Stealth-Midas MR8 System

K183644 · Medtronic Powered Surgical Solutions · OLO · May 22, 2019 · Neurology

Device Facts

• Record ID: K183644
• Device Name: Stealth-Midas MR8 System
• Applicant: Medtronic Powered Surgical Solutions
• Product Code: OLO · Neurology
• Decision Date: May 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous 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 a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

Device Story

Stealth-Midas MR8 System comprises electric and pneumatic drill handpieces equipped with passive optical trackers; enables navigation during spinal and cranial surgery when used with StealthStation S8 System and Integrated Power Console (IPC). Optical trackers allow real-time tracking of surgical tool-tip relative to patient anatomy; system aids surgeons in precisely locating structures during open or percutaneous procedures. Handpieces are reusable; surgical dissecting tools and MR8 ClearView burs are single-use. System provides visual navigation feedback to surgeons via StealthStation interface; facilitates accurate bone removal and tissue dissection. Benefits include enhanced surgical precision and guidance during complex neurosurgical and spinal interventions.

Clinical Evidence

Bench testing only. Navigation accuracy analysis confirmed navigated instrument accuracy (3D < 2.00 mm, 2D < 3.00 mm). CAD model evaluation verified software representation. Formative and summative usability testing confirmed users can safely and effectively perform the navigated workflow and assemble the device with StealthStation S8 software.

Technological Characteristics

System includes electric/pneumatic handpieces, attachments, and dissecting tools. Materials: stainless steel, aluminum, ceramic, phenolic, epoxy, chrome-coated brass, Torlon 4301, carbide, diamond/TDC coatings. Sensing: passive optical (infrared) tracking. Connectivity: interfaces with StealthStation S8 and IPC. Sterilization: non-sterile (handpieces/attachments), sterile (tools/burs).

Indications for Use

Indicated for drilling, burring, and removal of hard tissue and bone in spinal and cranial surgical procedures where stereotactic surgery is appropriate and anatomical structures can be referenced to CT/MR models, fluoroscopic images, or digitized landmarks.

Regulatory Classification

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.

Predicate Devices

• Stealth-Midas System (K160713)
• MR8 Drill System (K183515)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Medtronic Powered Surgical Solutions Jenna Groves Regulatory Affairs Manager 4620 North Beach Street Fort Worth, Texas 76137

Re: K183644

Trade/Device Name: Stealth-Midas MR8 System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW Dated: December 21, 2018 Received: December 26, 2018

Dear Jenna Groves:

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

May 22, 2019

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For: CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 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) K183644

Device Name Stealth-Midas MR8 System

### Indications for Use (Describe)

The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous 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 a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

| Type of Use (Select one or both, as applicable) |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size: 12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## K183644

## 510(k) Summary

December 17, 2018

- I. Company: Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, TX 76137 Telephone Number: [phone]
- Contact: Jenna Groves Regulatory Affairs Manager Telephone Number: [phone] Fax: [phone] Email: [e-mail]
- II. Proprietary Trade Name: Stealth-Midas MR8 System
- III. Common Name: Orthopedic, Neurologic Stereotaxic Instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- Classification: Class II V.
- VI. Product Code(s): OLO, HAW

#### VII. Product Description:

The Stealth-Midas MR8 consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation in conjunction with the StealthStation S8 System and the Integrated Power Console (IPC). The system allows the navigation of a selection of currently available surgical dissecting tools. The navigated handpieces are provided non-sterile and are reusable. The associated attachments are provided non-sterile and are reusable. The associated surgical dissecting tools and MR8 ClearView burs are provided sterile and are single-use.

#### VIII. Indications for Use:

The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous 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 a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

#### IX. Identification of Legally Marketed Devices (Predicate Devices):

- Stealth-Midas System (K160713) ●

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- . MR8 Drill System (K183515)
#### X. Comparison of the Technological Characteristic:

The only significant difference between the subject navigated handpieces and the currently cleared navigated handpieces are minor changes to the optical tracker geometry.

The passive optical tracking technology is identical to that employed in the use of the predicate navigated instrument. Navigational accuracy testing confirms that the subject navigated drill system is as accurate as the predicate system.

The currently cleared MR8 Drill System consists of pneumatic and electric handpieces, attachments, and surgical dissecting tools that are indicated for various cranial and spinal procedures. There are no changes to any of the attachments or surgical dissecting tools. The only significant difference between the subject handpiece and the currently available MR8 handpiece is the addition of a passive optical tracker to the hind to enable navigation of a selection of dissecting tool. As a drill, the Stealth-Midas MR8 is identical to the MR8 drill system, with the exception, as stated, an optical tracker has been attached to the hind of the handpiece to allow navigation. The addition of the tracker does not impact the ability of the drill system to perform to their intended use as a drill system. See below table for a comparison of qualitative characteristics.

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| Feature | Stealth-Midas System<br>MR8 (subject devices) | Stealth Midas System<br>(primary predicate)<br>K160713 | MR8 Drill System and MR8<br>ClearView (secondary predicate)<br>K183515 | Equivalence Discussion |
|--------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 CFR 882.4560<br>(Stereotaxic Instrument) | 21 CFR 882.4560 (Stereotaxic<br>Instrument) | 21 CFR 882.4360 (Motor, Drill,<br>Electric)<br>21CFR 882.4370 (Motor, Drill,<br>Pneumatic)<br>21 CFR 882.4310 (Drills, Burs,<br>Trephines & Accessories | Same<br>As a navigated drill, the Stealth-Midas<br>MR8 falls into the same regulation number<br>as the primary predicate Stealth-Midas and<br>has the same intended use.<br>Similar<br>The Stealth-Midas MR8 operates and<br>performs the same as the predicate MR8<br>drill and falls into a similar regulation. |
| Product Code | OLO, HAW | OLO | HBC, HBB, HBE, ERL, HSZ | Equivalent<br>The Stealth-Midas MR8 System is<br>indicated for use in navigated cranial and<br>spinal procedures. As such, it carries the<br>same OLO product code (orthopedic<br>stereotaxic instrument) as predicate<br>Stealth-Midas spine instruments and also<br>includes product code HAW (neurological<br>stereotaxic). HAW falls within the same<br>regulation number 21 CFR 882.4560 and<br>has the same intended use as OLO. |
| Intended Use | Incision / cutting, removal,<br>drilling, and sawing of soft<br>and hard tissue, bone, and<br>biomaterials. | Incision / cutting, removal,<br>drilling, and sawing of soft and<br>hard tissue, bone, and<br>biomaterials. | Incision / cutting, removal,<br>drilling, and sawing of soft and<br>hard tissue, bone, and biomaterials. | Equivalent<br>The Navigated Electric and Pneumatic<br>Stealth-Midas MR8 motors, with the<br>tracker on the hind of the motor, allow for<br>optical tracking of the -tip at the surgical<br>site. The subject Stealth-Midas MR8 and<br>the predicate devices have the same<br>intended use.<br>As a drill system the subject system<br>intended use is identical to that of the<br>predicate drill system. The only difference<br>between the subject and the predicate MR8 |

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| Indications for Use | The Stealth-Midas MR8 | The Stealth-Midas System is | The Medtronic MR8 | Handpieces is that the proposed Stealth-<br>Midas MR8 Handpieces are supplied with<br>a Tracker on the hind of the Handpieces.<br>Equivalent |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Stealth-Midas MR8<br>System is indicated for the<br>drilling, burring and<br>removal of hard tissue and<br>bone in spinal and cranial<br>surgical procedures.<br>Computer-assisted surgery<br>and its associated<br>applications are intended<br>as an aid for precisely<br>locating anatomical<br>structures in either open or<br>percutaneous procedures.<br>Their use is indicated for<br>any medical condition in<br>which the use of<br>stereotactic surgery may be<br>appropriate, and where<br>reference to a rigid<br>anatomical structure, such<br>as a long bone, or vertebra,<br>can be identified relative to<br>a CT- or MR-based model,<br>fluoroscopic images, or<br>digitized landmarks of<br>the anatomy. | indicated for the incision /<br>cutting, removal, drilling, and<br>sawing of soft and hard tissue,<br>bone, and biomaterials in spinal<br>surgical procedures. Computer-<br>assisted surgery and its<br>associated applications are<br>intended as an aid for precisely<br>locating anatomical structures<br>in either open or percutaneous<br>procedures. Their use is<br>indicated for any medical<br>condition<br>in which the use of stereotactic<br>surgery may be appropriate,<br>and where reference to a rigid<br>anatomical structure, such as a<br>long bone, or vertebra, can be<br>identified relative to a CT- or<br>MR-based model, fluoroscopic<br>images, or digitized landmarks<br>of the anatomy. | Drill System is indicated<br>for the incision/cutting,<br>removal, drilling, and<br>sawing of soft and hard<br>tissue, bone, and<br>biomaterials in<br>Neurosurgical (Cranial<br>and Craniofacial<br>including craniotomy);<br>Ear, Nose and Throat<br>(ENT), Maxillofacial,<br>Orthopedic,<br>Arthroscopic, Spinal,<br>Sternotomy, and General<br>Surgical Procedures.<br>Additionally, the MR8<br>Drill System is indicated<br>for the incision/cutting,<br>removal, drilling, and sawing of<br>soft and hard<br>tissue, bone, and<br>biomaterials during open<br>and minimally invasive<br>spine procedures, which<br>may incorporate<br>application of various<br>surgical techniques<br>during the following<br>lumbar spinal<br>procedures:<br>• Lumbar<br>Microdiscectomy<br>• Lumbar Stenosis<br>Decompression<br>• Posterior Lumbar<br>Interbody Fusion (PLIF) | The Navigated Electric and Pneumatic<br>Stealth-Midas MR8 motors, with the<br>tracker on the hind of the motor, allow for<br>optical tracking of the tool-tip at the<br>surgical site. The subject Stealth-Midas<br>MR8 and the predicate devices have the<br>same intended use, but the subject device<br>is indicated for both cranial and spinal<br>applications and the predicate Stealth-<br>Midas is indicated for spinal applications.<br><br>As a drill system the subject system<br>intended use is identical to that of the<br>predicate MR8 drill system. The only<br>difference between the subject motor and<br>the predicate motor is the Stealth-Midas<br>MR8 motors are supplied with a tracker or<br>the hind of the handpieces/motor. The<br>subject motor and the predicate motor are<br>both indicated for spinal and cranial<br>applications. | |
| | | | | |
| StealthStation<br>Operating<br>Principle<br>(Tracking<br>Method) | Optical (infra-red) | Optical (infra-red) | • Transforaminal Lumbar<br>Interbody Fusion (TLIF)<br>• Anterior Lumbar<br>Interbody Fusion (ALIF)<br>• Direct Lateral<br>Interbody Fusion (DLIF)<br>The Midas Rex MR8<br>ClearView Tools are<br>used only in conjunction<br>with the MR8 Drill<br>System to perform as<br>intended. Please refer to the Midas<br>Rex MR8<br>Drill System and<br>associated User's Guides<br>for the Indications of<br>Use. | Identical<br>The Operating Principle of the subject<br>Stealth-Midas MR8 device is identical to<br>the predicate Stealth-Midas |
| StealthStation<br>System<br>Accuracy<br>Requirements | 3D Accuracy Testing:<br><2.00 mm<br>2D Accuracy Testing:<br><3.00 mm | 3D Accuracy Testing:<br><2.27 mm<br>2D Accuracy Testing:<br><2.98 mm | N/A | Equivalent<br>The StealthStation S8 System accuracy<br>requirements are equivalent to the<br>StealthStation S7 System accuracy<br>requirements. Accuracy validation testing<br>conducted on the subject device confirms<br>the Stealth-Midas MR8 when used with<br>StealthStation S8 is equivalent in accuracy<br>as the predicate Stealth-Midas when used<br>with StealthStation S7. |
| System<br>Components | • Electric Handpiece w/<br>Passive Optical Tracker<br>• Pneumatic Handpiece w/<br>Passive Optical Tracker<br>• Attachments<br>• Surgical Dissecting<br>Tools | • Electric Handpiece w/<br>Passive Optical Tracker<br>• Pneumatic Handpiece w/<br>Passive Optical Tracker<br>• Attachments<br>• Surgical Dissecting Tools | • Electric Handpiece<br>• Pneumatic Handpiece<br>• Attachments<br>• Surgical Dissecting Tools | Equivalent<br>As a drill system the components are<br>identical to those of the predicate MR8<br>drill system. The only difference is an<br>improvement to the secondary lock<br>mechanism that requires a ¼ turn instead<br>of multiple rotations. Additional markings |
| | | | | were added to the subject handpiece to<br>provide a visual aid when locking.<br><br>Navigation compatibility is enabled by use<br>of a passive optical tracker, which is nearly<br>identical to the tracker of the predicate<br>navigated drills. The only difference is the<br>tracker on the subject device has a slightly<br>different geometry to allow differentiation<br>from the predicate Stealth-Midas device.<br><br>The Stealth-Midas MR8 offers a single<br>downward orientation for angled<br>attachments versus the Stealth-Midas<br>predicate device that offered a right or left<br>downward orientation angled attachment.<br>The single downward orientation versus a<br>right/left orientation has no impact on<br>functionality, performance or accuracy of<br>the Stealth-Midas MR8 device |
| Surgical<br>Dissecting Tools<br>– Overall Length | 3-42 cm | 3-42 cm | 3-42 cm | Similar<br>As a drill system there are no changes to<br>currently marketed components. Select<br>surgical dissecting tools, identified in the<br>device description, will be compatible with<br>spinal and/or cranial navigation. |
| Surgical<br>Dissecting Tools<br>– Head Diameter | 0.5 – 25 mm | 0.5 – 25 mm | 0.5 – 25 mm | Similar<br>As a drill system there are no changes to<br>currently marketed components. Select<br>surgical dissecting tools and MR8<br>ClearView burs, as identified in the device<br>description, will be compatible with spinal<br>and/or cranial navigation. |
| Attachment<br>Length | 2 – 40 cm | 2 – 40 cm | 2 – 40 cm | Similar |
| | | | | As a drill system there are no changes to<br>currently marketed components. Select<br>combinations of surgical dissecting tools,<br>MR8 ClearView burs and attachments, as<br>identified in the device description, will be<br>compatible with spinal or cranial<br>navigation. |
| Drill System<br>Operating<br>Principle | • Electric (Powered by<br>IPC)<br>• Pneumatic (Powered by<br>Pneumatic Pressure) | • Electric (Powered by IPC)<br>• Pneumatic (Powered by<br>Pneumatic Pressure) | • Electric (Powered by IPC)<br>• Pneumatic (Powered by<br>Pneumatic Pressure) | Identical<br>The operating principle of the subject<br>handpiece and the predicate handpieces are<br>identical. |
| System Interface | • IPC<br>• StealthStation System | • IPC<br>• StealthStation<br>System | • Electric (Powered by IPC)<br>• Pneumatic (N/A) | Equivalent<br>Both the subject Stealth-Midas MR8 and<br>the predicate Stealth-Midas interface with<br>the StealthStation. The predicate device<br>interfaces with the StealthStation S7<br>System and the subject device interfaces<br>with the StealthStation S8 System. |
| Sterilization &<br>Cleaning | • Non-sterile (Handpieces,<br>Attachments)<br>• Sterile (Surgical<br>Dissecting Tools and<br>MR8 ClearView burs) | • Non-sterile (Handpieces,<br>Attachments)<br>• Sterile (Surgical Dissecting<br>Tools and ClearView burs) | • Non-sterile (Handpieces,<br>Attachments)<br>• Sterile (Surgical Dissecting<br>Tools and MR8 ClearView<br>instrument) | Similar<br>The subject system will be used with<br>currently cleared Attachments as well as<br>Surgical Dissecting Tools and MR8<br>ClearView burs available with the MR8<br>Drill System. The sterilization and<br>cleaning parameters for the handpieces are<br>similar to those of the predicate<br>handpieces. |
| Materials | Attachments: Stainless<br>Steel, Aluminum, Ceramic,<br>Phenolic, Epoxy, Chrome<br>Coated Brass, Torlon 4301<br><br>Surgical Dissecting Tools:<br>Stainless Steel, Tool Steel,<br>Alloy Steel, Carbide, TDC<br>Coating, Diamond Coating | Attachments: Stainless Steel,<br>Aluminum, Ceramic, Phenolic,<br>Epoxy, Chrome Coated Brass,<br>Torlon 4301<br><br>Surgical Dissecting Tools:<br>Stainless Steel, Tool Steel,<br>Alloy Steel, Carbide, TDC<br>Coating, Diamond Coating in | Attachments: Stainless Steel,<br>Aluminum, Ceramic, Phenolic,<br>Epoxy, Chrome Coated Brass,<br>Torlon 4301<br><br>Surgical Dissecting Tools:<br>Stainless Steel, Tool S<br>teel, Alloy Steel, Carbide, TDC | Identical<br>The subject device uses identical materials<br>to the primary and secondary predicate. |

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| in Nickel Substrate,<br>Titanium Nitride<br>Tracker: Aluminum | Nickel Substrate, Titanium<br>Nitride<br>Tracker: Aluminum | Coating, Diamond Coating in<br>Nickel Substrate, Titanium Nitride<br>Tracker: N/A |
|---------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------|
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#### XI. Discussion of the Performance Testing

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed:

| Test | Description |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Navigation Accuracy Analysis | Confirmed navigated instrument accuracy |
| CAD Model Evaluation | Verified that CAD models are accurately reflected in the application software |
| Formative Usability | Confirmed users can follow the navigated workflow and assemble the device |
| Summative Testing | Confirmed users can safely and effectively use the Stealth-Midas MR8 navigated drill handpiece with the StealthStation S8 software. |

#### XII. Conclusions

The Stealth-Midas MR8 System has been shown through comparison and testing to be substantially equivalent to the identified predicate devices.