The WMT Implantable K-Wires are indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants. Additionally, WMT Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.

Device Description

The WMT Implantable K-Wires are offered in surgical grade stainless steel. A range of diameters are offered from the manufacturer and planning should be conducted prior to implantation to determine the best fit.

AI/ML Overview

The provided document, K132895, describes the WMT Implantable K-Wires. However, it is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. This type of regulatory submission typically focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, primarily through technological comparison and potentially non-clinical studies.

Crucially, this document does not contain information related to a study designed to prove the device meets specific acceptance criteria based on algorithm performance, human reader studies, or ground truth establishment, as would be common for AI/ML-based medical devices or diagnostic tools.

The document states:

"Through mechanical analysis the new wires do not represent a new worst-case." (Non-Clinical Evidence)
"A literature summary was provided to support the modified indications." (Non-Clinical Evidence)
"N/A" for "Substantial Equivalence - Clinical Evidence".

Therefore, I cannot provide the requested information for acceptance criteria and study details because the provided text does not describe such a study for this device.

Here's a breakdown of why this information is not available in the provided text in relation to your specific questions:

A table of acceptance criteria and the reported device performance: Not available. The document discusses mechanical analysis and literature summary, but no specific performance metrics or acceptance criteria are listed.
Sample size used for the test set and the data provenance: Not available. No "test set" in the context of an algorithm's performance is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/available. Ground truth establishment for a diagnostic algorithm is not part of this 510(k) summary.
Adjudication method for the test set: Not applicable/available.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available. Clinical studies, especially MRMC studies, for comparative effectiveness are not described and are marked "N/A" for clinical evidence.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical K-wire, not an algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. This device is not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document relates to a traditional medical device (K-wires) seeking 510(k) clearance based on substantial equivalence, not an AI/ML-based device that would typically involve the types of studies and criteria you are asking about.

Summary

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Wright Medical Technology, Inc

CONFIDENTIAL

Page 32 of 68

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 www.wmt.com

K132895 page 1 of 2

510(K) SUMMARY

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 CFR 807.92. this information serves as a Summary of Safety and Effectiveness for the use of the WMT Implantable K-Wires.

(a)(1). Submitted By:

Date:

Contact Person:

(a)(2). Proprietary Name:

Common Name:

Classification Name and Reference:

Device Product Code, Device Panel:

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 September 9. 2013

Leslie Fitch Regulatory Affairs Specialist II Office - (901) 867-4120 Fax - (901) 867-4190

WMT Implantable K-Wires

Pin, Fixation, Smooth

21 CFR 888.3040 - Class II

HTY: Pin, Fixation, Smooth

K101165, K120645 Pro-Toe VO Hammertoe Implant System and K022599 NEWDEAL K WIRE

(a)(4). Device Description

(a)(3). Predicate Device:

(a)(5). INTENDED USE

The WMT Implantable K-Wires are indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants. Additionally. WMT Implantable K-Wires are indicated for the fixation of osteotomies and

WMT Implantable K-Wires

Image /page/0/Picture/25 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic that appears to be a series of angled lines or shapes, possibly representing wings or a similar design element. The overall impression is a logo or branding element, likely for a company or product named Wright.

OCT
2 3 2013

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reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.

(a)(6). Technological Characteristics Comparison

The WMT Implantable K-Wires are technologically substantially equivalent to the predicate.

(b)(1). Substantial Equivalence - Non-Clinical Evidence

Through mechanical analysis the new wires do not represent a new worst-case. . A literature summary was provided to support the modified indications.

(b)(2). Substantial Equivalence - Clinical Evidence

N/A

(b)(3). Substantial Equivalence - Conclusions

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k). the subject wires can be expected to perform at least as well as the predicate system.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 23, 2013

Wright Medical Technology, Incorporated Ms. Leslie Fitch Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K132895

Trade/Device Name: WMT Implantable K-Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: September 9, 2013 Received: September 16, 2013

Dear Ms. Fitch:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Leslie Fitch

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erinfi Keith

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K132895

Device Name: WMT Implantable K-Wires

Indications For Use:

Prescription Use XXX (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)

Elizabeth L. Frank -S

Division of Orthopedic Devices

Concurrence of CDRH, Office of Device Evaluation (ODE) 1 of 1

CONFIDENTIAL

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.