with StealthStation™ Cranial v1.0.0 software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation™ Cranial v1.0.0 software (cranial software) works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image quidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. During surgery, positions of specialized surgical instruments are continuously updated on these images either by optical tracking or electromagnetic tracking.
Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.
Here's a breakdown of the acceptance criteria and study information for the StealthStation™ S8 System with StealthStation™ Cranial software, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 3D Positional Accuracy: Mean Error ≤ 2.0 mm | Optical Localization: Mean Error = 1.45 mmEM Localization: Mean Error = 0.84 mmMechanical Localization: Mean Error = 1.48 mm |
| Trajectory Angle Accuracy: Mean Error ≤ 2.0 degrees | Optical Localization: Mean Error = 0.60 degreesEM Localization: Mean Error = 0.47 degreesMechanical Localization: Mean Error = 0.39 degrees |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not explicitly state the numerical sample size for the test set used in the accuracy validation. It mentions "anatomically representative phantoms" and "a subset of system components and features that represent the worst-case combinations."
- Data Provenance: The testing was conducted in "laboratory and simulated use settings" and involved "anatomically representative phantoms." This indicates that the data is synthetic/simulated (phantom-based) rather than from human subjects. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying potentially U.S.-based testing or at least testing compliant with U.S. regulations. The study is prospective in nature, as it's a validation study for a new device.
3. Number and Qualifications of Experts for Test Set Ground Truth
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. Given the use of "anatomically representative phantoms," the ground truth likely refers to precisely engineered and measured targets within these phantoms, rather than clinical consensus among medical experts.
4. Adjudication Method for Test Set
The document does not specify an adjudication method. For phantom-based accuracy testing, adjudication by human experts is typically not required as the ground truth is pre-defined by the phantom design and precision measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document states, "Clinical testing was not considered necessary prior to release as this is not new technology." This indicates that the study focused on the device's standalone performance and equivalence to existing technology, not on its comparative effectiveness when used by human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone (algorithm only) performance study was done. The entire "Discussion of the Performance Testing" section details the accuracy validation of the device itself (StealthStation™ S8 System with StealthStation™ Cranial Software) using phantoms. This is fundamentally a standalone evaluation of the system's ability to achieve positional and trajectory accuracy.
7. Type of Ground Truth Used
The ground truth used was based on precisely measured targets within anatomically representative phantoms. This is a form of engineered or physical ground truth, not clinical ground truth derived from pathology, expert consensus, or outcomes data, as no clinical testing was performed.
8. Sample Size for Training Set
The document does not provide any information regarding a training set sample size. This type of device (stereotaxic instrument and navigation software) relies on geometric accuracy, image processing, and registration algorithms rather than machine learning models that typically require large training datasets with explicit ground truth labels in the same way, for example, an image classification AI would. Its functionality is based on established principles of image-guidance and tracking.
9. How Ground Truth for Training Set Was Established
As no training set is discussed or implied to be used for machine learning-based model training, there is no information on how a training set ground truth was established. The system's underlying algorithms are likely deterministic or based on classical computer vision/image processing, rather than requiring a labeled training set in the AI sense.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2017
Medtronic Navigation, Inc. Tia Fushimi-Bain Sr Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K162309
Trade/Device Name: Stealthstation S8 System Platforms and StealthStation Cranial Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, OLO, PGW Dated: August 16, 2016 Received: August 17, 2016
Dear Ms. Fushimi-Bain:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K162309
Device Name
StealthStation S8 System with StealthStation Cranial software
Indications for Use (Describe)
The StealthStation™ System, with Station™ Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and
stereotactic frame alternatives-based procedures ):
- · Tumor resections
- · General ventricular catheter placement
- · Pediatric ventricular catheter placement
- · Depth electrode, lead, and probe placement
- · Cranial biopsies
The user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
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)
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K162309
Device Name StealthStation S8 System Platform
Indications for Use (Describe)
The StealthStation™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
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!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
{4}------------------------------------------------
510(k) Summary
March 31, 2017
- l. Company: Medtronic Navigation. Inc. 826 Coal Creek Circle Louisville, CO 80027 Telephone Number: (720) 890-3200
- Contact: Tia Fushimi-Bain Senior Regulatory Affairs Specialist Telephone number: (720) 890-2178 Fax: (763) 367-2075 Email: tia.k.fushimi-bain@medtronic.com
Elizabeth Waite Senior Regulatory Affairs Specialist Telephone number: (720) 890-2182 Fax: (720) 890-3500 Email: elizabeth.waite@medtronic.com
- ll. Proprietary Trade Name: StealthStation™ S8 Platform with StealthStation™ Cranial Software
- lll. Common Name: Stereotaxic Instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- Classification: Class II V.
- VI. Product Code: HAW
- VII. Product Description: The StealthStation™ S8 System, with StealthStation™ Cranial v1.0.0 software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation™ Cranial v1.0.0 software (cranial software) works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image quidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. During surgery, positions of specialized surgical instruments are continuously updated on these images either by optical tracking or electromagnetic tracking.
Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.
VIII. Indications for Use:
The StealthStation™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation™ System is
{5}------------------------------------------------
indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The StealthStation™ System, with Station™ Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):
- · Tumor resections
- · General ventricular catheter placement
- · Pediatric ventricular catheter placement
- · Depth electrode, lead, and probe placement
- · Cranial biopsies
The user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.
IX. Identification of Leqally Marketed Devices (Predicate Devices):
K153660 - Synergy Cranial 3.0 Software K050438 - StealthStation™ System Update K133444 - StealthStation™ System Update
X. Comparison of the Technological Characteristics:
| Item | Subject Device | Software Predicate | Platform Predicate |
|---|---|---|---|
| Intended Use | Cranial SoftwareThe StealthStation®System, withStealthStation® Cranialsoftware is designed as anaid for locating anatomicalstructures in either open orpercutaneousneurosurgical procedures. | K153660, SynergyCranial 3.0 SoftwareThe StealthStation®System, withStealthStation® Cranialsoftware is designed as anaid for locating anatomicalstructures in either open orpercutaneousneurosurgical procedures. | K050438,StealthStation™System UpdateThe StealthStation™System is intended asan aid for preciselylocating anatomicalstructures in eitheropen or percutaneousprocedures. |
| StealthStation S8PlatformThe StealthStation®System is intended as anaid for precisely locatinganatomical structures ineither open orpercutaneous surgicalprocedures. | |||
| Item | Subject Device | Software Predicate | Platform Predicate |
| Indications forUse | The StealthStation™System, withStealthStation™ Cranialsoftware, is intended as anaid for locating anatomicalstructures in either open orpercutaneousneurosurgical procedures.Their use is indicated forany medical condition inwhich the use ofstereotactic surgery maybe appropriate, and wherereference to a rigidanatomical structure, suchas the skull, can beidentified relative to imagesof the anatomy.This can include, but is notlimited to, the followingcranial procedures(including stereotacticframe-based andstereotactic framealternatives-basedprocedures):Tumor resectionsGeneral ventricularcatheter placementPediatric ventricularcatheter placementDepth electrode, lead, andprobe placementCranial biopsiesThe user should consultthe "NavigationalAccuracy" section of theUser Manual to assess ifthe accuracy of the systemis suitable for their needs. | K153660, SynergyCranial 3.0 SoftwareThe StealthStation®System, withStealthStation® Cranialsoftware, is intended to aidin locating anatomicalstructures in either open orpercutaneousneurosurgical procedures.The system is indicated forany medical condition inwhich reference to a rigidanatomical structure canbe identified relative toimages of the anatomy.This can include, but is notlimited to, the followingcranial procedures(including stereotacticframe-based andstereotactic framealternatives-basedprocedures):- Cranial Biopsies(includingstereotactic)- Deep brain stimulation(DBS)lead placement- Depth electrodeplacement- Tumor ResectionsCraniotomies/Craniectomies- Skull Base Procedures- TranssphenoidalProceduresThalamotomies/Pallidotomies- Pituitary Tumor Removal- CSF Leak Repair- Pediatric VentricularCatheter Placement- General VentricularCatheter Placement | K050438,StealthStation™System UpdateThe StealthStation™System is intended asan aid for preciselylocating anatomicalstructures in eitheropen or percutaneousprocedures. TheStealthStation™System is indicated forany medical conditionin which the use ofstereotactic surgerymay be appropriate,and where reference toa rigid anatomicalstructure, such as theskull, a long bone, orvertebra, can beidentified relative to aCT or MR based model,fluoroscopy images, ordigitized landmarks ofthe anatomy. |
| SystemAccuracyRequirement | Under representativeworst-case configuration,the StealthStation S8System with StealthStationCranial v1.0.0 Software, | K153660, SynergyCranial 3.0 SoftwareUnder representativeworst-case configuration,the StealthStation® | Not Applicable |
| Item | Subject Device | Software Predicate | Platform Predicate |
| has demonstratedperformance in 3Dpositional accuracy with amean error $\leq$ 2.0 mm andin trajectory angleaccuracy with a mean error$\leq$ 2.0 degrees. | System withStealthStation® Cranialv3.0 Software, hasdemonstratedperformance in 3Dpositional accuracy with amean error $\leq$ 2.0 mm andin trajectory angleaccuracy with a meanerror $\leq$ 2.0 degrees. | ||
| ImagingModalities | X-Ray based, MR based,Nuclear Medicine based | K153660, SynergyCranial 3.0 SoftwareX-Ray based, MR based,Nuclear Medicine based | Not Applicable |
| View (Display)Features | Ultrasound Video In,Ultrasound Overlay,3D, 2D AnatomicOrthogonal,Trajectory 1 and 2, TargetGuidance, TrajectoryGuidance, Probes Eye,Look Ahead, MicroscopeInjection, Video Input,Endoscopic | K153660, SynergyCranial 3.0 SoftwareUltrasound Video In,Ultrasound Overlay,3D, 2D AnatomicOrthogonal,Trajectory 1 and 2, TargetGuidance, TrajectoryGuidance, Probes Eye,Look Ahead, MicroscopeInjection,Video Input | Not Applicable |
| Exam-to-ExamRegistrationFeatures | Identity MergeRegistration, ManualMerge Registration andAutomatic MergeRegistration | K153660, SynergyCranial 3.0 SoftwareIdentity MergeRegistration, ManualMerge Registration andAutomatic MergeRegistration. | Not Applicable |
| PatientRegistrationFeatures | PointMerge® registration(referred to as Landmarkregistrations), Tracer™registration, Touchregistration (previouslyTouch-N-Go™),StealthAiR® registration,O-arm® registration,Mechanical basedregistrations (StereotacticLocalizer Registration andStarFix™ Bone AnchorRegistration) | K153660, SynergyCranial 3.0 SoftwarePointMerge® registration,Tracer™ registration,Touch-N-Go™registration, StealthAiR®registration, O-arm®registration, StereotacticLocalizer Registration andStarFix™ Bone AnchorRegistration | Not Applicable |
| PlanningFeatures | Plan Entry and TargetSelection3D Model BuildingAdvanced Visualization | K153660, SynergyCranial 3.0 SoftwarePlan Entry and TargetSelection3D Model BuildingAdvanced Visualization | Not Applicable |
| Item | Subject Device | Software Predicate | Platform Predicate |
| Create Patient BasedAnatomical CoordinateSpaceStereotactic FrameSettingsBrain Atlas:Schaltenbrand-WahrenAtlas with Talairach GridSTarFix™ DesignerAnnotations | Create Patient BasedAnatomical CoordinateSpaceStereotactic FrameSettingsBrain Atlas:Schaltenbrand-WahrenAtlas with Talairach GridSTarFix™ DesignerAnnotations | ||
| Medical DeviceInterfaces | Microscope Navigation:Zeiss, LeicaUltrasound Navigation:Aloka and SonositeMedtronic O-arm®Stereotactic FrameSystems: Fischer ZD,Fischer RM, Integra CRWand Elekta LeksellNexframe® StereotacticSystemSTarFix™Platform System | K153660, SynergyCranial 3.0 SoftwareMicroscope Navigation:Zeiss, LeicaUltrasound Navigation:Aloka and SonositeMedtronic O-arm®Stereotactic FrameSystems: Fischer ZD,Fischer RM, Integra CRWand Elekta LeksellNexframe® StereotacticSystemSTarFix™Platform System | Not Applicable |
| CompatibleMedtronicOpticalInstrumentation | Medtronic instrumentstracked via optical markersor LEDs located oninstrument and patienttrackers via the opticallocalizing system. | K153660, SynergyCranial 3.0 SoftwareMedtronic instrumentstracked via optical markersor LEDs located oninstrument and patienttrackers via the opticallocalizing system | K050438StealthStation™System UpdateStealthStation S7supports opticalinstrumentationcompatible withStealthStation softwarevia optical localization. |
| CompatibleMedtronic EMInstrumentation | Medtronic instrumentstracked viaelectromagneticlocalization technologylocated within theinstrument and patienttrackers | K153660, SynergyCranial 3.0 SoftwareMedtronic instrumentstracked viaelectromagneticlocalization technologylocated within theinstrument and patienttrackers | K050438StealthStation™System UpdateStealthStation S7supports EMinstrumentationcompatible withStealthStation softwarevia EM localization. |
| SoftwareInterface (GUI) | Black and gray style withprocedure task overview inleft menu option andnext/back task flow atbottom of the screen.Software controls forimages, planning andinstrument managementare contained in a rightside bar. | K153660, SynergyCranial 3.0 SoftwareBlue style withchronological next/backtask flow at the top of thescreen. Image controls onthe left. Planninginformation on the right. | Not Applicable |
| Item | Subject Device | Software Predicate | Platform Predicate |
| ProgrammingLanguage | C++ | K153660, SynergyCranial 3.0 SoftwareC++ | Not Applicable |
| ScannerInterfaceTechnology (toimagingdevices) | Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export | K153660, SynergyCranial 3.0 SoftwareNetwork ConnectivityCD, DVD, USBDICOM ImportDICOM Export | Not Applicable |
| OpticalTechnology | Manufacturer: Identical(Northern Digital Inc.)Localizer: Vega | K153660, SynergyCranial 3.0 SoftwareOptical (infra-red) | K050438,StealthStation™System UpdateManufacturer: NorthernDigital Inc.Localizer: Polaris |
| ElectromagneticTechnology | Manufacturer: Identical(Medtronic Navigation,Inc.)Localizer: AxiEM IIIEmitter Types: Side, Flat | K153660, SynergyCranial 3.0 SoftwareElectromagneticMechanical basedstereotactic | K050438,StealthStation™System UpdateManufacturer:Medtronic Navigation,Inc.Localizer: AxiEMEmitter Types: Side |
| Computer | Intel-based PC | Not Applicable | K050438,StealthStation™System UpdateIntel-based PC |
| RFID Reader | Capability added tosystem. Functionality notyet available with thisrelease | Not Applicable | Not Available |
| NetworkConnectivity | Connection Type:Standard Ethernet2.4gHz and 5.0 gHzWireless connection | Not Applicable | K050438,StealthStation™System UpdateConnection Type:Standard EthernetConnection and modemconnection |
| Remote ServiceConnectivity | Remote service accessproviding capability forsecure remote desktopservice over high speedconnection (BrandedRemote Presence) | Not Applicable | Not Available |
| OperatingSystem | Linux-based: Ubuntu | Not Applicable | K133444,StealthStation™ S7,i7, FusionDebian Linux |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
XI. Discussion of the Performance Testing
{10}------------------------------------------------
Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the StealthStation™ S8 Platforms to establish substantial equivalence of the system and verify that the device will perform as intended meeting all of the design inputs:
- . AAMI/ANSI ES 60601-1:2012 - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (JEC 60601-1:2005, MOD)
- . IEC 60601-1-2:2007 - Medical Electrical Equipment - Part 1-2: General requirements for safety; Electromagnetic Compatibility - Requirements and Tests
- . 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 FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" demonstrating that the usability and human factors requirements were adequately met.
The following table summarizes the testing conducted on the StealthStation™ S8 System with StealthStation™ Cranial v1.0.0 Software:
Description
Under representative worst-case configuration, the StealthStation™ S8 System with StealthStation™ 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. This performance was determined using anatomically representative phantoms and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components in a clinically relevant workflow.
There were three distinct end-to-end worst-case configuration pathways identified for the localization types (optical, electromagnetic and mechanical) in StealthStation™ Cranial software. The test configurations included CT images with slice spacing and thickness of 1.25 mm and T2-weighted MR images with slice spacing and thickness of 1.0 mm. In the imaging protocol, we recommend slice spacing and thickness for CT and MR imaging to be 1.0 mm or less. The following table summarizes the performance of the StealthStation™ S8 System using StealthStation™ Cranial software with optical, electromagnetic (EM) and mechanical localization.
| Performance Validation | Positional Error (mm) | Trajectory Angle Error (degrees) | ||||
|---|---|---|---|---|---|---|
| Mean | Standard Deviation | 99% CI* Upper | Mean | Standard Deviation | 99% CI* Upper | |
| Cranial S8 System with Optical Localization Performance Validation | 1.45 | 0.67 | 3.02 | 0.60 | 0.32 | 1.68 |
{11}------------------------------------------------
| Cranial S8System with | 0.84 | 0.37 | 1.69 | 0.47 | 0.25 | 1.24 | |||
|---|---|---|---|---|---|---|---|---|---|
| EM | |||||||||
| LocalizationPerformance | |||||||||
| Validation | |||||||||
| Cranial S8 | 1.48 | 0.47 | 2.58 | 0.39 | 0.31 | 1.12 | |||
| System with | |||||||||
| Mechanical | |||||||||
| Localization | |||||||||
| Performance | |||||||||
| Validation | |||||||||
| *CI (confidence interval) | |||||||||
| Software verification and validation testing for each requirement specification. | |||||||||
| Design verification and validation was performed using the StealthStation™ S8 | |||||||||
| System with the StealthStation™ Cranial software in laboratory and simulated | |||||||||
| use settings. The results support the safety of the device and demonstrate that | |||||||||
| the software should perform as intended in the specified use conditions. | |||||||||
| System integration performance testing for cranial surgical procedures using | |||||||||
| anatomical phantoms. |
The following table summarizes the quality assurance measures that were applied during development of the software component of the system:
| Description |
|---|
| Software Development Life Cycle |
| Software Risk Assessment |
| Software Configuration Management and Version Control |
Design verification and validation was performed using the StealthStation™ S8 System with StealthStation™ Cranial software in laboratory and simulated use settings. The results support the safety of the device and demonstrate that the software should perform as intended in the specified use conditions.
Clinical testing was not considered necessary prior to release as this is not new technology.
XII.Conclusions
The StealthStation™ S8 Platforms with Station™ Cranial software have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.
§ 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).