The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) and cervical spine (C2-C7). The T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use in skeletally mature patients.

When used in the cervical spine, the T2 STRATOSPHERE® Expandable System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When used in the cervical spine, the T2 STRATOSPHERE™ Expandable Corpectomy System may not be used with optional modular end caps. When used in the cervical spine at one or two levels, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation cleared for use in the cervical spine.

When used in the thoracolumbar spine, the T2 STRATOSPHERE® Expandable System is used to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 STRATOSPHERE™ Expandable Corpectomy System may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracolumbar spine.

When used in the cervical spine, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. When used in the thoracolumbar spine, the T2 STRATOSPHERE™ Expandable Corpectomy System is intended for use with autograft or allograft as an adjunct to fusion. The T2 STRATOSPHERE™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical and/or thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

Device Description

The T2 STRATOSPHERE™ Expandable Corpectomy System is an adjustable vertebral body replacement device and features a self-adjusting end cap which provides continuous angulation between 0-8° in any direction to accommodate the patient's anatomical requirements. The T2 STRATOSPHERE™ Expandable Corpectomy devices for use in the cervical spine are restricted to 13mm diameter centerpieces. The T2 STRATOSPHERE™ Expandable Corpectomy System is made of titanium alloy. This device is inserted between two vertebral bodies in the thoracolumbar or cervical spine and is expanded to aid in the surgical correction and stabilization of the spine. The centerpieces are available in multiple heights.

The system also features modular end caps which are available in various angles and diameters that are only for use in the thoracolumbar spine.

The device is not intended to be used as a stand-alone implant.

AI/ML Overview

The provided text describes the T2 STRATOSPHERE™ Expandable Corpectomy System, a vertebral body replacement device. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to predicate devices, rather than a study evaluating an AI device or algorithm in the context of diagnostic accuracy. Therefore, many of the requested categories (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission.

However, I can extract information related to the device's performance testing which serves as the "study that proves the device meets the acceptance criteria" in this context.

Here's a breakdown of the relevant information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Pre-determined acceptance criteria for various mechanical tests according to ASTM F2077 and ASTM Draft Standard F-04.25.02.02.	The subject devices met the pre-determined acceptance criteria for all tests.
MRI compatibility established in accordance with "Guidance for Industry and FDA Staff – Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment."	The subject Ø13mm centerpieces are identical in material and dimensions to Predicate 6 (K173125), which was previously cleared for MRI compatibility. Therefore, they are justifiably classified as MR-Conditional.
Safety profile equivalent to predicate devices for cervical use.	A clinical literature review was performed, and it was determined that the safety profile for cervical use is equivalent to predicate devices.

Details on the "Study" (Device Performance Testing)

Sample size used for the test set and the data provenance: Not explicitly stated as a "sample size" in the context of patients or images, but rather the number of devices or components tested. The provenance is internal testing by Medtronic Sofamor Danek, USA Inc.
- Test methods and materials: The testing involved mechanical and MRI evaluations of the T2 STRATOSPHERE™ Expandable Corpectomy System devices and components (specifically Ø13mm centerpieces for MRI).
- Mechanical Tests: Static Compression, Compression Fatigue, Static Torsion, Torsion Fatigue, Expulsion.
- MRI Testing: Evaluated according to FDA guidance for passive implants.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth here refers to engineering specifications and regulatory standards (ASTM standards and FDA guidance documents).
Adjudication method for the test set: Not applicable in the traditional sense of clinical adjudication. The assessment of meeting acceptance criteria is based on direct measurement against defined engineering and regulatory standards.
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: Not applicable. This device is a surgical implant, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used:
- Mechanical Testing: Engineering specifications and performance requirements derived from ASTM F2077 and ASTM Draft Standard F-04.25.02.02.
- MRI Compatibility: FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment."
- Clinical Literature Review (for cervical use): Existing published clinical literature regarding the safety and performance of similar devices.
The sample size for the training set: Not applicable. This device does not use an AI algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) submission for a physical medical device, not an AI/ML powered medical device. Therefore, the "study" described focuses on engineering validation (mechanical and MRI testing) and a literature review to demonstrate substantial equivalence to previously cleared predicate devices, rather than clinical efficacy through traditional comparative studies involving human readers or AI algorithms.

Summary

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September 19, 2018

Medtronic Sofamor Danek, USA Inc. Kanesha Hines Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K181328

Trade/Device Name: T2 STRATOSPHERE™ Expandable Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP, PLR Dated: August 17, 2018 Received: August 20, 2018

Dear Ms. Hines:

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

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

Sincerely,

Brent Showalter -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) K181328

Device Name

T2 STRATOSPHERETM Expandable Corpectomy System

Indications for Use (Describe)

The T2 STRATOSPHERE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) and cervical spine (C2-C7). The T2 STRATOSPHERE™ Expandable Corpectorny System is intended for use in skeletally mature patients.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

MEDTRONIC T2 STRATOSPHERE™ Expandable Corpectomy System

September 2018

Submitter:	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133Fax: (901) 346-9738
Contact Person	Kanesha HinesRegulatory Affairs SpecialistDirect Telephone: (901)399-2670
Date Prepared	September 19, 2018
Name of Device	T2 STRATOSPHERE™ Expandable Corpectomy System
Common Name	Spinal Vertebral Body Replacement Device
ClassificationName	Spinal Intervertebral Body Fixation Orthosis: 21 CFR 888.3060
Classification	Class II
Product Codes	MQP, PLR 21 CFR 888.3060
Predicate Devices	There are six (6) Predicates.Primary Predicate 1- Globus FORTIFY CORPECTOMYSPACERS (K162315, S.E. 11/09/2017)Predicate 2- Aesculap MODULIFT VBR SYSTEM (K172032. S.E.11/20/2017)Predicate 3- - Nuvasive X-CORE MINI CERVICALEXPANDABLE VBR System (K151651, S.E. 09/25/2015)Predicate 4- Osteotech VBR (K012254, S.E. 10/16/2001)Predicate 5- Medtronic T2 ALTITUDE™ EXPANDABLECORPECTOMY System (K100976, S.E. 10/21/2010)Predicate 6- Medtronic T2 STRATOSPHERE™ EXPANDABLECORPECTOMY System (K173125, S.E. 12/20/2017)The predicates have not been subject to a design related recall.
Description of Devices	The T2 STRATOSPHERE™ Expandable Corpectomy System isan adjustable vertebral body replacement device and features aself-adjusting end cap which provides continuous angulationbetween 0-8° in any direction to accommodate the patient'sanatomical requirements. The T2 STRATOSPHERE™Expandable Corpectomy devices for use in the cervical spine arerestricted to 13mm diameter centerpieces. The T2STRATOSPHERE™ Expandable Corpectomy System is made oftitanium alloy. This device is inserted between two vertebralbodies in the thoracolumbar or cervical spine and is expanded toaid in the surgical correction and stabilization of the spine. Thecenterpieces are available in multiple heights.The system also features modular end caps which are availablein various angles and diameters that are only for use in thethoracolumbar spine.The device is not intended to be used as a stand-alone implant.
Indications for Use	The T2 STRATOSPHERE™ Expandable Corpectomy Systemis a vertebral body replacement system intended for use in thethoracolumbar spine (T1-L5) and cervical spine (C2-C7). TheT2 STRATOSPHERE™ Expandable Corpectomy System isintended for use in skeletally mature patients.When used in the cervical spine, the T2 STRATOSPHERE®
When used in the thoracolumbar spine, the T2STRATOSPHERE® Expandable System is used to replace acollapsed, damaged, or unstable vertebral body due to tumor ortrauma (i.e. fracture). The T2 STRATOSPHERE™ ExpandableCorpectomy System may be used with or without optionalmodular end caps which accommodate individual anatomicrequirements. The device is to be used with supplementalfixation cleared for use in the thoracolumbar spine.
When used in the cervical spine, the T2 STRATOSPHERE™Expandable Corpectomy System is intended for use withautograft or allogenic bone graft comprised of cancellous and/orcorticocancellous bone graft as an adjunct to fusion. When usedin the thoracolumbar spine, the T2 STRATOSPHERE™Expandable Corpectomy System is intended for use withautograft or allograft as an adjunct to fusion. The T2STRATOSPHERE™ Expandable Corpectomy System is alsointended to restore the integrity of the spinal column even in theabsence of fusion for a limited time in patients with advancedstage tumors involving the cervical and/or thoracolumbar spinein whom life expectancy is of insufficient duration to permitachievement of fusion, with bone graft used at the surgeon'sdiscretion.
Comparison ofTechnologicalCharacteristicswith the PredicateDevices	T2 STRATOSPHERE™ Expandable Corpectomy System ImplantsThe primary predicate is Globus FORTIFY CORPECTOMYSPACERS (K162315, S.E. 11/09/2017). The subject implants havesimilar intended use, indications, and same materials as PrimaryPredicate 1 (K162315, S.E. 11/09/2017) and Predicate 2 (K172032,S.E. 11/20/2017). The subject and all predicate devices have similarscientific fundamental technology.
	Performance Data
Design verification testing for the subject implants was completed inaccordance with- ASTM F2077, Test Methods For Intervertebral Body FusionDevices- ASTM Draft Standard F-04.25.02.02, Static Push-out Test Methodfor Intervertebral Body Fusion DevicesThe tests completed were:- Static Compression- Compression Fatigue- Static Torsion- Torsion Fatigue- ExpulsionThe subject devices met the pre-determined acceptance criteria forall tests. Therefore, Medtronic believes design verification testingdemonstrated that the subject implants are substantially equivalent tothe predicate Medtronic devices.MRI TestingMRI testing was conducted in accordance with the Guidance forIndustry and FDA Staff – Establishing Safety and Compatibility ofPassive Implants in the Magnetic Resonance (MR) Environment.The MRI testing was submitted and cleared in the Predicate 6(K173125, S.E. 12/20/2017) submission.The subject and Predicate 6 Ø13mm centerpieces are identical inmaterial and dimensions. Therefore, the subject Ø13mm centerpiecesdo not present a new worst case and are justifiably classified as MR-Conditional.
Performance Data	A clinical literature review was performed to support the use of thesubject devices in the cervical spine. The risks of cervical use wereidentified and mitigated through design and surgical technique.Based on clinical literature, it was determined that the safety profileof the subject devices is equivalent to that of the predicate devices.
Conclusion	Based on the test results and additional supporting informationprovided in this premarket notification, Medtronic believes thesubject devices are at least as safe as and effective as the legallymarketed predicate devices:• Primary Predicate 1- Globus FORTIFY Spacers(K162315, S.E. 11/09/2017)
• Predicate 2- Aesculap MODULIFT VBR System (K172032, S.E. 11/20/2017)
• Predicate 3- NuVasive X-CORE MINI (K151651, 09/25/2015)
• Predicate 4- Osteotech VBR (K012254, 10/16/2001)
• Predicate 5- Medtronic T2 ALTITUDE™ Expandable Corpectomy System (K100976, S.E. 10/21/2010)
• Predicate 6- Medtronic T2 STRATOSPHERE™ Expandable Corpectomy System (K173125, S.E. 12/20/2017)

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Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.