The ASPIRON™ ACP System is intended for anterior inter-vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);
· Spondylolisthesis
· Trauma (including fractures, dislocation)
· Spinal stenosis
· Tumors
· Deformity (defined as scoliosis, kyphosis, or lordosis)
· Pseudoarthrosis
· Failed previous fusion

WARNING: The device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Description

ASPIRON™ ACP System consists of a variety of shapes and size of bone plates, screws and associated instruments. All implant components are made from a titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. ASPIRON ™ ACP System is intended to provide stabilization of the cervical vertebra for various indications. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study (K131200)

The ASPIRON™ ACP System, an anterior cervical plate system, established substantial equivalence by demonstrating mechanical performance equivalent to its predicate devices. The study involved non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test Performed	Acceptance Criteria Description	Reported Device Performance
Mechanical Performance	Construct Test (ASTM F1717)	Performance equivalent to predicate devices (Maxima™ K061002, Blackstone™ III° K012184, ZEPHIR™ K994239)	"The mechanical performance of ASPIRON™ ACP System met the acceptance criteria which have been established from the predicate devices.""The testing met all acceptance criteria and verifies that performance of the ASPIRON™ ACP System is substantially equivalent to the predicate devices."
	Static compression bending	Performance equivalent to predicate devices	Met acceptance criteria, substantially equivalent to predicates
	Static torsion test	Performance equivalent to predicate devices	Met acceptance criteria, substantially equivalent to predicates
	Compression bending fatigue	Performance equivalent to predicate devices	Met acceptance criteria, substantially equivalent to predicates
	Torsion fatigue test	Performance equivalent to predicate devices	Met acceptance criteria, substantially equivalent to predicates
	Screw back out test	Performance equivalent to predicate devices	Met acceptance criteria, substantially equivalent to predicates

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

Sample Size: The document does not explicitly state the numerical sample size for each performance test. It refers to these as non-clinical "bench testing." Typically, these tests involve multiple samples to ensure statistical validity, but the exact number is not provided in this summary.
Data Provenance: The tests were conducted in a non-clinical setting (bench testing). No country of origin for the data is specified beyond the manufacturer being in Korea. This was a retrospective study in the sense that the device was tested against established performance criteria derived from existing predicate devices.

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

Not applicable. This was a bench test evaluating mechanical performance against engineering standards and predicate device performance, not a study requiring expert clinical assessment for ground truth.

4. Adjudication Method for the Test Set

Not applicable. Ground truth was established by adherence to ASTM standards and comparison to predicate device performance, not through expert adjudication of patient cases.

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

No, an MRMC comparative effectiveness study was not done. This was a bench testing study for mechanical performance, not a clinical study involving human readers or cases.

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

Not applicable. This device is a physical medical implant (anterior cervical plate system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here. The device's performance was evaluated inherently "standalone" in its mechanical properties.

7. The Type of Ground Truth Used

The ground truth used was:

Adherence to recognized consensus standards (specifically ASTM F1717 for construct testing).
Performance data from legally marketed predicate devices (Maxima™ K061002, Blackstone™ III° K012184, ZEPHIR™ K994239) as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical implant and does not involve a "training set" in the context of machine learning or AI algorithms.

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

Not applicable, as there is no "training set."

Summary

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K131200 Page 1 of 3

5. 510(k) Summary

Manufacturer:	U & I Corporation20, Sandan-ro, 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,Korea, 480-859
Sponsor:	U & I Corporation20, Sandan-ro, 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,Korea, 480-859
Sponsor Contact:	Gyeong-Je Kwon, Regulatory Affairs Specialist+82 31 852 0102 (ext.610)kkjane@youic.com	AUG 2 9 2013
Date Prepared:	April 25, 2013
Device Name:	Trade Name: ASPIRONTM ACP System
Classification Name:	Spinal Intervertebral Body Fixation Orthosis, per 21 CFR888.3060
Common Name:	Anterior Cervical Plate
Product Code:	KWQ
Predicate Devices:	MaximaTM Anterior Cervical Plate System (K061002)Blackstone TM III° Anterior Cervical Plating System(K012184)ZEPHIR TM Anterior Cervical Plate System (K994239)

Description of Device:

U&i CORPORATION

ASPIRON™ ACP System

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Intended Use:

· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);
· Spondylolisthesis
· Trauma (including fractures, dislocation)
· Spinal stenosis
· Tumors
· Deformity (defined as scoliosis, kyphosis, or lordosis)
· Pseudoarthrosis
· Failed previous fusion

WARNING: The device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Substantial Equivalence:

The ASPIRON™ ACP System is substantially equivalent to Maxima™ Anterior Cervical Plate System (K061002), Blackstone™ III° Anterior Cervical Plating System (K012184) and ZEPHIR™ Anterior Cervical Plate System (K994239) in design, material, mechanical performance, function and intended use.

The mechanical performance of ASPIRON™ ACP System met the acceptance criteria which have been established from the predicate devices.

1. Comparison Technological Characteristics
  The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities;
· The similar indications for use
Similar design features .
Incorporate the same or similar materials ●
. The equivalent mechanical performance
1. Performance Testing

ASPIRON™ ACP System

U&i CORPORATION

Page 10 of 46

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The ASPIRON™ ACP System was tested in a non clinical setting (bench testing) to assess that to no new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the ASPIRON™ ACP System is substantially equivalent to the predicate devices.

The following tests were performed:

1. Construct Test (ASTM F1717)
- (1) Static compression bending test
- (2) Static torsion test
- (3) Compression bending fatigue test
- (4) Torsion fatigue test
1. Component Test
- (1) Screw back out test

3. Conclusion

The data and information provided in this submission support the conclusion that the ASPIRON™ ACP System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.

U&i CORPORATION

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.

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

August 29, 2013

Gyeong-Je Kwon Regulatory Affairs Specialist U & I Corporation 20, Sandan-ro, Uijeongbu-si, Gyeonggi-do, Korea 480-859

Re: K131200

Trade/Device Name: ASPIRIONTM ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 1, 2013 Received: July 3, 2013

Dear Gyeong-Je Kwon:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Gyeong-Je Kwon

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 reculation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 MIDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportal"roblem/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/MedicalDeviecs/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Erin I. Keith

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 Statement

510(k) Number (if known):

Device Name: ASPIRON™ ACP System

Indications for Use:

Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);
Spondylolisthesis
Trauma (including fractures, dislocation)
. Spinal stenosis
Tumors
. Deformity (defined as scoliosis, kyphosis, or lordosis)
. Pseudoarthrosis
Failed previous fusion

WARNING: The device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

ASPIRON™ ACP System

Image /page/5/Picture/19 description: The image shows the logo for U&I Corporation. The logo consists of the letters "U&I" in a stylized font, followed by the word "CORPORATION" in a blocky, sans-serif font. The text is black and the background is white.

Page 8 of 46

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.