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 focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria and outcome metrics. Therefore, many of the requested details about acceptance criteria, specific performance metrics, and study methodologies common in AI/Diagnostic device approvals are not present in this document.

However, I can extract the information that is available and explain why other details are missing.

Here's the analysis based on the provided text:

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

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence in Indications/Intended Use	Demonstrated equivalence for the ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & CO07) to the previously cleared OmniAxial Connector (CO04).
Equivalence in Manufacturing Methods	Demonstrated equivalence
Equivalence in Interconnection (Attachment) Mechanism	Demonstrated equivalence
Equivalence in Basic Design	Demonstrated equivalence
Equivalence in Materials	Demonstrated equivalence (Titanium alloy ASTM F136-98).

Explanation of Table Details: The "acceptance criteria" here are implied by the 510(k) process for substantial equivalence. For a 510(k) submission, the primary "acceptance criterion" is that the new device is "substantially equivalent" to a legally marketed predicate device. This is evaluated across various aspects like intended use, technology, materials, and safety/effectiveness. The document states that "Documentation was provided which demonstrated the ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & CO07) to be substantially equivalent..." based on these factors. No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical stress test results with defined pass/fail thresholds) are explicitly stated in this summary as "acceptance criteria."

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable/Not mentioned. This document describes a 510(k) for a spinal implant system, not a diagnostic or AI device that typically uses a "test set" of patient data for performance evaluation. The "study" here is a substantial equivalence comparison to a predicate device.
Data Provenance: Not applicable/Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not mentioned. No "test set" requiring expert ground truth is described.

4. Adjudication method for the test set

Not applicable/Not mentioned. No "test set" requiring adjudication is described.

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 is not an AI-assisted diagnostic device, so an MRMC study is not relevant.

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

Not applicable. This is not an AI or algorithm-based device.

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

The "ground truth" in a 510(k) for a device like this is the established safety and effectiveness of the predicate device. The new device leverages this by demonstrating substantial equivalence. The document doesn't detail performance studies of the device itself, but rather its similarity to an already approved device.

8. The sample size for the training set

Not applicable/Not mentioned. This device does not involve machine learning or a "training set."

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

Not applicable/Not mentioned. This device does not involve machine learning or a "training set."

Summary of the "Study" (Demonstration of Substantial Equivalence):

The "study" in this context is the submission of documentation to the FDA to demonstrate substantial equivalence of the ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & CO07) to a previously cleared predicate device, the OmniAxial Connector (CO04).

Methodology: The manufacturer provided documentation comparing the new device components to the predicate device across several key attributes.
Proof of Meeting Criteria: The FDA's letter (K030252) confirms that based on the submitted information, the device is determined to be "substantially equivalent." This means the FDA accepted the manufacturer's provided documentation as sufficient proof that the new device meets the implied "acceptance criteria" of being comparable to the predicate device in terms of:
- Indications/Intended Use
- Manufacturing Methods
- Interconnection (attachment) mechanism
- Basic Design
- Materials (Titanium alloy ASTM F136-98)

This type of 510(k) summary typically does not include raw performance data, clinical trial results, or detailed statistical analyses that would be found for novel devices or AI/diagnostic systems. It focuses on the comparison to an already approved product.

Summary

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510(k) SUMMARY

K030252
Page 1 of 1

FEB 2 1 2003

Manager

Sponsor:	Eurosurgical, SAB.P.23-18 rue RobespierreBeaurains, France 62217Phone: 33-3-21215960, Fax: 33-3-21215970
ContactPerson:	Emmanuel Margerit, Regulatory Affairs and Quality

Proprietary ORIA Spinal Clip System Trade Name:

Device The ORIA Spinal Clip System includes components that fit together to form a Description: 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.

Intended Use: When used as a nonpedicle, noncervical posterior system, the ORLA 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 (1) degenerative spondylolisthesis with objective evidence of sacral spine: neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis. (6) spinal tumor, and (7) failed previous fusion (pseudarthrosis).

The ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & Materials: CO07) are manufactured from titanium alloy (ASTM F136-98).

Substantial Equivalence: Documentation was provided which demonstrated the ORIA Spinal Clip System Extended OmniAxial Connectors (CO05 & CO07) to be substantially equivalent to the previously cleared OmniAxial Connector (CO04). The substantial equivalence is based upon equivalence in indications/intended use. manufacturing methods, interconnection (attachment) mechanism, basic design and materials.

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Public Health Service

Image /page/1/Picture/2 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" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, representing health and human services.

FEB 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030252

Trade/Device Name: ORIA Spinal Clip System Extended Omniaxial Connector 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. Iisting 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

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Page 2 – Ms. Karen E. Warden

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. 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): |< 030252

Device Name: ORIA Spinal Clip System

Indications for Use:

(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

Miriam C. Provost

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510(k) Number: K030252

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.