The APEX Spine System intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).
The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis). tumor, and previous failed fusion (pseudo-arthrosis).
The APEX Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

Device Description

The APEX Spine System is a rod-based system designed to interface with various spinal anatomies. The system consists of spinal rods, monoaxial screws, polyaxial screws, bolt-type pedicle screws, various lateral connectors, and various cross (transverse) connectors.

AI/ML Overview

The provided text describes the APEX Spine System, a spinal fixation system, and its substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, the information requested regarding acceptance criteria, study details, ground truth establishment, sample sizes for training/test sets, expert involvement, and MRMC studies, is not applicable to this submission. The submission pertains to a traditional medical device (spinal implants) and relies on mechanical and dynamic testing for performance data, as opposed to clinical study data involving human readers or AI algorithms.

Here's a breakdown of the relevant information from the provided text for a traditional medical device:

1. Acceptance Criteria and Device Performance (for this traditional device):

Acceptance Criteria	Reported Device Performance
Mechanical and dynamic performance demonstrating equivalence or superiority to predicate devices.	"The test results demonstrate that the mechanical performance of the APEX Spine System is at least comparable to, if not better than, those of the predicate devices."

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

Not applicable. This submission describes a physical medical device (spinal implants) and its mechanical and dynamic testing, not a study involving a test set of data. The "test set" here refers to the physical samples of the device and predicate devices used in mechanical testing.

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

Not applicable. Ground truth is not established by experts in the context of mechanical testing for a physical device. Performance is determined by objective engineering standards and measurements.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical data analysis, not for mechanical testing of a physical device.

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. An MRMC study is relevant for AI/ML-powered diagnostic or assistive devices involving human readers. This submission describes a physical spinal implant.

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

Not applicable. This question pertains to AI algorithm performance.

7. The type of ground truth used:

Not applicable/Objective Mechanical Measurements. For this device, "ground truth" would be the scientifically established physical and mechanical properties and performance standards for spinal fixation systems.

8. The sample size for the training set:

Not applicable. Training sets are used for machine learning algorithms.

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

Not applicable. Training sets and their ground truth are specific to machine learning.

Summary of the Study and Device Proof:

The APEX Spine System's compliance is demonstrated through mechanical and dynamic testing. The study's objective was to show that the device's performance is substantially equivalent to legally marketed predicate devices. The performance data explicitly states: "The test results demonstrate that the mechanical performance of the APEX Spine System is at least comparable to, if not better than, those of the predicate devices." This statement serves as the proof that the device meets the implicit acceptance criterion of being mechanically equivalent or superior to existing, cleared devices.

The basis for substantial equivalence also relies on similarities in design, material, manufacturing standards, intended use, indications, and contraindications compared to the predicate devices. The fundamental scientific technology is described as "identical to previously cleared systems."

Summary

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510(k) SUMMARY

SUBMMITTER:	SpineCraft2215 Enterprise DriveWestchester, IL 60154-5819	DEC 2 2 2006
CONTACT PERSON:	Ami Akallal-Asaad, Regulatory Affairs Manager
DATE PREPARED:	November 02, 2006
CLASSIFICATION NAME:	Spinal Interlaminal Fixation Orthosis - 888.3050Spinal Pedicle Fixation - 888.3070(b)(1)
PROPRIETARY NAME:	APEX Spine System
COMMON NAME:	Spinal Fixation System
PRODUCT CODE:	KWP, MNH, MNI
CLASSIFICATION PANEL:	87
PRODUCT DESCRIPTION:	The APEX Spine System is a rod-based system designed tointerface with various spinal anatomies. The system consistsof spinal rods, monoaxial screws, polyaxial screws, bolt-typepedicle screws, various lateral connectors, and various cross(transverse) connectors.
MATERIALS:	The APEX Spine System is manufactured from implant gradetitanium Alloy (Ti-6Al-4V) conforming to ASTM standard F-136and ISO 5832-3.
INDICATIONS FOR USE:	The APEX Spine System intended to provide immobilizationand stabilization of spinal segments in skeletally maturepatients as an adjunct to fusion in the treatment of thefollowing acute and chronic instabilities or deformities of thethoracic, lumbar, and sacral spine: severe spondylolisthesis(grades 3 and 4) of the L5-S1 vertebra; degenerativespondylolisthesis with objective evidence of neurologicimpairment; fracture; dislocation; scoliosis; kyphosis; spinaltumor; and failed previous fusion (pseudoarthrosis).The APEX Spine System is also indicated for pedicle screwfixation for the treatment of severe spondylolisthesis (Grades3 and 4) of the L5-S1 vertebra in skeletally mature patientsreceiving fusion by autogenous bone graft having implantsattached to the lumbar and sacral spine (L3 to sacrum) withremoval of the implants after the attainment of a solid fusion.

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and and and a man a control and consideration and model and and comments of the mail foundeline

The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis). tumor, and previous failed fusion (pseudo-arthrosis).

The APEX Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The APEX Spine System is substantially equivalent to the SUBSTANTIAL EQUIVALENCE: following predicate devices:

트 MONARCH Spine System: K010576, K024348 -DePuy AcroMed.
.. MOSS MIAMI Spinal System: K965145 - DePuy, Inc.
I OPTIMA Spinal System: K051971 - U&I Corp.
트 Global Spinal Fixation System: K001668 - D.K.M. Co., Ltd.

The substantial equivalence of the APEX spine system to the above mentioned predicate devices is based upon equivalence in design, material, manufacturing standards, intended use, as well as indications and contraindications. The fundamental scientific technology of this system is identical to previously cleared systems.

PERFORMANCE DATA: Mechanical and dynamic testing of the APEX Spine System was performed. The test results demonstrate that the mechanical performance of the APEX Spine System is at least comparable to, if not better than, those of the predicate devices.

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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SpineCraft, Inc. % Ms. Ami Akallal-Asaad Regulatory Affairs Manager 2215 Enterprise Drive Suite 1504 Westchester, Illinois 60154

DEC 2 2 2006

Re: K062513

Trade/Device Name: APEX Spine System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, KWQ, MNI, MNH Dated: November 2, 2006 Received: November 6, 2006

Dear Ms. Akallal-Asaad:

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 - Ms. Ami Akallal-Asaad

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 vours.

Opaubere Buchund

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

Enclosure

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SAN AND AND AND AND CARD COLLEGE OF CARAL COLLECT COLLECT COLLECT COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTIO

A. Indication for Use Statement

510(k) Number (if known): K062513

Device Name: APEX Spine System

Indication for Use:

The APEX Spine System intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The APEX Spine System is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scollosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

Prescription Use: ____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Paulin

estorative. and Neurological Devices

510(k) Number K062513

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.