Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Instruments are specifically designed for use with the StealthStation™ System, which 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 skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Instruments are also compatible with the IPC® POWEREASE® System.

Device Description

The Navigated INFINITY™ Instruments are non-sterile, reusable and single use instruments that can be operated manually or under power. These instruments are intended to be used when implanting components of the INFINITY™ OCT System. The Navigated INFINITY™ Instruments are also compatible with the StealthStation® and IPC® POWEREASE® Systems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Navigated INFINITY™ Instruments":

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report for new device approval. As such, the information provided for some of your requested points is limited or not applicable in the context of a 510(k).

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Maintain Navigation Accuracy	Navigation Accuracy Analysis Confirmed navigated instrument accuracy
Instrument Functionality under Expected Use Conditions	Anatomical Simulated Use Confirmed instrument functionality under expected use conditions
Navigation System Functionality under Expected Use Conditions	Navigation Simulated Use Confirmed navigation system functionality under expected use conditions
Accurate Reflection of CAD Models in Application Software	CAD Model Evaluation Verified that the CAD models are accurately reflected in the application software
Proper Mating of Instruments with Appropriate Devices	Implant/Instrument Mating Conditions Verified that the instruments can be assembled with the appropriate devices according to their intended use
Spine Tools Package Meets Interface Needs of Spine Application Software	Spine Tools Package Functional Testing Verified that the Spine Tools package has met the required interface needs of the spine application software

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample size (e.g., number of instruments tested, number of simulated cases) for any of the performance tests.
- Data Provenance: Not specified. Given the nature of a 510(k) and the types of tests listed (simulated use, accuracy analysis, CAD evaluation, functional testing), it is highly probable that the data provenance is retrospective (using internal testing data) and likely in-house laboratory or engineering testing, rather than clinical data from a specific country of origin.
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. For the types of engineering and functional tests described (e.g., navigation accuracy, instrument functionality, CAD evaluation), "ground truth" would likely be established through engineering specifications, validated measurement systems, and perhaps expert observation from R&D engineers, rather than clinical experts like radiologists.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided and is unlikely to be relevant for the non-clinical, performance-based tests described in the 510(k) summary. Adjudication methods like 2+1 are typically used for clinical endpoints, especially in image interpretation.
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, an MRMC comparative effectiveness study was not done. The device (Navigated INFINITY™ Instruments) is a surgical navigation instrument, not an AI-powered diagnostic or assistive tool for "human readers." Therefore, this type of study and its associated effect size are not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The term "standalone" and "algorithm only" are typically used for AI/software devices. This device is a physical surgical instrument that works with existing navigation systems (StealthStation™ System, IPC® POWEREASE® System). The performance tests listed (e.g., Navigation Accuracy Analysis, Anatomical Simulated Use) assess the instrument's accuracy and functionality within the intended surgical navigation system, which inherently involves human interaction (the surgeon). Therefore, a "standalone algorithm only" performance is not applicable in the context of this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the tests described:
  - Navigation Accuracy Analysis: Ground truth would likely be established through pre-defined engineering specifications and validated measurement systems (e.g., comparing navigated position to physically measured, known positions).
  - Functional/Simulated Use Tests: Ground truth would be defined by the device's design specifications and intended functionality (i.e., whether it performs as designed under various conditions).
  - CAD Model Evaluation: Ground truth would be the original CAD models themselves and the expectation of their accurate representation in the software.
  - No expert consensus, pathology, or outcomes data is explicitly mentioned or seems relevant for these specific engineering tests.
The sample size for the training set:
- This question is not applicable. The "Navigated INFINITY™ Instruments" are physical surgical instruments, not a machine learning model that requires a training set. The underlying navigation systems (StealthStation™) might have calibration data or algorithms, but the instruments themselves do not have a "training set" in the sense of AI.
How the ground truth for the training set was established:
- This question is not applicable as there is no "training set" for these physical instruments.

Summary

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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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Medtronic Sofamor Danek USA, Inc. Tejas Patel Sr. Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132

Re: K173338

Trade/Device Name: Navigated INFINITY™ Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 20, 2017 Received: October 23, 2017

Dear Tejas Patel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

January 18, 2018

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for 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)

K173338

Device Name Navigated INFINITY™ Instruments

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

January 10, 2018

l. Company: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 Telephone Number: (901) 396-3133
- Contact: Tejas Patel Sr. Regulatory Affairs Specialist Telephone number: (901) 396-3133 Email: tejaskumar.r.patel@medtronic.com
II. Proprietary Trade Name: Navigated INFINITY™ Instruments

Common Name: Stereotaxic Instrument, Navigated Screwdriver, Navigated Tap, Navigated Drill Bit and Navigated Drill Tap (DT) Guide

Classification Name: Stereotaxic Instrument (21 CFR 882.4560)

Classification: Class II

Product Code: OLO

lll. Predicate Device:

Navigated VERTEX SELECT® Instruments (K143628, S.E. 02/12/2015) This predicate has not been subject to a design-related recall. This predicate is the primary predicate for this submission.

The following reference devices are also used in this submission:

INFINITY™ OCT System (K163375, S.E. 08/21/2017) ●
IPC® POWEREASE® System (K111520, S.E. 10/26/2011; K123270, S.E. 01/11/2013)
SteathStation® System (K050438, S.E. 06/02/2005; K170011, S.E. 05/01/2017) ●
NavLock™ tracker (K124004, S.E. 03/22/2013) ●

IV. Device Description:

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Navigated INFINITY™ Instruments are also compatible with the StealthStation® and IPC® POWEREASE® Systems.

Note: The subject devices are not intended to support occipital screw placement.

V. Indications for Use:

Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Instruments are specifically designed for use with the StealthStation® System, which 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 skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Instruments are also compatible with the IPC® POWEREASE® System.

VI. Comparison of the Technological Characteristics with the Predicate Device:

The Navigated INFINITY™ Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery and are specifically designed for use with the StealthStation® System. Identical to the predicates, the Navigated INFINITY™ Instruments attach to the NavLock™ Tracker, which allows for optical navigation of the surgical instruments. These devices have similar designs as the predicate devices and incorporate the same design features to enable navigation and use with the IPC® POWEREASE® System, when desired.

The following technological differences exist between the subject and predicate devices:

. The subject Navigated INFINITY™ Instruments are intended to be used with INFINITY™ OCT System screws whereas the predicate Navigated VERTEX SELECT® Instruments are intended to be used with the VERTEX® Reconstruction System screws.
. The subject navigated drill bits are non-sterile and single use while the predicate drill bits are sterile and single use.
The subject devices include an additional drill tap guide with an optional Navlock positioner feature to hold the Navlock tracker in position to face the camera throughout the drilling and tapping process.

The instrument modifications detailed in this submission have no impact on the technological characteristics of either the existing instruments or the StealthStation® and IPC® POWEREASE® Systems.

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VII. Performance Data:

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
Anatomical Simulated Use	Confirmed instrument functionality underexpected use conditions
Navigation Simulated Use	Confirmed navigation system functionality underexpected use conditions
CAD Model Evaluation	Verified that the CAD models are accuratelyreflected in the application software
Implant/Instrument MatingConditions	Verified that the instruments can be assembledwith the appropriate devices according to theirintended use
Spine Tools PackageFunctional Testing	Verified that the Spine Tools package has met therequired interface needs of the spine applicationsoftware

VIII. Conclusions

The Navigated INFINITY™ Instruments have 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).