The Frontier LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation (i.e. lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

Device Description

The Frontier LLC is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and includes associated instrumentation. The body of the implant includes size ranges of 8-16mm wide, 18mm high and lengths of 40-60mm. There are five sizes of locking plates and 5 sizes of corresponding screws. Implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and PEEK Optima LT1. The implant is available with no lordosis built into the implant design.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, specifically an interbody fusion device. The focus is on demonstrating substantial equivalence to predicate devices rather than proving specific clinical efficacy through the detailed acceptance criteria and study designs typically associated with novel drug or high-risk device approvals.

Therefore, the requested information elements (1-9) which are typically relevant for AI/software-as-a-medical-device (SaMD) or clinical trial-based approvals, are largely not applicable in this context. This submission relies heavily on bench testing and cadaveric testing to show that the new device performs similarly to existing, legally marketed devices.

Here's how each point applies to the provided information:

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

Acceptance Criteria	Reported Device Performance
Material Composition:	Implants manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and PEEK Optima LT1.
Size Ranges:	Implant body: 8-16mm wide, 18mm high, 40-60mm long. Five sizes of locking plates and 5 sizes of corresponding screws.
Mechanical Performance (Bench Testing):	Static and dynamic axial compression (following ASTM F2077-03). Static and dynamic compression shear (following ASTM F2077-03). Static torsion (following ASTM F2077-03). Subsidence testing (following ASTM F2267-04). Expulsion testing (following a recognized protocol to allow comparative evaluation).
Implantation Safety & Stability (Cadaveric Testing):	Demonstrate implantation safety, stability, and freedom from loosening or dislodgement of the implant.

Explanation: The acceptance criteria are implicit in the tests performed, which aim to demonstrate that the device's characteristics (materials, dimensions, mechanical strength, stability) are comparable to the predicate devices and suitable for its intended use. The "reported device performance" reflects that the device successfully met the requirements of these tests, confirming its substantial equivalence.

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 for Bench Testing: Not explicitly stated for each test (e.g., number of specimens tested for axial compression). Common for mechanical testing, a sufficient number of samples would be chosen to ensure statistical significance where applicable or to meet the requirements of the ASTM standards.
Sample Size for Cadaveric Testing: Not explicitly stated (e.g., number of cadaveric spines/specimens).
Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by or for Frontier Medical, LLC. This is pre-clinical data, not patient-derived data, therefore "country of origin of the data" and "retrospective or prospective" are not applicable in the patient data sense. The testing is essentially prospective in that it's designed and executed to evaluate the new device.

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. For a 510(k) submission based on bench and cadaveric testing of a mechanical implant, "ground truth" as it relates to expert clinical opinion or diagnostic accuracy is not relevant. The "ground truth" for the performance is derived directly from physical measurements and observations during the standardized mechanical and cadaveric tests. While engineers and possibly surgeons (for cadaveric implantation) would be involved, they are performing objective measurements and procedures, not establishing a "ground truth" from subjective assessment.

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

Not Applicable. This concept is relevant for studies involving human assessment of images or clinical outcomes where discrepancies need resolution. For bench and cadaveric testing, results are objective measurements or observations; "adjudication" in this sense isn't used. Test procedures follow established standards (e.g., ASTM F2077-03, ASTM F2267-04) for consistency.

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 type of study is specific to diagnostic aids, often AI-powered, where human readers interpret medical images. The Frontier LLC Interbody Fusion Device is a physical implant for spinal fusion.

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

Not Applicable. This is relevant for AI algorithms. The Frontier LLC Interbody Fusion Device is a physical medical implant.

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

Ground Truth for Bench Testing: Established by adherence to industry-standard ASTM test methods and direct physical measurements (e.g., load, displacement, cycles to failure). The "ground truth" is the quantitative result of these standardized mechanical tests.
Ground Truth for Cadaveric Testing: Established through direct observation and qualitative assessment of implantation safety, stability, and freedom from loosening/dislodgement in human cadaveric spines, likely performed by skilled surgeons or biomechanical engineers.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of an AI algorithm or statistical model for this device. The device itself is directly tested.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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KII2700

NOV 1 200

510(k) SUMMARY Frontier Medical's Lateral Locking Cage (LLC) Interbody Fusion Device

Date: Contact: Trade Name: Product Class: Classification: Product Codes:

May 31, 2012 Matthew Songer, M.D. Frontier Medical, LLC President 512 Fourth Streets 906-232-1200 Gwinn, MI 49841 Frontier LLC Interbody Fusion Device Class II 21 CFR §888.3080 Orthosis, intervertebral body fusion device OVD 87

Name of Device and Name/Address of Sponsor

Frontier Medical, LLC 512 Fourth Street Gwinn, MI 49841

Panel Code:

Common or Usual Name Intervertebral body fusion device

Predicate Devices

The Frontier LLC was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices are the CoRoent XL-Keeled Device (K081611), and the Medtronic Clydesdale (K100175).

Intended Use / Indications for Use

Technological Characteristics

Performance Data

Static and dynamic axial compression, static and dynamic compression shear, and static torsion were completed following ASTM F2077-03. Subsidence was tested following ASTM F2267-04. Expulsion testing was conducted following a recognized protocol to allow comparison evaluation of intervertebral

•

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body fusion device assemblies, and characterize their resistance to expulsion. The above pre-clinical testing performed on the Frontier LLC Interbody Fusion Device indicated that the Frontier LLC Interbody Fusion Device is substantially equivalent to the predicate devices and is adequate for the intended use.

Cadaveric testing was conducted to demonstrate implantation safety, stability, and freedom from loosening or dislodgement of the implant.

Summary:

The Frontier LLC Interbody Fusion Device and predicate devices have intended use, to provide mechanical stability in the lumbar disc space to facilitate biologic fusion. The indications for use of the Frontier LLC Interbody Fusion Device are the same as the predicate devices. Moreover, the device is very similar in its size to the predicate device. The materials used are also the same as in the predicate device. Furthermore, bench testing and cadaveric demonstrates that these differences do not adversely impact device performance.

Conclusion:

Frontier Medical Devices concludes that the LLC Interbody Fusion Device is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of a human figure embracing the world, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the emblem. The emblem is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Letter Date: November 1, 2012

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

Frontier Medical Devices, Incorporated % Silver Pine Consulting, LLC Mr. Rich Jansen, Pharm. D. Regulatory Consultant 13540 Guild Avenue Apple Valley, Minnesota 55124

Re: K112700

Trade/Device Name: Frontier Lateral Locking Cage (Frontier LLC) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: October 19, 2012 Received: October 19, 2012

Dear Mr. Jansen:

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 - Mr. Rich Jansen, Pharm. D.

CFR Part 807); labeling (21 CFR Part 801); medical device 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/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,

Mark N. Melkerson

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K112700 Device Name: Frontier Lateral Locking Cage (Frontier LLC)

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrenee of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

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

510(k) Number

K112700

Page 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.