The PERIMETER® C Spinal System is intended to be used for anterior 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 who have had six weeks of non-operative treatment. 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. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.

Device Description

The PERIMETER® C Spinal System consists of spacers of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures. This device is offered in PEEK-OPTIMA® (i.e., POLYETHERETHERKETONE) with tantalum markers. Medical grade titanium implants and medical grade PEEK implants may be used together. Never use titanium or titanium alloy implants with stainless steel in the same construct.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the PERIMETER® C Spinal System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Mechanical Test Standards:	Met:
Static Torsion (per ASTM F2077-03)	Results indicate acceptance criteria were met.
Static Compression (per ASTM F2077-03)	Results indicate acceptance criteria were met.
Dynamic Compression (per ASTM F2077-03)	Results indicate acceptance criteria were met.
Dynamic Torsion (per ASTM F2077-03)	Results indicate acceptance criteria were met.
Static Compression-Shear (per ASTM F2077-03)	Results indicate acceptance criteria were met.
Subsidence (per ASTM F2267-04)	Results indicate acceptance criteria were met.
Expulsion Testing	Results indicate acceptance criteria were met.
Overall Goal:	Met:
Demonstrate substantial equivalence to predicate devices	Substantial equivalence demonstrated through mechanical tests and engineering rationale.

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

The provided 510(k) summary focuses on non-clinical mechanical testing for the PERIMETER® C Spinal System. Therefore, there is no "test set" in the context of patient data (e.g., medical images, clinical outcomes).

Sample Size for Test Set: Not applicable, as this refers to mechanical test specimens, not patient data. The document does not specify the number of individual test articles (implants) used for each mechanical test.
Data Provenance: Not applicable. The data comes from in-vitro mechanical testing, not a country of origin for patient data. This is a retrospective analysis of device performance against established ASTM standards.

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

Not applicable. For mechanical testing, the "ground truth" is defined by the established ASTM standards and engineering principles. The results are compared against these predetermined criteria, not against expert human interpretations of patient data.

4. Adjudication Method for the Test Set

Not applicable. Mechanical test results are measured and directly compared to quantitative acceptance criteria defined by the ASTM standards. There is no need for adjudication as you would have for subjective interpretations of clinical findings.

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 submission is for a medical implant (spinal system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI is not relevant.

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

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used for demonstrating the device's performance against its acceptance criteria is:

Standardized Mechanical Test Criteria: Specifically, the requirements outlined in ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices) and ASTM F2267-04 (Standard Test Method for Evaluating the Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression).
Engineering Rationale: Complementary engineering analysis to support the mechanical test results.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI-driven device requiring data for model training.

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

Not applicable. As there is no training set, there is no ground truth to be established for it.

Summary

{0}------------------------------------------------

K100967

AUG - 5 2011

PERIMETER® C Spinal System 510(k) Summary August 2011

Medtronic Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 (901) 346-9738 Fax: Brad Sheals Contact:

Proposed Proprietary Trade Name: PERIMETER® C Spinal System II.

Classification Name(s): Intervertebral Body Fusion Device (Per 21 CFR Section III. 888.3080); Product Code(s): ODP
Description: The PERIMETER® C Spinal System is intended to be used for anterior IV. 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. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and implanted via an open, anterior approach. See the package insert for labeling limitations.

Senior Regulatory Affairs Specialist

This device is offered in PEEK-OPTIMA® (i.e., POLYETHERETHERKETONE) with tantalum markers.

Medical grade titanium implants and medical grade PEEK implants may be used together. Never use titanium or titanium alloy implants with stainless steel in the same construct.

Indications for Use: The PERIMETER® C Spinal System is intended to be used for V. anterior 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 who have had six weeks of non-operative treatment. 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. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.
sheet 1 of 2

{1}------------------------------------------------

Identification of the Legally Marketed Predicate Devices Use to Claim Substantial VI. Equivalence: The design features, materials and indications for use of the PERIMETER® C Spinal System are substantially equivalent to the previously cleared predicate devices (i.e., K073285, S.E. 05/15/2008; K094042, S.E. 06/30/2010 and K100214, S.E. 06/25/2010). The safety and effectiveness of the subject device is adequately supported by documentation within this premarket notification.

Brief Discussion of the Non-Clinical Tests Submitted VII.

For a determination of substantial equivalence, the following non-clinical mechanical tests were performed:

Static Torsion Testing per ASTM F2077-03
Static Compression Testing per ASTM F2077-03
Dynamic Compression Testing per ASTM F2077-03
Dynamic Torsion Testing per ASTM F2077-03
Static Compression- Shear per ASTM F2077-03
Subsidence Testing per ASTM F2267-04
Expulsion Testing

Conclusions Drawn from the Non-Clinical Tests VIII.

Results of non-clinical mechanical tests and an engineering rationale indicate that the acceptance criteria were met demonstrating substantial equivalence of the subject device to the listed predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MI) 20993-0002

Medtronic Sofamor Danek USA % Mr. Brad Sheals Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132

AUG 5 2011

Re: K100967

Trade/Device Name: PERIMETER® C Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 28, 2011 Received: July 29, 2011

Dear Mr. Sheals:

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

{3}------------------------------------------------

Page 2 - Mr. Brad Sheals

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark McKesson

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

Enclosure

{4}------------------------------------------------

l00967

510(k) Number (if known): K100967

Device Name: PERIMETER® C Spinal System

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 -------

Ame H. H.

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

510(k) Number

sheet 1 of 1

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.