When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical JBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

Device Description

The Aleutian Spinal System consists of a hollow tube or horseshoe-shaped structures manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.

Materials: The implants are manufactured from Invibio™ PEEK OPTIMA® LT1 per ASTM F2026. Tantalum beads/ rods are to be made of Grade UNS R05200, UNS R05400 according to ASTM F560.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.

AI/ML Overview

The provided text describes a medical device submission (510(k)) for the Aleutian IBF System. It outlines the device's description, intended use, and substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way an AI/ML device submission would.

This document pertains to a traditional medical device (an intervertebral body fusion device made of PEEK, Tantalum) and its substantial equivalence to other physically similar medical devices already on the market. The evaluation criteria for such a device are primarily based on material properties, mechanical testing, and comparison with predicate devices, not on performance metrics like accuracy, sensitivity, or specificity against a ground truth dataset, which would be typical for AI/ML devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to the information contained in this 510(k) summary for a physical implant.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical Performance: Must demonstrate substantial equivalence in mechanical properties to predicate devices.	Finite Element Analysis (FEA): Performed to demonstrate that new components would not result in a new "worst-case device." Validation: FEA validated by static compression and static torsion testing per ASTM F2077.
Material Biocompatibility: Materials must be medical grade and biocompatible.	Materials: Invibio™ PEEK OPTIMA® LT1 per ASTM F2026; Tantalum beads/rods of Grade UNS R05200, UNS R05400 according to ASTM F560. (Implicitly meets biocompatibility standards by using approved medical-grade materials).
Clinical Intended Use Equivalence: Indications for use must be substantially equivalent to predicate devices.	Intended Use: - Cervical Intervertebral Body Fusion (C2-T1 for cervical disc disease) - Lumbar Intervertebral Body Fusion (L2-S1 for DDD with Grade I spondylolisthesis) - Vertebral Body Replacement (T1-L5 for tumors/trauma/fracture) (Substantially equivalent to predicates K082698, K071795, K100042).
Design/Function Equivalence: Design and function must be substantially equivalent to predicate devices.	Description: Hollow tube or horseshoe-shaped structures from PEEK with machined teeth. Function: Provides support and stabilization for spinal fusion. (Substantially equivalent to predicates K082698, K071795, K100042).

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

This information is not provided. The study conducted was primarily mechanical testing and finite element analysis, not a clinical study with a "test set" of patients or data in the typical sense.

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 this type of device and study. The ground truth for mechanical performance typically relies on established engineering principles, material standards (ASTM), and validated testing methods.

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

Not applicable.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

The "ground truth" in this context is based on established engineering standards (ASTM F2077 for static compression and torsion testing) and the mechanical performance and material properties of the predicate devices. The finite element analysis (FEA) was validated against these physical tests.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of this device and the provided study, which involves mechanical testing and FEA.

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

Not applicable.

Summary

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JAN 1 0 2012

510(k) Summary Aleutian IBF System K2M. Inc.

This safey and effectiveness summary for the Aleutian ISF System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

1. Submitter :	Contact Person :
K2M, Inc.	Nancy Giezen
751 Miller Drive SE	K2M, Inc.
Suite F1	751 Miller Drive SE, Suite F1
Leesburg, VA 20175	Leesburg, VA 20175
	Telephone: 703-777-3155
Date Prepared: January 10, 2011

2. Tradename:	Aleutian IBF System
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Fusion Device with Bone Graft, lumbar (Product Code: MAX)Intervertebral Fusion Device with Bone Graft, cervical (Product Code: ODP)Spinal Vertebral Body Replacement Device (Product Code: MQP)
Regulation Number:	888.3080, 888.3060
Device Class:	Class II

3. Description of the device:

Materials: The implants are manufactured from Invibio™ PEEK OPTIMA® LT1 per ASTM F2026. Tantalum beads/ rods are to be made of Grade UNS R05200, UNS R05400 according to ASTM F560.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.

4. Intended Use:

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KII3/38

5. Predicate or legally marketed devices which are substantially equivalent:

Documentation was provided which demonstrated that the subject Aleutian Spinal System components are substantially equivalent to devices previously cleared in K2M's Aleutian Spinal System (K082698), NuVasive's CoRoent System (K071795) and DiFusion Technology's (K100042).

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:

Finite element analysis (which was validated by static compression and static torsion testing per ASTM F2077) was performed to demonstrate that the components added to the Aleutian IBF System in this 510(k) submission would not result in a new worst-case device. The preclinical testing performed demonstrates that the subject devices are substantially equivalent to the predicates referenced.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

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

K2M, Inc. % Ms. Nancy Giezen Manager Regulatory Affairs 71 Miller Drive SE, Suite F1 Leesburg, Virginia 20175

JAN 1 0 2012

Re: K113138

Trade/Device Name: Aleutian Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP, MQP Dated: December 16, 2011 Received: December 19, 2011

Dear Ms. Giezen:

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 Part 801); medical device reporting (reporting of medical

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Page 2 – Ms. Nancy Giezen

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rico-relation daverse or child/S) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by steens over (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 n you about o specifica 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 note the regulations 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 I ba may over in ones gettirers, 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 vours.

Sincerely yours,
Euinel Keith

Sr 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): K/13138

Aleutian Spinal System Device Name :

Indications For Use :

When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

Prescription use X

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Over-the-counter use ( PER 21 CFR 801.109)

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 of Surgical, Orthopedic, and Restorative Devices

KI13138 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.