TREND II Spinal Fixation System - STEP Series is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1-Sacrum/Ilium) for the following indications:

Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Degenerative Spondylolisthesis with objective evidence of neurologic impairment
Fractures
Dislocation
Scoliosis
Kyphosis
Spinal tumor
Failed previous fusion (pseudarthrosis)

Device Description

TREND II Spinal Fixation System- STEP Series includes cannulated screw, non-cannulated screw, rod, set screw, hook, and transverse link. Different types or sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The system components are manufactured from Ti6Al4V based which complies with ASTM F136 /ISO 5832-3.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, focusing on the substantial equivalence of "TREND II Spinal Fixation System- STEP Series" to predicate devices. It does not describe an AI medical device or a study involving human-in-the-loop or standalone AI performance. Therefore, I cannot extract the information required to answer your prompt regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI device.

The document primarily discusses:

Device Type: Thoracolumbosacral pedicle screw system (a traditional medical implant, not AI)
Regulatory Class: Class II
Product Code: NKB
Indications for Use: Spinal immobilization and stabilization for various conditions (e.g., degenerative disc disease, fractures, scoliosis)
Predicate Devices: Comparison to "Paonan" Armstrong Posterior Spinal Fixation System (K161225) and MYKRES Spinal System (K051704).
Performance Data: Mechanical testing (static/dynamic axial compression bending, static torsion, pullout test) to demonstrate substantial equivalence, referring to ASTM F1717 and ASTM F543. These are engineering performance tests for physical implants, not AI algorithm performance.

Therefore, it is impossible to provide the requested information about acceptance criteria and an AI study from this document.

Summary

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July 25, 2018

Paonan Biotech Co., Ltd. Ms. Vivi Tsai Regulatory Affairs 3F. No. 50. Lane 258. Rueiguang Road Neihu District, Taipei City 114 TAIWAN

Re: K180226

Trade/Device Name: TREND II Spinal Fixation System- STEP Series Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: July 13, 2018 Received: July 13, 2018

Dear Ms. Tsai:

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 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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ronald P. Jean -S

for 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) K180226

Device Name

TREND II Spinal Fixation System - STEP Series

Indications for Use (Describe)

TREND II Spinal Fixation System - STEP Series is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/liac spine (T1-Sacrum/Ilium) for the following indications:

Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Degenerative Spondylolisthesis with objective evidence of neurologic impairment
Fractures
Dislocation
Scoliosis
Kyphosis
Spinal tumor
Failed previous fusion (pseudarthrosis)

Type of Use (Select one or both, as applicable)
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Research Use (Part 21 CFR 201.3 Subject to Discretion)	Over-The-Counter Use (21 CFR 201.3 Subject to Discretion)
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Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

ADMINISTRATIVE INFORMATION

Manufacturer Name	Paonan Biotech Co.,Ltd.
Manufacturer Address	3F, No.50, Lane.258, Rueiguang Rd.,Neihu District, Taipei City, Taiwan,R.O.C.
DEVICE NAME	TREND II Spinal Fixation System- STEP Series
Contact Person/Date Prepared	Vivi Tsai/July 20, 2018

Common / Classification Name

Thoracolumbosacral Pedicle Screw System, 21 CFR 888.3070, Class II

Product code: NKB

Predicate Device

Primary predicate device: "Paonan" Armstrong Posterior Spinal Fixation System (K161225)

	Subjective Device	Primary PredicateDevice	Additional predicates
System name	TREND II Spinal Fixation System-STEP Series	"Paonan" Armstrong PosteriorSpinal Fixation System	MYKRES Spinal System
510(k) Number	--	K161225	K051704
Manufacturer	PAONAN	PAONAN	Showa Ika
Materials	Ti6Al4V	Ti6Al4V	Ti6Al4V
Classification	888.3070	888.3070	888.3070
Product Code	NKB	NKB	MNI
SubsequentProduct Code	N/A	N/A	KWP, MNH
RequiredStandard	Ti6Al4V-ISO 5832-3, ASTMF 136	Ti6Al4V-ISO 5832-3, ASTMF 136	Ti6Al4V-ISO 5832-3, ASTMF 136
Application	thoracic, lumbar to sacrum	thoracic, lumbar to sacrum	thoracic, lumbar to sacrum
Intend Use	To provide	To provide	To provide

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	immobilization andstabilization forposterior, non-cervical, pediclefixation of thethoracic, lumbar, andsacral/iliac spine (T1 –Sacrum/Ileum) inskeletally maturepatients.	immobilization andstabilization forposterior, non-cervical, pediclefixation of thethoracic, lumbar, andsacral/iliac spine (T1 –Sacrum/Ileum) inskeletally maturepatients.	immobilization andstabilization forposterior, non-cervical, pedicle andnon-pedicle fixationof the thoracic,lumbar, and sacralspine in skeletallymature patients.
Indication	Degenerative disc diseases Degenerative Spondylolisthesis Fractures Dislocation Scoliosis kyphosis Spinal tumor Failed previous fusion(pseudarthrosis)	Degenerative disc diseases Degenerative Spondylolisthesis Fractures Dislocation Scoliosis kyphosis Spinal tumor Failed previous fusion(pseudarthrosis)	Degenerative Spondylolisthesis Fractures Dislocation Scoliosis kyphosis Spinal tumor Failed previous fusion(pseudarthrosis)
Component	Cannulated screw, non-cannulated screw, rod, set screw,hook, transverse link	Cannulated screw,mono-axial screw,poly-axial screw,block, washer, rod,link, connector, setscrew	rods, mono-axialscrew, poly-axialscrew, hooks andconnectors
Sterilization	Non-sterile	Non-sterile	Non-sterile
Mechanical Test	Static and dynamiccompression test,Static Torsional Test perASTM F1717, and Pullout Test perASTM F543	Static and dynamiccompressionbending Test, StaticTorsional Test perASTM F1717Axial grippingcapacity test andAxial torquegripping capacitytest per ASTMF1798	Static compression,static torsion, anddynamiccompression perASTM F1717

Device Description

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of individual patients. The system components are manufactured from Ti6Al4V based which complies with ASTM F136 /ISO 5832-3.

Indications for Use

TREND II Spinal Fixation System- STEP Series is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – Sacrum/Ilium) for the following indications:

Degenerative disc diseases (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
Degenerative Spondylolisthesis with objective evidence of neurologic impairment.
Fractures
Dislocation
Scoliosis
Kyphosis
Spinal tumor
Failed previous fusion (pseudarthrosis)

Performance Data:

Mechanical testing including static/dynamic axial compression bending test and static torsion test for spinal corpectomy model were conducted referring to ASTM F1717 to demonstrate substantial equivalence to the predicate system. In addition, pullout test of multiaxial screw was performed according to ASTM F543. The results demonstrate substantial equivalence of TREND II Spinal Fixation System- STEP Series to the predicate device(s).

Conclusion of Substantial Equivalence:

The TREND II Spinal Fixation System- STEP Series has been demonstrated to be substantially equivalent to the predicate(s) with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device(s).

Regulation Number and Section

N/A