The Navigated Disc Preparation Instruments are intended to facilitate a discectomy or boney resection during spinal surgery. The Navigated T2 STRATOSPHERE™ templates are intended to facilitate size selection of vertebral body replacement devices during spinal surgery. The Navigated Capstone™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for Elevate™ Spinal System, they are intended to be used to facilitate implant size selection.

The Navigated Probe is intended to be used during pedicle preparation. The Navigated Inserters are intended to be used for the placement of an implant.

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.

Device Description

Medtronic Navigated Reusable Instruments are spine preparation instruments made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic single-use sterile spheres on each of the tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.

The purpose of this submission is to seek clearance for Navigated T2 STRATOSPHERE™ Inserters and Navigated Template, compatible with T2 STRATOSPHERE™ Expandable Corpectomy System for lateral and posterior procedures in thoracolumbar cases only.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Navigated T2 STRATOSPHERE Inserters and Navigated Templates. It describes the device, its intended use, and the performance testing conducted to establish substantial equivalence to predicate devices. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

Here's what can be extracted and what information is missing:

1. Table of acceptance criteria and the reported device performance

The document provides a high-level description of performance testing but does not clearly define specific quantitative acceptance criteria or detailed reported performance values.

Test	Description	Acceptance Criteria (Not Explicitly Stated in Document)	Reported Device Performance (Not Explicitly Stated in Document)
Navigation Accuracy Analysis	Confirmed navigated instrument accuracyin both 2D and 3D space.	Likely involves a specific accuracy threshold (e.g., within X mm or degrees) for both 2D and 3D measurements, but not provided.	The document only states "Confirmed navigated instrument accuracy", no specific values.
Anatomical Simulated Use	Confirmed instrument functionality underexpected use conditions	Likely involves subjective or objective assessment of instrument performance in simulated anatomical models (e.g., smooth operation, correct fit, no breakage) but not provided.	The document only states "Confirmed instrument functionality under expected use conditions", no specific observations.
Navigated Simulated Use	Confirmed navigation system functionalityunder expected use conditions	Likely involves successful tracking, registration, and guidance accuracy during simulated procedures, but not provided.	The document only states "Confirmed navigation system functionality under expected use conditions", no specific observations.
CAD Model Evaluation	Verified that the CAD models areaccurately reflected in the applicationsoftware.	Likely involves verification of geometric accuracy and representation, but not provided.	The document only states "Verified that the CAD models are accurately reflected in the application software", no specific metrics.
Implant/ Instrument Mating Conditions	Verified that the instruments can beassembled with the appropriate devicesaccording to their intended use.	Likely involves successful and secure mating of various components, but not provided.	The document only states "Verified that the instruments can be assembled with the appropriate devices according to their intended use", no specific details.
Spine Tools Package Functional Testing	Verified that the Spine Tools package hasmet the required interface needs of thespine application software	Likely involves successful integration and data exchange between software modules, but not provided.	The document only states "Verified that the Spine Tools package has met the required interface needs of the spine application software", no specific outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The performance data section broadly describes "performance testing completed" but does not detail the nature of the test sets (e.g., number of instruments tested, number of simulated procedures, specific data sources).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document refers to "testing" but does not mention expert involvement in establishing ground truth for the test. Given the nature of the device (navigated surgical instruments), it's more likely that physical measurements and engineering specifications would serve as ground truth rather than expert interpretation of medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

An MRMC study is relevant for AI-powered diagnostic devices involving human interpretation of images. This document describes navigated surgical instruments, not a diagnostic AI device. Therefore, an MRMC study as you described would not be applicable to this type of device, and no such study is mentioned or implied.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided in the document in the context of an "algorithm-only" performance for an AI device. The device is a set of physical surgical instruments intended for use with a "StealthStation™ System" (a computer-assisted surgery system), implying a human-in-the-loop scenario. The performance tests ("Navigation Accuracy Analysis," "Anatomical Simulated Use," "Navigated Simulated Use") assess the combined device-system functionality.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Given the nature of the tests ("Navigation Accuracy Analysis," "CAD Model Evaluation," "Implant/ Instrument Mating Conditions"), the ground truth would most likely be based on engineering specifications, physical measurements (e.g., using metrology equipment), and functional verification against design requirements. However, the document does not explicitly state the type of ground truth used for each test.

8. The sample size for the training set

This information is not provided in the document. "Training set" is typically a term used for machine learning models. While the StealthStation™ System likely has underlying software and algorithms, the document describes the instruments and their compatibility, not the development of an AI model's training set.

9. How the ground truth for the training set was established

This information is not provided in the document, and likely not applicable in the context of "training set" for the surgical instruments themselves.

In summary, the provided document focuses on demonstrating substantial equivalence of physical surgical instruments and their compatibility with an existing navigation system through engineering and functional testing. It does not provide the detailed study design, specific acceptance criteria, or quantitative performance results typically found in reports for AI-based diagnostic or prognostic devices, which often involve extensive clinical data and human reader studies.

Summary

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August 26, 2019

Medtronic Sofamor Danek, USA Inc Elizabeth Hamilton Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K191039

Trade/Device Name: Navigated T2 STRATOSPHERE Inserters and Navigated Templates Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 24, 2019 Received: May 28, 2019

Dear Elizabeth Hamilton:

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

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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,

For, Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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)

K191039

Device Name

Navigated T2 Stratosphere Inserters and Navigated Templates

Indications for Use (Describe)

The Navigated Disc Preparation Instruments are intended to facilitate a discectorny or boney resection during spinal surgery. The Navigated T2 Stratosphere™ templates are intended to facilitate size selection of vertebral body replacement devices during spinal surgery. The Navigated Capstone™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for Elevate™ Spinal System, they are intended to be used to facilitate implant size selection.

The Navigated Probe is intended to be used during pedicle preparation. The Navigated Inserters are intended to be used for the placement of an implant.

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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K191039

510(K) SUMMARY April 15, 2019

I.	Company:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, TN 38132Telephone: (901) 396-3133Telefax: (901) 346-9738
	Contact:	Elizabeth Hamilton

Elizabeth Hamilton Contact: Regulatory Affairs Specialist Telephone number: (901) 399-3395 Email: elizabeth.c.hamilton@medtronic.com

Proprietary Trade Name: Navigated T2 STRATOSPHERE™ II. Inserters and Navigated Templates

Common Name: Stereotaxic Instrument, Navigated Instruments Classification Name: Stereotaxic Instrument (21CFR 882.4560) Classification: Class II Product Code: OLO

III. Predicate Devices:

. Primary Predicate- Navigated Elevate™ Inserter Disc prep Instruments (K163581, S.E.04/14/2017)
Predicate 2-T2 STRATOSPHERE™ Expandable Corpectomy System . (K173125, S.E. 12/20/2017)
. Predicate 3-Navigated Capstone® Trials, Clydesdale® Trials, Capstone® and Clydesdale® Inserter (K131425, S.E. 08/14/2013)

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Predicate 4-Navigated Disc Prep Instrument and Capstone® Trials . (K150231, S.E. 06/16/2015)

IV. Device Description

Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.

V. Indications for Use

The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy or boney resection during spinal surgery. The Navigated T2 STRATOSPHERE™ templates are intended to be used to facilitate size selection of vertebral body replacement devices during spinal surgery. The Navigated Capstone™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for Elevate™ Spinal System, they are intended to be used to facilitate implant size selection.

The Navigated Probe is intended to be used during pedicle preparation. The Navigated Inserters are intended to be used for the placement of an implant.

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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.

Substantial Equivalence VI

Substantial equivalence for the Navigated T2 Stratosphere™ Inserters and Navigated Templates was established in terms of design features, performance testing, materials, sterilization method and indications for use as compared to the predicate devices. The subject devices also have an identical principle of operation and incorporate the same features to enable compatibility with StealthStation® System as the predicate devices. Based on the information provided within this submission, the subject devices have demonstrated to be substantially equivalent to the previously marketed predicate devices.

VII. Performance Data

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. Table 6.0 below summarizes the performance testing completed.

Test	Description
Navigation Accuracy Analysis	Confirmed navigated instrument accuracyin both 2D and 3D space.
Anatomical Simulated Use	Confirmed instrument functionality underexpected use conditions
Navigated Simulated Use	Confirmed navigation system functionalityunder expected use conditions

Table 6.0: Description of Performance Testing

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Test	Description
CAD Model Evaluation	Verified that the CAD models areaccurately reflected in the applicationsoftware.
Implant/ Instrument Mating Conditions	Verified that the instruments can beassembled with the appropriate devicesaccording to their intended use.
Spine Tools Package Functional Testing	Verified that the Spine Tools package hasmet the required interface needs of thespine application software

Conclusion VIII.

Based on the test results and additional supporting information provided in this premarket notification, Medtronic believes the subject devices, (Navigated T2 STRATOSPHERE™ Inserters and Navigated Templates) are at least as safe and effective as the legally marketed predicate devices:

. Primary Predicate-Navigated Elevate™ Inserter Disc Prep Instruments (K163581, S.E. 04/14/2017)
Predicate 2- T2 STRATOSPHERE™ Expandable Corpectomy System . (K173125, S.E. 12/20/2017)
Predicate 3-Navigated Capstone® Trials, Clydesdale® Trials, Capstone® . and Clydesdale® Inserter (K131425, S.E. 08/14/2013)
. Predicate 4-Navigated Disc Prep Instrument and Capstone® Trials (K150231, S.E. 06/16/2015)

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).