The Velofix™ TLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Velofix™ TLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the Velofix™ TLIF Cage is to be used with autogenous bone graft material.

Device Description

The Velofix™ TLIF Cage consists of implants available in various heights, width, length and angle with an open architecture to accept packing of auto bone graft material. The Velofix™ TLIF Cage may be implanted a single device via a transforaminal approach and adopted to the anterior anatomy of the vertebral endplates.

The Velofix™ TLIF Cage device has two types: the one is consisted of cage body (PEEK), articulating component (Ti Alloy) and radiographic markers (Tantalum); the other is consisted of cage body and articulating component made of Ti Alloy. The articulating component is for attachment to the inserter instrument to allow the cage to pivot to the final positioning.

The Velofix™ TLIF Cage implant is manufactured from either

Polyetheretherketone (PEEK) with a titanium alloy for articulating component (Ti6Al4V ELI), and tantalum radiographic markers for spinal applications, or
Titanium alloy (Ti6Al4V ELI) for cage body and articulating component for spinal applications.

The Velofix™ TLIF Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Velofix™ TLIF Cage, specifically an update to introduce a titanium alloy version. The document focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested information points (such as acceptance criteria, reported device performance, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of regulatory submission. This document is a summary demonstrating equivalency, not a detailed study report.

Here's an attempt to answer the questions based only on the provided text, noting where information is not available:

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

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific quantitative acceptance criteria for performance in a clinical setting. It states that mechanical strength evaluation was conducted for comparison, but no specific criteria or reported performance values are given.

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

This information is not provided. The document explicitly states: "Any mechanical test in non clinical setting (bench testing) was not conducted on the Velofix™ TLIF Cage." It refers to a "mechanical strength evaluation" but does not detail a test set, sample size, or data provenance. This is a regulatory filing for a device, not a human clinical trial.

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)

This information is not provided. "Ground truth" in the context of device performance, especially for a spinal implant, would typically come from clinical outcomes, pathology, or expert assessment in a clinical trial. This document does not describe such a study.

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

This information is not provided. Since no clinical or bench test set with expert assessment is detailed, no adjudication method is mentioned.

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

This information is not provided. An MRMC study is relevant for AI or imaging interpretation devices. The Velofix™ TLIF Cage is an intervertebral body fusion device (an implant), not an AI or imaging device, so an MRMC study would not be applicable to its intended use.

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

This information is not provided. This question is relevant for AI algorithms. The Velofix™ TLIF Cage is a physical implant, so the concept of "standalone algorithm performance" does not apply.

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

This information is not provided. As a physical implant aiming for substantial equivalence, the "ground truth" for its performance would typically relate to fusion rates, complication rates, and pain reduction, assessed through clinical outcomes. However, this submission does not detail such studies or outcomes data as it relies on equivalency to existing devices.

8. The sample size for the training set

This information is not provided. This question is relevant for machine learning models. The Velofix™ TLIF Cage is a physical medical device, not an AI model, so there is no "training set."

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

This information is not provided. This question is relevant for machine learning models. As it's a physical device, this concept does not apply.

Summary of what the document does state about "studies" and "performance":

The document states:

"Any mechanical test in non clinical setting (bench testing) was not conducted on the Velofix™ TLIF Cage." (This refers to the proposed device, which is the titanium alloy version).
"However, the mechanical strength evaluation was conducted to compare data of proposed device of the Velofix™ TLIF Cage (K172419) and to verify there are no new safety and effectiveness issues were not raised by the proposed device." (K172419 is the primary predicate device, which was made of PEEK. This suggests a comparison of the new titanium version to the previously cleared PEEK version, not a de novo study against explicit criteria.)
The conclusion is that the device is "substantially equivalent to predicate devices with respect to indications for use and technological characteristics," implying that the performance is considered similar, therefore acceptable.

Summary

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November 14, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".

U&I Corporation Jee-Ae Bang RA Specialist 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si. Gyeonggi-do. 11781 Korea

Re: K181829

Trade/Device Name: Velofix™ TLIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 19, 2018 Received: October 23, 2018

Dear Jee-Ae Bang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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,

Katherine D. Kavlock -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: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K181829

Device Name Velofix™ TLIF Cage

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)
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6. 510(k) Summary

Manufacturer:	U & I Corporation20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,11781, Korea,
Sponsor:	U & I Corporation20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,11781, Korea,
Sponsor Contact:	Jee-Ae Bang, RA Specialist+82 31 860 6846bbangzhi@youic.com
Date Prepared:	July 06, 2018
Device Name:	Trade Name: VelofixTM TLIF Cage
Classification Name:	Spinal Intervertebral Body Fusion Device, Lumbar, per 21 CFR 888.3080
Common Name:	Intervertebral Body Fusion Device, IBF Device
Product Code:	MAX

Predicate Device:

Primary - Velofix™ TLIF Cage (K172419) Additional - Altus Spine Titanium Interbody Fusion System (K170512)

Purpose of submission:

This submission is to introduce a titanium alloy (per ASTM F136) of the Velofix™ TLIF Cage.

Description of Device:

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The Velofix™ TLIF Cage implant is manufactured from either

Polyetheretherketone (PEEK) with a titanium alloy for articulating component (Ti6Al4V ELI), and tantalum radiographic markers for spinal applications, or
Titanium alloy (Ti6Al4V ELI) for cage body and articulating component for spinal applications.

The Velofix™ TLIF Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.

Indications for Use:

The Velofix™ TLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the Velofix™ TLIF Cage is to be used with autogenous bone graft material.

Substantial Equivalence:

Velofix™ TLIF Cage is substantially equivalent to Velofix™ TLIF Cage (K172419) and Altus Spine Titanium Interbody Fusion System (K170512) in design, material, mechanical performance, function and intended use.

1. Comparison Technological Characteristics
  The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities;
The same indications for use ●
Similar design features ●
- . Pyramidal teeth on superior and inferior surfaces.
- Self-distracting nose which allows for insertion. .
- . Articulation mechanism which allows the cage to pivot to final positioning.
- Large graft cavity for bone graft packing to help aid in the fusion process. •
- . Anterior and posterior side holes.
- . Various lordosis angles(0°, 5°, 8°).
Incorporate the same or similar materials
The equivalent mechanical performance

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2. Performance Testing

Any mechanical test in non clinical setting (bench testing) was not conducted on the Velofix™ TLIF Cage. However, the mechanical strength evaluation was conducted to compare data of proposed device of the Velofix "" TLIF Cage (K172419) and to verify there are no new safety and effectiveness issues were not raised by the proposed device. The Velofix™ TLIF Cage is substantially equivalent to predicate devices.

3. Conclusion

The data and information provided in this submission support the conclusion that the Velofix™ TLIF Cage is substantially equivalent to predicate devices with respect to indications for use and technological characteristics.

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.