The Aleutian Spacer System is 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 of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord on and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even is the anserve of fusion for a prolonged period.

The Aleutian Spacer System is intended to be used with supplemental internal fixation. The supplemental fixation systems that may be used with this implant are the Denali System, Denali Deformity and Mesa Spinal system.

Device Description

The Aleutian Spacer System consists of a hollow tube structure manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes ond heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are desired to angage with the vertebral body end plates.

Materials: The devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (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 a partial vertebral body replacement device to assist in fusion and to provide support and stabilization of the thoraco-lumbar segments of the spine.

AI/ML Overview

The provided text is a 510(k) summary for the Aleutian Spacer System, a medical device. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and a study proving the device meets them as would be found in a performance study for a novel AI/software medical device.

Therefore, the requested information elements related to AI device performance evaluation (such as sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not present in this document.

Here's an analysis based on the provided text:

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

The document does not specify quantitative acceptance criteria or a formal performance study against such criteria. Instead, it emphasizes substantial equivalence to a predicate device. The "performance" reported is that the device is manufactured from medical-grade materials and its function is described.

Acceptance Criteria (Implied)	Reported Device Performance
Material safety and biocompatibility	Manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (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 as a vertebral body replacement device to assist in fusion	"The system functions as a partial vertebral body replacement device to assist in fusion and to provide support and stabilization of the thoraco-lumbar segments of the spine." Provides support and stabilization and restores height; designed to restore biomechanical integrity.
Compatibility with specified supplemental fixation systems	Intended to be used with Denali System, Denali Deformity, and Mesa Spinal system.
Substantial Equivalence to predicate device	No significant differences from other currently marketed systems that would adversely affect use. Substantially equivalent in design, function, material, and intended use to K051454.

2. Sample size used for the test set and the data provenance

Not applicable. This is not a performance study for an AI/software device involving a 'test set' of data. The "study" is a demonstration of substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No adjudication method was used as there was no test set requiring ground truth establishment.

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 a medical implant device, not an AI diagnostic or assistance tool. No MRMC study was conducted.

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

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

7. The type of ground truth used

Not applicable. The "ground truth" for a 510(k) for a physical implant device is typically established through engineering testing, material specifications, and comparison to existing, legally marketed devices (predicate devices).

8. The sample size for the training set

Not applicable. This is not an AI/software device requiring a training set.

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

Not applicable. No training set was used.

Summary

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K063399
FEB 23 2007

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

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

Submitter :

K2M. Inc. 751 Miller Drive SE Suite F I Leesburg, VA 20175 Contact Person : Richard W. Woods K2M, Inc. 751 Miller Drive SE. Suite F1 Leesburg, VA 20175 Telephone: 703-777-3155

Date Prepared: November 6, 2006

Tradename: Aleutian Spacer System Common Name: Vertebral Body Replacement Device Classification Name: Spinal Intervertebral Body Fixation Orthosis ( 888.3060 ) Product Code: MOP

3. Description of the device:

Function: The system functions as a partial vertebral body replacement device to assist in fusion and to provide support and stabilization of the thoraco-lumbar segments of the spine.

4. Intended Use:

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

Documentation was provided which demonstrated that the subject Aleutian Spacer System components are substantially equivalent to the components previously cleared in the Aleutian Spacer System of IQ(k) K051454 (SE 07/27/2005).

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

There are no significant differences between the Aleutian Spacer System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K2M, Inc. % Mr. Richard W. Woods 751 Miller Drive, SE - Suite F1 Leesburg, Virginia 20175

FEB 2 3 2007

Re: K063399

Trade/Device Name: Aleutian Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: January 23, 2007 Received: January 26, 2007

Dear Mr. Woods:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Richard W. Woods

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehum

Mark N. Melkerson Director Division of General, Restorative, and Neurologic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k): K063399

Device Name : Aleutian Spacer System

K063399 Indications For Use :

The Aleutian Spacer System is 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 Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The Aleutian Spacer System is intended to be used with supplemental internal fixation. The supplemental fixation system that may be used with this implant is the Denali Spinal System, Denali Deformity and Mesa Spinal system.

Prescription use	X
OR	Over-the-counter use
	( PER 21 CFR 801.109)
Te.
Di

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Concurrence of CDRH. Office of Device Evaluation ( ODE )

Obalare Bucheno

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K063399

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.