The Encore Anterior Spinal Staple System is intended for anterior vertebral body fixation to the T3-L5 spine. This system is indicated to be used with an anterior spinal system that consists of screws that are between 6.0 and 6.5mm diameter manufactured out of Ti alloy.

Device Description

The anterior vertebral body staple is designed to work in conjunction with the any existing spinal fixation systems utilizing 6.0mm to 6.5mm titanium screws. The staples are manufactured from Titanium alloy and are available as a single or double staple. The single staple has one hole for screw fixation with a 6.0mm -6.5mm titanium screws. The double staples are designed in pairs with specific superior and inferior components. Each has two screw holes allowing screws to pass through at a converging angle.

AI/ML Overview

This 510(k) submission document for the Encore Anterior Spinal Staple System does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

No Acceptance Criteria or Performance Data: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices based on design, indications, and materials. It does not include specific performance metrics, acceptance criteria, or a report of a study designed to test these criteria.
No Clinical Study Details: There is no mention of a clinical study, human reader study, or standalone algorithm performance study. The device is a spinal implant, which typically would involve mechanical testing for safety and effectiveness, but these details are not provided in this summary.
No Ground Truth Information: Since no study is described, there's no information about how ground truth would be established for any test set (training or evaluation).

Limitations of the Provided Document:

The provided text is a standard 510(k) summary, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process often relies on comparisons of technical characteristics, materials, and intended use, rather than extensive new clinical performance data, especially for Class II devices like this spinal fixation system.

Therefore, I cannot provide the requested information because the document does not contain it.

Summary

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K030667 p'/%

MAY 28 2003
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510(k) Summary of Safety and Effectiveness

Submitter's name: (1) Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 (512) 834-6255 Debbie De Los Santos February 19, 2003
Encore Anterior Spinal Staple System Trade or proprietary device name: Anterior Spinal Staple System Common or usual name: 888.3060 - Spinal Intervertebral Body Classification name: Fixation Orthosis
Predicate devices: (3)

(2)

AcroMed KASS (K974757) Blackstone Medical (K022605)

Subject device description: (4)

(5) Subiect device intended use:

(6) Basis for Substantial Equivalence:

The Encore Anterior Spinal Staple System is similar in design, indications and materials to AcroMed's Kaneda Anterior Spinal System (K974757) and Blackstone Spinal Fixation System (K022605).

MAY 28 2003
DR

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

MAY 28 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debbie De Los Santos Supervisor, Regulatory/OA Manager Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758

Re: K030667

Trade Name: Encore Anterior Spinal Staple System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: February 28, 2003 Received: March 3, 2003

Dear Ms. De Los Santos:

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.

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 - Ms. Debbie De Los Santos

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 (301) 594-4639. 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/dsma/dsmamain.html

Sincerely yours,

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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KO306 510(k) Number (if known):

Encore Anterior Spinal Staple System Device Name: _

Indications For Use:

Encore Anterior Spinal Staple 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)

Prescription Use (per 21 CFR 801.109) OR

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

for Mark N. Melkerson
Division Sign Off

on of General, Restorative and Neurological Devices

510(k) Number K030667

Regulation Number and Section

N/A