The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.

The SOVEREIGN™ Interbody System may be used as a stand-alone device or in conjunction with supplemental fixation.

When used as a stand-alone device, the SOVEREIGN™ interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.

Device Description

The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant is lens-shaped with three holes for placement of titanium screws. The SOVEREIGN™ Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the PEEK interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted.

The SOVEREIGN™ Spinal System interbody device is manufactured from PEEK Optima® (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.

AI/ML Overview

The provided document is a 510(k) summary for the SOVEREIGN™ Spinal System, specifically addressing an update to include modified screws. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format alongside performance data. Instead, it states that the testing was performed "in accordance with ASTM Standard F2077-03 'Test Methods for Intervertebral Body Fusion Devices'" and "ASTM Standard F2267-04 'Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression'." The acceptance criterion can be inferred to be meeting the performance requirements or demonstrating comparable performance to the predicate device as outlined by these ASTM standards.

The reported device performance is summarized as: "Based on the non-clinical testing conducted in accordance with ASTM F2077 and ASTM F2267 and additional supporting documentation provided in this premarket notification, the subject device demonstrated substantial equivalence to the predicate SOVEREIGN™ Spinal System (K091813 - S.E. 11/17/2009) in terms of design, intended use, indications for use and fundamental technology."

Acceptance Criteria (Inferred)	Reported Device Performance
Static Screw Push-out Testing: Conformity with relevant test methods (ASTM F2077-03) and performance comparable to predicate device.	Demonstrated substantial equivalence to predicate device based on non-clinical testing.
Static Compression Testing: Conformity with relevant test methods (ASTM F2077-03) and performance comparable to predicate device.	Demonstrated substantial equivalence to predicate device based on non-clinical testing.
Compression Fatigue Testing: Conformity with relevant test methods (ASTM F2077-03) and performance comparable to predicate device.	Demonstrated substantial equivalence to predicate device based on non-clinical testing.
Static Compression-Shear Testing: Conformity with relevant test methods (ASTM F2267-04) and performance comparable to predicate device.	Demonstrated substantial equivalence to predicate device based on non-clinical testing.
Compression-Shear Fatigue: Conformity with relevant test methods (ASTM F2267-04, inferred) and performance comparable to predicate device.	Demonstrated substantial equivalence to predicate device based on non-clinical testing.
Static Subsidence Testing: Conformity with relevant test methods (ASTM F2267-04) and performance comparable to predicate device.	Demonstrated substantial equivalence to predicate device based on non-clinical testing.
Analysis of Particulate from Fatigue Testing: Conformity with relevant test methods (ASTM Standard Practice for Characterization of Particles) and performance comparable to predicate device.	Demonstrated substantial equivalence to predicate device based on non-clinical testing.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of implants, screws tested). It simply lists the types of tests performed.

Regarding data provenance, this is a pre-market notification (510(k)) for a medical device, which involves bench testing (non-clinical) of the physical device. Therefore, the data provenance is from laboratory testing, not human subjects. There is no information on country of origin for the data as it pertains to clinical studies, nor is it retrospective or prospective in a clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable to the provided document. The "ground truth" for these types of mechanical tests is established by adherence to specified ASTM standard test methods and the resulting physical measurements (e.g., load, displacement). There are no human experts "establishing ground truth" in the way one would for diagnostic imaging.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

This question is not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation (e.g., radiology reads). For mechanical bench testing, results are objective measurements.

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

This question is not applicable. The SOVEREIGN™ Spinal System is a physical intervertebral fusion device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant to its regulatory submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This question is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

As mentioned, for this type of submission, the "ground truth" is defined by the objective physical measurements obtained during controlled laboratory testing following established ASTM standards. The goal is to demonstrate that the device performs mechanically as intended and is comparable to a predicate device.

8. The Sample Size for the Training Set

This question is not applicable. The SOVEREIGN™ Spinal System is not an AI algorithm, so there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for a physical medical implant.

Summary

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K110063 page 1 of 3

OCT - 4 2011

SOVEREIGN™ Spinal System 510(k) Summary Date Prepared: September 28, 2011

I.	Company:	Medtronic Sofamor Danek, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132
	Contact:	Sowmya ShettyRegulatory Affairs SpecialistTelephone: (901) 396-3133Fax: (901) 346-9738
II.	Product Name:	SOVEREIGNTM Spinal System
	Common Name:	Intervertebral Fusion Device
	Classification:	21 CFR 888.3080
	Product Code:	OVD

III. Description: The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant is lens-shaped with three holes for placement of titanium screws. The SOVEREIGN™ Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the PEEK interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted.

IV. Indications for Use: The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletaily mature and have had six months of non-operative treatment. These implants may be imipiante via a laparoscopic or an open anterior approach.

The SOVEREIGN™ Interbody System may be used as a stand-alone device or in conjunction with supplemental fixation.

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V. Summary of the Technological Characteristics:

The purpose of this 510(k) is to include modified screws to the SOVEREIGN™ Spinal System. The new subject, screw contains a larger major diameter near the head of the screw which will allow some interference between the screw and implant.

This system is cleared for indications from levels L2 to S1. The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The SOVEREIGN™ Spinal System is manufactured from PEEK Optima® (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.

The subject and the predicate SOVEREIGN™ Spinal System are substantially equivalent in terms of design, material, indications for use, intended use and fundamental technology.

VI. · Identification of Legally Marketed Devices:

The design features, materials, and indications for use of the subject SOVEREIGN™ Spinal System fixed angle screws are substantially equivalent to the previously cleared predicate SQVEREIGN™ Spinal System (K09) 8/3 -S.E. 11/17/2009).

VII. Discussion of the Non-clinical Testing:

Medtronic believes that documentation provided demonstrates that the subject SOVEREIGN™ Spinal System devices do not introduce new issues of safety or effectiveness. The following testing was performed on the subject device:

Static Screw Push-out Testing
Static Compression Testing in accordance with ASTM Standard F2077-03 "Test Methods for Intervertebral Body Fusion Devices"
Compression Fatigue Testing in accordance with ASTM Standard F2077-03 "Test Methods for Intervertebral Body Fusion Devices"
Static Compression-Shear Testing in accordance with ASTM Standard F2267-04 "Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression''
Compression-Shear Fatigue in accordance with ASTM Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression'

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Static Subsidence Testing in accordance with ASTM Standard Test Method for Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression" 7. Analysis of Particulate from Fatigue Testing in accordance with ASTM Standard Practice for Characterization of Particles"

Conclusion: VIII.

Based on the non-clinical testing conducted in accordance with ASTM F2077 and ASTM F2267 and additional supporting documentation provided in this premarket notification, the subject device demonstrated substantial equivalence to the predicate SOVEREIGN™ Spinal System (K091813 - S.E. 11/17/2009) in terms of design, intended use, indications for use and fundamental technology.

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Food and Drug Administration 10003 New Hampshire Avenue Document Control Room WO66-G609 Silver Spring, MD 20993-0002

Medtronic Sofamor Danek, Inc. Spinal and Biologies % Ms. Sownva Sheity 1800 Pyramid Place Memphis, Tennessee 38122

4 2011

Re: K110063

Trade/Device Name: Sovereign Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: September 06. 2011 Received: September 07. 2011

Dear Ms. Shetty:

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 fiability warranties. We remind you; however, that device labeling must be truthful and not misleading.

ff 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 vour device complies with other requirements of the Act

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Page 2 - Ms. Sowmva Sheity

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 Pari 807); labeling (21 CFR Pari 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/CDRH/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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Erinet Keith

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

Enclosure

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510(k) Number (if known): K110063

Device Name: SOVEREIGN™ Spinal System

Indications for Use:

The SOVEREIGN™ interbody system may be used as a stand-alone device or in conjunction with supplemental fixation.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K110063 510(k) Number_

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.