The Pallas M Spinal system is intended for posterior, noncervical pedicle and non-pedicle fixation 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 Pallas M Spinal System consists of rods, screws, revision rod system, Miss pedicle screw system and associated instruments. The Pallas M Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Pallas M Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants and specialized instruments are available for the application and removal of the Pallas M Spinal System. The products are supplied clean and "NON STERILE".

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pallas M Spinal System:

Based on the provided 510(k) summary, the device is a spinal fixation system, and its performance is evaluated through bench testing, rather than clinical studies involving human or AI performance. Therefore, many of the requested categories (like sample size of a test set, experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable to this type of submission.

The acceptance criteria are based on established standards for spinal implants.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ASTM F1717-04 Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model (Characterization of components and system)	Bench testing performed, including: - Static axial compression bending test - Dynamic axial compression bending test - Static torsion test (of worst-case Pallas M Spinal System structure)
Conformity to ASTM F136 (Material specification for Ti-6Al-4V ELI)	Fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
Conformity to relevant ISO Standards (for materials)	Devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO Standards.

Explanation: The device aims to meet the mechanical performance and material specifications defined by these ASTM and ISO standards for spinal implant systems. The reported performance indicates that the required bench tests were conducted and the materials conform to the specified standards, implying the device met the criteria outlined in those standards.

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of "samples" in a clinical sense. For bench testing, "worst-case" configurations of the spinal system were tested. The mechanical testing report (Appendix 1) would typically contain detailed specimen numbers, but this is not included in the summary.
- Data Provenance: Bench testing, performed by the manufacturer, Korea Bone Bank Co., Ltd. (South Korea).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device underwent bench testing against engineering standards, not clinical ground truth established by medical experts for diagnostic or clinical performance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for human interpretation or clinical outcomes, not for mechanical bench testing. The results are typically interpreted against the pass/fail criteria defined in the ASTM standard.
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:
- N/A. This is a hardware spinal implant, not an AI or imaging device that would involve human readers or AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware spinal implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Standards: The ground truth for performance is compliance with established engineering and biocompatibility standards (e.g., ASTM F1717-04 for mechanical performance, ASTM F136 for material composition and biocompatibility).
The sample size for the training set:
- N/A. There isn't a "training set" in the context of mechanical bench testing for a physical implant. The design process and selection of materials are based on general engineering principles and material science.
How the ground truth for the training set was established:
- N/A. See point 7.

Summary

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MAR - 7 2011

510(k) Summary

The following 510(k) summary is being submitted as required by 21 CFR Part 807.92: Date: 09/02/2010

1. Submission information:

Submitter: Min Seob Kim	Official Correspondent:
Korea Bone Bank Co., Ltd	Kodent Inc.
402, 408-411, Acetechnotower 9th,	Joyce Bang
345-30, Gasandong, Keumcheongu,	325 N. Puente st. Unit B
Seoul, South Korea	Brea, CA 92821
Tel: 82-02-2014-0475	Email: kodentinc@gmail.com
Fax: 82-02-2104-0478	Phone: 714-525-0114
	Fax: 714-525-0116

Device Information 2.

Trade Name:	Pallas M Spinal System
Common Name:	Pedicle Screw Spinal Fixation System
Classification Name:	Spinal Pedicle Fixation
	Spondylolisthesis Spinal Fixation
Product Code:	MNH, MNI
Regulation Number:	21 CFR 888.3070

General Description 3.

Indication for Use 4.

The Pallas M Spinal system is intended for posterior, noncervical pedicle fixation 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 turnor and failed previous fusion (pseudarthrosis).

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5. Materials:

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

6. Performance Data:

Performance data per ASTM F1717 were submitted to characterize the subject Pallas M Spinal System components addressed in this notification. Bench testing (static and dynamic axial compression bending test and static torsion test of the worst case Pallas M Spinal System structure) has been performed as listed in section 10. Mechanical testing (appendix 1-mechanical testing report) in accordance with ASTM F 1717-04-Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model.

7. Predicate Devices:

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

EOS Spinal System (Korea Bone Bank Co., Ltd .; K082509)
GSS Pedicle Screw System (GS Medical Co., Ltd .; K053573)

Comparison to Predicate Devices: 8.

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

9. Conclusion

Based on the information provided in this premarket notification, Korea Bone Bank Co., Ltd . concludes that The Palla M Spinal System is safe, effective and substantially equivalent to the predicate devices as described herein.

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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 consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

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

Korea Bone Bank Co., Ltd. % Kodent Inc. Ms. Joyce Bang 325 N. Puente Street, Unit B Brea, California 92821

MAR - 7 2011

Re: K102574

Trade/Device Name: Pallas M Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: February 14, 2011 Received: February 14, 2011

Dear Ms. 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. Iisting 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 your device complies with other requirements of the Act

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Page 2 - Ms. Joyce Bang

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 (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.

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/ReportalProblem/default.htm for 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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Aling Vs. Mh.
for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(K) Number (if known): KIO2574

Device Name: Pallas M 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)
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(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

K102574 510(k) Number_

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.