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 describes a 510(k) summary for the ORIA Spinal Clip System. This document focuses on demonstrating substantial equivalence to a predicate device, as required for certain medical devices by the FDA. Such summaries typically do not include detailed performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies, which are more common for novel or higher-risk devices requiring more extensive clinical validation.

Therefore, many of the requested details cannot be found in the provided text.

Here's an analysis based on the information that is available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical robustness thresholds). The acceptance criterion implicitly revolves around demonstrating "substantial equivalence" to a legally marketed predicate device.
Reported Device Performance: The document states: "Documentation was provided which demonstrated the ORIA Spinal Clip System Polyaxial Screws to be substantially equivalent to the previously cleared Type "V" screws." This is the core "performance" reported – that it is equivalent to another device. No specific numerical performance metrics are provided for the ORIA Spinal Clip System itself beyond this statement of equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to a legally marketed predicate device	The ORIA Spinal Clip System Polyaxial Screws were demonstrated to be substantially equivalent to the previously cleared Type "V" screws.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified.
Data Provenance: Not specified. The document refers to "documentation" being provided, but does not detail the nature of this documentation (e.g., specific study data, design comparisons, material testing results).

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 specified. The "ground truth" here is the established safety and efficacy of the predicate device, against which the new device is compared. There is no mention of a test set requiring expert ground truth establishment in the context of diagnostic accuracy or similar performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified.

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 spinal implant system, not an AI-assisted diagnostic tool or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a spinal implant system, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for demonstrating substantial equivalence is the established regulatory status and safety/effectiveness profile of the predicate device. The documentation for the ORIA system likely focused on demonstrating similar materials, design, mechanical properties, and intended use to the predicate device, rather than patient outcomes or pathology related to the ORIA system itself.

8. The sample size for the training set

Not applicable/Not specified. This is a medical device (spinal implant), not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a spinal implant system, not a machine learning algorithm.

Summary

{0}------------------------------------------------

510(k) SUMMARY

FEB 0 5 2003

Sponsor:	Eurosurgical, SAB.P.23-18, rue RobespierreBeaurains, France 62217Phone: 33-3-21215960, Fax: 33-3-21215970
Official ContactPerson:	Emmanuel Margerit, Regulatory Affairs and Quality Manager
Proprietary TradeName:	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 for eachof four defined indications and to fit the patient's anatomical and physiologicalrequirements. 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.
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 components are manufactured from implant gradematerials of pure commercial titanium and titanium alloy described by ASTMStandards F-67-95 GR2 and ASTM F-136-98, respectively, or of implant gradestainless steel described by ASTM Standard F-138-97, Grade 2 (316LVM StainlessSteel).
SubstantialEquivalence:	Documentation was provided which demonstrated the ORIA Spinal Clip SystemPolyaxial Screws to be substantially equivalent to the previously cleared Type "V"screws. The substantial equivalence is based upon equivalence in fundamentalscientific technology and indications/intended use.

Confidential: VORIA SPINAL CLIP SYSTEM Polyaxial Screw Modification

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines forming the body and wings.

Public Health Service

FEB 0 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Eurosurgical, SA c/o Ms. Karen E. Warden, MEBE Representative and Consultant REO Spine Line 7000 Hampton Center, Suite G1 Morgantown, West Virginia 26505

K023994 Re:

Trade Name: ORIA Spinal Clip System Regulation Number: 888.3070 and 888.3050 Regulation Name: Pedicle Screw Spinal System and Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI and KWP Dated: January 7, 2003 Received: January 8, 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.

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Page 2 - Ms. Karen E. Warden, MEBE

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,

Mike N Milken

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative 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): K023994

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) 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 LS-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).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	for Mark N
--	------------

concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number	K023994
Prescription Use(Per 21 CFR 801.109)	OR	Over-the-Counter Use

Confidential: ORIA SPINAL CLIP SYSTEM Polyaxial Screw Modification

Page 22

Regulation Number and Section

N/A