The provided text describes the CHARLOTTE™ Snap-Off Screw and states that its substantial equivalence was confirmed by testing conforming to ASTM F543-02. However, the document does not explicitly state acceptance criteria or provide a detailed study report with device performance metrics against specific criteria.

Therefore, I cannot populate the table with acceptance criteria and reported device performance from the provided text. Additionally, the document does not contain information on sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.

Based on the provided text, none of the specific details required for your request are available.

The document primarily focuses on:

The intended use and device description of the CHARLOTTE™ Snap-Off Screw.
Stating its substantial equivalence to a previously cleared device (K043583).
Mentioning conformance to ASTM F543-02 as the basis for confirming substantial equivalence, which is a standard for metallic medical bone screws.
The FDA's 510(k) clearance letter.

To fully answer your request, a detailed study report or the specific performance data against ASTM F543-02 would be needed.

Summary

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APR 1 ] 2005

K050819

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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™ Snap-Off Screw.

Submitted By:	Wright Medical Technology, Inc.
Date:	March 30, 2005
Contact Person:	Wesley L. Reed Regulatory Affairs Specialist
Proprietary Name:	CHARLOTTE™ Snap-Off Screw
Common Name:	Bone Fixation Screw
Classification Name and Reference:	21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener - Class II
Device Product Code and Panel Code:	21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener – Class II

DEVICE INFORMATION

A. INTENDED USE

The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

· Fixation of Small Bone Fragments
· Weil osteotomy
· Mono-cortical fixation
· Osteotomies and fractures fixation in the foot and hand

B. DEVICE DESCRIPTION

The design features of the CHARLOTTE™ Snap-Off Screw are summarized below:

Screw

Manufactured from ASTM F136 (Ti-6AI-4V ELI) .
Available in one diameter and three lengths .
Self drilling and self tapping features on distal threads .

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K050819

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C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the CHARLOTTE™ Snap-Off Screw are substantially equivalent to the previously cleared CHARLOTTE™ Snap-Off Screw (K043583). This was confirmed by testing conforming to ASTM 543-02. The safety and effectiveness of the CHARLOTTE™ Snap-Off Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle's head with three parallel lines representing the feathers.

APR 1 1 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: K050819

Trade/Device Name: CHARLOTTE™ Snap-Off Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 30, 2005 Received: March 31, 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/industry/support/index.html.

Sincerely yours,

Hypt Elwdie

Miriam C. Provost, Ph.D. 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™ Snap-Off Screw

Indications For Use:

The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

· Fixation of Small Bone Fragments
· Weil osteotomy
· Mono-cortical fixation
· Osteotomies and fractures fixation in the foot and hand

Prescription Use
X
(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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Stupt Purda

(Division Division of General, Restorative, and Neurological Devices

510(k) Number_ 6050819

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.