The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK™ device is to be used with supplemental fixation. The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open anterior approach.

Device Description

The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is designed for use as a cervical interbody fusion device. The device is manufactured from polyetheretherketone (PEEK OPTIMA™) and is to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The ANATOMIC™ PEEK CERVICAL FUSION SYSTEM consists of hemi-cylindrical cages of various widths, heights and depths. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Sofamor Danek ANATOMIC PEEK™ CERVICAL FUSION SYSTEM. This document describes a medical device and its clearance process, not an AI/ML powered device. As such, many of the requested fields are not applicable.

Here's the information that can be extracted or that is not applicable given the nature of the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Primary Goal of Submission: To seek clearance for the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an alternative to autogenous bone graft.	The published clinical outcomes demonstrated that the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, in anterior cervical interbody fusion procedures to treat patients diagnosed with cervical disc disease, poses no new risks to patients.
Device Design/Components: No changes to the actual implants or existing devices.	No changes were made to the existing devices, nor were any new components added to the system.
Safety: Device (with allogenic bone graft) poses no new risks to patients.	"Published clinical outcomes demonstrated that the use of allogenic bone graft...poses no new risks to patients."
Equivalency: The design features, materials, manufacturing, and sterilization methods are equivalent to the previously cleared ANATOMIC PEEK™ CERVICAL FUSION SYSTEM components.	The submission concluded that the device is substantially equivalent to legally marketed predicate devices, with the exception of broadening the indications to include allogenic bone graft.

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

Sample Size: Not explicitly stated. The document refers to "Published retrospective clinical data," but does not provide details on the number of patients or studies.
Data Provenance: "Published retrospective clinical data." The country of origin is not specified.

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)

Not applicable. This is a medical device clearance document, not an AI/ML study involving expert ground truth for interpretation. The "ground truth" here is established clinical outcomes data from published literature.

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

Not applicable. No expert adjudication method is described as this is not an AI/ML performance evaluation. The data is from published clinical studies.

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

Not applicable. This is a medical device, not an AI/ML system. No MRMC study was performed involving AI assistance.

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

Not applicable. This is a physical medical device (intervertebral body fusion device), not an algorithm.

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

Type of Ground Truth: "Published clinical outcomes." This would typically refer to patient outcomes data, such as fusion rates, symptom improvement, or adverse event rates as reported in the medical literature.

8. The sample size for the training set

Not applicable. This is a medical device and not an AI/ML system that undergoes a "training" process in the computational sense. The "training" in the context of device development would be the design and testing phases, which are not detailed as "training sets."

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

Not applicable. See point 8. The device's safety and effectiveness were established through non-clinical testing and referencing established clinical data of similar devices and procedures.

Summary

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Medtronic Sofamor Danek ANATOMIC PEEK™ CERVICAL FUSION SYSTEM 510(k) Summary - K130177

September 2013

Company:

Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738

2 3 2013

Contact:

Lee Grant Distinguished Regulatory Affairs Advisor

Proposed Proprietary Trade Name: ANATOMIC PEEK™ CERVICAL FUSION SYSTEM

Classification Name(s): Intervertebral Body Fusion Device (per 21CFR Section 888.3080); Product Code: ODP

Description: The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is designed for use as a cervical interbody fusion device. The device is manufactured from polyetheretherketone (PEEK OPTIMA™) and is to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The ANATOMIC™ PEEK CERVICAL FUSION SYSTEM consists of hemi-cylindrical cages of various widths, heights and depths. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Indications for Use: The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK™ device is to be used with supplemental fixation. The ANA TOMIC PEEK™ CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open anterior approach.

Summary of the Technological Characteristics: The purpose of this 510(k) submission is to seek clearance for the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an alternative to autogenous bone graft. No changes have been made to the actual implants.

Identification of Legally Marketed Devices: The components contained in this application are identical to those cleared in K112444 (SE 11/15/11) with the exception of

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the inclusion of allogenic cancellous and/or corticocancellous bone graft as an alternative bone graft material.

Discussion of Supporting Retrospective Clinical Data and Non-Clinical Testing: Published retrospective clinical data for the cervical interbody fusion devices similar to the ANATOMIC PEEK™ CERVICAL FUSION SYSTEM was provided in support of this application. The published clinical outcomes demonstrated that the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, in anterior cervical interbody fusion procedures to treat patients diagnosed with cervical disc disease as defined above poses no new risks to patients. No changes were made to the existing devices, nor were any new components added to the system. Therefore, no additional testing was required or performed.

Conclusion: The design features, materials used, manufacturing and sterilization methods are equivalent to the previously cleared ANATOMIC PEEK™ CERVICAL FUSION SYSTEM components with the exception of broadening the indications to include the aforementioned use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an alternative graft material.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is centered on the image and is the only element in the image. The text is likely part of a document or letterhead.

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 stylized caduceus symbol, which features a staff with a serpent entwined around it. Above the caduceus, there are three horizontal lines that curve upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WOlver Silver Spring, MD 20993-0002

September 23, 2013

Medtronic Sofamor Danek USA. Incorporated Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis. Tennessee 38132

Re: K130177

Trade/Device Name: ANATOMIC PEEK™ Cervical Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: August 7, 2013 Received: August 14. 2013

Dear Mr. Grant:

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. Iisting 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 mislcading.

ff your device is classified (see above) into cither 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Lee Grant

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin I. Keith

for

Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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September 2013

510(k) Number (if known): _ K130177

Device Name: ANATOMIC PEEK™ CERVICAL FUSION SYSTEM

Indications for Use:

The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of nonoperative treatment. The ANATOMIC PEEK™ device is to be used with supplemental fixation. The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open anterior approach.

Prescription Use x (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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.