The Stealth-Midas System is indicated for the drilling, burring and removal of hard tissue and bone in spinal 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 Description

The Stealth-Midas System consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation with the StealthStation System. The system allows the navigation of a selection of currently available surgical dissecting tools. The navigated handpieces are provided non-sterile and are reusable.

AI/ML Overview

The document provided describes the Stealth-Midas System, a medical device intended for spinal surgical procedures, and lists some performance testing. However, it does not contain the requested detailed acceptance criteria or a comprehensive study report with specific performance metrics such as sensitivity, specificity, or reader improvement. The information available is limited to a summary of performance testing and a declaration of substantial equivalence to predicate devices.

Based on the provided text, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance (Based on available information):

Acceptance Criteria Category	Reported Device Performance
Navigation Accuracy	Confirmed navigated instrument accuracy
CAD Model Evaluation	Verified that the CAD models are accurately reflected in the application software
Formative Usability	Confirmed users can follow the navigated workflow and assemble the device
Substantial Equivalence	Demonstrated through comparison and testing against identified predicate devices (Midas Rex Electric Surgical Drill/Saw System (K081475), Midas Rex MR7 Pneumatic High Speed System (K090112), Navigated VERTEX SELECT® Instruments (K143628)). Specific metrics not detailed.

Missing Information/Not Provided in the Document:

Detailed Acceptance Criteria and Specific Performance Results: While categories of testing are mentioned, the document lacks specific quantitative acceptance criteria (e.g., "accuracy must be within X mm") and the exact numerical results obtained from the tests. For example, for "Navigation Accuracy Analysis," it only states "Confirmed navigated instrument accuracy," without providing the actual accuracy achieved.
Sample Size used for the test set and data provenance: The document mentions "testing was completed" but does not specify the sample size for any of the tests (e.g., number of instruments tested for navigation accuracy, number of users for usability, number of cases/models for CAD evaluation). It also does not mention data provenance (e.g., country of origin, retrospective or prospective nature).
Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
Adjudication method for the test set: Not mentioned.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication that an MRMC study was conducted, nor is there any mention of an effect size for human reader improvement with or without AI assistance. The device is a navigated surgical instrument, not an AI-assisted diagnostic tool, so such a study would likely not be relevant or performed in this context.
Standalone Performance: The document does not describe a "standalone (i.e., algorithm only without human-in-the-loop performance)" study. The device is described as an aid for surgery, implying human interaction.
Type of ground truth used: For the navigation accuracy, the ground truth would likely be a precisely measured physical reference. For CAD model evaluation, the ground truth would be the original CAD models. For usability, the ground truth would be successful task completion and user feedback against predefined usability goals. These are not explicitly detailed in the document.
Sample size for the training set: The document does not refer to any AI/ML models that would require a "training set." The device described is a navigated surgical instrument, not an AI-driven diagnostic or predictive system in the context of what would typically have a "training set" of data.
How the ground truth for the training set was established: Not applicable, as no training set for an AI/ML model is indicated.

Summary of the Study (Based on available information):

The document refers to "Performance Testing" which was "completed to ensure the functionality and compatibility with the identified Medtronic products." This testing primarily focused on:

Navigation Accuracy Analysis: To confirm that the addition of the passive optical tracker to the drill handpieces resulted in accurate navigation of the instruments. The document states, "Navigational accuracy testing confirms that the subject navigated drill system is as accurate as the predicate navigated Vertex Select instruments."
CAD Model Evaluation: To verify that the CAD models used by the application software accurately reflected the physical design.
Formative Usability: To confirm that users could effectively follow the navigated workflow and properly assemble the device.

The overall conclusion drawn from this testing and comparison was that the "Stealth-Midas System has been shown through comparison and testing to be substantially equivalent to the identified predicate devices." This implies that the performance results met the standards set by the predicate devices, though specific quantitative measures are not provided.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medtronic Powered Surgical Solutions Mr. John Connor Senior Regulatory Affairs Specialist Medtronic Navigation 826 Coal Creek Circle Louisville, Colorado 80027

Re: K160713

Trade/Device Name: Stealth-Midas System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: March 14, 2016 Received: March 15, 2016

Dear Mr. Connor:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

May 26, 2016

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forth in the quality systems (QS) 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" (21CFR 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160713

Device Name Stealth-Midas System

Indications for Use (Describe)

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

March 14, 2016

I. Company: Medtronic Powered Surgical Solutions 4620 North Beach St. Fort Worth, TX 76137 Telephone Number: (817) 788-6400
- Contact: John Connor Senior Regulatory Affairs Specialist Telephone number: (720) 890-2311 Fax: (720) 890-3500 Email: john.m.connor@medtronic.com
II. Proprietary Trade Name: Stealth-Midas System
III. Common Name: Orthopedic Stereotaxic Instrument
IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
V. Classification: Class II
Product Code: OLO VI.

VII. Product Description:

VIII. Indications for Use:

The Stealth-Midas System is indicated for the drilling, burring and removal of hard tissue and bone in spinal 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 CTor MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

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IX. Identification of Legally Marketed Devices (Predicate Devices)

Midas Rex Electric Surgical Drill/Saw System (K081475) ●
. Midas Rex MR7 Pneumatic High Speed System (K090112)
Navigated VERTEX SELECT® Instruments (K143628)

X. Comparison of the Technological Characteristics:

The currently available Midas Rex Drill System consists of pneumatic and electric handpieces, attachments, and surgical dissecting tools. There are no changes to any of the attachments or surgical dissecting tools. The only significant difference between the subject navigated handpieces and the currently available handpieces is the addition of a passive optical tracker to the hind to enable navigation of a selection of dissecting tools, and a secondary lock to eliminate any motion of the dissecting tool relative to the optical tracker. The addition of a tracker does not impact the ability of the drill system to perform to their intended use as a drill system.

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

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 AccuracyAnalysis	Confirmed navigated instrument accuracy
CAD Model Evaluation	Verified that the CAD models are accuratelyreflected in the application software
Formative Usability	Confirmed users can follow the navigatedworkflow and assemble the device

XII. Conclusions

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

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).