(154 days)
When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.
When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).
The ORIA Spinal Clip System includes components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of four defined indications and to fit the patient's anatomical and physiological requirements. The components include: Lumbar, thoracic, and pedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rods in various lengths; Connectors with set screws (sacral, transverse, lateral); Connecting elements; Instruments and Sterilizer trays.
The provided text is a 510(k) summary for the ORIA Spinal Clip System. A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This document focuses on demonstrating substantial equivalence rather than proving device performance against specific acceptance criteria through a clinical study or a standalone algorithm evaluation.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text because it primarily describes the device, its intended use, and its substantial equivalence to a predicate device. Clinical performance data, often generated through detailed studies with specific acceptance criteria, are typically found in more comprehensive clinical sections of a PMA (Premarket Approval) or sometimes in 510(k) de novo submissions, but are not explicitly detailed in this summary.
Here's an attempt to populate the table and answer the questions based on the type of information present in a 510(k) summary, rather than a clinical trial report:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary focused on substantial equivalence, explicit "acceptance criteria" for device performance in a clinical study context and corresponding "reported device performance" are not typically presented in the way they would be for a novel device undergoing extensive clinical trials or an AI/ML algorithm. Instead, the "performance" demonstrated for substantial equivalence is primarily based on equivalence in design, materials, and function to a predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as per 510(k)) |
|---|---|
| Indications for Use: The device shares the same intended uses as the predicate device. | The ORIA Spinal Clip System has indications for use as a nonpedicle, noncervical posterior system, for severe spondylolisthesis (Grades 3 & 4) at L5-S1, and as a pedicle screw system in the non-cervical spine. These indications are stated to be equivalent to those of the predicate device. |
| Anatomic Sites: The device is used in the same anatomic locations as the predicate device. | The ORIA Spinal Clip System is indicated for use in the lumbar, thoracic, and sacral spine, including L3 and below for specific conditions. This is stated to be equivalent to the predicate device. |
| Design: The fundamental design principles and structure are similar to the predicate device. | The ORIA Spinal Clip System includes components to form a construct for spinal fusion surgery, with various designs and sizes (hooks, screws, rods, connectors, etc.). The design is considered equivalent to the predicate device. |
| Material of Manufacture: The device is made from equivalent materials as the predicate device. | The ORIA Spinal Clip System Lateral Intermediate Connector (AL01) is manufactured from titanium and stainless steel. These materials are stated to be equivalent to the predicate device. |
| Function: The device performs its intended mechanical and biological roles in a similar manner to the predicate device. | The system functions to fit together to form a construct for spinal fusion, providing immobilization and stabilization of spinal segments as an adjunct to fusion. This function is considered equivalent to the predicate device. |
| Safety and Effectiveness: Although not explicitly stated as "acceptance criteria," the overall implication of substantial equivalence is that the device is as safe and effective as the predicate. | The FDA's letter states, "We have reviewed... and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... 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." This indicates the FDA found sufficient evidence of substantial equivalence for safety and effectiveness without requiring further clinical studies at this stage for performance. |
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 / Not Provided: The 510(k) summary does not describe a "test set" in the context of a clinical study or algorithm evaluation. The substantial equivalence determination is based on a comparison to a predicate device's existing regulatory clearance and established performance, not new clinical data specific to the ORIA Spinal Clip System detailed in this document.
- Data Provenance: Not provided, as no specific test set data is mentioned.
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 / Not Provided: No "ground truth" for a test set is described, as no clinical study data is presented. The determination of substantial equivalence relies on regulatory review and comparison by FDA experts to existing cleared devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No adjudication method is mentioned as there is no described test set or clinical study requiring one.
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 / Not Provided: This device is a mechanical spinal implant system, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This device is a mechanical spinal implant system, not an algorithm. Standalone performance for an algorithm is not relevant or described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided: No "ground truth" is established or discussed as no new clinical performance data from a specific study is presented for the ORIA Spinal Clip System itself in this summary. The "ground truth" for showing safety and effectiveness is largely based on the predicate device's established performance and regulatory clearance.
8. The sample size for the training set
- Not Applicable / Not Provided: No "training set" is applicable or described, as this is a mechanical device, not an AI/ML system.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: No "training set" or method for establishing its ground truth is applicable or described.
{0}------------------------------------------------
K031471
page 1 of 1
510(k) SUMMARY
| Sponsor: | Eurosurgical, SAB.P.23-18 rue RobespierreBeaurains, France 62217Phone: 33-3-2121 5960, Fax: 33-3-2121 5970 |
|---|---|
| ContactPerson: | Emmanuel Margerit, Regulatory Affairs and Quality Manager |
| ProprietaryTrade Name: | ORIA Spinal Clip System |
| DeviceDescription: | The ORIA Spinal Clip System includes components that fit together to form aconstruct for use during spinal fusion surgery. The system contains componentsof various designs and sizes that allow the surgeon to build an implant system foreach of four defined indications and to fit the patient's anatomical andphysiological requirements. The components include: Lumbar, thoracic, andpedicular hooks; Sacral screws; Pedicle screws; Set screws; Locking nuts; Rodsin various lengths; Connectors with set screws (sacral, transverse, lateral);Connecting elements; Instruments and Sterilizer trays. |
| Intended Use: | When used as a nonpedicle, noncervical posterior system, the ORIA Spinal ClipSystem is indicated for: (1) degenerative disc disease (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history andradiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5)deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7)tumor resection, and/or (8) failed previous fusion. |
| ORIA Spinal Clip System is indicated for skeletally mature patients: (1) havingsevere spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receivingfusions using autogenous bone graft only; (3) who are having the device fixed orattached to the lumbar and sacral spine (L3 and below); and (4) who are havingthe device removed after the development of solid fusion mass. | |
| When used as a pedicle screw system in the non-cervical spine of skeletallymature patients, the ORIA Spinal Clip System is indicated for immobilization andstabilization of spinal segments as an adjunct to fusion in the treatment of thefollowing acute and chronic instabilities or deformities of the thoracic, lumbar,and sacral spine: (1) degenerative spondylolisthesis with objective evidence ofneurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis,(6) spinal tumor, and (7) failed previous fusion (pseudarthrosis). | |
| Materials: | The ORIA Spinal Clip System Lateral Intermediate Connector (AL01) ismanufactured from titanium and stainless steel. |
| SubstantialEquivalence: | Documentation was provided which demonstrated the ORIA Spinal ClipSystem Lateral Intermediate Connector (AL01) to be substantially equivalentto a previously cleared device. The substantial equivalence is based uponequivalence in indications for use, anatomic sites, design, material ofmanufacture, and function. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures. The figures are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2003
Eurosurgical, SA c/o Ms. Karen E. Warden Reo Spine Line 7000 Hampton Center, Suite G1 Morgantown, WV 26505
Re: K031471
Trade/Device Name: Oria Spinal Clip System Regulation Number: 21 CFR 888.3050, 888.3070, Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, MNH, MNI Dated: 8/20/2003 Received: 8/22/2003
Dear Ms. Warden:
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.
{2}------------------------------------------------
Page 2 - Ms. Karen E. Warden
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 Office of Compliance at (301) 594- 4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Muller
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use Statement
510(k) Number (if known):
Device Name: ORIA Spinal Clip System
Indications for Use:
When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.
When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).
R. Mark N. Millman
1, Restorative
510(k) Number K031471
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
Confidential: ORIA SPINAL CLIP SYSTEM
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.