(120 days)
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 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.
The ROI-A System is part of the ROI Interbody Fusion System family, and is comprised of various sizes and configurations of implants to accommodate individual patient anatomy. The ROI-A is intended to be used for interbody fusion of the lumbar spine, and is also indicated for use as a partial vertebral body replacement of the thoraco-lumbar spine.
The provided text describes a 510(k) submission for the LDR Spine ROI Interbody Fusion System (ROI-A Implant System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through extensive clinical studies.
Based on the information provided in the document:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for a spinal implant, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating substantial equivalence through non-clinical (laboratory) testing, rather than clinical performance metrics typically associated with AI/software devices. The document explicitly states:
| Acceptance Criteria (Implicit for 510(k) substantial equivalence with minor design changes) | Reported Device Performance |
|---|---|
| Maintain identical intended uses, indications, materials of manufacture, processing, packaging, and surgical technique after minor design modifications. | Minor design modifications were made. The Predicate and Proposed devices have identical intended uses, indications, materials of manufacture, processing, packaging, and surgical technique. |
| Provide reasonable assurance of safety and effectiveness post-design changes. | The results of non-clinical (laboratory) validation testing demonstrate that the proposed design changes provide reasonable assurance of safety and effectiveness. |
| Mechanical and biocompatibility performance equivalent to or better than the predicate device. | (Implicitly met through non-clinical validation testing, but specific metrics are not detailed in this summary.) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical data for AI/software. The "test set" here refers to the physical devices undergoing laboratory testing. The document does not specify the number of implants used for non-clinical (laboratory) validation testing.
- Data Provenance: The data is from "non-clinical (laboratory) validation testing." The location of these labs or specific provenance of the materials used in testing is not detailed. There is no clinical data provenance as "Clinical performance data was not required to support this submission."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There is no mention of human expert involvement for establishing ground truth as there were no clinical studies or human interpretation components discussed for this device's performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There was no clinical data or expert review process described that would require an adjudication method.
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 device is a physical spinal implant, not an AI or software-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as this is a physical medical device and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. For the non-clinical (laboratory) validation testing, the "ground truth" would be established by engineering specifications, material properties, and biomechanical standards, rather than clinical ground truth types like pathology or outcomes data.
8. The sample size for the training set:
Not applicable. As a physical device, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable.
Study Proving Acceptance Criteria:
The study proving the acceptance criteria (which, in this 510(k) context, is primarily substantial equivalence and demonstration of safety and effectiveness through non-clinical means) is explicitly stated as:
- "Non-clinical (laboratory) validation testing"
The document indicates that "The results of non-clinical (laboratory) validation testing demonstrate that the proposed design changes provide reasonable assurance of safety and effectiveness." This testing aimed to ensure that the minor design modifications to the predicate device did not negatively impact its performance or safety, maintaining the "identical intended uses, indications, materials of manufacture, processing, packaging, and surgical technique." No further details about the specific tests conducted (e.g., fatigue testing, static compression, expulsion resistance) are provided in this summary.
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JUN 2 5 2009
LDR Spine ROI Interbody Fusion System ROI-A Implant System
510(k) Summary of Safety and Effectiveness
SUBMITTED BY
LDR Spine USA 4030 W. Braker Lane, Suite 360 Austin, TX 78759
FOREIGN ESTABLISHMENT REGISTRATION NUMBER
3004788213
US AGENT ESTABLISHMENT REGISTRATION NUMBER
3004903783
CONTACT PERSON
Noah Bartsch Manager, Clinical, Regulatory and Quality Affairs Phone: 512-344-3319 Fax: 512-344-3350
DATE PREPARED
February 24, 2009
CLASSIFICATION NAME
MAX 888.3080- Intervertebral Fusion Device with Bone Graft, Lumbar MQP 888,3060 - Spinal Intervertebral Body Fixation Orthosis
COMMON NAME
Intervertebral Body Fusion Device (MAX) Spinal Vertebral Body Replacement Device (MQP)
PROPRIETARY NAME
LDR Spine ROI Interbody Fusion System ROI-A Implant System
DEVICE DESCRIPTION
The ROI-A System is part of the ROI Interbody Fusion System family, and is comprised of various sizes and configurations of implants to accommodate individual patient anatomy. The ROI-A is intended to be used for interbody fusion of the lumbar spine, and is also indicated for use as a partial vertebral body replacement of the thoraco-lumbar spine.
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INDICATIONS:
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 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.
COMPARISON TO THE PREDICATE:
Minor design modifications were made to the Predicate ROI-A System, resulting in the Proposed device design. The Predicate and Proposed devices have the identical intended uses, indications, materials of manufacture, processing, packaging, and surgical technique.
PERFORMANCE DATA:
Clinical performance data was not required to support this submission.
The results of non-clinical (laboratory) validation testing demonstrate that the proposed design changes provide reasonable assurance of safety and effectiveness.
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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 its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
Public Health Service
JUN 25 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LDR Spine USA % Noah Bartsch, M.S., R.A.C. 4030 W. Braker Lane, Suite 360 Austin, TX 78759
Re: K090507
Trade/Device Name: LDR Spine ROI Interbody Fusion System; ROI-A Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, MQP Dated: May 22, 2009 Received: May 26, 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 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/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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Milliken
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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8
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: LDR Spine RQI Interbody Fusion System - ROI-A Implant System
Indications for Use:
When used as an intervertebral body fusion device, the RO! Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, 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 RO! 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 implants are intended to be implanted singularly (for ROI-A).
| Prescription Use | AND/OR | Over-The-Counter Use |
|---|---|---|
| X(Part 21 CFR 801 Subpart D) | (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)
-バ (EXT for MXM) 6/24109
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ K090507
§ 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.