The Mega 5.5 Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous 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.

In addition, the Mega 5.5 Spine System is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

Device Description

The MEGA5.5 Spine System is a top-loading multiple component, posterior spinal fixation systems which consists of pedicle screws (mono, long-arm, multi-axial long-arm screw), rods, locking bolt, and a transverse linking mechanism (cross-link). The M EGA5.5 Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The MEGA5.5 Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the MEGA 5.5 Spine System.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "MEGA 5.5 Spine System," which is a pedicle screw spinal fixation system. The study described is mechanical testing to demonstrate the substantial equivalence of the device to legally marketed predicate devices.

Here's an analysis of the provided information relative to your requested categories:

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

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it states that the mechanical testing "demonstrates equivalence to the above predicate devices." This implies that the performance of the MEGA 5.5 Spine System met or exceeded the performance of the predicate devices under the specified ASTM standard.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence to predicate devices based on ASTM F 1717 standards.	Demonstrated equivalence through static and dynamic comprehension bending, static tension bending, and static torsion.

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 specify the sample size (e.g., number of screws, rods tested) for the mechanical testing. It also does not provide details on data provenance like country of origin or whether the data was retrospective or prospective, as mechanical testing is typically performed in a lab setting rather than with patient data.

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)

This category is not applicable. For mechanical testing of a spinal implant, "ground truth" as it relates to clinical or imaging expert assessment is not established. The ground truth is determined by the physical properties and performance metrics measured according to the ASTM standard.

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

This category is not applicable to mechanical testing. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or assessment, not for direct physical testing of device components.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical spinal implant, not an AI software B medical device that assists human readers.

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

No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm.

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

The "ground truth" for this study is defined by the objective measurements and engineering standards outlined in ASTM F 1717 for spinal implant mechanical testing. It relies on physical measurements and compliance with established engineering specifications rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This category is not applicable. Mechanical testing of a physical implant does not involve a "training set" in the context of machine learning or AI models. There is no algorithm being trained.

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

This category is not applicable for the same reason as above; there is no training set for mechanical testing.

Summary

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510(k) Summary

JAN 0 8 2013

New Device: Mega 5.5 Spine System

Submitter and US Official Correspondent 1.

Submitter:	BK MEDITECH CO., LTD.
Address:	215-5 Yodang-ri, Yanggam-myun, Hwasung-si
	Gyeonggi-do, 445-930, Korea
Tel:	+82-31-352-9135-8
Fax:	+82-31-352-9134
Contact:	Mr. Byungjun Park, R&D Manager
E-mail:	bjpark@bkmeditech.co.kr

US Official Correspondent:

Shin Kuk Yoo, Consultant LSK BioPartners, Inc. 8 East Broadway, Suite 611 Salt Lake City, UT 84111, USA Telephone No.: 714-313-7442 Fax No.: 801-303-7455 Email: skyone@l SK BioPartners.com

2. DeviceInformation

Proprietary/Trade Name:	MEGA 5.5 Spine System
Common/Usual Name:	Pedicle Screw Spinal Fixation System
Classification Name:	Pedicle screw spinal system
Regulation Number:	21 CFR 888.3070
Device Class:	Class II
Product Code:	MNH, MNI

Identification of Legally Marketed Predicate Devices 3.

Substantial equivalence for the MEGA 5.5 Spine System is based in its similarities in indication for use, design features, operational principles and material composition when compared to the predicate device cleared under the following submissions:

Mega Spine System (K072436, BK MEDITECH Co., Ltd.)
· OPTIMATM Spinal System (K031585, U&I Corporation, America)
· DELTA, Spinal Fusion System (K071857, Jemo Spine, LLC)
· Moss Miami Spinal System Polyaxial Screws (K030383, DePuy AcroMed, Inc)

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4. DescriptionofDevice

ട. IndicationsforUsc

The Mega 5.5 Spine System is a pedicte screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous 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.

6. Performance Testing

Mechanical testing as listed in ATTACHMENT II that was conducted in accordance with ASTM F 1717 demonstrates equivalence to the above predicate devices. This testing included static and dynamic compression bending, static tension bending, and static torsion. The subject spinal implant system is therefore substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use, and performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Public Health Service

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

Letter dated: January 8, 2013

BK Meditech Company, Limited % LSK BioPartners, Incorporated Mr. Shin Kuk Yoo 8 East Broadway, Suite 611 Salt Lake City. Utah 84111

Re: K123476

Trade/Device Name: MEGA 5.5 Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: November 9, 2012 Received: November 13. 2012

Dear Mr. Shin Kuk Yoo:

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 vour 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Shin Kuk Yoo

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.htmfor 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.goy/MedicalDevices/Resourcesfor You/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

510(k) number (if known): __K123476

Device Name: Mega 5.5 Spine System

Indications for Use:

The Mega 5.5 Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous 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.

In addition, the Mega 5.5 Spine System is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald-P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123476

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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 (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to 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 (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.