(76 days)
The ROI-C is indicated for use to replace a vertebral body that has been resected or excised due to turnor 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-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.
The ROI-C Implants are D-shaped blocks in a variety of heights and length x width combinations. The ROI-C implants feature a closed graft space and the inferior and superior surface of the devices have a pattern of teeth to provide increased stability. The devices are manufactured from radiolucent PEEK, and are compatible with titanium anchors available for use with the ROI-C system.
This document is a 510(k) summary for the LDR Spine ROI-C Partial Vertebral Body Replacement System. It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics are provided in this 510(k) summary. The document states that "Results of the non-clinical analysis and verification activities indicate that the ROI-C system is substantially equivalent to the predicate device system." This implies that the device likely met certain performance criteria to demonstrate substantial equivalence, but those criteria are not detailed (e.g., strength, fatigue life, biocompatibility, etc.).
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. This is a 510(k) summary for a spinal implant, which relies on non-clinical performance data to demonstrate substantial equivalence, not clinical study data with human subjects or image data for algorithm evaluation. Therefore, there is no "test set" in the context of clinical or imaging data. The non-clinical analysis and verification activities would involve laboratory testing of the device itself.
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. As noted above, this is for a physical medical device (vertebral body replacement system) and relies on non-clinical performance data, not a diagnostic or imaging algorithm that requires expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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 implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The ground truth for a physical medical implant like this would be established through engineering specifications, material properties, biomechanical testing standards, and conformity to design requirements, rather than expert consensus on clinical or imaging data.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states:
"8. Non-Clinical Performance Data
Results of the non-clinical analysis and verification activities indicate that the ROI-C system is substantially equivalent to the predicate device system."
This indicates that the study to prove the device met acceptance criteria was a non-clinical analysis and verification activities. These typically involve:
- Mechanical Testing: Such as compression, fatigue, subsidence, and expulsion testing to ensure the device can withstand the physiological loads it will experience in the spine.
- Material Characterization: Testing the PEEK material for its mechanical properties, biocompatibility, and chemical stability.
- Design Verification: Confirming that the device dimensions, features (like the teeth for stability, closed graft space), and material composition meet the design specifications.
- Compatibility Testing: Ensuring compatibility with the associated titanium anchors.
The "predicate device" is the LDR Spine MC+ Partial Vertebral Body Replacement System (K043479). The goal of the non-clinical testing was to demonstrate that the ROI-C system performs similarly to the predicate device regarding safety and effectiveness for its intended use. The specific test results and acceptance criteria (e.g., "must withstand X N of force for Y cycles without failure") are not detailed in this summary.
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Image /page/0/Picture/1 description: The image shows the logo for "LDR" with the tagline "a passion for innovation" underneath. The logo consists of a stylized eye-like graphic to the left of the letters "LDR", which are in a bold, sans-serif font. The tagline is in a smaller, lighter font and is centered below the "LDR" letters.
MAY 2 9 2008
510(k) Summary
LDR Spine USA ROI-C Partial Vertebral Body Replacement System
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
(512) 344-3319 Phone: (512) 344-3350 Fax: noahbartsch@ldrspine.com Email:
3. Date 510(k) Summary Prepared
March 12, 2008
| 4. Trade Name | LDR Spine ROI-C System |
|---|---|
| Common Name | Spinal Partial Vertebral Body Replacement Device |
| Classification | MQPSpinal Intervertebral Body Fixation Orthosis – Class IIper 888.3060 |
5. Legally Marketed Equivalent Predicate Device
LDR Spine MC+ Partial Vertebrai Body Replacement System (K043479)
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Image /page/1/Picture/1 description: The image shows the logo for LDR, which includes a stylized eye graphic to the left of the letters "LDR" in bold, black font. Below the logo, the text "a passion for innovation" is written in a smaller, lighter font. The logo appears to be for a company or organization that values innovation and has a focus on vision or insight, as suggested by the eye graphic.
6. Device Description
The ROI-C Implants are D-shaped blocks in a variety of heights and length x width combinations. The ROI-C implants feature a closed graft space and the inferior and superior surface of the devices have a pattern of teeth to provide increased stability. The devices are manufactured from radiolucent PEEK, and are compatible with titanium anchors available for use with the ROI-C system.
7. Intended Use of the device
The ROI-C 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-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.
8. Non-Clinical Performance Data
Results of the non-clinical analysis and verification activities indicate that the ROI-C system is substantially equivalent to the predicate device system.
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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). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is 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
LSR Spine USA, Incoporated % Mr. Noah Bartsch Manager, Clinical, Regulatory & Quality Affairs 4030 West Braker Lane, Suite 360 Austin, Texas 78759
Re: K080728 Trade/Device Name: LDR Spine ROI-C Implant Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis. Regulatory Class: Class II Product Code: MQP Dated: May 2, 2008 Received: May 5, 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.
MAY 2 9 2008
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
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. Mulhearn
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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K080728
Page 1 of 1
Indications for Use Statement
Page 1 of 1
510(k) Number (if known): K080728
Device Name: LDR Spine ROI-C Implant
Indications for Use:
The ROI-C is indicated for use to replace a vertebral body that has been resected or excised due to turnor 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-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.
Prescription Use _ X (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. Ogden for mkm
Division of Gener and Neurological Devices
510(k) Number K080728
§ 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.