The ROI-T System 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 of heights and lordosis angles. The shape of the ROI-T allows for a larger implant (length and width) to be used. The ROI-T implants are provided in both an open and enclosed graft design. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants.

AI/ML Overview

The provided text is a 510(k) summary for the LDR Spine ROI-T System, which is a spinal partial vertebral body replacement device. This summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (mechanical testing), rather than detailed clinical studies with acceptance criteria for device performance as would be expected for an AI/ML medical device.

Therefore, many of the requested fields regarding acceptance criteria and study details for an AI/ML device cannot be extracted from this document.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document in the context of specific performance metrics or acceptance criteria typically seen for AI/ML devices. The document states:

"Mechanical test results demonstrate that the proposed ROI-T System is substantially equivalent to the predicate device."
This implies that the acceptance criteria for the ROI-T system were to demonstrate mechanical properties (strength, stability, etc.) that were comparable to or better than those of the predicate device (LDR Spine ROI System, K043349). However, the specific numerical values of these criteria or the reported performance metrics are not detailed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The study mentioned is "mechanical test results," which are non-clinical and do not involve human patient data or test sets in the context of AI/ML evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Ground truth establishment by experts is relevant for clinical or diagnostic AI/ML studies, not for mechanical testing of a medical implant.

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

Not applicable. Adjudication methods are used in clinical studies, particularly for establishing ground truth from expert opinions, which is not relevant here.

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. This is a mechanical device, not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. This is a mechanical device, not an algorithm.

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

For mechanical testing, the "ground truth" would be established by validated engineering standards and testing methods. The document does not specify these methods but implies adherence to relevant standards for spinal implants.

8. The sample size for the training set

Not applicable. This isn't an AI/ML device that requires a training set.

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

Not applicable. This isn't an AI/ML device that requires a training set or ground truth in that context.

Summary

{0}------------------------------------------------

1077132

Image /page/0/Picture/1 description: The image shows the letters "LDR" in a bold, sans-serif font. Below the letters, the word "spine" is written in a smaller, sans-serif font. The letters are black and the background is white. The image is simple and clear.

A Passion for Innovation

510(k) Summary LDR Spine ROI-T System

AUG 3 0 2007

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

James Burrows Director of Clinical Marketing LDR Spine USA 4030 West Braker Lane, Suite 360 Austin, TX 78759

Phone: (512) 344-3307 (512) 344-3350 Fax: Email: jamesburrows@ldrspine.com

నా Date 510(k) Summary Prepared: July 30, 2007

1. Trade Name: Common Name: Classification:
  :

LDR Spine ROI-T System Spinal Partial Vertebral Body Replacement Device MQP: Spinal Intervertebral Body Fixation Orthosis - Class II per 888.3060

5. Legally Marketed Equivalent Predicate Device:

LDR Spine ROI System (K043349)

{1}------------------------------------------------

K072132
Page 2 of 2

6. Device Description

The ROI-T implants are crescent shaped blocks in a variety of heights and lordosis angles. The shape of the ROI-T allows for a larger implant (length and width) to be used.

The ROI-T implants are provided in both an open and enclosed graft design. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants.

Intended Use of the Device 7.

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

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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LDR Spine USA, Incorporated c/o Mr. James Burrows Director of Clinical Marketing 4030 West Braker Lane, Suite 360 Austin. Texas 78759

AUG 3 0 2007

K072132 Re:

Trade/Device Name: LDR Spine ROI-T System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: August 1, 2007 Received: August 2, 2007

Dear Mr. Burrows:

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.

{3}------------------------------------------------

Page 2 - Mr. James Burrows

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 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,

Barbara Burchum

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

{4}------------------------------------------------

Indications for Use Statement

K072132

Page 1 of 1

510(k) Number (if known):

Device Name: LDR Spine ROI-T 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)

Karlane Buchnd
Division Sign. Off

Division of G neral, Restorative. and Neurological Devices

510(k) Number K072137

Confidential

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.