SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM by SYNTHES (USA)

The Synthes Spine Occipital-Cervical Plate/Rod and Hook System is intended to provide stabilization to promote fusion of the cervical spine and occipital-cervical junction (occiput - T3) for the following indications:

Degenerative disease of the cervical vertebrae (neck pain of discogenic origin with . degeneration of the disc as confirmed by patient history and radiographic studies)
Spondylolisthesis of the cervical vertebrac ●
Spinal stenosis of the cervical vertebrae .
Atlanto-axial fracture with instability ●
Occipital-cervical dislocation D
Revision of cervical spine fusion surgeries .
Tumors .

Device Description

The Synthes Spine Occipital-Cervical Plate/Rod and Hook System consists of plate/rod. hooks, set screws The plate/rods, hooks, and set screws are and bone screws for the occipital region of the skull. manufactured from the titanium alloy TiAlNb (ASTM F1295). The bone screws are manufactured from commercially pure titanium Grade 4 (ASTM F67). The Occipital-Cervical Plate/Rod and Hook System is intended to provide stabilization to promote fusion of the occipital-cervical junction (occiput-T3) for the following indications:

Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with ● degeneration of the disc as confirmed by patient history and radiographic studies)
. Spondvlolisthesis of the cervical vertebrae
Spinal stenosis of the cervical vertebrae ●
Atlanto-axial fracture with instability ●
Occipital-cervical dislocation .
Revision of cervical spine fusion surgeries .
Tumors ●
The plate/rod is a 3.5 mm or 6.0 mm diameter rod that transitions into a 3.5mm reconstruction plate at the opposite end. The plate/rod is bent and cut to an appropriate length. The plate portion of the implant is fixed to the occiput with screws and the rod portion is attached to the cervical spine with hooks. Hooks are available in both right and left opening configurations to allow bilateral placement of the hook/rod construct.
Manual surgical instruments that will be marketed with this system include Bending Pliers for 3.5 rods, a 2.5mm Hex screwdriver and holding forceps.

AI/ML Overview

The provided document describes a medical device, the Synthes Spine Occipital-Cervical Plate/Rod and Hook System, and its approval process, specifically a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical trials with specific acceptance criteria in the way a new drug or diagnostic algorithm would.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this document because it outlines a regulatory pathway based on equivalence to an existing, cleared device, not an effectiveness study with predefined performance metrics.

However, I can extract the information that is present in the document relevant to its "effectiveness" and "acceptance criteria" in the context of a 510(k) by interpreting "acceptance criteria" as the criteria for regulatory clearance.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (for 510(k) Equivalence)	Reported Device Performance/Characteristics
Material Composition	Identical to numerous other cleared Synthes Spinal products (TiAlNb (ASTM F1295) for plate/rods, hooks, set screws; commercially pure titanium Grade 4 (ASTM F67) for bone screws).
Indication/Intended Use	Same as the Ransford Cervical Fixation System (K965221) and listed indications (degenerative disc disease, spondylolisthesis, spinal stenosis, atlanto-axial fracture with instability, occipital-cervical dislocation, revision of cervical spine fusion, tumors).
Mechanical Performance (Static & Fatigue)	Documented in accordance with ASTM standard F1717. Clearly demonstrated performance characteristics satisfy requirements of posterior cervical and upper thoracic (T1-T3) fixation.
Surgical Technique & Instrumentation	Same as that of the Synthes USS Hook/Rod systems.

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

Sample Size: Not applicable. The "test" mentioned here refers to mechanical bench testing, not a clinical study involving patients. The document does not specify the number of samples (e.g., number of implants) used for the mechanical testing.
Data Provenance: Not applicable in the context of clinical patient data. The "testing" refers to mechanical testing performed in accordance with ASTM standards, presumably by the manufacturer.

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

Not applicable. This device's clearance is based on substantial equivalence and mechanical testing, not on adjudicated expert-reviewed clinical outcomes.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring adjudication in this regulatory submission.

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 a surgical implant, not an AI-powered diagnostic device, and no MRMC study was conducted or required for this 510(k) submission.

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

Not applicable. This is a surgical implant, not a software algorithm.

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

The "ground truth" for the regulatory acceptance of this device relies on:
- Mechanical Testing Standards: Adherence to ASTM standard F1717 for static and fatigue performance.
- Predicate Device Characteristics: Direct comparison of material composition, indications for use, and surgical technique to a legally marketed predicate device (Ransford Cervical Fixation System, K965221).

8. The sample size for the training set

Not applicable. This is a hardware implant, not a machine learning model.

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

Not applicable. This is a hardware implant, not a machine learning model.

Summary

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Additional Information C. Safety and Effectiveness Information NOV 25 1998

[510(k) Summary]

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

(610) 647-9700 Contact: Jonathan M. Gilbert 9/4/98

Device: Synthes Spine Occipital-Cervical Plate/Rod and Hook System compared to the Ransford Cervical Fixation System (K965221).

Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with ● degeneration of the disc as confirmed by patient history and radiographic studies)
. Spondvlolisthesis of the cervical vertebrae
Spinal stenosis of the cervical vertebrae ●
Atlanto-axial fracture with instability ●
Occipital-cervical dislocation .
Revision of cervical spine fusion surgeries .
Tumors ●

The plate/rod is a 3.5 mm or 6.0 mm diameter rod that transitions into a 3.5mm reconstruction plate at the opposite end. The plate/rod is bent and cut to an appropriate length. The plate portion of the implant is fixed to the occiput with screws and the rod portion is attached to the cervical spine with hooks. Hooks are available in both right and left opening configurations to allow bilateral placement of the hook/rod construct.

Manual surgical instruments that will be marketed with this system include Bending Pliers for 3.5 rods, a 2.5mm Hex screwdriver and holding forceps.

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

The Synthes Spine Occipital-Cervical Plate/Rod and Hook System is indicated for the same clinical indications as that of the Ransford Cervical Fixation System (K965227).

Material composition is identical to numerous other Synthes Spinal products that have been cleared via the 510(k) process. The surgical technique 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 recommended.

Based on the above, the Synthes Spine Occipital-Cervical Plate/Rod and Hook System is substantially equivalent to the Ransford Cervical Fixation System (K965221).

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Image /page/1/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized image of an eagle with three heads. The eagle's heads are in profile, facing right, and are connected by a single body.

NOV 2 5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jonathan M. Gilbert Senior Regulatory Affairs Associate Synthes Spine 1690 Russell Road Paoli. Pennsylvania 19301

Re: K982322

Trade Name: Occipital-Cervical Plate/Rod and Hook System Regulatory Class: II Product Code: KWP Dated: September 4, 1998 Received: September 8, 1998

Dear Mr. Gilbert:

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 (OS) 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.

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Page 2 - Mr. Jonathan M. Gilbert

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 toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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Intended Use Form

Page 1 of I

510(k) Number (if known): K982322

Device Name: Synthes Spine Occipital-Ccrvical Platc/Rod and Hook System

Indications for Use:

Degenerative disease of the cervical vertebrae (neck pain of discogenic origin with . degeneration of the disc as confirmed by patient history and radiographic studies)
Spondylolisthesis of the cervical vertebrac ●
Spinal stenosis of the cervical vertebrae .
Atlanto-axial fracture with instability ●
Occipital-cervical dislocation D
Revision of cervical spine fusion surgeries .
Tumors .

(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)

Over-the-Counter Use

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K982322

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.