The OctaFix Occipital Cervical Plating System is intended to provide stabilization to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlanto-axial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.

The UBP II Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 8mm-20mm threaded lengths) are used with the OctaFix Occipital Cervical Plating System to allow for occipital fixation. These UBP II Bone Screws are limited to occipital fixation only.

The C-Fix™ Cable System is used with the OctaFix Occipital Cervical Plating System to allow for wire/cable attachment to the posterior cervical spine.

The OctaFix 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spir the indications specified above.

Device Description

The Spinal Concepts, Inc. OctaFix Occipital Cervical Plating System consists of a single horse shoe shaped piece of alloyed titanium, resembling two rods that run axially along the cervical and upper thoracic spine and are joined by a flatter, plate-like section, that is intended for fixation to the occiput. Hooks, screws, and C-Fix™ cables are intended for fixation of the OctaFix Plate. UPB II Screws are intended for fixation to the occiput and Cannulated Side Loading Closed Screws are intended for fixation to the upper thoracic spine. The rods are to be fixed to the cervical spine through either cables or laminar hooks. Components of the OctaFix Occipital Cervical Plating System are manufactured from medical grade Ti-6AI-4V ELI titanium alloy per ASTM F-136 and may be supplied sterile or non-sterile.

AI/ML Overview

The provided document describes a medical device, the OctaFix Occipital Cervical Plating System, and its clearance through the 510(k) pathway, which establishes substantial equivalence to a predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical trial data that would establish performance against strict clinical acceptance criteria.

Therefore, the information typically requested in your query regarding acceptance criteria for device performance, ground truth establishment, expert adjudication, or MRMC studies for AI/algorithm-based devices is not directly applicable to this 510(k) submission for a spinal plating system.

Instead, the "acceptance criteria" for this device are primarily met by demonstrating substantial equivalence to an existing predicate device (Synthes CerviFix System) through:

Mechanical Testing: To verify the design changes and demonstrate that the device meets functional requirements (e.g., static and fatigue data).
Material Equivalence: Both devices are made from titanium alloy.
Functional Equivalence: Both systems provide similar components and mechanisms for spinal fixation (bone screws for occipital fixation, hooks/cables for cervical fixation, screws for thoracic fixation), and both are based on a rod-plate component.

Here's how to address your points given the available information:

A table of acceptance criteria and the reported device performance

Acceptance Criterion	Reported Device Performance
Design Verification	Mechanical testing data collected in accordance with ASTM 1717 provided.Static and fatigue data demonstrated that the design met all functional requirements.
Material Equivalence	Manufactured from medical grade Ti-6AI-4V ELI titanium alloy per ASTM F-136, similar to the predicate device.
Form, Fit, and Function	Determined to be substantially equivalent to the predicate device (Synthes CerviFix System) in terms of fit, form, and function.

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 for the mechanical testing. ASTM 1717 outlines standard testing procedures for metallic spinal implant constructs, which would involve a specific number of test articles. The document does not provide details on the number of devices tested.
- Data Provenance: The mechanical testing was conducted to verify design changes. This type of data is typically generated in a laboratory setting by the manufacturer (Spinal Concepts, Inc.) in the United States, as required for device clearance. It is inherently "prospective" in the sense of being generated specifically for the submission, but it's not clinical data.
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. This information pertains to studies establishing diagnostic or prognostic accuracy, typically with human interpretation as ground truth. For a mechanical device, performance is established through engineering and biomechanical testing, not expert interpretation of results in the traditional sense of a clinical study. The "experts" involved would be biomechanical engineers and material scientists.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for clinical studies where human experts assess cases (e.g., medical images). For mechanical testing, the "ground truth" is determined by the physical properties measured against engineering standards.
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
- No. This device is a passive implantable medical device (spinal plating system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm or software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the clinical sense. For the mechanical testing, the "ground truth" is established by the specified engineering standards (ASTM 1717) and the physical properties of the materials and design, which are quantitatively measured and compared against defined functional requirements and the predicate device's performance.
The sample size for the training set
- Not applicable. This concept relates to machine learning models. This device does not use a "training set."
How the ground truth for the training set was established
- Not applicable. See point 8.

Summary

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JUN 1 8 2002

12021009

OctaFix Occipital Cervical Plating System 510(k) Summary

SUBMITTED BY	Spinal Concepts, Inc.12012 Technology Blvd., Suite 100Austin, TX 78727
ESTABLISHMENTREGISTRATION NUMBER	1649384
CONTACT PERSON	David M. Hooper, Ph.D.Manager, Regulatory and Clinical Affairs
DATE PREPARED	June 4, 2002
CLASSIFICATION NAME	Spinal Interlaminal Fracture Orthosis (888.3050/KWP)Spinal Intervertebral Body Fixation Orthosis (888.3060/KWQ)
COMMON NAME	Spinal Fixation System
PROPRIETARY NAME	OctaFix Occiptal Cervical Plating System
PREDICATE DEVICE	Synthes CerviFix System (K011969)

DEVICE DESCRIPTION

INDICATIONS

The C-Fix™ Cable System is used with the OctaFix Occipital Cervical Plating System to allow for wire/cable attachment to the posterior cervical spine.

The OctaFix 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.

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MECHANICAL TEST DATA

Mechanical testing data, collected in accordance with ASTM 1717, were collected to verify the design changes. Static and fatigue data were provided to demonstrate that the design met all functional requirements.

BASIS OF SUBSTANTIAL EQUIVALENCE

The OctaFix Occipital Cervical Plating System and the CerviFix are substantially equivalent in terms of fit, form and function. Both are made from titanium alloy, and include bone screws of occipital fixation, hooks and cables for cervical fixation and screws for thoracic fixation. Both systems are based upon a rod-plate component.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three heads, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

JUN 1 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

David M. Hooper, Ph.D. Manager, Clinical and Regulatory Affairs Spinal Concepts, Inc. 12012 Technology Blvd., Suite 100 Austin, Texas 78727

Re: K021009

Trade/Device Name: OctaFix Occipital Cervical Plating System Regulation Number: 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: March 26, 2002 Received: March 28, 2002

Dear Dr. Hooper:

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 - David M. Hooper, Ph.D.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Sincerely yours,

Mark N Milkersen

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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INIDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): K021009

Device Name: Spinal Concepts, Inc. OctaFix Occipital Cervical Plating System

Indications for Use:

The C-Fix™ Cable System is used with the OctaFix Occipital Cervical Plating System to allow for wire/cable attachment to the posterior cervical spine.

The OctaFix 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spir the indications specified above. - - -

Mark n Milkeren
(Division Sign-Off)

Division of General, Festorative and Neurological Devices

510(k) Number K021009

(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: (Optional Format 1-2-96)

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.