The VelofixTM PEEK Cervical Cage is 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-T 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 to facilitate fusion. Patients should have at least six weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The VelofixTM PEEK Lumbar Cage is indicated for use with autogenous with degenerative disc disease(DD) at one or two levels for L2 to S1. These DDD patients may also have up w Grade I Spondylolisthesis 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 six months of non-operative treasment. These devices are intended to be used with supplemental fixation.

Device Description

The Velofix™ Interbody Fusion System consists of implants available in various heights, width and angle with an open architecture to accept packing of bone graft material.

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.
- o Bilaterally via a posterior(PLIF) approach;
- o As a single device via a transforaminal(TLIF) approach;

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(Cervical and Lumbar) Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.

AI/ML Overview

The provided text describes the "Velofix™ Interbody Fusion System," a spinal implant, and its mechanical performance testing. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or conducting a study to prove a device meets those criteria in a medical context (e.g., diagnostic accuracy for an AI device).

Therefore, the information requested about AI/algorithm performance, ground truth, expert review, and sample sizes for training/test sets is not applicable to this 510(k) summary, as it pertains to a physical medical device (interbody fusion system) and not an algorithmic/AI device.

However, I can extract information related to the device's mechanical performance and its acceptance criteria as outlined in the document, which are analogous to "acceptance criteria" for a physical device.

Here's a breakdown of the available information based on your request, adapted for a physical medical device:

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

The document states that the mechanical performance of the Velofix™ Interbody Fusion System "met the acceptance criteria which have been established from the predicate devices." It also explicitly lists the tests performed and implies that the results of these tests met criteria derived from the predicate devices. However, the specific numerical acceptance criteria and the specific numerical performance results (e.g., "withstanding X N of force") are not provided in this summary.

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance	Met acceptance criteria established from predicate devices.

Tests Performed:

For Velofix™ PEEK Cervical Cage:

Static compression test (according to ASTM F2077)
Static torsion test (according to ASTM F2077)
Dynamic compression test (according to ASTM F2077)
Dynamic torsion test (according to ASTM F2077)
Subsidence test (according to ASTM F2267)

For Velofix™ PEEK Lumbar Cage:

Static compression test (according to ASTM F2077)
Dynamic compression test (according to ASTM F2077)
Subsidence test (according to ASTM F2267)

The conclusion states: "The testing met all acceptance criteria and verifies that performance of the Velofix Interbody Fusion System is substantially equivalent to the predicate devices."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify the number of individual devices or prototypes tested for each mechanical test.
Data Provenance: The tests were conducted in a "non clinical setting (bench testing)." The manufacturer is U & I Corporation, located in Uijeongbu-si, Gyeonggi-do, Korea. Therefore, the testing was likely performed in Korea.
Retrospective or Prospective: Not applicable as this refers to bench testing, not clinical data.

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)

Not applicable. The "ground truth" for this device's performance is established by standardized mechanical testing protocols (ASTM F2077, ASTM F2267) and comparison to predicate device performance, not by expert medical review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically associated with human expert review of medical images or clinical outcomes, which is not relevant to mechanical bench testing.

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 study is for a physical medical device (spinal implant), not an AI-assisted diagnostic tool.

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

Not applicable. This study is for a physical medical device (spinal implant), not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Ground Truth Type: For mechanical performance, the "ground truth" is established by adherence to recognized international mechanical testing standards (ASTM F2077, ASTM F2267) and by demonstrating substantial equivalence to the established mechanical performance of predicate devices. These standards define the parameters and methods for evaluating the structural integrity and performance of the device under various loads.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical bench testing for a physical device.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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MAR 0 5 2014

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
Date Prepared:	February 28, 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:	Galaxy (ACIF, PLIF, TLIF) PEEK Cage (K122872)BAK/Cervical Interbody Fusion System (P980048)C-Thru™ Anterior Spinal System (K092336)Capstone Spinal System (K082342)

Description of Device:

The Velofix™ Interbody Fusion System consists of implants available in various heights, width and angle with an open architecture to accept packing of bone graft material.

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.
- o Bilaterally via a posterior(PLIF) approach;
- o As a single device via a transforaminal(TLIF) approach;

The implants are made of radiolucent polymer polyether-ether-ketone(PEEK-

Image /page/0/Picture/12 description: The image shows the logo for U&I Corporation. The logo is in black and white. The letters U&I are stacked on top of each other, with the "U" on top and the "I" on the bottom. The word "CORPORATION" is to the right of the letters U&I.

Velofix™ Interbody Fusion System

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OPTIMA LT 1, ASTM F2026) body with the x-ray markers made of tantalum markers (ASTM F560).

The Velofix™ PEEK(Cervical and Lumbar) Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.

Intended Use:

The Velofix 110 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 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.

Substantial Equivalence:

The Velofix™ Interbody Fusion System is substantially equivalent to Galaxy (ACIF, PLIF, TLIF) PEEK Cage (K122872), BAK/Cervical Interbody Fusion System (P980048), C-Thru™ Anterior Spinal System (K092336), Capstone Spinal System (K082342) in design, material, mechanical performance, function and intended use.

The mechanical performance of Velofix 110 Interbody Fusion 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

Velofix™ Interbody Fusion System

U&i CORPORATION

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Incorporate the same or similar materials .
The equivalent mechanical performance

2. Performance Testing

The 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 Velofix Interbody Fusion System is substantially equivalent to the predicate devices.

The following tests were performed:

1. Velofix™ PEEK Cervical Cage
- (1) Static compression test according to ASTM F2077
- (2) Static torsion test according to ASTM F2077
- (3) Dynamic compression test according to ASTM F2077
- (4) Dynamic torsion test according to ASTM F2077
- (5) Subsidence test according to ASTM F2267

2) Velofix™ PEEK Lumbar Cage

(1) Static compression test according to ASTM F2077
(2) Dynamic compression test according to ASTM F2077
(3) Subsidence test according to ASTM F2267
1. Conclusion

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

U&i CORPORATION

Velofix™ Interbody Fusion System

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

March 5, 2014

U & I Corporation Gyeong Je-Kwon Regulatory Affairs Specialist 20. Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do Korea, 480-859

Re: K132926

Trade/Device Name: Velofix™ Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Spinal intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: January 24, 2014 Received: January 27, 2014

Dear Mr. 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 oonly war an an 2011, 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 - Mr. 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 regulation (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 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,

Vincent 同 golin -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) KI32926

Device Name

VelofixTM Interbody Fusion System

Indications for Use (Describe)

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 . . . . . . ಿ ಹಿಂದಿ ಸಾಮಾ : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : 1 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 ਾ ਕੀਤੀ ਹੈ।

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

FORM FDA 3881 (1/14)

PSC Database Service TOOL INSTALLATION UF

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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.