The Slimplicity Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; spinal stenosis; pseudarthrosis; and failed previous fusions.

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

Device Description

The Slimplicity Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates, locking rivets pre-assembled, and bone screws, which can be assembled with associated instruments to provide immobilization of the cervical spine. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Slimplicity Anterior Cervical Plate System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "device performance" in the context of this document refer to the ability of the device to perform equivalently to a predicate device in specific engineering tests, not clinical performance against defined metrics.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For 510(k) submissions, "acceptance criteria" typically refers to meeting the performance characteristics of an equivalent device as demonstrated through standardized testing. The "reported device performance" is that the device meets or is equivalent to the predicate device in these tests. The document indicates that testing was performed to demonstrate substantial equivalence, implying the Slimplicity system met the performance standards set by the predicate devices.

Acceptance Criteria (Standard Test)	Reported Device Performance
Performance demonstrated to be substantially equivalent to predicate devices as defined by ASTM F1717-04 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."	The Slimplicity Anterior Cervical Plate System demonstrates substantial equivalence to the following predicate devices when tested in accordance with ASTM F1717-04: - Deltaloc Anterior Cervical Plate System (K993513) - Synthes Spine Anterior CSLP System (K030866) - Reflex Anterior Cervical Plate System (K031702)

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

Sample Size for Test Set: Not specified in the provided text. The ASTM F1717-04 standard would outline the specific sample size requirements for the mechanical testing of spinal implants.
Data Provenance: Not specified, but generally, mechanical testing for 510(k) predicate comparison is conducted in a laboratory setting, not on patient data. It is a prospective test in the sense that the testing is performed specifically for this submission. The "country of origin" is not stated, but the submission is to the US FDA.

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

This question is not applicable to this type of device submission or study. Ground truth in this context refers to the mechanical performance standards established by the ASTM F1717-04 standard, which is determined by a consensus body of experts in the field of medical device standards, not by individual clinical experts reviewing a "test set" of cases.

4. Adjudication Method for the Test Set

Not applicable. Mechanical tests for substantial equivalence do not involve adjudication by human experts. The results are quantitative and objective, based on physical measurements against a standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or algorithms that require human interpretation and would measure the improvement in human reader performance with or without AI assistance. The Slimplicity Anterior Cervical Plate System is a physical implant, and its evaluation for 510(k) clearance relies on mechanical and material properties, not reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This concept is applicable to software algorithms or AI devices. The Slimplicity Anterior Cervical Plate System is a hardware device.

7. The Type of Ground Truth Used

The "ground truth" used is the performance characteristics of legally marketed predicate devices as measured by a recognized mechanical testing standard (ASTM F1717-04). This standard simulates physiological loading conditions to assess the structural integrity and stability of spinal implant constructs.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this kind of physical device and its associated mechanical testing for 510(k) clearance. Training sets are used in machine learning for AI algorithms.

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

Not applicable, as there is no training set for this context.

Summary

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

APR 18 2006

510 (k) Summary of Safety and Effectiveness

Date Summary Prepared:	January 3, 2006
Submitter Information:	Spinal USA
	213 Eastside Lane
	Brandon, MS 39047
Contact Name:	Jeffrey Johnson
Phone:	601-992-7668
Fax:	601-992-0380
E-mail:	jeff@spinalusa.com
Device Trade Name:	Slimplicity Anterior Cervical Plate System
Common Name:	Spinal Intervertebral Body Fixation OrthosisAnterior Cervical Plate System
Regulatory Number:	888.3060
Classification:	Class II
Product Code:	KWQ

INTENDED USE:

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

DEVICE DESCRIPTION:

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

EQUIVALENT DEVICE:

Testing in accordance with ASTM F1717-04 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" of the Slimplicity Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the Deltaloc Anterior Cervical Plate System (K993513), Synthes Spine Anterior CSLP System (K030866) and the Reflex Anterior Cervical Plate System (K031702).

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spinal USA c/o Mr. Jeffrey Johnson 213 Eastside Lane Brandon, Mississippi 39047

APR 1 8 2006

Re: K060025

Trade/Device Name: Slimplicity Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: II Product Code: KWQ Dated: March 22, 2006 Received: March 29, 2006

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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.

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

Page 2 - Mr. Jeffery Johnson

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. 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Hebert Leonard

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K060025

Device Name: Slimplicity Anterior Cervical Plate System

Indications for Use:

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

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut Lemer(a)

Division of General, Restorative, and Neurological Devices

510(k) Number K060025

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.