(28 days)
The StealthStation™ System, with StealthStation™ Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic 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 spine or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as:
o Pedicle Screw Placement
- o Iliosacral Screw Placement
o Interbody Device Placement
The StealthStation System, also known as an Image Guided System (IGS), is comprised of a platform, clinical software, surgical instruments and a referencing system. The IGS tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The StealthStation Spine software helps guide surgeons during spine procedures such as spinal fusion and trauma treatments. StealthStation Spine 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.
Based on the provided text, the acceptance criteria and study proving the device meets these criteria for the StealthStation S8 Spine Software v1.3.0 can be summarized as follows:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (System Accuracy Requirements) | Reported Device Performance (StealthStation S8 Spine Software v1.3.0) |
|---|---|
| Mean positional error ≤ 2.0 mm | Worst-case Configuration: Mean positional error of ≤ 2.0 mm StealthAiR Spine (Specific feature): Positional Error – 1.01 mm Overlapping Slices (Specific feature): Positional Error – 0.51 mm |
| Mean trajectory error ≤ 2 degrees | Worst-case Configuration: Mean trajectory error of ≤ 2 degrees StealthAiR Spine (Specific feature): Trajectory Error – 0.37 degrees Overlapping Slices (Specific feature): Trajectory Error – 0.41 degrees |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for the test set used for the accuracy performance. It mentions "anatomically representative phantoms" were used.
- Data Provenance: The study was conducted using "anatomically representative phantoms." The country of origin of the data is not specified, but the applicant company is Medtronic Navigation, Inc., located in Louisville, Colorado, USA. The study design is implied to be prospective testing on phantoms rather than retrospective patient data.
3. 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 was performed on phantoms, which typically rely on engineered and measurable ground truth, not expert consensus on anatomical structures or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document, as the ground truth for phantom testing is typically established by the design of the phantom and measurement techniques, not human adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was mentioned. The device, StealthStation S8 Spine Software, is an image-guided surgery system, not an AI-assisted diagnostic tool that would typically be evaluated with MRMC studies comparing human reader performance. The software aids surgeons in precisely locating anatomical structures.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device's performance was evaluated in terms of its ability to measure positional and trajectory accuracy on phantoms. This can be considered a form of standalone performance assessment as it evaluates the system's inherent accuracy capabilities, albeit in a simulated (phantom) environment, without directly measuring human-in-the-loop clinical workflow improvement. The text refers to "System integration performance testing for spine surgical procedures using anatomical phantoms."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth was established by the design and measurement capabilities of the "anatomically representative phantoms." This type of ground truth is based on precise, engineered physical properties and known measurements of the phantom. It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
This information is not provided in the document. The document describes a software update (v1.3.0) to an existing device, and the focus of the 510(k) summary is on performance testing for substantial equivalence, not on the training data used for the algorithm's development.
9. How the ground truth for the training set was established:
This information is not provided in the document. As this document is a 510(k) summary for a software update, details about the original model training and ground truth establishment are typically not included unless significant changes related to the algorithm's core functionality or AI components are introduced which necessitate new data for training or re-training.
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May 29, 2020
Medtronic Navigation, Inc. Jason Woehrle Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K201189
Trade/Device Name: Stealthstation S8 Spine Software v1.3.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 30, 2020 Received: May 1, 2020
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K201189
Device Name StealthStation™ S8 Spine Software v1.3.0
Indications for Use (Describe)
The StealthStation™ System, with StealthStation™ Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic 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 spine or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as:
o Pedicle Screw Placement
- o Iliosacral Screw Placement
o Interbody Device Placement
| 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)
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510(k) Summary
April 30, 2020
- I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville. Colorado 80027 USA Telephone Number: 720-890-3200
- Contact: Jason Woehrle (Primary) Senior Regulatory Affairs Specialist Telephone Number: 949-399-1509 Fax Number: 720-890-3500
K. Elizabeth Waite (Alternate) Regulatory Affairs Manager Telephone Number: 720-890-2182 Fax Number: 720-890-3500
- Proprietary Trade Name: StealthStation™ S8 Spine Software v1.3.0 II.
- III. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- IV. Classification: Class II, Stereotaxic Instrument
- V. Product Codes: OLO
VI. Product Description
The StealthStation System, also known as an Image Guided System (IGS), is comprised of a platform, clinical software, surgical instruments and a referencing system. The IGS tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The StealthStation Spine software helps guide surgeons during spine procedures such as spinal fusion and trauma treatments. StealthStation Spine 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.
VII. Indications for Use
The StealthStation™ System, with StealthStation™ Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic 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 spine or pelvis, can be identified relative to images of the anatomy.
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This can include the following spinal implant procedures, such as:
o Pedicle Screw Placement o Iliosacral Screw Placement o Interbody Device Placement
VIII. Summary of the Technological Characteristics
| Feature | StealthStation S8 Spine Softwarev1.3.0 (Subject Devices) | Predicate Devices (StealthStationS8 Spine Software v1.0.0)K170011 |
|---|---|---|
| Intended Use | The StealthStation™ System, withStealthStation Spine Software, isintended as an aid for preciselylocating anatomical structures ineither open or percutaneousneurosurgical and orthopedicprocedures. | The StealthStation® System, withStealthStation Spine Software, isintended as an aid for preciselylocating anatomical structures ineither open or percutaneousneurosurgical and orthopedicprocedures. |
| Indications forUse | The StealthStation™ System, withStealthStation Spine Software, isintended as an aid for preciselylocating anatomical structures ineither open or percutaneousneurosurgical and orthopedicprocedures. Their use is indicatedfor any medical condition in whichthe use of stereotactic surgery maybe appropriate, and where referenceto a rigid anatomical structure, suchas the spine, can be identifiedrelative to images of the anatomy.This can include, but is not limitedto, the following procedures:• Pedicle Screw Placement•Iliosacral Screw Placement•Interbody Device Placement | The StealthStation® System, withStealthStation Spine Software, isintended as an aid for preciselylocating anatomical structures ineither open or percutaneousneurosurgical and orthopedicprocedures. Their use is indicated forany medical condition in which theuse of stereotactic surgery may beappropriate, and where reference to arigid anatomical structure, such as thespine, can be identified relative toimages of the anatomy.This can include, but is not limitedto, the following procedures:• Pedicle Screw Placement•Iliosacral Screw Placement•Interbody Device Placement |
| SystemAccuracyRequirements | Under representative worst-caseConfiguration, the StealthStationS8 Spine software v1.3.0, hasdemonstrated performance in 3Dpositional accuracy with a meanpositional error of ≤ 2.0 mm andmean trajectory error of ≤ 2degrees. | Under representative worst-caseConfiguration, the StealthStation S8Spine software v1.0.0, hasdemonstrated performance in 3Dpositional accuracy with a meanpositional error of ≤ 2.0 mmand mean trajectory error of ≤ 2degrees. |
| Feature | StealthStation S8 Spine Softwarev1.3.0 (Subject Devices) | Predicate Devices (StealthStationS8 Spine Software v1.0.0)K170011 |
| Mean Accuracy Values (StealthAiRSpine):Positional Error – 1.01 mmTrajectory Error – 0.37 degrees | Mean Accuracy Values:Positional Error – 1.30 mmTrajectory Error – 0.64 degrees | |
| Mean Accuracy Values(Overlapping Slices):Positional Error - 0.51 mmTrajectory Error -0.41 degrees | ||
| ImagingModalities | X-Ray Based Imaging | X-Ray Based Imaging |
| RegistrationFeatures | PointMerge RegistrationSurfaceMerge RegistrationFluoroMerge RegistrationAutomatic 2D Image RegistrationAutomatic 3D Image RegistrationStealthAiR Spine AutomaticRegistration | PointMerge RegistrationSurfaceMerge RegistrationFluoroMerge RegistrationAutomatic 2D Image RegistrationAutomatic 3D Image Registration |
| PlanningFeatures | Plan Entry and Target Selection3D Model BuildingDeformity Planning | Plan Entry and Target Selection3D Model BuildingDeformity Planning |
| MedicalDeviceInterfaces | O-arm Imaging SystemZiehm Vision FD Vario 3D C-ArmISO-C 3D C-ArmZiehm Vision RFD 3D C-armStealth-Midas MR8Orbic 3D C-Arm | O-arm Imaging SystemZiehm Vision FD Vario 3D C-ArmISO-C 3D C-ArmOrbic 3D C-Arm |
| View/DisplayFeatures | Look Sideways3DAnatomic OrthogonalTrajectory 1 and 2Trajectory GuidanceLook AheadProbe's EyeAP and LateralSynthetic AP and LateralMaximum Intensity ProjectionVideo Input | Look Sideways3DAnatomic OrthogonalTrajectory 1 and 2Trajectory GuidanceLook AheadProbe's EyeAP and LateralSynthetic AP and LateralMaximum Intensity ProjectionVideo Input |
| SoftwareInterface(GUI) | Black and gray style with proceduretask overview in left menu optionand next/back task flow at bottomof the screen. Software controls for | Black and gray style with proceduretask overview in left menu option andnext/back task flow at bottom of thescreen. Software controls for images, |
| Feature | StealthStation S8 Spine Softwarev1.3.0 (Subject Devices) | Predicate Devices (StealthStationS8 Spine Software v1.0.0)K170011 |
| images, planning and instrumentmanagement are contained in aright side bar. | planning and instrument managementare contained in a right side bar. | |
| ProgrammingLanguage | C++ | C++ |
| LocalizationTechnology | Optical (infra-red) | Optical (infra-red) |
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IX. Identification of Legally Marketing Devices
StealthStation S8 Spine Software v1.0.0 (K170011)
X. Discussion of the Performance Testing
The following table summarizes the testing conducted on the StealthStation S8 Spine Software v1.3.0
Description
Under representative worst-case configuration, the StealthStation S8 Spine Software v1.3.0 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.
Software verification and validation testing for each requirement specification. System integration performance testing for spine 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 |
XI. Conclusions
The StealthStation S8 Spine Software v1.3.0 has been shown through testing and comparison 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).