The Velofix™ PEEK Cervical Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Velofix™ PEEK Lumbar Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease(DDD) at one or two levels for L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.

Device Description

The Velofix™ Interbody Fusion System(K132926) consists of implants available in various heights, width and angle with an open architecture to accept packing of autogenous bone graft and consist of:

1. Cervical Interbody Fusion Device (Velofix™ PEEK Cervical Cage), which may be implanted as a single device via an anterior approach.
1. Lumbar Interbody Fusion Device (Velofix™ PEEK Lumbar Cage), which may be implanted.
- Bilaterally via a posterior(PLIF) approach; o
- o As a single device via a transforaminal(TLIF) approach;

The Velofix™ Interbody Fusion System(Pending:K140864) contains additional sizes in PEEK Lumbar cages of The Velofix™ Interbody Fusion System(Cleared: K132926).

The implants are made of radiolucent polymer polyether-ether-ketone(PEEK-OPTIMA LT 1, ASTM F2026) body with the x-ray markers made of tantalum markers (ASTM F560). The Velofix " PEEK Lumbar Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Velofix™ Interbody Fusion System, framed within your requested categories.

Important Note: The provided document is a 510(k) summary for a medical device (surgical implant), not an AI/software device. Therefore, many of your requested categories (like multi-reader multi-case studies, ground truth establishment for AI, training sets, etc.) are not applicable to this type of submission. I will address only the information that can be extracted from the provided text for a non-AI medical device.

Acceptance Criteria and Study for Velofix™ Interbody Fusion System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Established from Predicate Devices)	Reported Device Performance
Mechanical Performance	Demonstrated Substantial Equivalence to Predicate Devices in: - Static Compression Strength (ASTM F2077) - Dynamic Compression Strength (ASTM F2077)	Met all acceptance criteria.
Material Composition	Radiolucent PEEK-OPTIMA LT 1 (ASTM F2026) body with tantalum markers (ASTM F560)	Confirmed: PEEK-OPTIMA LT 1 (ASTM F2026) body with tantalum markers (ASTM F560).
Design Features	Similar design features to predicate devices (K132926, K122872, K082342)	Confirmed: Similar design features.
Intended Use	Similar indications for use as predicate devices	Confirmed: Similar indications for use.
Fundamental Scientific Technology	Similar basic fundamental scientific technology as predicate devices	Confirmed: Similar basic fundamental scientific technology.

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

Sample Size: Not explicitly stated as a number of devices or iterations. The testing refers to "The additional size of Velofix™ Interbody Fusion System," implying the specific new sizes being introduced were tested.
Data Provenance: The testing was a "non clinical setting (bench testing)." This indicates in-vitro laboratory testing, not human or animal data.
Retrospective/Prospective: Not applicable, as this was bench testing.

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

Not applicable. This section is for AI/software devices relying on expert interpretation of data. For mechanical devices, performance is assessed via standardized engineering tests, not expert consensus on "ground truth."

4. Adjudication Method for the Test Set

Not applicable. This applies to clinical interpretation or AI output review. Mechanical bench testing results are objective measurements against defined standards.

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

Not applicable. This refers to studies involving human readers and AI for diagnostic or interpretative tasks. This device is a surgical implant undergoing mechanical performance testing.

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

Not applicable. This category refers to AI algorithm performance.

7. The Type of Ground Truth Used

Engineering Standards: The "ground truth" for this device's performance is established by recognized engineering and material standards, specifically ASTM F2077 for static and dynamic compression, and ASTM F2026 and F560 for material specifications. The acceptance criteria were based on the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This section refers to AI model training. The "training" for this device involved adhering to established engineering principles and manufacturing processes.

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

Not applicable. This refers to AI model training.

Summary of the Study:

The study described is a non-clinical bench testing assessment of the mechanical performance of the Velofix™ Interbody Fusion System, specifically focusing on additional sizes being introduced. The goal was to demonstrate substantial equivalence to previously cleared predicate devices (Velofix™ Interbody Fusion System K132926, Galaxy PLIF PEEK Cage K122872, and Capstone Spinal System K082342).

The testing included:

Static compression test according to ASTM F2077
Dynamic compression test according to ASTM F2077

The "acceptance criteria" were established by the performance of the predicate devices in these tests. The new device sizes met all acceptance criteria, thereby verifying that its performance is substantially equivalent to the predicate devices. The materials used (PEEK-OPTIMA LT 1 with tantalum markers) also conform to specified ASTM standards.

Summary

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5. 510(k) Summary

JUL 2 2 2014

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:	Ji Yea Lee, Regulatory Affairs Assistant+82 31 852 0102 (ext.632)jylee@youic.com
Date Prepared:	April 01, 2014
Device Name:	Trade Name: Velofix™ Interbody Fusion System
Classification Name:	Spinal Intervertebral Body Fusion Device, CervicalSpinal Intervertebral Body Fusion Device, Lumbar, per 21 CFR 888.3080
Common Name:	Intervertebral Body Fusion Device, IBF Device
Product Code:	ODP, MAX
Predicate Devices:	Velofix™ Interbody Fusion System(K132926)Galaxy PLIF PEEK Cage (K122872)Capstone Spinal System (K082342)

Description of Device:

The Velofix™ Interbody Fusion System(K132926) consists of implants available in various heights, width and angle with an open architecture to accept packing of autogenous bone graft and consist of:

1. Cervical Interbody Fusion Device (Velofix™ PEEK Cervical Cage), which may be implanted as a single device via an anterior approach.
1. Lumbar Interbody Fusion Device (Velofix™ PEEK Lumbar Cage), which may be implanted.
- Bilaterally via a posterior(PLIF) approach; o
- o As a single device via a transforaminal(TLIF) approach;

The Velofix™ Interbody Fusion System(Pending:K140864) contains additional sizes in PEEK Lumbar cages of The Velofix™ Interbody Fusion System(Cleared:

Velofix™ Interbody Fusion System

Image /page/0/Picture/13 description: The image shows the logo for USI Corporation. The logo consists of the letters "U" and "S" stacked on top of each other, with the letter "I" to the right. To the right of the letters is the word "CORPORATION" in a bold, sans-serif font. The logo is black and white.

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K132926).

Intended Use:

Substantial Equivalence:

The additional size of Velofix™ Interbody Fusion System is substantially equivalent to Velofix™ Interbody Fusion System(Cleared:K132926), Galaxy PLIF PEEK Cage (K122872), and Capstone Spinal System (K082342) in design, material, mechanical performance, function and intended use.

The mechanical performance of The additional size of Velofix™ Interbody Fusion System met the acceptance criteria which have been established from the predicate devices.

Comparison Technological Characteristics

The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities;

Velofix™ Interbody Fusion System

CORPORATION

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The similar indications for use .
Similar design features .
Incorporate the same or similar materials ●
The equivalent mechanical performance

2. Performance Testing

The additional size of Velofix™ Interbody Fusion 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 The additional size of Velofix™ Interbody Fusion System is substantially equivalent to predicate devices.

The following tests were performed:

(1) Static compression test according to ASTM F2077
(2) Dynamic compression test according to ASTM F2077

Conclusion

The data and information provided in this submission support the conclusion that the Velofix™ Interbody Fusion System(K140864) is substantially equivalent to predicate devices with respect to indications for use and technological characteristics.

Velofix™ Interbody Fusion System

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G699 Silver Spring, MD 20993-0002

July 22, 2014

U & I Corporation Ms. Ji Yea Lec Regulatory Affairs Assistant 20. Sandan-ro. 76beon-gil (Rd) Uijeongbu-si, Gyeonggi-do Republic of Korea 480-859

Re: K140864

Trade/Device Name: Velofix™ Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: April 22. 2014 Received: April 28, 2014

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 (sec above) into either class 11 (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 devicerelated adverse events) {21 CFR 803}; good manufacturing practice requirements as set forth in

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Page 2 - Ms. Ji Yca Lec

the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 Industry and Consumer Education 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.

Sincercly yours,

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) K140864

Device Name

VelofixTM Interbody Fusion System

Indications for Use (Describe)

The VelofixTM PEEK Cervical Cage is intervertebral body fusion in skeletally mature patients with decenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment with an intervertebral cage.

The VelofixTM PEEK Lumbar Cage is indicated for use with autogenous bone graft in patients with degeneralive disc disease(DD) at one or two levels for 1,2 to Sh. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Katherine D. Kavlock, PhD

Division of Orthopedi

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Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.