PREMIER ANTERIOR CERVICAL PLATE SYSTEM by SOFAMOR DANEK USA

The PREMIER™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

Device Description

The PREMIER™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (slide washers and set screws are preassembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 and may be supplied either sterile or non-sterile.

AI/ML Overview

The provided text describes a 510(k) submission for the PREMIER™ Anterior Cervical Plate System, focusing on its substantial equivalence to previously marketed devices. This type of submission relies on demonstrating equivalence through comparison to legally marketed predicate devices, often using mechanical test data, rather than clinical studies with explicit acceptance criteria related to device performance in an AI or diagnostic context.

Therefore, the sections of your request related to AI/diagnostic performance, such as sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, are not applicable to the information provided in the K992110 510(k) summary.

Acceptance Criteria and Device Performance (Based on the provided text):

The primary acceptance criteria for a 510(k) submission are related to demonstrating substantial equivalence to a predicate device. The performance is assessed through mechanical testing to show the device functions similarly and safely.

Acceptance Criteria Category	Specific Criteria (Implicit for 510(k))	Reported Device Performance (Summary from text)
Material Composition	Device materials are biocompatible and meet established standards.	Components made from titanium alloy as described by ASTM F-136.
Mechanical Strength & Durability	Device demonstrates similar mechanical properties (e.g., strength, fatigue resistance) to predicate devices.	"Mechanical test data were provided in support of this notification." (Specific metrics like tensile strength, torsional strength, fatigue life are not detailed in this summary.)
Intended Use & Indications	Device's intended use and indications for use are within the scope of or comparable to predicate devices.	Intended for anterior interbody screw fixation of the cervical spine. Indicated for temporary stabilization during cervical spinal fusions in patients with degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, and/or failed previous fusions. (Matches predicate device indications implicitly).
Safety & Effectiveness	Device is as safe and effective as the predicate device(s).	Demonstrated substantial equivalence to commercially available cervical plating systems, implying comparable safety and effectiveness where no new safety concerns arise.

Irrelevant/Not Applicable Information for this 510(k) Summary:

The following requested information is not relevant to a 510(k) submission for a non-AI medical device and is therefore not present in the provided text:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for mechanical testing or a non-clinical 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI/diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of device performance as one might for a diagnostic claim. Ground truth for mechanical testing would involve engineering standards and measurements.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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

K'y92110

SEP 1 4 1991

PREMIER™ Anterior Cervical Plate System 510(k) Summary June 21, 1999

I.	Company:	Sofamor Danek1800 Pyramid PlaceMemphis, Tennessee 38132(901) 396-3133
II.	Product Name:	PREMIERTM Anterior Cervical Plate System
	Classification Name:	Spinal intervertebral body fixation orthosis

The PREMIER™ Anterior Cervical Plate System consists of a variety of III. shapes and sizes of bone plates (slide washers and set screws are preassembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 and may be supplied either sterile or non-sterile.
The PREMIER™ Anterior Cervical Plate System is intended for anterior IV. interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The PREMIER™ Anterior Cervical Plate System was claimed to be V. substantially equivalent to commercially available cervical plating systems. Literature concerning these devices was supplied in support of establishing equivalence.
Mechanical test data were provided in support of this notification.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the text "Public Health Service" in a bold, sans-serif font. The text is arranged horizontally, with each word clearly legible. The overall appearance is simple and straightforward, focusing on conveying the name of the organization.

ن تي تي

Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.

SEP 1 4 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Vice President, Research and Regulatory Affairs Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K992110

Trade Name: Premier™ Anterior Cervical Plate and Screw System Regulatory Class: II Product Code: KWQ Dated: June 21, 1999 Received: June 22, 1999

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System , Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Dr. Richard W. Treharne Page 2

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Page _ 1 of _ 1 June 21, 1999

510(k) Number (if known): K 992 // 0

Device Name:

Indications for Use:

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K992110

Prescription Use(Per 21 CFR 801.109)2-96)	X
---------------------------------------------------	---

Over-The-Counter Use(Optional Format 1-)
----------------------------------------------	--

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.