The Aaxter A3 Posterior Spinal System is intended for posterior pedicle and non-pedicle fixation in the non-cervical spine as an adjunct to fusion in skeletally mature patients for the following indication: spondylolisthesis (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attainment to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

In addition, the Aaxter A3 Posterior 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 of the vertebral body

· Dislocation

· Scoliosis

· Kyphosis

· Spinal tumor

Device Description

The Aaxter A3 Posterior Spinal System is a posterior spinal system which is a top loading multiple components, posterior pedicle and hook fixation system intended to provide segmental stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.

The Aaxter A3 Posterior Spinal System consists of variety of rods, hooks, screws, and cross links used to build a spinal construct for stabilization and promotion of spinal fusion in the thoracic-lumbar and sacral regions.

The Aaxter A3 Posterior Spinal System implant system components are supplied non-sterile for single use and are made from medical titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Specialized instruments made from surgical grade stainless steel are used for all the operations of the Aaxter A3 Posterior Spinal System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Aaxter A3 Posterior Spinal System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Device Performance
Mechanical Performance:
Static Compression Bending (per ASTM F1717)	Substantially equivalent to legally marketed predicate devices.
Static Torsion (per ASTM F1717)	Substantially equivalent to legally marketed predicate devices.
Dynamic Compression Bending (per ASTM F1717)	Substantially equivalent to legally marketed predicate devices.
Pullout Testing (per ASTM F1798)	Substantially equivalent to legally marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify the exact sample sizes (e.g., number of test constructs, individual screws, rods) for each mechanical test. It only states that these tests were performed according to ASTM standards.

The data provenance is not explicitly mentioned. Given it's a regulatory submission from a company in Taiwan (Aaxter Co., Ltd), the testing was likely conducted in a lab affiliated with the company or a certified testing facility, potentially within Taiwan or another country capable of performing the specified ASTM tests. This was a retrospective evaluation as it was part of a 510(k) submission, confirming the device's substantial equivalence to existing devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device submission. The "ground truth" for a mechanical orthopedic implant like the Aaxter A3 Posterior Spinal System is established through adherence to recognized international standards (ASTM F1717 and ASTM F1798) and comparison to predicate devices, rather than expert clinical consensus or pathological review of patient data. The "ground truth" here is the performance metrics defined by the standards and the performance of previously cleared devices.

4. Adjudication Method (for the test set)

This information is not applicable. Mechanical tests against standards do not typically involve adjudication in the human expert sense. The results are objective measurements compared against specified criteria and predicate device data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic algorithms or imaging interpretation, not for mechanical orthopedic implants.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This information is not applicable. This device is a physical pedicle screw spinal system and does not involve algorithms or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this submission is the mechanical performance standards (ASTM F1717 and ASTM F1798) and the performance characteristics of legally marketed predicate devices. The goal was to demonstrate "substantial equivalence" to these benchmarks.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI or algorithm-based system that requires a "training set" in the machine learning sense. The design and manufacturing processes are informed by engineering principles and material science, not data training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

1.4 510(k) SUMMARY

MAR 166 2011

510(K) SUMMARY

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

Submission Information:

Contact:	Kason TsaiR&D Dept.
Sponsor:	Aaxter Co., LtdAddress:No. 8-3, Sec. 1, Jhongsing Rd.,Wugu Township, Taipei County 24872, Taiwan(886)-2-8976-9238 (TEL)(886)-2-8976-9287 (FAX)E-Mail: kason@aaxter.com
Contact(In USA):	Eric Kung4905 Washtenaw Avenue Ann Arbor MI 48108, USA734-645-8888(TEL)734-470-6076(FAX)E-Mail:erickung@comcast.net
Data Prepared:	May 11, 2010
Device Identification
Trade Name:Common Name:	Aaxter A3 Posterior Spinal SystemPedicle Screw Spinal System
Classification Name:	a) Appiliance, Fixation, Spinal Interlaminal(KWP per 21 CFR) § 888.3050b) Spinal Pedicle Fixation Orthosis (MNI)Per 21 CFR § 888.3070c) Spondylolisthesis Spinal FixationOrthosis (MNH) per 21 CFR § 888.3070

1-14

page 1 of 3

{1}------------------------------------------------

Substantially Equivalent Predicate Legally Marketed Devices:

The Subject Aaxter A3 Posterior Spinal System is substantially equivalent in function materials, design, operational principles, composition, labeling, and intended use to:

OPTIMATM, Spinal System MNI. MNH-(K031585) U&I America, Spinal Hook System™, KWP-(K031595)

Device Description:

Indications for Use:

· Degenerative spondylolisthesis with objective evidence of neurological impairment

· Fracture of the vertebral body

· Dislocation

page 2 of 3

{2}------------------------------------------------

Scoliosis
Kyphosis
Spinal tumor

Statement of Technological Comparison:

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

Performance data:

Static compression bending, static torsion and dynamic compression bending testing per ASTM F1717 and pullout testing per ASTM F1798 were performed on the Aaxter A3 Posterior Spinal System. Test results were substantially equivalent to legally marketed predicate devices.

page 3 of 3

I-16

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "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.

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

MAR 1 6 2011

Aaxter Co., Ltd. % Mr. Eric Kung 4905 Washtenaw Avenue Ann Arbor, Michigan 48108

Re: K101374

Trade/Device Name: Aaxter A3 Posterior Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: March 11, 2011 Received: March 11, 2011

Dear Mr. Kung:

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

{4}------------------------------------------------

Page 2 - Mr. Eric Kung

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/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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

A
B-2t
for

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

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K101374 Device Name: Aaxter A3 Posterior Spinal System Indications for Use:

İn addition, the Aaxter A3 Posterior 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 of the vertebral body
· Dislocation
· Scoliosis
Kyphosis
Spinal tumor

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(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)

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

510(k) Number	K101374
---------------	---------

	4-25
page 1 of 1

Regulation Number and Section

N/A