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 IIBF 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 IBF System consists of a hollow tube structure 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 devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA LTI (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads /rods to be 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 510(k) summary for the Aleutian IBF System, which is an intervertebral body fusion device. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a study proving those criteria are met for performance.

Here's an analysis based on the provided text:

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

The document does not explicitly state acceptance criteria in terms of clinical performance metrics (e.g., successful fusion rates, complication rates, improvement in patient-reported outcomes). Instead, the acceptance criteria appear to be related to the biomechanical equivalence of the device's design and materials to predicate devices.

Acceptance Criteria (Inferred)	Reported Device Performance
Biomechanical performance under compressive and torsional loading (per ASTM F2077) should not result in a new worst-case device compared to predicate devices.	Finite element analysis (FEA) 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 under both compressive and torsional loading when testing per ASTM F2077. This implies the new components met or exceeded the performance of the predicate device.
Materials of construction must be the same as previously cleared devices and meet established standards.	The subject Aleutian IBF System components are made of the same materials (Medical Grade PEEK OPTIMA LTI per ISO 10993-1 USP Class VI and ASTM F2026; Tantalum beads/rods per ASTM F560) as components previously cleared in K082698 and DePuy AcroMed Bengal (K081917).
Dimensions and configurations of components must be similar to predicate devices.	The subject Aleutian IBF System components are presented as having "similar dimensions and configurations" to components previously cleared in K082698 and DePuy AcroMed Bengal (K081917).

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

The document does not describe a clinical study with a test set of patients or specimens for performance evaluation. The "study" mentioned is a finite element analysis (FEA), which is a computational simulation. Therefore, there is no sample size in the traditional sense, nor is there data provenance in terms of country or retrospective/prospective collection from patients.

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. Since no clinical test set or human expert review of performance data is described, there's no mention of experts establishing ground truth for a test set. The FEA would have been designed and interpreted by engineers, but their number and qualifications are not provided here.

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

Not applicable. No test set requiring adjudication in the clinical sense is described.

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 not an AI-based device, and no MRMC study or comparative effectiveness study involving human readers is mentioned.

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

This is not an algorithm or AI device. The "standalone" performance, in this context, would be the structural integrity and biomechanical performance of the device itself, which was evaluated via FEA.

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

For the biomechanical evaluation (FEA), the "ground truth" is derived from established engineering principles, material properties (e.g., ASTM F2026 for PEEK, ASTM F560 for Tantalum), and the specified testing standard (ASTM F2077). This is a simulated ground truth based on accepted scientific and engineering methodologies, not biological ground truth from patients.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set. The FEA model is built based on design specifications and material properties, not trained on data.

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

Not applicable. As there is no training set for an AI model, there's no ground truth established for it.

Summary

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

This safety and effectiveness summary for the Aleutian IBF System is provided as required per Section 513(i(i)(i) of the Food, Drug and Cosm Act.

1. Submitter :

K2M, Inc. 751 Miller Drive SE Suite F1 Leesburg, VA 20175 Contact Person : Nancy Giezen K2M, Inc. 751 Miller Drive SE, Suite Fl Leesburg, VA 20175 Telephone: 703-777-3155

JUL 22 2010
Received

Date Prepared: May 7, 2010

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

3. Description of the device:

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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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.

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

Documentation was provided which demonstrated that the subject Aleutian IBF System components are made of the same materials with similar dimensions and configurations as components previously cleared in the Aleutian IBF System 510(k) K082698 and to the DePuy AcroMed Bengal (K081917).

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

Finite element analysis 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 under both compressive and torsional loading when testing per ASTM F2077.

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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 consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

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

K2M, Inc. % Ms. Nancy Giezen 751 Miller Drive SE, Suite F1 Leesburg, Virginia 20175

UUL & 9 2010

Re: K101302

Trade/Device Name: - Aleutian IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX, MQP Dated: June 23, 2010 Received: June 25, 2010

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, 3 rue 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 lindility 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 af the Act or any Federal statutes and regulations administered by other Federal agencies. Yourmust

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Page 2 - Ms. Nancy Giezen

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.

http://www.fda.gov/MedicalDevices/Resourcecenter/YourIndustry/default.htm.

Sincerely yours,

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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K101302

Page 1 of 1

510(k) Number (if known):

Device Name : Aleutian IBF System

Indications For Use :

"When used as a 'lumbar intervertebral-body-fusion-device,-the-Aleutian-implants-are-indicated-forspinal 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.

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 turnors 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.

Prescription use x OR

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 )

ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K101302

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.