T2 XVBR 1.5 SPINAL SYSTEM by MEDTRONIC SOFAMOR DANEK USA, INC.

The T2 ALTITUDE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 ALTITUDE™ Expandable Corpectomy Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.

Device Description

The T2 ALTITUDE™ Expandable Corpectomy System is a distractible system used in corpectomy procedures. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral or posterior approach using a minimally invasive technique or implanted through a lateral, posterior or anterior approach through a traditional open technique. T2 ALTITUDE™ Expandable Corpectomy System constructs may not be used with stainless steel supplemental fixation devices. The construct is not intended to be used as a stand alone device. Titanium constructs comprised from one of the following Medtronic spinal systems or their successors must be used with the T2 ALTITUDE™ Expandable Corpectomy System. The T2 ALTITUDE™ Expandable Corpectomy System contains an expandable centerpiece, which is made of titanium afloy, cobalt chrome, and nitinol and is available in multiple diameters and heights to accommodate the patient's anatomical requirements. The T2 ALTITUDE™ Expandable Corpectomy System's optional end caps may be attached to the T2 ALTITUDE™ Expandable Corpectomy System's expandable centerpieces as needed to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

AI/ML Overview

This document is a 510(k) summary for the T2 ALTITUDE™ Expandable Corpectomy System, a medical device. The information provided heavily focuses on the regulatory process of demonstrating substantial equivalence to predicate devices, rather than a clinical study establishing performance criteria.

Therefore, many of the requested categories (acceptance criteria, device performance, sample size, ground truth, expert qualifications, MRMC, standalone studies, training set details) cannot be extracted directly from the provided text. The document does not describe a study that "proves the device meets the acceptance criteria" in terms of clinical performance or accuracy in a way an AI/diagnostic device would. Instead, it asserts substantial equivalence to existing devices based on design and intended use.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as performance metrics in terms of clinical outcomes or accuracy. The "acceptance criteria" here implicitly refer to meeting the requirements for demonstrating substantial equivalence to predicate devices, primarily through design, materials, and intended use as described in the 510(k) process.
Reported Device Performance: No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, clinical success rate) are reported. The document focuses on the design and intended use being substantially equivalent to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable/not provided. This document describes a regulatory submission for substantial equivalence, not a clinical trial with a "test set" in the context of diagnostic or AI device performance evaluation.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/not provided. This is not a study assessing diagnostic accuracy or expert consensus.

4. Adjudication method for the test set

Not applicable/not provided.

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

No. This is not an AI device, and no MRMC study is mentioned.

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

No. This is a surgical implant, not an algorithm.

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

Not applicable in the context of device performance in a clinical study. The "truth" for this submission is the established safety and effectiveness of its predicate devices, which it claims to be substantially equivalent to.

8. The sample size for the training set

Not applicable/not provided. This is not an AI device.

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

Not applicable/not provided. This is not an AI device.

Summary of available information related to "acceptance criteria" and "study":

The "study" in this context is the 510(k) submission process, where the manufacturer (Medtronic Sofamor Danek, Inc.) provides documentation to the FDA to demonstrate substantial equivalence to already legally marketed devices.

Acceptance Criteria for 510(k) Substantial Equivalence:

The implicit "acceptance criteria" for this device, leading to its clearance, are that it is substantially equivalent to one or more predicate devices. This means it has:

The same intended use as a legally marketed predicate device.
The same technological characteristics as the predicate device, OR different technological characteristics that do not raise different questions of safety and effectiveness, and the company can demonstrate that the device is as safe and effective as the legally marketed device.

Reported "Device Performance" (in the context of substantial equivalence):

The document states:
"Documentation was provided which demonstrated that the T2 ALTITUDE™ Expandable Corpectomy System components are substantially equivalent to previously cleared devices such as the T2 XVBRTM Spinal System K071033 (S.E. 08/14/2007), K082112 (S.E. 08/27/2008), and K091883 (S.E. 09/21/2009)."

This is the core "proof" of the device meeting its regulatory acceptance criteria. The performance here refers to meeting the safety and effectiveness profile of its predicates, not a measured clinical outcome from a specific study within this document. The FDA's clearance (OCT 21 2010 letter) confirms that, based on the submitted documentation, the device is considered substantially equivalent.

Key Predicate Device(s):
T2 XVBRTM Spinal System (K071033, K082112, K091883)

In essence, for this type of medical device 510(k) submission, the "study" is the comparison against predicates, and the "acceptance criteria" are the regulatory guidelines for substantial equivalence. No clinical performance study data is presented in this summary document.

Summary

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T2 ALTITUDE™ Expandable Corpectomy System 510(k) Summary October 18, 2010

I.	Company:	Medtronic Sofamor Danek, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
	Contact:	Jennifer HackneyRegulatory Affairs SpecialistOCT 21 201
II.	Trade Name:	T2 ALTITUDE™ Expandable Corpectomy System
III.	Classification Name:	Spinal Intervertebral Body Fixation Orthosis (21 CFR888.3060)
IV.	Product Code:	MQP

Description: The T2 ALTITUDE™ Expandable Corpectomy System is a distractible V. system used in corpectomy procedures. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral or posterior approach using a minimally invasive technique or implanted through a lateral, posterior or anterior approach through a traditional open technique. T2 ALTITUDE™ Expandable Corpectomy System constructs may not be used with stainless steel supplemental fixation devices. The construct is not intended to be used as a stand alone device. Titanium constructs comprised from one of the following Medtronic spinal systems or their successors must be used with the T2 ALTITUDE™ Expandable Corpectomy System.

	Anterior	Posterior
VANTAGE® Anterior Fixation System	X
TSRH® Spinal System	X	X
CD HORIZON® Spinal System	X	X

The T2 ALTITUDE™ Expandable Corpectomy System contains an expandable centerpiece, which is made of titanium afloy, cobalt chrome, and nitinol and is available in multiple diameters and heights to accommodate the patient's anatomical requirements. The T2 ALTITUDE™ Expandable Corpectomy System's optional end

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caps may be attached to the T2 ALTITUDE™ Expandable Corpectomy System's expandable centerpieces as needed to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

VI. Indications for Use: The T2 ALTITUDE™ Expandable Corpectomy System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-LS) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 ALTITUDE™ Expandable Corpectomy Centerpiece may be used with or without optional modular endcaps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2 ALTITUDE™ Expandable Corpectomy System is intended to be used with allograft and/or autograft.
Substantial Equivalence: Documentation was provided which demonstrated that the VII. T2 ALTITUDE™ Expandable Corpectomy System components are substantially equivalent to previously cleared devices such as the T2 XVBRTM Spinal System K071033 (S.E. 08/14/2007), K082112 (S.E. 08/27/2008), and K091883 (S.E. 09/21/2009).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract shape.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Medtronic Sofamor Danek, Inc. % Ms. Jennifer Hackney Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132

OCT 2 1 2010

Re: K100976

Trade/Device Name: T2 ALTITUDE™ Expandable Corpectomy System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: October 1, 2010 Received: October 4, 2010

Dear Ms. Hackney:

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

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Page 2 - Ms. Jennifer Hackney

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcessforYou/Industry/default.htm.

Sincerely yours.

Clarence Phillip

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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OCT 2 1 2010

のお気になるので、この時には、その後は、その後は、この時には、こので、このことになる。

510(k) Number (if known): K100976

Device Name: T2 ALTITUDE™ Expandable Corpectomy System

all all and the are a comment of the

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR X Per 21 CFR 801.109

Over-The-Counter Use

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

KIDD976 510(k) Number_

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.