The CHARLOTTE™ 7.0 MUC Screw and Washer are manufactured from Stainless Steel conforming to ASTM F138. The Screws are offered in varying overall lengths and thread lengths to accommodate variability among patients and the Washer are offered for straight or oblique screw placement.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the CHARLOTTE™ 7.0 MUC Screw and Washer. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or detailed performance metrics against acceptance criteria typical for AI/software devices.

Therefore, many of the requested categories (e.g., sample sizes, expert qualifications, MRMC studies, standalone performance) are not applicable to this type of traditional medical device submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance Conformance	The CHARLOTTE™ 7.0 MUC Screw and Washer was confirmed to be substantially equivalent to previously cleared predicate devices (CHARLOTTE™ High-Demand Compression Screw and Wright's Pre-amendment Tibia Bolt with Washers) by testing conforming to ASTM F543-02. This standard specifies mechanical tests for metallic bone screws.
Material Conformance	Manufactured from Stainless Steel conforming to ASTM F138. This standard specifies wrought 18 chromium-8 nickel stainless steel for surgical implants.
Design Features	Design features are substantially equivalent to the predicate devices.
Indications for Use (IFU)	Indications for Use are substantially equivalent to the predicate devices: Fixation of bone fractures or for bone reconstruction (e.g., long bones, small bones, foot/hand fractures, arthrodesis, osteotomies, tibio fibular diastasis, hindfoot arthrodesis).

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

This information is not applicable/provided. The submission relies on demonstrating substantial equivalence to predicate devices through material and mechanical testing, not a clinical test set with patient data.

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

This information is not applicable/provided. Ground truth, in the context of AI/software, refers to verified clinical diagnoses or outcomes. For this bone screw, "ground truth" would relate to the physical properties and performance against engineering standards.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods are typically used in clinical studies to resolve discrepancies among expert readers.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices to assess changes in human reader performance.

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

No, a standalone performance evaluation was not done. This concept is specific to AI algorithms.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering standards and specifications:

ASTM F138: For material composition of the stainless steel.
ASTM F543-02: For mechanical performance testing of metallic bone screws.
Comparison to predicate devices: The "ground truth" for its clinical utility and safety is its substantial equivalence to previously cleared devices which have an established record of safe and effective use.

8. The Sample Size for the Training Set

This information is not applicable/provided. "Training set" refers to data used to train AI algorithms, which is not relevant for this traditional medical device.

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

This information is not applicable/provided, as there is no AI training set.

Summary

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MAR 2 9 2007

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™ 7.0 MUC Screw and Washer.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Device Product Code and Panel Code:

Wright Medical Technology, Inc.

March 28, 2007

Wesley Reed

Regulatory Affairs Specialist II

CHARLOTTE™ 7.0 MUC Screw and Washer

Screw and Washer

21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener - Class II

Orthopedics/87/HWC

DEVICE INFORMATION

A. INTENDED USE

The CHARLOTTE™ 7.0 MUC Screw and Washer are indicated for fixation of bone fractures or for bone reconstruction. Examples include:

· Fixation of bone fragments, in long bones or small bones fractures
· Fracture management in the foot or hand
· Arthrodesis in hand, foot or ankle surgery
· Mono or Bi-cortical osteotomies in the foot or hand or in long bones
· Treatment of inferior tibio fibular diastasis
· Hindfoot arthrodesis

B. DEVICE DESCRIPTION

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C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the CHARLOTTE™ 7.0 MUC Screw and Washer are substantially equivalent to the previously cleared CHARLOTTE™ High-Demand Compression Screw and Wright's Pre-amendment Tibia Bolt with Washers. This was confirmed by testing conforming to ASTM 543-02. The safety and effectiveness of the CHARLOTTE™ 7.0 MUC Screw and Washer is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAR 2 9 2007

Re: K070525

Trade/Device Name: CHARLOTTE™ 7.0 MUC Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: February 8, 2007 Received: February 28, 2007

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

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Page 2 - Mr. Wesley L. Reed

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. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Bucher

Mark N. Melkerson, M.S. 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™ 7.0 MUC Screw and Washer

Indications For Use:

The CHARLOTTE™ 7.0 MUC Screw and Washer are indicated for fixation of bone fractures or for bone reconstruction. Examples include:

Fixation of bone fragments, in long bones or small bones fractures
Fracture management in the foot or hand
Arthrodesis in hand, foot or ankle surgery
Mono or Bi-cortical osteotomies in the foot or hand or in long bones
Treatment of inferior tibio fibular diastasis
Hindfoot arthrodesis

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

510(k) Number Tailgatebend

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.