The GLOBAL SPINAL FIXATION SYSTEM™ posterior spinal fixation device 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 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.

In addition, the GLOBAL SPINAL FIXATION 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 (pseudarthrosis).

Device Description

The GLOBAL SPINAL FIXATION SYSTEM™ Spinal System is a multiple component spinal fixation system comprised of variety of single-use, non-sterile devices that allow Spirial industry of the mant construct in order to provide stabilization and promote spinal fusion. The implants are manufactured from titanium alloy, Ti-6Al-4V ELI that conforms to ASTM 136 98 and include pedicle screws, set screws, rods, c.en that ochlorne to no se se (cross) linking mechanism. Various sizes of these implants are available.

AI/ML Overview

The provided text describes a 510(k) submission for the GLOBAL SPINAL FIXATION SYSTEM™. This is a spinal implant system and the performance data provided is related to bench testing, not an AI/ML powered medical device. Therefore, many of the requested fields regarding AI/ML device performance are not applicable.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Reported Device Performance: This information is related to the mechanical performance of the spinal fixation system.
Sample size for the test set and data provenance: Not applicable for a spinal implant system's mechanical bench testing.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable for mechanical bench testing. The "ground truth" for mechanical testing is typically established by engineering standards.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is not an AI-powered device.
Standalone (algorithm only without human-in-the-loop) performance: Not applicable.
Type of ground truth used: For mechanical bench testing, the "ground truth" is typically defined by established engineering standards and specifications (e.g., ASTM F1717).
Sample size for the training set: Not applicable as this is not an AI-powered device.
How the ground truth for the training set was established: Not applicable.

Here's a table summarizing the relevant information:

Acceptance Criteria and Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance	Study Proving Compliance
Mechanical Performance	Equivalence to predicate devices as demonstrated by ASTM F1717	Demonstrates equivalence to listed predicate devices	Bench testing conducted in accordance with ASTM F1717.

Additional Information (from the prompt's request but mostly N/A for this device):

Sample size used for the test set and the data provenance: Not specified, as "test set" in this context refers to the samples used for bench testing. The data provenance would be the laboratory where the bench tests were performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance is based on engineering standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Engineering standards and specifications (specifically ASTM F1717).
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary, the provided document describes a traditional spinal implant system and its mechanical performance testing, not an AI/ML driven medical device. Therefore, most of the questions relating to AI/ML device performance are not relevant to this submission.

Summary

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FEB 1 7 2005

[10]

510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

Submission Information:

Contact:	Betty LimRegulatory Affairs
Sponsor:	U&i CorporationYongHyun-Dong 529-1, UijungbuKyonggi-Do, Korea 480-050Phone: 82-31-852-0102(ext. 612)Fax: 82-31-852-0108
Date Prepared:	January 3, 2005
Device Identification:
Trade Name:	GLOBAL SPINAL FIXATION SYSTEM™
Common Name:	Pedical Screw Spinal Fixation System
Classification Name:	Spinal Pedical Screw (MNI) per 21 CFR § 888.3070Spondylolisthesis Spinal Fixation Device System (MNH) per 21 CFR § 888.3070

Substantially Equivalent Predicate Legally Marketed Devices:

The subject GLOBAL SPINAL FIXATION SYSTEM™ is substantially equivalent in function, design, composition, labeling, and intended use to:

GLOBAL SPINAL FIXATION SYSTEM™, Spinal System MNH, MNI - (K001668). TRIPLE-FIX Spinal Fixation System - KWP, MNH, MNI -- (K992147) 1SOLA Spinal System -- MNH, MNI, KWQ -- (K980485)

The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operational principles to the above listed predicate devices.

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Device Description:

Indications for Use:

The GLOBAL SPINAL FIXATION 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 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.

Statement of Technological Comparison:

The subject spinal implant system is substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles.

Performance Data:

Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

FEB 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Betty Lim Regulatory Affairs U&I Corporation YongHyun-Dong 529-1, Uijungbu Kyonggi-Do, Korea 480-050

Re: K042928

Trade/Device Name: Global Spinal Fixation System™ Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI Dated: January 10, 2005 Received: January 18, 2005

Dear Ms. Lim:

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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Lim

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 premated 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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[5] INDICATIONS for USE STATEMENT

510(k) Number (if known): K042928

Device Name: GLOBAL SPINAL FIXATION SYSTEM™

Indications for Use: The GLOBAL SPINAL FIXATION SYSTEM™ posterior spinal fixation device 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 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.

メ (Per 21 CFR OR Over-the-Counter Use Prescription Use 801.109) (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number	K042978
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Page 1 ofU&I Corporation Global Spinal Fixation System116 Supplementary information

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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.