The CHARLOTTE™ Small MTP Fusion Plate is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces.

Indications for Use:

Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
Deformity due to hallus valgus
Deformity due to arthritis in the first metatarsal-phalangeal joint
Loss of motion- hallux rigidus
Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsal-phalangeal joint
Revision procedures where other treatments or devices have failed; and
Chronic instability in the first metatarsal-phalangeal joint

Device Description

The CHARLOTTE™ Small MTP Fusion Plate consists of plates, and previously cleared screws. The design features of the CHARLOTTE™ Small MTP Fusion Plate are summarized below:

Plate

Manufactured from ASTM F139
Left and Right configurations

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for a medical device called the "CHARLOTTE™ Small MTP Fusion Plate." A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.

For a 510(k) submission, the "study that proves the device meets the acceptance criteria" is typically not a clinical trial demonstrating efficacy against a specific clinical outcome. Instead, it's a demonstration of substantial equivalence to a predicate device. This is primarily done through comparison of design features, material composition, indications for use, and performance testing (e.g., mechanical testing, biocompatibility testing) to show that the new device performs as intended and is as safe and effective as the predicate.

Given this context, I will extract information related to the device's characteristics and the evidence provided for substantial equivalence, rather than a traditional clinical study's acceptance criteria and performance metrics.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated for Substantial Equivalence)	Reported Device Performance (vs. Predicate Device)
Design Features: Comparable design to predicate device.	The design features of the CHARLOTTE™ Small MTP Fusion Plate are substantially equivalent to WMT's Bone Fusion Plate.
Material: Manufactured from appropriate and safe materials.	Manufactured from ASTM F139 (a recognized medical-grade material for stainless steel).
Indications for Use: Same or very similar indications as the predicate device.	The indications for use of the CHARLOTTE™ Small MTP Fusion Plate are substantially equivalent to WMT's Bone Fusion Plate.
Safety and Effectiveness: Adequate support from information and data.	The safety and effectiveness of the CHARLOTTE™ Small MTP Fusion Plate is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not describe a clinical "test set" in the sense of patient data. The evaluation for substantial equivalence would involve bench testing (e.g., mechanical strength, fatigue testing) of the device itself and a review of existing data/literature for the materials and predicate device.

Sample Size for Test Set: Not applicable in the context of human clinical data. The "test set" would refer to mechanical test specimens of the device. The specific number of devices or components tested is not provided in this summary.
Data Provenance: Not applicable for clinical data. The "analysis data" mentioned would be from bench testing conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. "Ground truth" in the context of a 510(k) for a plate device refers to the established performance characteristics and safety profile of the predicate device and the materials used, as well as the results of in-vitro physical and mechanical testing. There would not be human experts establishing "ground truth" on a test set in the way one would for diagnostic imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is not assessed using a clinical adjudication method with multiple readers/experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device or a device where human interpretation is a primary performance metric.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is an orthopedic implant, not a software algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for substantial equivalence for this device is based on:

Established performance of the predicate device: The safety and effectiveness profile of the WMT Bone Fusion Plate.
Material standards: Conformance to ASTM F139.
Engineering and biomechanical principles: Underlying the design and function of bone fusion plates.
Bench testing data: Mechanical and materials analysis data derived from testing the device itself to ensure it meets performance specifications (though specific results are not detailed in this summary).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

Summary

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

K051884 p1/2

AUG 5 - 2005

Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in all capital letters. Below the word is a graphic of what appears to be a stylized letter "W". In the bottom right corner of the image is the trademark symbol.

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 CHARLOTTE™ Small MTP Fusion Plate.

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

DEVICE INFORMATION

A. INTENDED USE

Indications for Use:

· Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
· Deformity due to hallus valgus
· Deformity due to arthritis in the first metatarsal-phalangeal joint
· Loss of motion- hallux rigidus
· Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsal-phalangeal joint
· Revision procedures where other treatments or devices have failed; and
· Chronic instability in the first metatarsal-phalangeal joint

headquarters

Wright Medical Technology, Inc. 5677 Airline Road

Arlington. TN 38002 901.867.9971 phone www.wmt.com

international subsidiarie. 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

011.81.3.3538.0474 Japan

011-33-1-45-13-24-40 France 011.44.1483.721.404 UK

011.49.4161.745130 Germany

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

K0:8541 p½

B. DEVICE DESCRIPTION

The CHARLOTTE™ Small MTP Fusion Plate consists of plates, and previously cleared screws. The design features of the CHARLOTTE™ Small MTP Fusion Plate are summarized below:

Plate

· Manufactured from ASTM F139
Left and Right configurations

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the CHARLOTTE™ Small MTP Fusion Plate are substantially equivalent to WMT's Bone Fusion Plate. The safety and effectiveness of the CHARLOTTE™ Small MTP Fusion Plate is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Wesley L. Reed Regulatory Affairs Specialist _________ 5677 Airline Road Arlington, Tennessee 38002

e,,

Re: K051884 KU31884
Trade/Device Name: CHARLOTTE™ Small MTP Bone Fusion Plate System 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 12, 2005

AUG 5 - 2005

Dear Mr. Reed:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreased of the enactment date of the Medical Device Amendments, or to commerce pror to that 2011-17, in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmetic rear (110-) that to device, subject to the general controls provisions of the Act. The 1 ou may, dicrolore, manes of the Act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is elassinod (tional controls. Existing major regulations affecting your device can may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease be activised that I Drivice and that your device complies with other requirements of the Act that I DI has intates and regulations administered by other Federal agencies. You must of any I odefar statutes and equirements, 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 (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 -Mr. Wesley L. Reed

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lett notification. The FDA finding of substantial equivalence of your device to a legally prematics notification "The 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 If you don't 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 other general miletimational 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,

Hyde Rlurdu

Mark N. Melkerson Acting 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):

Device Name: CHARLOTTE™ Small MTP Bone Fusion Plate System

Indications For Use:

The CHARLOTTE™ Small MTP Bone Fusion Plate System is intended to help The CHARLOT TE - Omail wa, and to maintain the position of the toe during fusion. increase the fato of bony athe is secondary in the transmission of gait forces.

Indications for Use:

Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
Deformity due to hallus valgus
Deformity due to arthritis in the first metatarsal-phalangeal joint
Loss of motion- hallux rigidus
· Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsalphalangeal joint
· Revision procedures where other treatments or devices have failed; and
· Chronic instability in the first metatarsal-phalangeal joint

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 CDRHz Office of Device Evaluation (ODE)

Stypk Hurda

1 of 1

(Division Sign-Off Division of General, Perforative, and Neurological Devices

510(k) Number_

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.