The Spinal USA RCS Anterior Buttress Plate System is intended to stabilize the allograft or autograft at one level (TI-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

Device Description

The Spinal USA RCS Anterior Buttress Plate System is a temporary implant used to prevent allograft or autograft extrusion. The Spinal USA RCS Anterior Buttress Plate System consists of plates and bone screws. The Spinal USA RCS Anterior Buttress Plate System is also intended to provide stabilization and augment development of a solid spinal fusion. The Spinal USA RCS Anterior Buttress Plate System fixates to the anterior portion of the thoracolumbar vertebral body. The construct may be employed alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. The components will be provided non-sterile.

AI/ML Overview

This document is a 510(k) summary for a medical device (Spinal USA RCS Anterior Buttress Plate System) focusing on its intended use and equivalence to previously cleared devices. It does not contain information about explicit acceptance criteria or a study that rigorously proves the device meets specific performance criteria in terms of quantitative metrics or clinical outcomes.

Instead, the document asserts "substantial equivalence" to predicate devices based on "equivalence in intended use, indications, anatomic sites, performance and material of manufacture." This is a regulatory pathway for lower-risk devices, not a detailed performance study.

Therefore, most of the requested information cannot be extracted from this document as it doesn't describe such a study.

Here's what can be stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not specify quantitative acceptance criteria or report device performance against such criteria. The basis for clearance is "substantial equivalence" to predicate devices, implying similar performance is expected, but no specific performance metrics are provided for the Spinal USA RCS Anterior Buttress Plate System itself.

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

Not applicable. No "test set" in the context of a performance study is described. The document relies on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth establishment by experts is described as there is no performance study.

4. Adjudication Method for the Test Set

Not applicable. No test set or associated adjudication method is described.

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

No. An MRMC comparative effectiveness study was not done.

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

No. This device is a physical implant, not an algorithm. Therefore, a "standalone algorithm performance" study is not relevant or described.

7. The Type of Ground Truth Used

Not applicable. No specific ground truth is mentioned. The clearance is based on substantial equivalence rather than a study validating performance against a definitive ground truth.

8. The Sample Size for the Training Set

Not applicable. No training set is mentioned as this is a physical medical device clearance, not an AI/algorithm-based device.

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

Not applicable. No training set or ground truth establishment is mentioned.

Summary of what the document does state regarding "acceptance criteria" and "study":

Acceptance Criteria: The primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to legally marketed predicate devices. This means that the device must be shown to have the same intended use, indications, anatomic sites, performance, and material of manufacture as already cleared devices.
Study/Proof: The "study" or proof provided is a documentation effort demonstrating substantial equivalence. The document states: "Documentation was provided which demonstrated the Spinal USA RCS Anterior Buttress Plate System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture." This is a regulatory submission process, not a clinical trial or performance study with quantitative results against predefined acceptance criteria for the new device.

Summary

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510 (k) Summary of Safety and Effectiveness

092659

Date Summary Prepared:

August 27, 2009

Submitter Information:

Spinal USA 2050 Executive Drive Pearl, MS 39208

NOV 1 7 2009

Contact Name:Phone:Fax:E-mail:	Jeffrey Johnson601-420-4244601-420-5501jeff@spinalusa.com
Device Trade Name:	Spinal USA RCS Anterior Buttress Plate System
Common Name:	Anterior Buttress Plate System
Regulatory Number:Classification:Product Code:	888.3060-Spinal Intervertebral Body Fixation OrthosisClass IIKWQ

INTENDED USE:

The Spinal USA RCS Buttress Plate System is intended to stabilize the allograft or autograft at one level (TI-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

DEVICE DESCRIPTION:

EQUIVALENT DEVICE:

Documentation was provided which demonstrated the Spinal USA RCS Anterior Buttress Plate System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of an eagle or bird in flight, composed of three curved lines. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Spinal USA % Mr. Jeffrey Johnson Manager of Regulatory Affairs 2050 Executive Drive Pearl, Mississippi 39208

NOV 17 2009

Re: K092659

Trade/Device Name: Spinal USA RCS Anterior Buttress Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 27, 2009 Received: August 28, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Jeffrey Johnson

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jonita 3

Mark N. Melkerson ന Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K092659

Device Name: Spinal USA RCS Anterior Buttress Plate System

Indications for Use:

The Spinal USA RCS Anterior Buttress Plate System is intended to stabilize the allograft or autograft at on level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. The device is not intended for load bearing applications.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Souta for Mark Nekkosen
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092659

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.