The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 variety of open or minimally invasive approaches. These approaches include anterior, lateral, and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

Device Description

The PERIMETER® Interbody Fusion Device consists of interbody cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

AI/ML Overview

This 510(k) premarket notification for the PERIMETER® Interbody Fusion Device primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through material and design similarity, and an engineering rationale. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of diagnostic accuracy, which would be typical for an AI-powered diagnostic device.

However, I can extract the information relevant to performance data as presented in the document, which in this case pertains to biocompatibility and mechanical testing for a physical medical device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description of Acceptance Criteria	Reported Device Performance and How it Meets Criteria
Biocompatibility	The materials used in the device (implants and instruments) must be biocompatible for long-term implantation in the human body. (Implied criterion based on general medical device regulations and the "safe and effective use" claim).	Device Performance: The implants are made from Titanium alloy. The non-sterile instruments are manufactured from stainless steel. Meets Criteria: The document states: "The titanium alloy and stainless steel material used for the subject PERIMETER® Interbody Fusion Devices implants and instruments (trials) have a long clinical history of safe and effective use in similar commercially available medical devices. Therefore, no additional biocompatibility testing is required." This indicates that the materials themselves, based on prior use and regulatory acceptance, are deemed biocompatible, and no new testing was necessary to prove this.
Mechanical Testing	The device must demonstrate mechanical equivalence to predicate devices, ensuring it can withstand the intended physical stresses in the spinal environment without new worst-case scenarios. (Implied criterion for interbody fusion devices, often aligned with FDA guidance for spinal systems).	Device Performance: The subject devices (new PERIMETER® Interbody Fusion Devices) incorporate additional interbody cages manufactured from medical grade titanium alloy (Ti-6Al-4V ELI) that are packaged sterile, and new instruments (trials). Meets Criteria: The document states: "In accordance with, Guidance for Industry and FDA Staff - Spinal System - 510(k)'s", Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. It was determined that subject devices do not represent a new worst case. Therefore, an engineering rationale was used to demonstrate substantial equivalence. As a new worst case has not been indicated and an engineering rationale was deemed adequate to prove equivalence to the predicate device, no additional mechanical testing is required." This indicates that through an engineering rationale, rather than new physical testing, the device was determined to be mechanically equivalent to existing, cleared devices and did not introduce new safety concerns.

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

This document describes a spinal implant (interbody fusion device), not an AI-powered diagnostic device or a system that uses test sets in the traditional sense of AI/software validation. Therefore, there is no information provided about:

Sample size used for a "test set."
Data provenance (country of origin, retrospective/prospective).

The "performance data" provided refers to material characteristics and mechanical equivalence reasoning, not data from patient studies.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. This device is a physical implant, and its regulatory submission is based on material science, mechanical properties, and equivalence to predicate devices, not on the interpretation of medical images or patient data by experts for establishing ground truth in an AI context.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of an AI algorithm or diagnostic performance being evaluated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI device or a diagnostic tool that would typically undergo an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical implant, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this type of device is established through:

Established Material Standards: Compliance with ASTM F136 for Titanium Alloy and the "long clinical history of safe and effective use" for both titanium alloy and stainless steel.
FDA Guidance Documents: Adherence to "Guidance for Industry and FDA Staff - Spinal System - 510(k)'s" for mechanical evaluation.
Predicate Device Performance: The safety and effectiveness of the existing predicate devices (K111525 and K090353) serve as the established "ground truth" or benchmark for demonstrating substantial equivalence. The claim is that the new device is "as safe and effective" as the predicates.

8. Sample Size for the Training Set

Not applicable, as this is not an AI device.

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

Not applicable, as this is not an AI device.

Summary

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Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medtronic Sofamor Danek USA, Incorporated Ankit K. Shah Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

March 7, 2016

Re: K160418

Trade/Device Name: PERIMETER® Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 15, 2016 Received: February 16, 2016

Dear Ankit Shah:

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 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K160418

Device Name

PERIMETER® Interbody Fusion Device

Indications for Use (Describe)

The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral, and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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PERIMETER® Interbody Fusion Device 510(k) Summary February 2016

I.	Submitter:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, TN 38132Telephone: (901)396-3133Fax: (901) 346-9738
	Contact:	Ankit K. ShahSenior Regulatory Affairs Specialist
	Date Prepared:	February 25, 2016
II.	Device
	Name of Device:	PERIMETER® Interbody Fusion Device
	Common or Usual Name:	Intervertebral body fusion device (21 CFR 888.3080)
	Classification Name:	Intervertebral fusion device with bone graft,lumbar
	Regulatory Class:	Class II
	Product Code:	MAX
III.	Predicate Device	K111525 (S.E. 08/24/2011) PERIMETER® InterbodyFusion Device – Primary Predicate
		K090353 (S.E. 09/29/2009) – PERIMETER® InterbodyFusion Device - Additional Predicate
		The predicates device have not been subjectto a design related recall.

IV. Device Description:

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The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.

Indications for Use: v.

VI. Comparison of Technological Characteristics with Predicate Device

The subject PERIMETER® Interbody Fusion Devices have identical: indications for use, intended use, design, material (Titanium Alloy per ASTM F136), levels of attachment and fundamental scientific technology as the PERIMETER® Interbody Fusion Devices predicate previously cleared by the FDA in K111525 (S.E. 08/24/2011). Additionally, the new PERIMETER® Interbody Fusion Devices are provided sterile identical to that of the predicate 2 devices found in K090353 (S.E. 09/29/2009). The purpose of this submission is to include additional interbody cages manufactured from medical grade titanium alloy (Ti-6Al-4V ELI) that are packaged sterile via gamma irradiation.

Instruments (trials) are also being added to provide appropriate sizing options for implant sizes already cleared in predicate 510(k)s. The non-sterile trials are manufactured using stainless steel and have identical indications for use, intended use, materials and design to the instruments cleared under the predicate 510(k)s.

VII. Performance Data

The following performance data are provided in support of the substantial equivalence determination.

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Biocompatibility

Identical to the primary predicate devices the implants in the subject PERIMETER® Interbody Fusion Device are made using Titanium alloy.

The non-sterile instruments are manufactured using stainless steel and are identical to the materials used for the instruments cleared under predicate submissions.

The titanium alloy and stainless steel material used for the subject PERIMETER® Interbody Fusion Devices implants and instruments (trials) have a long clinical history of safe and effective use in similar commercially available medical devices. Therefore, no additional biocompatibility testing is required.

Mechanical Testing

In accordance with, Guidance for Industry and FDA Staff - Spinal System - 510(k)'s", Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. It was determined that subject devices do not represent a new worst case. Therefore, an engineering rationale was used to demonstrate substantial equivalence. As a new worst case has not been indicated and an engineering rationale was deemed adequate to prove equivalence to the predicate device, no additional mechanical testing is required.

Conclusion VIII.

Based on a risk analysis, engineering rationale, and additional supporting documentation provided in this pre-market notification, the subject PERIMETER® Interbody Fusion Devices (implants and instruments) are as safe and effective as the following predicates K111525 (S.E. 08/24/2011) PERIMETER® Interbody Fusion Device – Primary Predicate and K090353 (S.E. 09/29/2009) - PERIMETER® Interbody Fusion Device -Predicate 2.

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.