When intended to promote fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex, 3.5 mm and 4.0 mm (occept 10), components of the Synthes CerviFix™ System are indicating for the following:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
spondylolisthesis
spinal stenosis
fracture/dislocation
atlantoaxial fracture with instability
occipitocervical dislocation
revision of previous cervical spine surgery
tumors

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system, and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.

Device Description

Synthes CerviFix System consists of rods, plate/rods, hooks, clamps, screws, nuts and transconnectors. The implants are composed of the titanium alloy Ti6Al7Nb (ASTM F1295) or commercially pure grade 4 Titanium (ASTM F67).

AI/ML Overview

The provided text is a 510(k) Summary for the Synthes CerviFix System, a medical device. This document describes the device, its indications for use, classification, and the basis for its substantial equivalence to previously cleared devices.

Crucially, this document is a 510(k) Summary, which is a premarket notification for devices demonstrating substantial equivalence to a predicate device. It is not a clinical study report or a direct description of acceptance criteria and performance data from a specific study designed to "prove the device meets acceptance criteria" in terms of clinical outcomes or diagnostic accuracy.

Therefore, many of the requested elements for describing a study and acceptance criteria (like sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not typically found in a 510(k) Summary for a spinal fixation system.

The "study" mentioned in the document refers to pre-clinical biomechanical testing, which is used to demonstrate that the device's performance is similar to already cleared predicate devices. It does not involve human subjects or diagnostic performance metrics described in the prompt.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document states, "Pre-clinical testing shows the biomechanical performance of the CerviFix System is similar to the performance of previously cleared spinal systems with similar indications."

Reported Device Performance:
The document implies that the pre-clinical biomechanical testing confirmed this "similarity" to predicate devices. However, no specific quantitative performance metrics, test results (e.g., fatigue strength, pull-out strength values), or detailed acceptance limits are provided in this summary. The acceptance criterion is qualitative: "biomechanical performance... similar to... previously cleared spinal systems."

Acceptance Criteria Category	Specific Acceptance Criteria (as implied/stated)	Reported Device Performance (as implied/stated)
Biomechanical Performance	Similar to previously cleared spinal systems with similar indications.	Pre-clinical testing demonstrated similarity to previously cleared spinal systems. (No specific quantitative data provided in this summary.)

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

Sample Size: Not applicable/Not specified. The "test set" here refers to the components of the device undergoing pre-clinical biomechanical testing, not a dataset of patient images or clinical cases. The number of implants or test specimens used in the biomechanical testing is not provided.
Data Provenance: Not applicable/Not specified. This refers to pre-clinical laboratory testing, not human data.

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

Not applicable. "Ground truth" in the context of diagnostic accuracy or clinical outcomes is not relevant here. The "ground truth" for biomechanical testing would be established by standardized testing methods and engineering principles, not expert clinicians.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1) are used for resolving discrepancies in expert interpretations, which is not relevant to pre-clinical biomechanical testing.

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 spinal fixation system, not an AI-powered diagnostic device. No MRMC study or AI assistance is mentioned or relevant to this type of device.

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

Not applicable. This device is a manual surgical implant, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: For the pre-clinical testing, the "ground truth" implicitly would be established engineering standards, material properties, and comparative biomechanical data from predicate devices. It is not clinical "expert consensus," "pathology," or "outcomes data."

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI algorithm for this device. If interpreted very broadly as the data informing the design, it would be engineering specifications and prior device performance data, but no explicit "sample size" is mentioned.

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

Not applicable. As above, there is no "training set" in the AI sense. For the design and comparative testing, the "ground truth" (i.e., expected performance benchmarks) would be established by engineering principles, regulatory standards (e.g., ASTM standards for biomechanical testing of spinal implants), and the known performance characteristics of the predicate devices.

Summary

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

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

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

(610) 647-9700 Contact: Jonathan Gilbert 6/16/00

DEVICE

INDICATIONS

Hooks, Plate/Rods, Rods and Screws

DDD (neck pain of discogenic origin with degeneration of the disc as ● confirmed by patient history and radiographic studies)
spondylolisthesis ●
spinal stenosis ●
fracture/dislocation .
atlantoaxial fracture with instability ●
occipitocervical dislocation .
revision of previous cervical spine surgery .
tumors ●

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws and Nuts

The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

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

CLASSIFICATION:

CLASSIFICATION.
The classification of the CerviFix System is Class II, as per the Code of Federal The Classincation of the Certific Dy50: Appliance, Fixation, Spinal, Interlaminal and Regulations, I the 21, Societererebral body fixation orthosis. The product code is KWP. The Panel code is 87.

BASIS OF SUBSTANTIAL EQUIVALENCE:

DASHS OF SUBOTIC TENE & CerviFix system are similar to the components of The components of the Byraise of Pre-clinical testing shows the biomechanical previously cleared spinal systems. " The similar to the performance of previously cleared spinal systems with similar indications.

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

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right. The profiles are stacked on top of each other and are connected by a series of curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2001

Mr. Jonathan Gilbert Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301

Re: K011969

Trade Name: Synthes CerviFix™ System Regulatory Number: 888.3050 Regulatory Class: Class II Product Code: KWP Dated: June 22, 2001 Received: June 25, 2001

Dear Mr. Gilbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have 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 stated in the energians ) to device Amendments, or to devices that have been reclassified in chaculient dait 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, controls providents or active, 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 (1 climation in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good 699. I I suobtainany orquirement, 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 inspections, the Food and Drig Fring Fring result in regulatory action. In addition, FDA may publish comply with the GMT regularing 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.

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

Page 2 - Mr. Jonathan Gilbert

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will allow you to begin naketing your device of your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to notification. The FDA finding of substantal equivaled of 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 If you desire specific advice for your devices), please contact the (fice of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the of vour de additionally 809.10 for in vitro diagnostic concess, promotion and advertising of your device,
(301) 594-4659. Additionally, for questions on the promotion and advertising o (301) 594-4659. Additionally, for questions on the process. Also, please note the regulation please contact the Office of Complance at (30) - 19-10-5. They CFR 807.97). Other general
entitled, "Misbranding by reference to premarket notification the Division of Small entitled, "Misbranding by telefice under the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from the Divisi information on your responsibilities murber (800) 638-2041 or at (301) 443-6597, or at its
Manufacturers Assistance at its toll-free 1115 to in the time Manufacturers 71ssilstairs ===================================================================================================================================================

Sincerely yours,

Osmtcheee rwo for

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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Page 1 of 1

510(k) Number (if known): K011969_

Device Name: Synthes CerviFix System

Indications for Use:

Hooks, Plate/Rods, Rods and Screws

Hooks, Tiale/Koas, Aous and Ber ons
When intended to promote fusion of the cervical spine and occipitocervical junction When michaed to promote rast it of the sand screw (3.2 mm cortex) components of the Synthes CerviFix™ System are indicated for the following:

//vir ix Byscoin of discogenic origin with degeneration of the disc as . confirmed by patient history and radiographic studies)
spondylolisthesis .
spinal stenosis ●
fracture/dislocation .
atlantoaxial fracture with instability .
occipitocervical dislocation .
revision of previous cervical spine surgery .
tumors .

When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote The rod and noon components are used dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws and Nuts

Nous, Clamps, Screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is The use of these serews (5.5 mill, 1.6 in teating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal The Symnes Cer nr x - Bystem caaallel connectors from that system, and via the System using the 5.5 milli 6.5 min parares transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.

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

Concurrence of CDRH-Office of Device Evaluation (ODE)
Prescription Use	X
OR Over-the-Counter Use

(Division Sign-Off)

Synthes Spine Co., LP
Synthes CerviFix System Special 510(k)	Division of General, Restorative and Neurological Devices
	ConfidentialJune 22, 2001

510(k) Number	K011969
---------------	---------

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.