VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The VENUS Lumbar Intervertebral body Fusion Cage System is intend to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The VENUS Lumbar Intervertebral body Fusion Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Implants are made of PEEK-OPTIMA " LTI body with the titanium marker pins made of Titanium alloy (Ti-6AI-4V ELI). The purpose of this submission is to add a new Lumbar Interbody device: VENUS DLIF Cages and to expand the size of the devices.

AI/ML Overview

This is a 510(k) summary for a medical device (VENUS Lumbar Intervertebral body Fusion Cage System), not a study report that details acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, device performance, study design, and ground truth establishment is not available in the provided text.

The document primarily focuses on establishing "substantial equivalence" of the VENUS Lumbar Intervertebral body Fusion Cage System to existing legally marketed predicate devices. This type of regulatory submission usually relies on demonstrating that the new device has similar technological characteristics and the same intended use as the predicate devices, rather than presenting a standalone clinical study with defined acceptance criteria and performance metrics.

Here's what can be extracted, and why other information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable / Not Provided. This document does not describe acceptance criteria or present performance data from a specific study. Substantial equivalence claims are often based on non-clinical testing (e.g., mechanical, biocompatibility) and comparison to predicate devices, rather than performance against pre-defined numerical thresholds in a clinical setting.

2. Sample size used for the test set and the data provenance

Not Applicable / Not Provided. No "test set" in the context of clinical performance evaluation is mentioned. The submission is based on the substantial equivalence principle, comparing the new device's design, materials, and intended use to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided. No "ground truth" establishment by experts for a test set is discussed.

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

Not Applicable / Not Provided. No adjudication method is mentioned, as there is no described test set or expert evaluation.

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 / Not Provided. This device is a physical implant (Lumbar Intervertebral body Fusion Cage System), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI performance evaluation is irrelevant and not performed.

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

Not Applicable / Not Provided. As noted above, this is a physical medical implant, not an algorithm.

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

Not Applicable / Not Provided. No ground truth in the context of clinical or diagnostic performance is discussed. The "truth" in this submission lies in demonstrating that the device's characteristics are similar to predicate devices.

8. The sample size for the training set

Not Applicable / Not Provided. This concept is not relevant to this type of device submission. There is no training set for an algorithm.

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

Not Applicable / Not Provided. As above, this concept is not relevant.

Summary of what the document does state regarding the study (non-clinical testing for substantial equivalence):

The document explicitly states under "5. Non-clinical Testing":

"The proposed line extension for the VENUS Lumbar Intervertebral body Fusion Cage System does not constitute a new worst case for the intended use and is substantially equivalent to the predicate device (K110783)."

This indicates that the safety and effectiveness of the new devices (line extension, expanded sizes) are being demonstrated by their substantial equivalence to an already cleared predicate device (K110783), which presumably underwent its own testing (mechanical, biocompatibility, etc.) at the time of its 510(k) clearance. For the current submission (K120063), the "study" is effectively a comparison to predicates, affirming that no new "worst case" scenarios are introduced that would necessitate new or more rigorous testing beyond what was done for the predicate.

This 510(k) submission is a regulatory filing, not a clinical trial report. It aims to demonstrate that a device is "substantially equivalent" to an existing legally marketed device, meaning it's as safe and effective as the predicate. This process often relies on non-clinical testing (e.g., mechanical tests, biocompatibility tests) rather than human clinical trials with specific performance metrics and acceptance criteria as would be found for a novel device or a diagnostic algorithm.

Summary

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APR 1 9 2012

K120063
page 1 of 2
L&K BIOMED

510(k) SUMMARY

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

1. Submitter:	L&K BIOMED Co., Ltd.#1104, Ace High-end Tower 3 cha, 371-50, Gasan-Dong,Geumcheon-gu, Seoul 153-803 Republic of Korea
Contact Person:	Hee Kyeong JooPhone. 82-2-2624-1475FAX. 82-2-2624-1477E-mail: hkjoo83@gmail.com
Date Prepared	January 6, 2012

2. Device Identification

Trade Name	VENUS Lumbar Intervertebral body Fusion Cage System
Common/Usual Name	Intervertebral Fusion Device
Regulation Name	Intervertebral body fusion device (21 CFR 888.3080)
Regulatory Class	Class II
Product Code	MAX

3. Description of the Device

4. Indications for Use

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K120063
page 2 of 2

L&K BIOMED

5. Non-clinical Testing

The proposed line extension for the VENUS Lumbar Intervertebral body Fusion Cage System does not constitute a new worst case for the intended use and is substantially equivalent to the predicate device (K110783).

6. Summary of technology characteristics

The VENUS Lumbar Intervertebral body Fusion Cage System shares technological characteristics similar to the predicate devices. These characteristics include similar design, the same materials and the same intended use.

7. Predicate or legally marketed devices which are substantially equivalent

The design feature and indications for the subject VENUS Lumbar Intervertebral body Fusion Cage System is substantially equivalent to the following predicates:

L&K BIOMED: VENUS Lumbar Intervertebral Body Fusion Cage System(K110783) .
GS Medical: Any Plus PEEK Cage (K100516) .
STRYKER SPINE :AVS PEEK Spacer System (K083661,K090816,K093704) .
Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162) .
Spine Art : JULIET OL , DYNAMIK Intervertebral body fusion device . (K081888, K101720)
Medtronic Sofamor Danek: CLYDESDALE Spinal System . (K100175,K112405,K113528)

8. Conclusion

The VENUS Lumbar Intervertebral body Fusion Cage System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

APR 1 9 2012

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

L&K BIOMED Company, Limited % Hee Kyeong Joo Manager #1104, Ace High-end Tower 3 cha, 371-50, Gasan-Dong Geumcheon-gu, Seoul 153-803 Republic of Korea

Re: K120063

Trade/Device Name: VENUS Lumbar Intervertebral body Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: March 28, 2012 Received: March 30, 2012

Dear Hee Kyeong Joo:

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 r read be active 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 or uny I catalog and the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 – Hee Kyeong Joo

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 (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 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.

Sincerely yours,

Erine Keith

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

Enclosure

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Indications for Use

510(k) Number : K/20063

Device Name : VENUS Lumbar Intervertebral body Fusion Cage System Indications for Use :

VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System is to be used with supplemental fixation: Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

Prescription Use (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 OF NEEDED)

Special 510(K)	Page 13/65
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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number	K120063
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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.