The ROI-A Implant is 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. The ROI-A is intended to be implanted singularly. Supplemental internal fixation is required to properly utilize this system.

Device Description

The ROI-A implants are cylinder shaped blocks in a variety of footprints, heights and lordosis angles.

The ROI-A implants feature a closed graft space. The inferior and superior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. An anchoring plate in two parts is associated to the device to further enhance its stability.

AI/ML Overview

This 510(k) summary for the LDR Spine ROI-A Implant describes a medical device, specifically a spinal intervertebral body fixation orthosis. The document focuses on establishing substantial equivalence to a predicate device, which is a common pathway for medical device approval in the US.

Based on the provided information, no clinical study involving human readers or AI algorithms for diagnostic purposes was conducted or is applicable to this device submission. The acceptance criteria and the "study" proving the device meets them are entirely based on non-clinical mechanical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical performance for spinal implants	"Mechanical test results demonstrate that the proposed ROI-A Implant is substantially equivalent to the predicate device."

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

Test Set Sample Size: Not applicable. The "test set" in this context refers to the samples used for mechanical testing of the device itself, not a dataset of patient images or clinical cases. The specific number of devices tested mechanically is not provided in this summary.
Data Provenance: Not applicable in the traditional sense of clinical data. The mechanical testing would have been conducted in a laboratory setting by LDR Spine USA, likely in the US (Austin, TX, is the company's address). This is a non-clinical study.

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

Not applicable. Ground truth in the context of diagnostic AI or human reader studies does not apply here. The "ground truth" for mechanical testing would be established by engineering standards and validated testing methodologies.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1) are for resolving discrepancies in expert interpretations of clinical data, which is not relevant to mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, often in conjunction with AI. This submission is for a physical implantable device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

Mechanical Performance Standards: The "ground truth" for the mechanical testing of the ROI-A Implant is based on established engineering and biomechanical standards for spinal intervertebral body fixation orthoses. The goal was to prove substantial equivalence to the predicate device, implying that its mechanical properties (e.g., strength, durability, stability) are comparable to an already approved device.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned in the context of this device because it is not an AI/ML algorithm or a diagnostic device that requires training on a dataset.

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

Not applicable, as no training set was used.

Summary of Device Acceptance:

The LDR Spine ROI-A Implant was accepted for market based on the demonstration of substantial equivalence to existing predicate devices (LDR Spine ROI System K043349 and LDR Spine MC+ System K043479). This equivalence was primarily proven through non-clinical mechanical testing. The 510(k) summary explicitly states: "Mechanical test results demonstrate that the proposed ROI-A Implant is substantially equivalent to the predicate device." The FDA's letter confirms this finding of substantial equivalence, allowing the device to proceed to market. There is no mention of clinical trials, human subject data, or AI performance studies in this submission.

Summary

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a pession for innovation

APR - 7 2008

510(k) Summary LDR Spine ROI-A Implant

1. Owner's Name & Address

LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

Phone: (512) 344-3333 Fax: (512) 344-3350

2. Contact Person

Noah Bartsch, MS, RAC

Manager, Clinical, Regulatory & Quality Affairs LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

Phone: (512) 344-3319 Fax: (512) 344-3350 Email: noahbartsch@ldrspine.com

3. Date 510(k) Summary Prepared: February 27, 2008

1. Trade Name: LDR Spine ROI-A Implant Common Name: Spinal Partial Vertebral Body Replacement Device Classification: MQP: Spinal Intervertebral Body Fixation Orthosis - Class II per 888.3060

5. Legally Marketed Equivalent Predicate Device: LDR Spine ROI System (K043349) LDR Spine MC+ System (K043479)

6. Device Description

The ROI-A implants are cylinder shaped blocks in a variety of footprints, heights and lordosis angles.

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7. Intended Use of the device

The ROI-A is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumaffracture. 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. The ROI-A is intended to be implanted singularly. Supplemental internal fixation is required to properly utilize this system.

8. Non-Clinical Performance Data

Mechanical test results demonstrate that the proposed ROI-A Implant is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2008

LDR Spine USA, Incorporated c/o Mr. Noah Bartsch Manager of Clinical, Regulatory, and Quality Affairs 4030 West Braker Lane, Suite 360 Austin, TX 78759

Re: K080572

Trade/Device Name: ROI-A Partial Vertebral Body Replacement System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: March 28, 2008 Received: March 31, 2008

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 such 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); 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.

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Page 2 - Mr. Noah Bartsch

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Millman

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

Enclosure

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K080572
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Indications for Use Statement

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1080592 510(k) Number (if known):

Device Name: LDR Spine ROI-A Implant

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)

Nirl R.S. Qal firmen

Division of General, Restorative, and Neurological Devices

510(k) Number K080572

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.