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).

Device Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the ORIA Spinal Clip System. It describes a medical device (spinal clip system) and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The summary states that the "ORIA Spinal Clip System Lengthened Lateral Connector (AL06)" was found substantially equivalent to a previously cleared device (Lateral Connector AL02). This equivalence is based on design principles, materials, manufacturing methods, and intended use, not on a performance study against specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.

Here's why and what kind of information is present:

Substantial Equivalence: The document is a 510(k) submission, a common pathway for medical device clearance in the US. This pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive new clinical trials or performance studies with specific acceptance criteria in all cases.
Focus on Design and Materials: The core of the substantial equivalence argument for this device revolves around the lengthened lateral connector being made of the same material (titanium alloy), having similar manufacturing methods, an equivalent interconnection mechanism, and a basic design similar to the previously cleared connector.

To directly answer your specific points based only on the provided text, many cannot be addressed:

Table of acceptance criteria and reported device performance: Not applicable. No specific performance acceptance criteria or reported performance metrics are mentioned. The comparison is based on substantial equivalence to a predicate device's design and materials.
Sample size for the test set and data provenance: No test set or associated data is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is discussed.
Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is not mentioned. The device is a spinal implant, not typically evaluated through MRMC studies in this context.
Standalone performance study (algorithm only without human-in-the-loop performance): Not applicable. This is a hardware device, not an algorithm.
Type of ground truth used: Not applicable. No ground truth determination for performance evaluation against acceptance criteria is described.
Sample size for the training set: Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable. No training set is involved.

The K030253 document is primarily a regulatory clearance document demonstrating substantial equivalence based on material, design, and intended use, not a performance study report with acceptance criteria.

Summary

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510(k) SUMMARY

K030253

Page 1 of 1

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 components ofvarious 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; Rods invarious 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 having thedevice removed after the development of solid fusion mass.
	When used as a pedicle screw system in the non-cervical spine of skeletally maturepatients, 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, andsacral 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 Lengthened Lateral Connector (AL06) ismanufactured from titanium alloy (ASTM F136-98).
SubstantialEquivalence:	Documentation was provided which demonstrated the ORIA Spinal Clip SystemLengthened Lateral Connector (AL06) to be substantially equivalent to thepreviously cleared Lateral Connector (AL02). The substantial equivalence isbased upon equivalence in indications/intended use, manufacturing methods,interconnection (attachment) mechanism, basic design and materials.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2003

Eurosurgical, S.A. c/o Ms. Karen E. Warden, MEBE REO Spine Line 7000 Hampton Center, Suite G1 Morgantown, WV 26505

Re: K030253

Trade/Device Name: ORIA Spinal Clip System Lengthened Lateral Connector for Extremity Regulation Number: 21 CFR 888.3050, 888.3070 Regulation Name: Spinal intervertebral body fixation orthosis; Spondylolisthesis spinal fixation device system; Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, MNH, MNI Dated: January 21, 2003 Received: January 24, 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

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Page 2 - Ms. Karen E. Warden

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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" (21 CFR 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,

Miriam C. Provost

for 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

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Indications for Use Statement

510(k) Number (if known): K030253

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) spinal stenosis; (5) deformities (i.e., scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) turnor resection, and/or (8) failed previous fusion.

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 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).

(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 -----------

uriam C. Provost

ral, Restorative

0(k) Number K030253

Regulation Number and Section

§ 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.