The GII Spinal Fixation System When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII@ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the GII@ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S 1) 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 a solid fusion mass.

The GII system is also a hook and sacral/iliac screw fixation system of the non-cervical spine indicated for (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).

Device Description

The new plates are offered in a series of sizes designated by the number of slots or holes within the plates. The I ho w plates are single slot. The new plates are provided precurved to more closely match the natural lordotic curve of the lumbar spine. Two different curves are offered in each size.

The devices are produced of a polyner matrix of Polyetherketonekctone (PEKEKK) Resins and long fiber carbon filaments.

The new plates are intended to be used with the existing pedicle screws, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. Because the new material is not a metallic material, precautions against mixing dissimilar metals or of a galvanic/corrosive interaction with the existing implants is eliminated.

The previously cleared indications for use are unchanged.

AI/ML Overview

This document is a 510(k) premarket notification for the GII OstaPek® Plate from COLIGNE AG. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain a detailed study report with acceptance criteria and reported device performance in the way typically expected for an AI/ML device.

This submission is for a medical implant (spinal fixation system), not a software/AI device that would involve performance metrics like sensitivity, specificity, or accuracy based on human interpretation or algorithm output. The "acceptance criteria" here refer to compliance with material, mechanical, and biocompatibility standards, which are physical tests rather than clinical study results comparing algorithm performance.

Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory document. I will answer the applicable points based on the information provided.

1. Table of acceptance criteria and the reported device performance

For this medical implant, acceptance criteria and performance are related to physical and biological properties.

Acceptance Criteria Category	Specific Criteria (Implicit from text)	Reported Device Performance (Summary from text)
Material Standards	Compliance with material standards	Devices produced of Polyetherketonekctone (PEKEKK) Resins and long fiber carbon filaments. Eliminates concerns about mixing dissimilar metals or galvanic/corrosive interaction.
Mechanical Testing	Compliance with mechanical testing standards	Fatigue and static testing complete. Test results demonstrate new plates perform equivalently or superiorly to previously cleared GII Spinal Fixation System plates.
Biocompatibility	Compliance with biocompatibility standards	Biocompatibility testing complete.
Labeling	Specific warnings and precautions	Labeling contains required warnings and precautions.

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

Test Set Sample Size: Not explicitly stated for mechanical and biocompatibility testing. These tests typically involve a specific number of samples per test type according to the relevant standards (e.g., n=5 or n=10 per test for fatigue).
Data Provenance (Country of Origin, Retrospective/Prospective): Not applicable in the context of device performance testing. The company is based in Zurich, Switzerland, and the submission is to the US FDA. The testing would have been conducted in a laboratory setting, not on patient data.

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

Number of Experts & Qualifications: Not applicable. Ground truth for mechanical and biocompatibility testing is established through standardized laboratory methods and measurements, not by human expert consensus or clinical interpretation.

4. Adjudication method for the test set

Adjudication Method: Not applicable. Standardized lab tests have defined pass/fail criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

MRMC Study: No. This is not a diagnostic device or an AI/ML software; it is a physical implant. Therefore, an MRMC study is not relevant.

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

Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: For this device, ground truth is established through:
- Validated Physical Measurements: Mechanical properties (e.g., strength, fatigue life) are measured using calibrated testing equipment against established engineering standards (e.g., ASTM standards).
- Biocompatibility Testing: Assessed through in-vitro and in-vivo biological response tests following ISO standards.
- Material Characterization: Chemical composition and properties verified against material specifications.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device is not an AI/ML model that requires a training set. The "development" would involve engineering design and prototyping, not data training.

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

Ground Truth for Training Set: Not applicable. See point 8.

Summary

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510(k) Summary InformationPremarket Notification, Section 510(k)	COLIGNE AG.OCTOBER 21, 2005
-----------------------------------------------------------------------------	---------------------------------

Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:

Device Name: 1.

Trade Name: GII OstaPek® Plate

Common Pedicle screw spinal system Name(s):

Classification Pedicle screw spinal system, spine plate Name(s):

Establishment Name & Registration Number: 2.

Name:	coLigne AG
Number:	9614472

3. Classification(s):

Sec. & 888.3070 Pedicle screw spinal system

(a) Identification. Pedicle screw spinal systems are multiple component devices, made from a variety of matcrials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.

(b) Classification. (1) Class II (special controls), when intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal turnor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:

(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and

(iv) Labeling that contains these two statements in addition to other appropriate labeling information:

"Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown."

*Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient."

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(2) Class III (premarket approval), when intended to provide immobilization and stabilization of sainal (2) Class in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc signifits in the moracie, and sither severe spondylolisthesis (grades 3 and 4) at LS-SI or degenerative spondylolisthesis with objective evidence of neurologic impairment.

Device Class:	Class II or Class III for the requested indications
Classification Panel:	Orthopaedic and Rehabilitation Devices Panel
Product Code(s):	MNI, MNH, KWP

Equivalent Predicate Device: 4.

COLIGNE AG. believes that the GII OstaPek® Plate is substantially equivalent to the plates currently offered in the GII Spinal Fixation System identified below:

K980852 - K032604, GII Spinal Fixation System

Equivalence can be seen in the design, material composition, surgical technique and intended use.

Device Description: 5.

General description of the new plate.

General description of the new patel.
The new plates are offered in a series of sizes designated by the number of slots or holes within the plates. The I ho w plates are single slot. The new plates are provided precurved to more closely match the natural lordotic curve of the lumbar spine. Two different curves are offered in each size.

The devices are produced of a polyner matrix of Polyetherketonekctone (PEKEKK) Resins and long fiber carbon filaments.

The previously cleared indications for use are unchanged.

Testing Summary. Fatigue, static and biocompatibility testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the new plates perform in a manner equivalent or superior to the previously cleared GII Spinal Fixation System plates.

Indications for Use. The GII Spinal Fixation System When used as a pedicle screw fixation system in the non-cervical posterior spinc in skeletally mature patients, the GII@ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the GII@ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (LS-S 1) 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 a solid fusion mass.

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Applicant Name & Address: 6.

coLigne AG Utoquai 43 Zurich, Switzerland 8008 41-433-438000 41-433-438009 - fax Registration Number: 9614472

7. Company Contact:

Robert Lange coLigne AG Utoquai 43 Zurich, Switzerland 8008 41-433-438000 41-433-438009 – fax

Submission Correspondent: 8.

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

0. Performance Standards:

United States Food and Drug Administration mandated performance s tandards for this device do not exist. Various voluntary performance are utilized. Voluntary standards utilized include ASTM, Standard Various volunary performance as certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 13485 series quality regulations.

coLigne AG. also meets appropriate general controls authorized under Sections 501, 502, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2005

CoLigne AG c/o David W. Schlerf Buckman Company, Incorporated 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389

Re: K051089

Trade/Device Name: GII Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, KWP, MNH Dated: September 22, 2005 Received: September 26, 2005

Dear Mr. Schlerf:

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 is 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 numsi 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- David W. Schlerf

This letter will allow you to begin marketing your device as described in your Section 5 10(k) i his letter will anow you to ocgin nameoning your article of your device to a legally premarket nothleadon: The FDA mining of basistants
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 If you desire specific advice for your device on our an and one as note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the No contact the Office of Complance at (21) = 1) = 1 = 1 807.97). You may obtain "Misoranding by reference to premanterialities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number : K051089

GII Spinal Fixation System Device Name(s):

Indications For Use:

The GII Spinal Fixation System When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the GII@ In the foll correcar posteries of the following: (1) degenerative Spondylolisthesis with objective evidence of neurologic impairment, (2) spondylonomon (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the GII@ Spinal In addition, which about for skeletally mature patients: (1) having severe System 16 Thereates 3 and 4) of the fifth lumbar/first sacral (L5-S 1) spondylonstiles. (eseiving fusions using autogenous bone graft only; (3) who John, (2) who are receiving or attached to the lumbar and sacral spine (L3 and are having the device intos in g the device removed after the development of a solid fusion mass.

The GII system is also a hook and sacral/iliac screw fixation system of the The On System 15 also a 1100r (1) degenerative disc disease (defined as back non of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degencrative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use __

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

(Per 21 CFR 801.109)

(Optional format 1-2-96)

510(k) Number 4051 084

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.