The EOS Spinal System is a posterior 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 EOS Spinal 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 EOS Spinal System is a top-loading multiple component, posterior spinal fixation system which consists fixation system which consists of pedicle screws, connectors, and a transverse (cross) linking mechanism.

The EOS Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The EOS Spinal System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the EOS Spinal System.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the EOS Spinal System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered:

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

This document does not specify quantitative acceptance criteria or detailed device performance metrics in the way a clinical study report would. It states that "Performance data per ASTM F1717 were submitted to characterize the subject EOS Spinal System components." However, the actual performance values and the acceptance criteria they were measured against are not provided. The focus is on demonstrating equivalence to predicate devices.

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

Not applicable. This is a submission for a spinal system, not an AI/software device that processes data for diagnosis or prognosis. The "test set" here refers to physical components tested against engineering standards (ASTM F1717), not a dataset of patient information.

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. Ground truth as typically understood in AI/software validation is not relevant for this type of device. The "ground truth" for the performance testing would be the ASTM F1717 standard itself, and the testing would be conducted by engineers or testing laboratories.

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

Not applicable. This is not a study involving human readers or expert consensus on medical images or patient data.

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 document describes a physical medical device (spinal implant system), not an AI-assisted diagnostic tool or software.

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

Not applicable. This is not an algorithm or software.

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

Not applicable. The "ground truth" for the device's performance is adherence to mechanical and material standards (ASTM F1717) for medical implants.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/machine learning model.

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

Not applicable. This is a physical device, not an AI/machine learning model.

Summary of available information related to performance:

The document states that the EOS Spinal System's performance data was submitted per ASTM F1717. This standard is "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This implies that the device underwent mechanical testing to characterize its stability, strength, and other mechanical properties under simulated surgical conditions.

The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices, rather than showing that the device meets absolute acceptance criteria through clinical trials. The comparison to predicate devices (4CIS® Vane Spine System (Solco Biomedical Co., Ltd .; K060702) and GSS Pedicle Screw System (GS Medical Co., Ltd .; K053573)) is based on "design, materials, indications and intended use, packaging, labeling, and performance." The implicit "acceptance criteria" here is that the performance of the EOS Spinal System is comparable to, and not worse than, that of the predicate devices under the standards like ASTM F1717.

Summary

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510(k) Summary

Submitter:

Korea Bone Bank Co., Ltd. Shim Young Bok #402 Acetechnotower 9th, 345-30. Gasandong, Keumcheongu, Seoul, South Korea Phone: 82-02-2404-0475 Fax: 82-02-2104-0478

Device Information

Contact:

DEC 1 5 2008

Kodent Inc. Jung Bae Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs. CA 90670 Email: kodentinc@kodent.co.kr Phone: 562-404-8466 Fax: 562-404-2757

Trade Name:	EOS Spinal System
Common Name:	Pedicle Screw Spinal Fixation System
Classification Name:	Spinal Pedicle FixationSpondylolisthesis Spinal Fixation
Product Code:	MNH, MNI
Regulation Number:	888.3070

Indication for Use:

In addition, the EOS Spinal 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, spinal tumor and failed previous fusion (pseudarthrosis).

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Device Description:

Materials:

The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO Standards.

Performance Data:

Performance data per ASTM F1717 were submitted to characterize the subject EOS Spinal System components addressed in this notification.

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

- 4CIS® Vane Spine System (Solco Biomedical Co., Ltd .; K060702)
- GSS Pedicle Screw System (GS Medical Co., Ltd .; K053573)

Comparison to Predicate Devices:

Testing and other comparisons have established that the subject of EOS Spinal System is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR & 807.93

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Korea Bone Bank, Co., Ltd. % Kodent Inc. Jung Bae Bang 13340 E. Firestone Boulevard, Suite J Santa Fe Springs, California 90670

DFC 1 5 2008

Re: K082509

Trade/Device Name: EOS Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: December 5, 2008 Received: December 5, 2008

Dear Jung Bae Bang:

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 - Jung Bae Bang

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Milliman

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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Indication for Use

510(K) Number (if known):

Device Name: FOS Spinal System

Indication for Use:

Prescription Use x____________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter

(Part 21 CFR 801 Subpart D)

(Per 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)

Mark A. Millisum

510:

Page 1 of 1

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.