The SC-AcuFix Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following 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), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

Device Description

The SC-AcuFix Thinline Anterior Cervical Plate System consists of various sizes of bone plates, screws and surgical instruments. The screws are used to secure the vertebral bodies of the cervical spine through an anterior approach. The plates have an integrated locking mechanism that captures the screw upon full insertion, preventing screw-backout. Plates and screws are manufactured from titanium alloy (ASTM F-136) and may be supplied sterile or non-sterile.

AI/ML Overview

The medical device in question is the SC-AcuFix Thinline Anterior Cervical Plate System, a spinal fixation system.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Design Requirements)	Reported Device Performance
Static data requirements	Met design requirements
Fatigue data requirements	Met design requirements

Note: The specific numerical values or detailed specifications of the "design requirements" for static and fatigue data are not provided in the document. The document only states that these requirements were met.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size used for the mechanical testing (static and fatigue data). It only mentions that "Mechanical testing data, collected in accordance with ASTM 1717, was collected."
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that it's mechanical testing of a medical device, it is inherently prospective, as the tests are performed to evaluate the device's properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The "ground truth" for mechanical testing is established through standardized testing protocols (like ASTM 1717) and engineering principles, not through expert clinical consensus on patient data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of data by multiple readers, often for diagnostic devices. For mechanical testing, the results are derived from physical measurements and analysis, not expert interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed as this is a mechanical engineering study for a spinal implant, not a study evaluating human reader performance with medical images or clinical data.

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

This information is not applicable. This device is a physical medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this study was established by standardized mechanical testing protocols (specifically ASTM F-1717, an ASTM International standard for spinal implants) and engineering performance specifications (labeled as "design requirements" in the text). The device's performance was compared against these predefined physical and mechanical thresholds.

8. The Sample Size for the Training Set

This information is not applicable. This is a mechanical testing study, not a machine learning study where a "training set" would be used to train an algorithm. The device itself is not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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FEB 1 3 2002

K013979
page 1 of 1

SC-AcuFix Thinline Anterior Cervial Plate 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	November 30, 2001
CLASSIFICATION NAME	KWQ: Spinal Intervertebral Body Fixation Orthosis. Class II.
COMMON NAME	Spinal Fixation System
PROPRIETARY NAME	SC-AcuFix Thinline Anterior Cervical Plate System
PREDICATE DEVICE	SCI Anterior Cervical Plate System, later trademarkedSC-AcuFix (K990005). This is a design modification perestablished design control procedures.

DEVICE DESCRIPTION

INDICATIONS

MECHANICAL TEST DATA

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

Spinal Concepts, Inc.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2002

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

K013979 Re:

Trade Name: SC-AcuFix Thinline Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: January 28, 2002 Received: January 29, 2002

Dear Dr. Hooper:

We have reviewed your Section 510(k) premarket 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) 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,

Miriam C. Provost

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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Kdl3979

INIDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known):

Device Name:

Spinal Concepts, Inc. SC-AcuFix Thinline Anterior Cervical Plate System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use: (Per 21 CFR 801.109)

Over-The-Counter: (Optional Format 1-2-96)

iriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K'013979

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.