Threaded K-Wire is manufactured from PEEK and is 1.6 mm in diameter over its entire length. Both ends of the K-Wire are threaded, providing for two implants per device. The diameter of the pin allows it to function well with standard K-Wire drivers and the device is meant to be trimmed to length once in place.

AI/ML Overview

The provided text addresses the FDA 510(k) submission for the "Threaded PEEK K-Wire," which is a medical device, not a diagnostic AI/ML device. Therefore, the questions related to AI/ML device performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this document.

The document discusses the testing and criteria used to demonstrate substantial equivalence to a predicate device, which is a common pathway for medical device clearance.

Here's a breakdown of the relevant information provided:

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

The document lists the types of nonclinical testing performed to establish substantial equivalence and demonstrate the device performs as intended. It states that "The Threaded PEEK K-Wire met all specified criteria performing as intended." However, specific quantitative acceptance criteria values and corresponding reported performance values are not detailed in the provided text.

The tests performed were:

Simulated use Testing
Ultimate Strength Testing
Initial Stiffness Testing
Suture Strength Testing
Cyclic Testing

The conclusion explicitly states: "The results of this testing demonstrate that the Threaded PEEK K-Wire performs as intended and demonstrate that the Threaded PEEK K-Wire is substantially equivalent to its predicates."

2. Sample sizes used for the test set and the data provenance:

Sample Size: The document mentions "All testing was performed on test units representative of finished devices." However, it does not specify the sample size (number of units) used for each test.
Data Provenance: The testing is described as "Nonclinical Testing," which means it was performed in a lab setting, not using human patient data. Therefore, questions of country of origin or retrospective/prospective clinical data are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the document describes nonclinical mechanical testing, not a diagnostic study requiring expert ground truth establishment.

4. Adjudication method for the test set:

This question is not applicable as there is no human interpretation or ground truth adjudication involved in the mechanical tests described.

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:

This question is not applicable as this is a medical implant device, not an AI/ML diagnostic system. No MRMC study was conducted or is relevant here.

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

This question is not applicable as this is a medical implant device, not an AI/ML diagnostic system.

7. The type of ground truth used:

The "ground truth" for the mechanical tests would be the established engineering and material science standards and performance specifications for bone fixation devices and PEEK material. The testing aims to meet these predefined performance benchmarks. "Pathology" or "outcomes data" are not applicable to this type of testing.

8. The sample size for the training set:

This question is not applicable as this is a medical implant device undergoing nonclinical testing, not an AI/ML device requiring a training set.

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

This question is not applicable for the same reason as above.

Summary

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K133235 Page 1 of 2

510(k) Summary

Device Trade Name:	Threaded PEEK K-Wire
Manufacturer:	MTP Solutions LLC124 South 600 West, Suite 100Logan, UT 84321
Contact:	Mr. Robert HoyDirector of Technical & Clinical ResearchPhone: (614) 448-6358Fax: (435) 213-4878bob@venturemd.com
Prepared by:	Musculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	April 4, 2014
Common Name:	Threaded Fixation Pin
Classification:	21 CFR 888.3040 Smooth or threaded metallic bonefixation fastener
Class:	II
Product Code:	MBI

Indications for Use:

The Threaded PEEK K-Wire is intended for use with suture in metatarsal ligament and tendon repairs.

Device Description:

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Predicate Devices:

The Threaded PEEK K-Wire is substantially equivalent to the Arthrex, Inc. PushLock (K101679, K082810, K071177, K063479, K061863, K051219) with respect to its indications for use, principles of operation, materials and design.

Technological Characteristics Comparison:

The Threaded PEEK K-wire is similar to the Arthrex PushLock with regards to principles of operation, materials and design with both the subject and predicate devices being manufactured from PEEK, cylindrical in shape with threads or ribs and acting to compress suture against a bone tunnel wall. There are no substantial differences in technological characteristics between the devices and as such the Threaded PEEK K-Wire introduces no new issues of safety or effectiveness.

Nonclinical Testing:

All necessary testing has been performed for the Threaded PEEK K-Wire to assure substantial equivalence to the predicate and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Clinical data were not needed to support the safety and effectiveness of the subject device.

The device design was qualified through the following tests:

. Simulated use Testing
. Ultimate Strength Testing
Initial Stiffness Testing .
. Suture Strength Testing
. Cyclic Testing

The results of this testing demonstrate that the Threaded PEEK K-Wire performs as intended and demonstrate that the Threaded PEEK K-Wire is substantially equivalent to its predicates.

Conclusion:

The Threaded PEEK K-Wire met all specified criteria performing as intended and did not raise any new issues of safety or effectiveness. The Threaded PEEK K-Wire is substantially equivalent to the Arthrex PushLock predicate with regards to indications for use, as the Threaded PEEK K-Wire indications for use represent a subset of the Arthrex PushLock indications for use. The fundamental scientific technology of the Threaded PEEK K-Wire is the same as described in the Arthrex PushLock predicates. Therefore, the Threaded PEEK K-Wire is substantially equivalent to the Arthrex, Inc. PushLock (K101679, K082810, K071177, K063479, K061863, K051219).

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 7, 2014

MTP Solutions LLC Mr. Robert Hoy Director of Technical & Clinical Research 124 South 600 West, Suite 100 Logan, Utah 84321

Re: K133235

Trade/Device Name: Threaded PEEK K-Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 28, 2014 Received: March 4, 2014

Dear Mr. Hoy:

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. 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 - Mr. Robert Hoy

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Ronald P. Jean -S for

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

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Threaded PEEK K-Wire - Traditional 510(k)

Indications for Use

510(k) Number (if known): K133235

Device Name: Threaded PEEK K-Wire

Indications for Use:

The Threaded PEEK K-Wire is intended for use with suture in metatarsal ligament and tendon repairs.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

Elizabet同級rank -S

Division of Orthopedic Devices

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.