The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

Device Description

The APTUS K-Wire System consists of stainless steel wires of various dimensions and characteristics intended to be used for fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

AI/ML Overview

This 510(k) summary for the Medartis AG APTUS® K-Wire System (K092038) does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document is a premarket notification for a medical device seeking clearance to market based on substantial equivalence to existing devices. It focuses on administrative information, device description, and a claim of equivalence to previously cleared predicate devices.

Here's a breakdown of what the document does provide, and why it doesn't meet your request:

Information Present in the Document:

Manufacturer Name: Medartis AG
Device Name: APTUS® K-Wire System
Intended Use: "The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants."
Classification: Class II, Product Code HTY, Regulation 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener)
Device Description: "The APTUS K-Wire System consists of stainless steel wires of various dimensions and characteristics intended to be used for fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants."
Equivalence Claim: The document states the APTUS K-Wire System is substantially equivalent to previously cleared devices based on sharing the same intended use, operating principle, basic design, similar materials, and similar packaging/sterilization.

Why the Document Doesn't Meet Your Request:

The provided text describes a substantially equivalent pathway to FDA clearance for K092038. This pathway does not typically require the manufacturer to establish entirely new performance acceptance criteria and conduct extensive studies (like clinical trials or standalone performance studies with expert ground truth) to prove the device meets those criteria, as you would for a novel device or a PMA submission.

Instead, the core of a 510(k) relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is done by showing:

Same intended use.
Similar technological characteristics. (e.g., materials, operating principles, design).
If there are differences in technological characteristics, demonstrating via performance data (e.g., bench testing, non-clinical tests) that these differences do not raise new questions of safety and effectiveness.

Therefore, the document explicitly states: "Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS K-Wire System is substantially equivalent to previously cleared devices." This suggests that the "proof" of meeting safety and effectiveness is tied to the predicate device's established performance, rather than the generation of new, extensive performance data against explicit, novel acceptance criteria for this specific device.

To directly answer your numbered points based only on the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The document states substantial equivalence based on material, design, and intended use similarities, not specific performance metrics against defined acceptance criteria.
Sample size used for the test set and the data provenance: Not applicable/Not mentioned. No specific "test set" for performance evaluation is described in the context of substantial equivalence to the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not mentioned. Ground truth for a test set is not discussed.
Adjudication method for the test set: Not applicable/Not mentioned.
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 device is a K-Wire system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a K-Wire system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not mentioned.
The sample size for the training set: Not applicable/Not mentioned.
How the ground truth for the training set was established: Not applicable/Not mentioned.

In summary, this 510(k) submission doesn't contain the type of performance study details you're looking for, as its basis for clearance is demonstrating substantial equivalence to a predicate, not demonstrating performance against specific, newly defined acceptance criteria through a clinical or algorithmic performance study.

Summary

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510(k) Summary

K092038*"1/2

510(k) Summary

SEP 2 3 2009

Medartis AG APTUS® K-Wire System

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Medartis AG Austrasse 24 CH-4051 Basel, Switzerland Telephone: +41 (0) 61 228 18 18 Fax: +41 (0) 61 228 18 00

Official Contact:

Rosina Cifelli Regulatory Affairs Manager, Medartis AG

Representative/Consultant:

Kevin A. Thomas Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 email: kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Product Code: Classification Panel: Reviewing Branch:

APTUS® K-Wire System Pin, fixation, smooth Smooth or threaded metallic bone fixation fastener 21 CFR 888.3040 Class II HTY Orthopedic Products Panel Orthopedic Devices Branch

INTENDED USE

The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

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K092038 #2/2

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS K-Wire System is substantially equivalent to previously cleared devices. The APTUS K - Wire System has the following similarities to the predicate devices:

. has the same intended use,
. uses the same operating principle,
. incorporates the same basic design,
incorporates the same or very similar materials, and .
has similar packaging and is sterilized using the same materials and processes. .

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

SEP 2 3 2009

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

Medartis AG % PaxMed International, LLC Mr. Kevin Thomas 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K092038

Trade/Device Name: APTUS® K-Wire System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: July 2, 2009 Received: July 6, 2009

Dear Mr. Thomas:

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 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 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. Kevin Thomas

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Barbave Buehm

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

Enclosure

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Indications for Use

510(k) Number (if known): K192038

APTUS® K-Wire System Device Name:

Indications for Use:

The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 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 of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092038

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.