K Number

Device Name

LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Manufacturer

LDR SPINE USA

Date Cleared

2009-07-14

(90 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K083857,K043479

Intended Use

When used as an intervertebral body fusion device, the LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine Cervical Interbody Fusion System implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

When used as a vertebral body replacement device, the ROI-C and MC+ implants are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.

Device Description

ROI-C consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an enclosed graft space. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the anchors.

The D-shaped ROI-C PEEK implants (PEEK OPTIMA LT1) feature two slots which allow for use with specially designed (and optional) supplemental fixation - the ROI-C Anchoring Plate. The Anchoring Plate, made of titanium alloy (TiAl6V4) can be inserted to obtain fixation to the vertebral bone, by locking in place to the PEEK implant via Locking Tabs.

MC+ consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an open or enclosed graft space design. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the Anchoring Clip.

MC+ is intended to be used with supplemental internal fixation (i.e. anchoring clips). MC+ is designed for use with one Anchor Clip. The mechanism by which the Anchoring Clip locks into the MC+ device is achieved via the mating slot in the anterior face and the anti-backout tabs of the Anchoring Clip itself.

AI/ML Overview

The provided text is a 510(k) Summary for the LDR Spine Cervical Interbody Fusion System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing and comparison of design, materials, and indications for use. It is not a clinical study report for an AI/ML medical device.

Therefore, the document does not contain the information required to populate the requested table and answer the study-specific questions for an AI/ML device. The "acceptance criteria" discussed are related to mechanical performance of an implantable medical device, not diagnostic or predictive performance of an algorithm.

Here's what can be extracted and a clear statement about the absence of other requested information:

Acceptance Criteria and Device Performance (Mechanical)

Acceptance Criteria	Reported Device Performance
Mechanical Test Standards:	Demonstrated substantial equivalence to predicate devices.
ASTM F2077	Testing performed in accordance with this standard.
ASTM F2267	Testing performed in accordance with this standard.

Explanation of Missing Information:

The provided document describes an intervertebral fusion system (an implanted medical device), not an AI/ML software device. Therefore, the following information is not applicable or not present in the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set of clinical data for an algorithm is mentioned. The "test set" refers to mechanical testing of the physical implant.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth established by expert consensus is relevant for diagnostic AI. This document does not describe such a process.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to mechanical testing of an implant.
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, as this is not an AI device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical implant, "ground truth" would relate to mechanical properties or biological outcomes, not diagnostic labels. The document mentions compliance with ASTM standards for mechanical testing.
The sample size for the training set: Not applicable, as this is not an AI device.
How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, the provided text is a 510(k) summary for a physical medical implant (intervertebral fusion system), and as such, it does not contain the type of AI/ML device performance data, study design, or ground truth information that your questions are designed to elicit.

Summary

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LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices)

510(k) Summary of Safety and Effectiveness

JUL 1 4,2009

SUBMITTED BY	LDR Spine USA4030 W. Braker Lane, Suite 360Austin, TX 78759
FOREIGN ESTABLISHMENTREGISTRATION NUMBER	3004788213
US AGENT ESTABLISHMENTREGISTRATION NUMBER	3004903783
CONTACT PERSON	Noah BartschManager, Clinical, Regulatory and Quality AffairsPhone: 512-344-3319Fax: 512-344-3350
SUBMISSION PREPARED BY	Lisa PetersonQA Consulting, Inc.Phone: 512-507-0746
DATE PREPARED	July 13, 2009
CLASSIFICATION NAME	ODP 888.3080 - Intervertebral Fusion Device withBone Graft, Cervical
COMMON NAME	Intervertebral Body Fusion Device (ODP)Spinal Vertebral Body Replacement Device (MQP)
PROPRIETARY NAME	LDR Spine Cervical Interbody Fusion System
PREDICATE DEVICE(S)	Predicate devices include several recently downclassified cages, as well as cleared VBR systems:- BAK/C (P980048, Zimmer Spine, Approved4/20/01)- Affinity Cage System (P000028, Medtronic,Approved 6/13/02)- ROI-C VBR (K083857, LDR Spine, Cleared2/12/09)- MC+ Partial VBR (K043479, LDR Spine,Cleared 6/30/05)

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SUBSTANTIAL EQUIVALENCE

The LDR Spine Cervical Interbody Fusion System was determined to be substantially equivalent to several commercially available systems.

DEVICE DESCRIPTION

ROI-C

MC+

INDICATIONS:

Page 2 of 3

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MECHANICAL TEST DATA

Mechanical test results demonstrate that the proposed LDR Spine Cervical Interbody Fusion System is substantially equivalent to the predicate device. Testing was performed in accordance with ASTM F2077 and ASTM F2267.

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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 stylized eagle with three lines representing its wings and body. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JUL 1 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LDR Spine USA % Mr. Noah Bartsch, M.S., R.A.C. Manager, Clinical, Regulatory & Quality Affairs 4030 W. Braker Lane, Suite 360 Austin, TX 78759

Re: K091088

Trade/Device Name: LDR Spine Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MQP Dated: April 12, 2009 Received: April 15, 2009

Dear Mr. Bartsch:

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.

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 (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.

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Page 2 - Mr. Noah Bartsch, M.S., R.A.C.

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/CDRH0ffices/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Charlyne Vuchnich

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 (if known):

Device Name:

LDR Spine Cervical Interbody Fusion System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(EXT for MXM

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

1088 510(k) Number_K09

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.