The ROI-T 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-T may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.

Device Description

The ROI-T Implants are crescent shaped blocks in a variety heights and lordosis angles. The shape of the ROI-T offers more options to the surgeon to adapt to the patient' anatomy.

The ROI-T Implant features a closed graft space and offers superior vascularization of that space. The inferior and superior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants.

AI/ML Overview

This device, the LDR Spine ROI-T Implant, is a medical device and not an AI/ML-driven diagnostic tool. Therefore, the questions related to AI/ML specific acceptance criteria, studies, ground truth, and expert involvement are not applicable in this context.

Acceptance Criteria and Device Performance:

The primary acceptance criteria for medical devices like the LDR Spine ROI-T Implant, especially for 510(k) submissions, revolve around demonstrating substantial equivalence to a legally marketed predicate device. This typically involves non-clinical performance data (e.g., mechanical testing, biocompatibility) rather than clinical studies with human readers or AI performance metrics.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical performance study focused on mechanical properties.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (ROI-T System) for mechanical properties.	"Finite Element Analysis results demonstrated that the proposed ROI-T Implant is substantially equivalent to the predicate device."

Sample Size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of Finite Element Analysis (FEA). FEA is a computer-based simulation, not a traditional test set with a sample size of physical units.
- Data Provenance: Not applicable. FEA is a computational method.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. FEA uses engineering principles and material properties as its "ground truth" or input data, not expert consensus in a medical diagnostic sense. Engineers or biomechanical experts would design and validate the FEA model.
Adjudication method for the test set:
- Not applicable. FEA results are analyzed and validated against engineering standards or established methods, not through an adjudication process.
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:
- No. This is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI/ML device.
The type of ground truth used:
- The "ground truth" for non-clinical performance data like FEA is based on:
  - Material properties: Established scientific and engineering data for the materials used (e.g., titanium alloys).
  - Biomechanical principles: Accepted biomechanical models and principles related to spinal load-bearing and stability.
  - Predicate device performance: The known mechanical performance characteristics of the legally marketed predicate device, against which the new device's FEA results are compared.
The sample size for the training set:
- Not applicable. This is not an AI/ML device. FEA involves defining geometries, material properties, and boundary conditions, not a data training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.

Summary

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K080569
Page 1 of 2

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MAY - 7 2008

510(k) Summary LDR Spine ROI-T Implant

1. Owner's Name & Address

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

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

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

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

4.	Trade Name:	LDR Spine ROI-T Implant
	Common Name:	Spinal Partial Vertebral Body Replacement Device
	Classification:	MQP: Spinal Intervertebral Body Fixation Orthosis - Class IIper 888.3060

1. Legally Marketed Equivalent Predicate Device: LDR Spine ROI-T System (K072132) LDR Spine RO! System (K043349)

6. Device Description

The ROI-T Implants are crescent shaped blocks in a variety heights and lordosis angles. The shape of the ROI-T offers more options to the surgeon to adapt to the patient' anatomy.

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7. Intended Use of the device

The ROI-T 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-T may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.

8. Non-Clinical Performance Data

Finite Element Analysis results demonstrated that the proposed ROI-T Implant is substantially equivalent to the predicate device ..

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2008

LDR Spine USA % Mr. Noah Bartsch, M.S., RAC Manager, Clinical, Regulatory and Quality Affairs 4030 West Braker Lane, Suite 360 Austin, TX 78759

Re: K080569

Trade/Device Name: LDR Spine ROI-T Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: April 17, 2008 Received: April 18, 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 (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., RAC

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 M Wilkinson

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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K080569
Page lot 1

Indications for Use Statement

Page 1 of 1

510(k) Number (if known):

Device Name: LDR Spine ROI-T Implant

Indications for Use:

X 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)

Neil R.P. Ogden for MK

Division of General, Restorative. and Neurological Devices

510(k) Number K080569

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.