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K Number
K212397
Device Name
StealthStation S8 Cranial v2.0
Manufacturer
Medtronic Navigation
Date Cleared
2021-12-22

(142 days)

Product Code
HAW
Regulation Number
882.4560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StealthStation System, with StealthStation 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
Device Description
The StealthStation™ Cranial Software v2.0 works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, 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. The changes to the currently cleared StealthStation™ S8 Cranial Software are as follows: - Addition of white matter tractography (WMT) fiber tract creation for the brain referred to as diffusion Magnetic Resonance Imaging (dMRI) tractography. dMRI tractography will process diffusion-weighted MRI data into 3D fiber tract models that represent whitematter tracts. This will be marketed as a software option called Stealth™ Tractography. - Addition of the Medtronic SenSight™ directional DBS lead to the existing list of view overlays. - Minor changes to the software were made to address user preferences and to fix minor anomalies.
More Information

K203639

StealthViz™ Advanced Planning Application with StealthDTI™ Package, K081512

No
The summary describes image processing for dMRI tractography but does not mention the use of AI or ML algorithms for this or any other function.

No.
The device is an image-guided surgery system intended as an aid for locating anatomical structures during neurosurgical procedures. It does not directly provide therapy but rather assists the surgeon in performing therapeutic procedures.

No.

The device is an image-guided system intended as an aid for locating anatomical structures during neurosurgical procedures. It tracks the position of instruments relative to surgical anatomy using diagnostic or intraoperative images but does not diagnose medical conditions itself. It is a surgical navigation tool, not a diagnostic one.

No

The device description explicitly states that the software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system, and platform/computer hardware. This indicates it is part of a larger hardware/software system, not a standalone software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
  • Device Intended Use: The StealthStation System with StealthStation Cranial software is intended as an aid for locating anatomical structures in neurosurgical procedures. It uses imaging data (MRI, X-Ray, Nuclear Medicine) to guide surgical instruments in relation to the patient's anatomy during surgery.
  • No Specimen Analysis: The device does not analyze specimens taken from the human body. It processes medical images and tracks the position of surgical instruments.

Therefore, the device's function and intended use fall outside the scope of In Vitro Diagnostics. It is a surgical navigation system.

N/A

Intended Use / Indications for Use

The StealthStation System, with StealthStation 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

Product codes (comma separated list FDA assigned to the subject device)

HAW

Device Description

The StealthStation™ Cranial Software v2.0 works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, 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.

The changes to the currently cleared StealthStation™ S8 Cranial Software are as follows:

  • Addition of white matter tractography (WMT) fiber tract creation for the brain referred to as diffusion Magnetic Resonance Imaging (dMRI) tractography. dMRI tractography will process diffusion-weighted MRI data into 3D fiber tract models that represent whitematter tracts. This will be marketed as a software option called Stealth™ Tractography.
  • Addition of the Medtronic SenSight™ directional DBS lead to the existing . list of view overlays.
  • Minor changes to the software were made to address user preferences and to fix ● minor anomalies.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray based, MR based, Nuclear Medicine based

Anatomical Site

Cranial / brain, skull

Indicated Patient Age Range

Normal and abnormal brains in both pediatric and adult populations

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Summative usability validation and clinical expert evaluation were performed by representative users on datasets not used for development, composed of normal and abnormal brains in both pediatric and adult populations.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Performance testing, Software verification and validation testing, Summative usability validation and clinical expert evaluation.
Sample Size: Not specified.
Key Results:

  • Under representative worst-case configuration, the StealthStation™ S8 System with StealthStation™ Cranial Software v2.0 has demonstrated performance in 3D positional accuracy with a mean error

§ 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).

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December 22, 2021

Medtronic Navigation Carey Brenner Sr. Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K212397

Trade/Device Name: StealthStation S8 Cranial v2.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: November 3, 2021 Received: November 5, 2021

Dear Carey Brenner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

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,

Adam D. Pierce, Ph.D. 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) K212397

Device Name StealthStation S8 Cranial v2.0

Indications for Use (Describe)

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

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510(k) Summary

  • l. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200
    • Contact: Carey Brenner (Primary) Senior Requlatory Affairs Specialist Telephone Number: 720.352.1146 Fax Number: 720,890,3500 Email: carey.j.brenner@medtronic.com

Rishi Sinha Director Requlatory Affairs Telephone number: 720.890.2485 Fax: 720.890.3500 Email: rishi.k.sinha@medtronic.com

  • II. Proprietary Trade Name: StealthStation S8 Cranial Software v2.0 Stealth Tractography
    1. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
  • IV. Classification: Class II, Stereotaxic Instrument
  • V. Product Codes: HAW

VI. Predicate Device

StealthStation™ S8 Cranial Software v1.3.2, K203639 Reference Device: StealthViz™ Advanced Planning Application with StealthDTI™ Package, K081512

VII. Product Description

The StealthStation™ Cranial Software v2.0 works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, 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.

The changes to the currently cleared StealthStation™ S8 Cranial Software are as follows:

  • Addition of white matter tractography (WMT) fiber tract creation for the brain referred to as diffusion Magnetic Resonance Imaging (dMRI) tractography. dMRI tractography will process diffusion-weighted MRI data into 3D fiber tract models that represent whitematter tracts. This will be marketed as a software option called Stealth™ Tractography.

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  • Addition of the Medtronic SenSight™ directional DBS lead to the existing . list of view overlays.
  • Minor changes to the software were made to address user preferences and to fix ● minor anomalies.

VIII. Indications for Use

The StealthStation™ System, with StealthStation™ 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

IX. Comparison of the Technological Characteristics

| Attribute | Subject Device
Cranial Software version 2.0 | Predicate Device
Cranial Software (K203639) |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The StealthStation™ System, with
StealthStation™ Cranial software is
designed as an aid for locating anatomical
structures in either open or percutaneous
neurosurgical procedures. | The StealthStation™ System, with
StealthStation™ Cranial software is
designed as an aid for locating anatomical
structures in either open or percutaneous
neurosurgical procedures. |
| Indications for
Use | The StealthStation™ System, with
StealthStation™ 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 StealthStation™ System, with
StealthStation™ 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 |
| System
Accuracy
Requirement | Under representative worst-case
configuration, the StealthStation™ S8
System with StealthStation™ Cranial v2.0
Software, has demonstrated performance
in 3D positional accuracy with a mean error
$\le$ 2.0 mm and in trajectory angle accuracy
with a mean error $\le$ 2.0 degree. | Under representative worst-case
configuration, the StealthStation™ S8
System with StealthStation™ Cranial
Software, has demonstrated performance
in 3D positional accuracy with a mean error
$\le$ 2.0 mm and in trajectory angle accuracy
with a mean error $\le$ 2.0° |
| Attribute | Subject Device
Cranial Software version 2.0 | Predicate Device
Cranial Software (K203639) |
| Imaging
Modalities | X-Ray based, MR based, Nuclear Medicine
based | X-Ray based, MR based, Nuclear Medicine
based |
| View (Display)
Features | Ultrasound Video In, Ultrasound Overlay,
3D, 2D Anatomic Orthogonal, Trajectory 1
and 2, Target Guidance, Trajectory
Guidance, Probes Eye, Look Ahead,
Microscope Injection, Video Input,
Endoscopic | Ultrasound Video In, Ultrasound Overlay,
3D, 2D Anatomic Orthogonal, Trajectory 1
and 2, Target Guidance, Trajectory
Guidance, Probes Eye, Look Ahead,
Microscope Injection, Video Input,
Endoscopic |
| Exam-to-Exam
Registration
Features | Identity Merge Registration, Manual Merge
Registration and Automatic Merge
Registration | Identity Merge Registration, Manual Merge
Registration and Automatic Merge
Registration |
| Patient
Registration
Features | PointMerge™ registration (referred to as
Landmark registrations),
Tracer™ registration,
Touch registration (previously
Touch-N-Go™),
StealthAiR™ registration,
O-arm™ registration,
Mechanical based registrations
(Stereotactic Localizer Registration and
StarFix™ Bone Anchor Registration) | PointMerge™ registration (referred to as
Landmark registrations),
Tracer™ registration,
Touch registration (previously
Touch-N-Go™),
StealthAiR™ registration,
O-arm™ registration,
Mechanical based registrations
(Stereotactic Localizer Registration and
StarFix™ Bone Anchor Registration) |
| Planning
Features | 3D Model Building, including fiber tracts
with Standard DTI and Enhanced CSD
techniques
Plan Entry and Target Selection
Advanced Visualization
Create Patient Based Anatomical
Coordinate Space
Stereotactic Frame Settings
Brain Atlas: Schaltenbrand- Wahren Atlas
with Talairach Grid
STarFix™ Designer Annotations | 3D Model Building (which includes DTI
fiber tracts imported from StealthViz)
Plan Entry and Target Selection
Advanced Visualization
Create Patient Based Anatomical
Coordinate Space
Stereotactic Frame Settings
Brain Atlas: Schaltenbrand- Wahren Atlas
with Talairach Grid
STarFix™ Designer Annotations |
| Medical Device
Interfaces | Microscope Navigation:
Zeiss, Leica
Ultrasound Navigation:
Aloka and Sonosite
Medtronic O-arm®
Stereotactic Frame
Systems: Fischer ZD,
Fischer RM, Integra CRW
and Elekta Leksell
Nexframe® Stereotactic
System
STarFix™Platform System | Microscope Navigation:
Zeiss, Leica
Ultrasound Navigation:
Aloka and Sonosite
Medtronic O-arm®
Stereotactic Frame
Systems: Fischer ZD,
Fischer RM, Integra CRW
and Elekta Leksell
Nexframe® Stereotactic
System
STarFix™Platform System |
| Compatible
Medtronic
Optical
Instrumentation | Medtronic instruments tracked via optical
markers or LEDs located on instrument
and patient trackers via the optical
localizing system. | Medtronic instruments tracked via optical
markers or LEDs located on instrument
and patient trackers via the optical
localizing system. |
| Attribute | Subject Device
Cranial Software with dMRI
Tractography | Predicate Device
Cranial Software (K203639) |
| Compatible
Medtronic EM
Instrumentation | Medtronic instruments tracked via
Electromagnetic localization technology
located within the instrument and patient
trackers | Medtronic instruments tracked via
Electromagnetic localization technology
located within the instrument and patient
trackers |
| Software
Interface (GUI) | Black and gray style with procedure task
overview in left menu option and next/back
task flow at bottom of the screen.
Software controls for images, planning and
instrument management and tractography
editing are contained in a right side bar. | Black and gray style with procedure task
overview in left menu option and next/back
task flow at bottom of the screen.
Software controls for images, planning and
instrument management are contained in a
right side bar. |
| Programming
Language | C++/Java | C++ |
| Scanner
Interface
Technology (to
imaging
devices) | Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export | Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export |
| Optical
Technology | Manufacturer:
(Northern Digital Inc.)
Localizer: Vega | Manufacturer:
(Northern Digital Inc.)
Localizer: Vega |
| Electromagnetic
Technology | Manufacturer:
(Medtronic Navigation, Inc.)
Localizer: AxiEM III
Emitter Types: Side, Flat | Manufacturer:
(Medtronic Navigation, Inc.)
Localizer: AxiEM III
Emitter Types: Side, Flat |

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X. Discussion of the Performance Testing

The following table summarizes the testing conducted on the StealthStation™ Cranial Software v2.0

Description

Under representative worst-case confiquration, the StealthStation™ S8 System with StealthStation™ Cranial Software v2.0 has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error of ≤ 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.

Software verification and validation testing verified the software requirements are met and the software performs as intended.

Summative usability validation and clinical expert evaluation were performed by representative users on datasets not used for development, composed of normal and abnormal brains in both pediatric and adult populations.

Summative evaluations demonstrated StealthStation™ Cranial Software v2.0 with Stealth™ Tractography has been found to be safe and effective for the intended users, uses and use environments. Performance testing demonstrated the design and implementation of the correct creation and rendering of dMRI tracts in views in the application and the functionality of the dMRI tractography feature requirements.

Clinical expert evaluations included white matter tract generation and editing which are new in the StealthStation™ S8 software. Clinical experts assessed the rendering of the white matter tracts and their relationship to other key structures with respect to treatment planning, intraoperative navigation and the potential to aid clinical decision making.

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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

XII. Conclusions

The StealthStation™ Cranial Software v2.0 has been found through performance testing and comparison to be substantially equivalent to the identified predicate device. Performance testing in combination with the clinical expert evaluation demonstrates the StealthStation™ Cranial v2.0 software performs as intended and demonstrates substantial equivalence to the predicate device.