The Xing™ 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 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 Xing™ 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 (pseudarthrosis).

Device Description

The Xing™ Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a cross link linking mechanism. The Xing™ Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Xing™ System implant components are supplied non-sterile are single use and are 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 Xing™ Spine System.

AI/ML Overview

The provided text is a 510(k) Summary for the Xing™ Spine System. This document focuses on demonstrating substantial equivalence to predicate devices for a spinal implant (pedicle screw system), not an AI/ML-driven medical device for diagnosis or prognosis. As such, most of the requested information regarding AI/ML device performance criteria, studies, ground truth establishment, expert adjudication, and associated sample sizes is not applicable to this type of medical device submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical performance standards for spinal implants and the bench testing conducted to demonstrate conformance.

Here's the relevant information extrapolated from the document:

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

Acceptance Criteria (Standard)	Reported Device Performance (Method)
ASTM F1717-09	Static Tension Test Report
ASTM F1717-09	Static Compression Test Report
ASTM F1717-09	Static Torsion Test Report
ASTM F1717-09	Dynamic Fatigue Test Report
Overall Goal:	Equivalence to listed predicate devices (demonstrated through mechanical testing)

Notes:

The document explicitly states: "Mechanical testing as listed in APPENDIX 3 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices." This implies that the device successfully met the performance requirements/benchmarks established by this standard and shown by the predicate devices.
The document doesn't provide specific numerical results (e.g., maximum load, cycles to failure) from these tests in the summary provided. It only states that the tests were conducted and demonstrate equivalence.

The following questions are not applicable to this 510(k) submission as it pertains to a mechanical spinal implant, not an AI/ML device:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

For mechanical devices like the Xing™ Spine System, performance is typically demonstrated through bench testing against recognized industry standards (like ASTM F1717) and comparison to legally marketed predicate devices, rather than clinical studies with patients or expert panel reviews of data. The "ground truth" for such devices is conformance to engineering specifications and mechanical properties.

Summary

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510(k) Summary

Submitter: IMPLANOVA Co., Ltd. Tae Gon Jung #104, Gyongnam Techno-park,155-1 Nongso-ri, Juchon-myeon, Gimhae, Gyeongnam, 621-842, South Korea Phone: 82-55-329-5292 Fax: 82-55-329-5294

Device Information

Trade Name: Xing™ Spine System

Pedicle Screw Spinal Fixation System Common Name:

Classification Name: Pedicle Screw Spinal Fixation System

MNH, MNI Product Code:

Regulation Number: 21 CFR 888.3070

The date prepared: 7/11/2011

General Description

The Xing 10 Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a cross link linking mechanism.

The Xing™ Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Xing™ System implant components are supplied non-sterile are single use and are 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 Xing™ Spine System

Indication for Use

In addition, the Xing M 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 (pseudarthrosis).

FDA/CDRH/DCC DEC 06 2011 RECEIVED

Official Correspondent:

325 N. Puente St. Unit B

Phone: 714-525-0114

Fax: 714-525-0116

Email: kodentinc@gmail.com

Kodent Inc. April Lee

Brea, CA 92821

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411 995 DEC 1 2 2011

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Materials:

The devices are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.

Performance Data (Bench Testing):

Mechanical testing as listed in APPENDIX 3 that was conducted in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices.

Mechanical test reports were completed for the following test methods:

Static test: Tension, Compression and Torsion test report (ASTM F1717-09) -
Dynamic test: Fatigue test report (ASTM F1717-09) -

Predicate Devices:

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

- OPTIMA™, Spinal System (U & I Co., Ltd; K001668)
- Global Spinal Fixation System (D.K.M. Co., Ltd; K031585)
- 4CIS® Vane Spine System (Solco Biomedical Co., Ltd.; K060702)
- Title®2 Spinal System(ENDIUS, INC; K041808)
- DELTA SPINAL FUSION SYSTEM(JEMO SPINE, LLC; K071857)

Comparison to Predicate Devices:

The subject device, Xing™ Spine System, is substantially equivalent to OPTIMA™, Spinal System manufactured by U & I Co., Ltd which was cleared for marketing as K031585 and the Global Spinal Fixation System manufactured by D.K.M. Co., Ltd which was cleared for marketing as K001668 and the 4CIS Vane Spine System manufactured by Solco Biomedical Co., Ltd which was cleared for marketing as K060702 and the Title®2 Spinal System manufactured by ENDIUS, INC. which was cleared for marketing as K041808 and DELTA SPINAL FUSION SYSTEM manufactured by JEMO SPINE, LLC which was cleared for marketing as K071857.

	Subject Device	PredicateDevice	PredicateDevice	PredicateDevice	PredicateDevice	PredicateDevice
Company	Implanova co.,Ltd	U & I Co., Ltd	D.K.M. Co., Ltd	SolcoBiomedical Co.,Ltd	ENDIUS, INC.	JEMO SPINE,LLC

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KIII 995

page 3 of 4

DeviceName	Xing™ SpineSystem	OPTIMA™,Spinal System	Global SpinalFixation System	4 CIS VANESpine System	Title®2spinal system	DELTASPINALFUSIONSYSTEM
510(k)Number	N/A	K001668	K031585	K060702	K041808	K071857
DeviceClassification Name	Orthosis,Spondyloisthesis SpinalFixation	Orthosis,Spondyloisthesis SpinalFixation	Orthosis,Spondyloisthesis SpinalFixation	Orthosis,Spondyloisthesis SpinalFixation	appliance,fixation, spinalinterlaminal	orthosis, spinalpedicle fixation
Classification ProductCode	MNH, MNI	MNH, MNI	MNH, MNI	MNH, MNI	MNH, MNI,NKB	MNI
RegulationNumber	888.3070	888.3070	888.3070	888.3070	888.3050	888.3070
IntendedUse	See theindications foruse statement	Identical	Identical	Identical	Identical	Identical
Material	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI
ProductParts	Pedicle Screw,Rod(Straighttype & curvedtype), Nut,Transverse Link	Pedicle Screw,Rod(Straighttype & curvedtype), SetScrew,Transverse Link	Pedicle Screw,Rod(Straighttype & curvedtype),Connector,Transverse Link	Pedicle Screw,Rod, Set Screw,TransverseLink(Identical)	Pedicle Screw,Rod, Set Screw,Connector	Pedicle Screw,Rod, Set Screw
Size ofpediclescrew	4.0, 4.5, 5.0,5.5, 6.0, 6.5,7.0, 8.0 indiameter andfrom 20 to55mm in a 5mmincrement	5.0, 6.0, 7.0,7.5, 8.0mmdiameter in 30,35, 40, 45, 50,55mm length	5.0, 6.0, 7.0,7.5, 8.0mmdiameter in 30,35, 40, 45, 50,55mm length	4.0, 4.5, 5.5,6.5, 7.5, 8.0,8.5mm diameterin 25~60mmlength(Similar)
Pre-BendingRod	Available			Available
The amountofangulationpossible					60°	86°

Any differences between the subject devices and the predicate devices will not affect safety or efficacy. Please see APPENDIX 2 Predicate Device Information that contains:

K001668, K031585/K06072 Summary of Safety & Effectiveness documents -
OPTIMA™, Spinal System/Global Spinal Fixation System/4CIS Spine System product literatures

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Based on the comparison between the subject and predicate devices provided in Table 3, IMPLANOVA Co., Ltd believes that the Xing™ Spine System is substantially equivalent to the predicate devices.

Conclusion

Testing and other comparisons have established that the Xing™ Spine System is substantially equivalent in design, materials, indications, and performance to other predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.

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

DEC 1 2 2011

Implanova Co., Ltd. % Kodent, Inc. Ms. April Lee 325 North Puente Street, Unit B Brea, California 92821

Re: K111995

Trade/Device Name: Xing™ Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: November 30, 2011 Received: December 06, 2011

Dear Ms. Lee:

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 your device complies with other requirements of the Act

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Page 2 - Ms. April Lee

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/ycm115809.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.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,

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):	K111995
Device Name:	Xing™ Spine System

Indication for Use:

The Xing™ 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
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 Xing™ 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 (pseudarthrosis).

Prescription Use x (Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter _______ (Per 21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIII 445 510(k) Number_

Regulation Number and Section

N/A