The LP Cage® is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

Device Description

The LP Cage is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and associated instrumentation. All implantable components are manufactured from PEEK Optima LT1 and medical grade titanium alloy (Ti6Al4V-ELI).

AI/ML Overview

This document describes the pre-clinical performance testing of the Medyssey LP Cage, an intervertebral body fusion device.

1. Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Static axial compression	Device performance demonstrates substantial equivalence to predicate devices.	Completed following ASTM F2077-03. Indicated substantial equivalence to predicate devices and adequacy for intended use.
Dynamic axial compression	Device performance demonstrates substantial equivalence to predicate devices.	Completed following ASTM F2077-03. Indicated substantial equivalence to predicate devices and adequacy for intended use.
Static compression shear	Device performance demonstrates substantial equivalence to predicate devices.	Completed following ASTM F2077-03. Indicated substantial equivalence to predicate devices and adequacy for intended use.
Dynamic compression shear	Device performance demonstrates substantial equivalence to predicate devices.	Completed following ASTM F2077-03. Indicated substantial equivalence to predicate devices and adequacy for intended use.
Static torsion	Device performance demonstrates substantial equivalence to predicate devices.	Completed following ASTM F2077-03. Indicated substantial equivalence to predicate devices and adequacy for intended use.
Subsidence	Device performance demonstrates substantial equivalence to predicate devices.	Tested following ASTM F2267-04. Indicated substantial equivalence to predicate devices and adequacy for intended use.
Expulsion	Device performance demonstrates resistance to expulsion comparable to predicate devices.	Conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies and characterize their resistance to expulsion. Indicated substantial equivalence to predicate devices and adequacy for intended use.

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

The study refers to "pre-clinical testing" and the use of "recognized protocol" and ASTM standards for testing. However, the specific sample sizes (number of devices tested for each criterion) are not provided in the document. The data provenance is from Medyssey Co, LTD. in South Korea, and the testing appears to be prospective bench testing focused on the physical characteristics and performance of the device.

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

This document is for a medical device (LP Cage) and focuses on bench testing rather than diagnostic or observational studies. Therefore, no human experts were used to establish ground truth for the test set in the traditional sense of clinical readings. The "ground truth" for the device's performance is derived from its physical properties and mechanical behavior under standardized testing conditions against established engineering standards (ASTM).

4. Adjudication Method for the Test Set:

Given that this is bench testing of a physical device against engineering standards, an adjudication method is not applicable in the context of expert consensus or disagreement. The results are objective measurements against predefined criteria in the ASTM standards and the "recognized protocol" for expulsion testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. This document describes the pre-clinical bench testing of a physical medical device, not a diagnostic algorithm or a tool that assists human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a physical implant (LP Cage), not an algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept for this specific submission.

7. Type of Ground Truth Used:

The ground truth used for this study is based on engineering standards and established physical performance benchmarks outlined in ASTM standards (F2077-03, F2267-04) and a "recognized protocol" for expulsion testing. The substantial equivalence claim is based on the device's ability to meet or exceed the performance of predicate devices according to these objective tests.

8. Sample Size for the Training Set:

Not applicable. This document describes the pre-market submission for a physical medical device. There is no "training set" in the context of machine learning. The device itself is manufactured, and its properties are assessed through bench testing.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established for such a set.

Summary

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510(k) SUMMARY Medyssey's LP Cage

APR - 8 2011

Date:	May 28, 2010
Contact:	Israel AngelesVP Western US847-982-0100	Medyssey, LTD.8001 N. Lincoln Ave.Suite 401Skokie, IL 60077
Trade Name:	LP Cage
Product Class:	Class II
Classification:	21 CFR §888.3080 Orthosis, intervertebral body fusion device
Product Codes:	MAX
Panel Code:	87

Name of Device and Name/Address of Sponsor LP Cage

Medyssey Co, LTD. 722-3, 4f Science Tower, Jiheang-Dong Dongucheon-City, Gyenoggi-Do, S. Korea Dongucheon-City, Republic of Korea 722-3

Common or Usual Name

Intervertebral body fusion device

Predicate Devices

The LP Cage was shown to be substantially equivalent to legally marketed predicate devices. The predicate device for the Medyssey LP Cage is the IMPIX L (K072226).

Indications for Use

Technological Characteristics

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Performance Data

Static and dynamic axial compression, static and dynamic compression shear, and static torsion were completed following ASTM F2077-03. Subsidence was tested following ASTM F2267-04. Expulsion testing was conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. The above pre-clinical testing performed on the LP Cage indicated that the LP Cage is substantially equivalent to the predicate devices and is adequate for the intended use.

Summary:

The LP Cage and predicate devices have the same intended use, to provide mechanical stability in the lumbar disc space to facilitate biologic fusion. The indications for use of the LP Cage contain no new language that is not already included in at least one of the predicate devices. Moreover, the device is very similar in its size to the predicate devices. The materials used are also the same as in some predicate devices. There are no significant differences in technological characteristics compared to the predicates, and the minor differences that do exist do not raise any new types of safety or efficacy issues. Furthermore, bench testing demonstrates that these differences do not adversely impact device performance, as discussed below.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Medyssey Co., Ltd. % Silver Pine Consulting, LLC Rich Jansen, Pharm. D. 13540 Guild Avenue Apple Valley, Minnesota 55124

APR - 8 201

Re: K110067

Trade/Device Name: LP Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 11, 2011 Received: March 14, 2011

Dear Dr. Jansen:

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

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Page 2 - Rich Jansen, Pharm. D.

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 (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.

ff 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.html 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" (21CFB) 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 ne (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

A. is. R. ta

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 Statement

510(k) Number (if known): _K110067

Device Name: LP Cage

Indications for Use:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KII 0067 510(k) Number_

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.