The Compression Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Device Description

The CHARLOTTE™ Compression Plate consists of 3 sizes of plates and 2.7mm lockingscrews varying in length from 12mm to 24mm. All plates and screws are manufactured from stainless steel.

AI/ML Overview

This document pertains to the 510(k) summary for the CHARLOTTE™ Compression Plate, a medical device for bone fixation. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML device.

The provided text is a 510(k) premarket notification for a traditional medical device (a bone compression plate) and therefore, the questions posed, which are tailored for AI/ML device evaluations, are not applicable.

Here's why and what information is available:

Device Type: The CHARLOTTE™ Compression Plate is a physical implantable device made of stainless steel for bone fixation. It is not an AI/ML device, nor does it appear to incorporate any AI/ML components.
Approval Pathway: The document describes a 510(k) submission, which demonstrates substantial equivalence to a legally marketed predicate device (Compression Staple, K043059). This process primarily evaluates safety and effectiveness compared to an existing device, rather than requiring extensive performance studies against specific "acceptance criteria" for an AI/ML output.

Therefore, I cannot provide answers to the requested points (1-9) as they relate to the evaluation of AI/ML performance.

What the document does provide:

Intended Use: For fixation in various foot and ankle procedures (LisFranc arthrodesis, osteotomies, arthrodeses, etc.).
Device Description: Consists of 3 sizes of plates and 2.7mm locking screws, all made from stainless steel.
Substantial Equivalence: Claimed to be substantially equivalent to the previously cleared Compression Staple (K043059) in design features, material, and indications for use.
Regulatory Class: Class II medical device.
Product Code: HRS (Orthopedics).

If you have a document describing an AI/ML device, I would be happy to help assess its acceptance criteria and study details.

Summary

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Image /page/0/Picture/0 description: The image shows the word "WRIGHT." in large, bold, black letters. Above the word, there is handwritten text that reads "K051908 page 1 of 1". Below the word "WRIGHT.", there is a graphic of three black triangles pointing upwards, arranged in a row. The letters "TM" are located below the triangles.

AUG 1 0 2005

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the CHARLOTTE™ Compression Plate.

Submitted By:	Wright Medical Technology, Inc.
Date:	July 11, 2005
Contact Person:	Wesley L. Reed
	Regulatory Affairs Specialist
Proprietary Name:	CHARLOTTET™ Compression Plate
Common Name:	Compression Plate
Classification Name and Reference:	21 CFR 888.3030 Plate, Fixation, Bone -- Class II
Device Product Code and Panel Code:	Orthpedics/87/HRS

DEVICE INFORMATION

A. INTENDED USE

The CHARLOTTE™ Compression Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

B. DEVICE DESCRIPTION

The CHARLOTTE™ Compression Plate consists of 3 sizes of plates and 2.7mm lockingscrews varying in length from 12mm to 24mm. All plates and screws are manufactured from stainless steel.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the CHARLOTTE™ Compression Plate are substantially equivalent or identical to the previously cleared Compression Staple (K043059). The safety and effectiveness of the CHARLOTTE™ Compression Plate is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

headquarters

Wright Medical Technology, Inc. 5677 Alrline Road Arlington, TN 38002 901.867.9971 phon www.wmt.com international subsidiaries 011.32.2.378.3905 Belgium 905.826.1600 Canada 011.33.1.45.13.24.40 France 011.49.4161.745130 Germany 011.39.0250.678.227 Italy 011.81.3.3538.0474 lanar 011.44.1483.721.404 | |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming the body and wings, and two curved lines representing the legs and feet.

AUG 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Wesley L. Reed Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K051908 Trade/Device Name: CHARLOTTE™ Compression Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: July 11, 2005 Received: July 14, 2005

Dear Mr. Reed:

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. Wesley L. Reed

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/dsma/dsmamain.html

Sincerely yours,

Stipta Rlwdn

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: CHARLOTTE™ Compression Plate

Indications For Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Stypt Lurdu

I. Generet, Restorative S Nevrological Devices

KOS1908

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.