SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM by SYNTHES (USA)

The Posterior Cervical/Thoracic Hook/Rod System is intended to provide stabilization to promote tusion tollowing reduction of fracture/dislocation or trauma in the cervical/voper Ihoracic (C1-T3) spine.

Device Description

The Synthes Posterior Cervical/Thoracic Hook/Rod System consists of rods, clamps and set screws. These components are manufactured from the titanium alloy TiAlNb (ASTM F1295). The Posterior Cervical/Thoracic Hook/Rod System is intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Manual surgical instruments that will be marketed with this system include Rod Bending Plier for 3.5 rods, 2.5mm Hex screwdriver,and holding forcep. The rods are 3.5mm in diameter and are offered in lengths of 80 and 240mm. Hooks are available in both a left and right configuration to allow bilateral placement of the hook/rod construct.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SYNTHES Spine Posterior Cervical/Thoracic Hook/Rod System. This is a medical device, and the "study" referred to is the mechanical testing performed to demonstrate its safety and effectiveness, primarily through substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text. Please note that the information regarding AI-specific criteria (like MRMC studies, training set details, or ground truth establishment for AI models) is not applicable to this type of device submission as it predates widespread AI in medical devices and is focused on mechanical performance and substantial equivalence in a traditional sense.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance and Compliance
Static and Fatigue Performance Characteristics of the System	"Mechanical testing was performed in accordance with ASTM standard F1717. This testing documented both static and fatigue performance characteristics."
Meeting Requirements for Posterior Cervical and Upper Thoracic (C1-T3) Fixation	"This testing clearly demonstrated that the performance characteristics satisfy the requirements of posterior cervical and upper thoracic (C1-T3) fixation."
Clinical Indications Equivalence	"The SYNI HFS Spine Posterior Cervical/Thoracic Hook/Rod System is indicated for the same clinical indications as that of the AME Halifax Interlaminar Clamp System."
Material Composition Equivalence	"Material composition is identical to numerous other Synthes Spinal products that have been cleared via the 510(k) process."
Surgical Technique and Instrumentation Equivalence	"The surgical technique and instrumentation to implant this system is the same as that of the Synthes USS Hook/Rod systems."
Safety and Effectiveness for Levels of Use up to T3	"The levels of use to T3 do not have a significant effect on safety or effectiveness. This due to the fact that loading in these areas is not significantly different when compared to the cervical area. In addition, other systems such as the LIBERTY system by Sofamor Danek are cleared in the T1-T3 region."

Additional Information

Sample size used for the test set and the data provenance:
- The document refers to "mechanical testing" according to ASTM standard F1717. Mechanical testing typically involves a physical number of device units (the "sample size") subjected to various forces and cycles. However, the exact number of units tested is not specified in this summary.
- Data provenance: Not explicitly stated, but mechanical testing is typically performed in a laboratory setting, likely in the USA where Synthes is based. It is a retrospective evaluation of the device's physical properties.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this type of device. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717) and the physical properties of the materials and design, not by human expert assessment in the same way as, for example, image interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies or expert review processes, not standalone mechanical engineering tests of a device's physical performance.
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 mechanical implant, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical testing, the "ground truth" is defined by the engineering specifications and performance requirements outlined in ASTM F1717 and by the performance of the predicate devices (AME Halifax Interlaminar Clamp System and Synthes USS Hook/Rod systems) which the current device aims to be substantially equivalent to.
- For the clinical indications and material composition, the ground truth is established by the regulatory clearance of predicate devices and existing medical knowledge regarding spinal fixation.
The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning model. There is no concept of a "training set" in this context.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.

Summary

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

APR 1 6 1998

p. 3 April 3, 1998

Summary of Safety and Effectiveness Information [510(k) Summary]

SYNTHES (U.S.A.) 1690 Russell Road Paoli, PA 19301

(610) 647-9700 Contact: Barry E. Sands 1/28/98

Device: SYNTHES Spine Posterior Cervical/Thoracle Hook/Rod System compared to the AME Halifax Interlaminar Clamp System (K850039 & K962314).

Manual surgical instruments that will be marketed with this system include Rod Bending Plier for 3.5 rods, 2.5mm Hex screwdriver,and holding forcep.

The rods are 3.5mm in diameter and are offered in lengths of 80 and 240mm. Hooks are available in both a left and right configuration to allow bilateral placement of the hook/rod construct.

Mechanical testing was performed in accordance with ASTM standard F1717. This testing documented both static and fatigue performance characteristics. This testing clearly demonstrated that the performance characteristics satisfy the requirements of posterior cervical and upper thoracic (C1-T3) fixation.

The SYNI HFS Spine Posterior Cervical/Thoracic Hook/Rod System is indicated for the same clinical indications as that of the AME Halifax Interlaminar Clamp System. The levels of use to T3 do not have a significant effect on safety or effectiveness. This due to the fact that loading in these areas is not significantly different when compared to the cervical area. In addition, other systems such as the LIBERTY system by Sofamor Danek are cleared in the T1-T3 region.

Material composition is identical to numerous other Syrillies Spinal products that have been cleared via the 510(k) process. The surgical tochnique and instrumentation to implant this system is the same as that of the Synthes USS Hook/Rod systems.

This system is provided non-sterile; moist heat sterilization is recommonded.

Based on the above, the SYNTHES Spine Posterior Cervical/Thoracic Houk/Rod System is substantially equivalent to the AME Halifax Interlaminar Clamp System ..

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 1998

Mr. Barry E. Sands Manager, Regulatory Affairs SYNTHES Spine P.O. Box 0548 1690 Russell Road Paoli, Pennsylvania 19301

Re : K980358 SYNTHES Spine Posterior Cervical/Thoracic Hook/Rod System Regulatory Class: II Product Code: KWP Dated: January 28, 1998 Received: January 29, 1998

Dear Mr. Sands:

We have reviewed your Section 510 (k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 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 your device system subject to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f) (1) of the Act.

FDA identifies that any device system, if intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

1. You may not label or in any way promote this device system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the

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

package insert must include the following statement, "WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.";

1. All labeling for this device system, including the package label, must state that there are labeling limitations. The package insert must prominently state that the device system is intended for the specific use (s) described in the enclosure only; and
1. Pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device system for pedicular screw fixation/attachment must receive approval ---from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.

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 Druq 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 Reqister. 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.

FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or other manufacturers', may also be required.

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

Page 3 - Mr. Barry E. Sands

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Stephen Rhodes

lia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

p. 4 April 3, 1998 Page 1 of 1

510(k) Number (if known): NA K980358

Device Name: Posterior Cervical/Thoracic Hook/Rod System

Indications for Use:

The Postcrior Cervical/Thoracic Hook/Rod System is intended to provide stabilization to promote tusion tollowing reduction of fracture/dislocation or trauma in the cervical/voper Ihoracic (C1-T3) spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription
(Per 21 CFR 801.109)

Over-the-Counter Use_

Stetson Rhode

(Division Sign-Off) Division of General Restorative Devices K 9 8 0 3 S 510(k) Number

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.