The ACLP System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: Degenerative Disc Disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions, pseudoarthosis, and deformity (defined as kyphosis, lordosis and scoliosis).

Device Description

The ACLP System is an addition to Synthes' existing Anterior Cervical Vertebrae Plate System (Anterior CSLP). The ACLP System is composed of plates and screws which are made from titanium allov Ti-6Al-7Nb (ASTM F1295). These plates attach to the anterior cervical spine with a minimum of four screws per plate.

The plates range in length to accommodate one, two, three, and four level procedures. The plates in the system are pre-lordosed to accommodate the cervical spine minimizing the need for the surgeon to manually bend the plates.

The screws in the ACLP System are 4.0mm and 4.5mm conical head screws. They are self-drilling and self-tapping in both cancellous and cortical thread profiles and are available in lengths ranging from 12mm to 16mm.

AI/ML Overview

The provided text is a 510(k) summary for the Synthes Anterior Cervical Locking Plate (ACLP) System. It describes the device, its indications for use, and confirms its substantial equivalence to a predicate device. However, it does not include any information regarding acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for diagnostic devices or those involving AI/software.

Therefore, I cannot provide the requested information from the given text.

The provided document is a regulatory submission for a physical medical device (spinal implant), not a software or AI-driven diagnostic device that would typically have performance metrics like sensitivity, specificity, or accuracy that are established through specific studies with ground truth. The "acceptance criteria" for such a device are primarily related to mechanical testing, biocompatibility, and substantial equivalence to a legally marketed predicate device, rather than performance metrics on a dataset of patient images or conditions.

Key Reasons why the requested information cannot be found in the provided text:

Type of Device: The ACLP System is a physical implant (plates and screws for spinal fixation), not a diagnostic algorithm or AI-powered system that analyzes data.
Nature of 510(k) Submission: A 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device. For physical implants, this often involves comparing materials, design principles, indications for use, and sometimes results from mechanical or in-vitro testing to show equivalent safety and effectiveness. It does not typically involve large-scale clinical trials or performance studies against a "ground truth" as you would see for AI devices.
Missing Sections: The document focuses on the device description, indications for use, and the FDA's regulatory decision. It lacks sections detailing performance studies, statistical analyses, or human reader performance evaluations.

Summary

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K031276

JUL 2 2003

11.0 510(K) SUMMARY

DESCRIPTION

INDICATIONS

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2003 JUL

Mr. Jonathan Gilbert Project Manager, Regulatory Affairs SYNTHES Spine 1230 Wilson Drive West Chester, Pennsylvania 19380

Re: K031276

Trade Name: Synthes Anterior Cervical Locking Plate (ACLP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 21, 2003 Received: April 25, 2003

Dear Mr. Gilbert:

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 - Mr. Jonathan Gilbert

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) 594-4659. 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 vours.

fo Mark M. Wilkerson

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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3.0 INDICATIONS FOR USE FORM

510(k) Number (if known): K031276

Device Name: Synthes Anterior Cervical Locking Plate (ACLP) 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

Mark A. Millman

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

510(k) Number K031276

CONFIDENTIAL

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.