The provided document is a 510(k) summary for the CHARLOTTE™ Snap-Off Screw, a bone fixation screw. It details the device's intended use and design, and establishes substantial equivalence to a predicate device.

However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device.

The 510(k) pathway for this device, a metallic bone fixation fastener, relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through an independent study as would be seen for an AI/ML product.

Therefore, many of the requested details regarding acceptance criteria, study sample sizes, expert ground truthing, and AI-specific performance metrics are not applicable to this particular submission.

Here's a breakdown of what can be extracted and what is not available based on the request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document implies that the "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device, the "Wright Pre-amendment No. 223 Knowles Pin," as confirmed by testing conforming to ASTM 543-02. No specific numerical acceptance criteria (e.g., accuracy thresholds, sensitivity/specificity targets) for device performance itself are provided in this summary.
Reported Device Performance: The document states that "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." It does not provide specific performance metrics in terms of clinical outcomes or diagnostic accuracy, as it is a physical bone fixation device.

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

Not Applicable. This submission is for a physical medical device (bone fixation screw), not an AI/ML device that would use a test set of data for performance evaluation in the same manner. The "testing" mentioned refers to mechanical testing (ASTM 543-02) to establish equivalence, not to a "test set" of clinical data for an algorithm.

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)

Not Applicable. As this is not an AI/ML device, there is no "ground truth" to be established by experts for a test set in the context of diagnostic or prognostic performance. The equivalence is based on engineering and material standards.

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

Not Applicable.

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 device.

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

Not Applicable.

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

Not Applicable. The "ground truth", in a very broad sense for this device, would be compliance with ASTM F136 for material and ASTM 543-02 for mechanical properties, demonstrating equivalence to the predicate device.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable.

Summary regarding the provided document:

The 510(k) summary for the CHARLOTTE™ Snap-Off Screw is focused on establishing substantial equivalence for a physical medical device. The "study" mentioned is "testing conforming to ASTM 543-02" to confirm the substantial equivalence in design features, material, and indications for use to a predicate device. This is a regulatory pathway for devices that are not AI/ML and therefore does not include the detailed performance study information typically associated with AI/ML device submissions.

Summary

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K043583

JAN 2 6 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 CHARLOTTE™ High-Demand Compression Screw.

Submitted By:	Wright Medical Technology, Inc.
Date:	December 22, 2004
Contact Person:	Wesley L. ReedRegulatory 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 bonefixation fastener - Class II
Device Product Code and Panel Code:	21 CFR 888.3040 Smooth or threaded metallic bonefixation 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-6A1-4V ELI)
. Available in one diameter and three lengths
Self drilling and self tapping features on distal threads .

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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 Wright Pre-amendment No. 223 Knowles Pin. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the symbol. The caduceus is rendered in black and white, and the text is also in black.

Public Health Service

JAN 2 6 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: K043583

Trade/Device Name: CHROLOTTE™ 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: December 27, 2004 Received: December 28, 2004

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,

for Mark A. Millmann

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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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 (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)

O - Mark - 1 - Wilkinson

1 of 1

Division of General, Restorative, and Neurological Devices
5190: Number

K043583

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.