When used as an intervertebral body fusion device, the ROI Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

When used as a vertebral body replacement device, The ROI System of implants is indicated for use to replace a vertebral body that has been resected or excised due to turnor of trauma/fracture: The device is intended for use as a partial vertebral body: replacement in the thoracolumbar spine (from 74 to 15) 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 bane.

The ROI-A implants are intended to be implanted singularly while the ROF-T implantsmay be implanted singularly or in pairs.

Device Description

The proposed ROI: Interbody Fusion System will be offered in two: (2) configurations of various sizes. The configurations are designed based on surgical approach, and consist of: 1) ROI-T, transforaminal approach and-2) ROI-A, antentor approach.

AI/ML Overview

The provided text describes the LDR Spine ROI Interbody Fusion System, its indications for use, and a 510(k) summary, but it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical or performance study with defined metrics.

Here's a breakdown of what is and isn't in the document, based on your requested information:

A table of acceptance criteria and the reported device performance:
- Not provided. The document states: "Mechanical test results demonstrate that the proposed ROI Interbody Fusion System is substantially equivalent to the predicate device." This indicates that mechanical testing was performed, but no specific acceptance criteria (e.g., minimum compression strength, fatigue life) or quantitative performance results are listed or compared in a table. The core assertion is "substantial equivalence," not meeting defined performance thresholds.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document refers to "Mechanical test results," which are typically laboratory-based engineering tests, not involving human subjects or data provenance in the clinical sense. No sample sizes for these tests are mentioned.
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/Not provided. This type of information is relevant for studies involving the interpretation of medical images or clinical judgment to establish ground truth, often for AI/ML device evaluations. This document concerns a physical implant and mechanical testing, where "ground truth" would be engineering specifications and measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods are used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments, particularly for establishing ground truth from multiple readers. This is not mentioned as part of the mechanical test summary.
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 MRMC study was done. This device is an interbody fusion system (a physical implant), not an AI/ML-driven diagnostic tool that would typically involve a multi-reader multi-case study to assess AI assistance to human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in the context of "ground truth" as you've defined it. For mechanical testing, the "ground truth" would be established engineering standards and physical measurements of mechanical properties (e.g., strength, stiffness, fatigue life) of the device and its predicate.
The sample size for the training set:
- Not applicable/Not provided. This is relevant for AI/ML models. For mechanical testing, there's no "training set."
How the ground truth for the training set was established:
- Not applicable/Not provided. Same as above, there's no training set mentioned.

In summary, the provided document is a regulatory submission for a physical medical device (an implant) and details its indications for use and a claim of substantial equivalence based on mechanical testing. It does not include the detailed performance study information with acceptance criteria, sample sizes, expert ground truth establishment, or AI-related metrics that you've requested. These types of details are typically found in more extensive study reports or clinical trial summaries, which are not part of this 510(k) summary.

Summary

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K82a262

FEB -2 2009

LDR Spine ROI Interbody Fusion System

510(k) Summary of Safety and Effectiveness

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
DATE PREPARED	December 2, 2008
CLASSIFICATION NAME	MAX 888.3080- Intervertebral Fusion Device withBone Graft, LumbarMQP 888.3060 - Spinal Intervertebral Body FixationOrthosis
COMMON NAME	Intervertebral Body Fusion Device (MAX)Spinal Vertebral Body Replacement Device (MQP)
PROPRIETARY NAME	LDR Spine ROI Interbody Fusion System

DEVICE DESCRIPTION

INDICATIONS:

When used as an intervertebral body fusion device, the ROI Interbody Fusion System is indicated for intervertebral body fusion of the tumbar spine, from 1,2 to St, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of. degenerative discodisease (DDD) with up to Grade I spandyklisthesis: DDD is defined es back pain of discogenic origin with degeneration of the disc confirmed by history and rediographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

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The ROI-A implants are intended to be implanted singularly while the ROF-T implantsmay be implanted singularly or in pairs.

MECHANICAL TEST DATA

Mechanicalitest results demonstrate that the proposed RQI: Interbody Fusion System is substantially equivalent to the predicate device ..

. ਕੁਹ

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 12 2011

LDR Spine USA % Mr. Noah Bartsch Manager, Clinical, Regulatory and Quality Affairs 4030 W. Braker Lane, Suite 360 Austin, Texas 78759

Re: K082262

Trade/Device Name: LDR Spine ROI Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX, MQP Dated: December 2, 2008 Received: December 4, 2008

Dear Mr. Bartsch:

This letter corrects our substantially equivalent letter of February 2, 2009.

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 (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

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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.

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/CDRH/CDRHOffices/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,
Mark N. Mulkern

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): K082262

Device Name:

LDR Spine RO! Interbody Fusion System

Indications for Use:

When used as a vertebral body replacement device, The ROI System of implants 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. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.

The ROI-A implants are intended to be implanted singularly while the ROI-T implants may be implanted singularly or in pairs.

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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number	K082262

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.