Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning, and as fracture fixation devices in certain other smallbone fractures.

Indications

For use as guide wires in hip pinning procedures, .
. For use in aligning and reducing long bone fractures,
For use in securing non-long bone fractures such as olecranon fractures; patella fractures; . tibial plateau fractures; small hand and foot bone fractures; humeral, radial and ulnar fractures; etc.
For use with cerclage wire/cable in treating greater trochanter fractures. .

Device Description

The subject Kirschner Wires include both threaded and smooth components, and are available in a range of diameters and lengths. Both the threaded and smooth designs feature a trocar point. This submission includes both sterile and non-sterile product offerings.

AI/ML Overview

This submission for the Osteonics® Acetabular Wedge System (Osteo Kirschner Wires) is a 510(k) premarket notification, indicating it's a submission for a device seeking to demonstrate substantial equivalence to a legally marketed predicate device. As such, the typical "acceptance criteria" and "study proving device meets acceptance criteria" as might be found for a novel device undergoing clinical trials or rigorous performance testing are not present in the same format.

Instead, the acceptance criteria for a 510(k) submission are primarily centered on demonstrating substantial equivalence to a predicate device. The "study that proves the device meets acceptance criteria" in this context is the comparison between the proposed device and its predicate devices.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance (Comparison to Predicate)
Same Intended Use	The subject and predicate devices share the same intended uses.
Same Technological Characteristics (Materials)	The subject and predicate devices are both manufactured from implantable stainless steel that complies with ASTM F-138-92.
Same Technological Characteristics (Design/Dimensions)	The subject Osteo Kirschner Wires come in threaded and smooth designs, as do the predicate devices cited. The subject devices come in diameters and lengths consistent with the range available for the predicate devices.
Performance (if significantly different characteristics)	"As the subject Osteo Kirschner Wires are stainless steel wires with diameters not smaller than those featured in the predicate device systems, testing is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner Wires."

Study Details (as applicable to a 510(k) submission)

Sample size used for the test set and the data provenance:
- Sample size: Not applicable in the context of a traditional performance study. The "test set" here is the comparison of the proposed device's specifications against those of the predicate devices. No new data from a patient cohort was generated for this comparison.
- Data provenance: The data provenance comes from the design specifications of the Osteo Kirschner Wires and the known specifications of the predicate devices. It is entirely retrospective in the sense that it relies on existing information about materials, dimensions, and intended uses. The manufacturer is Osteo AG, located in Switzerland.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context would be the established specifications and intended uses of the predicate devices, which are already legally marketed and accepted. No panel of experts was convened to establish a "ground truth" for this substantial equivalence determination.
Adjudication method for the test set:
- Not applicable. There was no "test set" requiring adjudication in the sense of clinical outcomes or expert review of data. The FDA's review process itself acts as an adjudication of the substantial equivalence claim, comparing the submitted device's characteristics against the predicate's.
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 physical medical instrument (Kirschner Wires), not an AI-powered diagnostic or treatment system. Therefore, an MRMC study and AI-related metrics are irrelevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software-only device.
The type of ground truth used:
- The "ground truth" for this 510(k) submission is the established performance and safety profile of the legally marketed predicate devices. The argument is that because the Osteo Kirschner Wires are technologically equivalent (materials, design, intended use) and perform similarly to these predicates, they are equally safe and effective.
The sample size for the training set:
- Not applicable. There is no concept of a "training set" for this type of mechanical device submission.
How the ground truth for the training set was established:
- Not applicable. As explained above, there is no training set in this context.

Summary

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Osteonics® Acetabular Wedge System

510(k) Summary

510(k) SUMMARY Osteo Kirschner Wires

AUG 1 1 1997

Submission Information

Name and Address of the Sponsor:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677
Name and Address of the Manufacturer:	Osteo AG

Name and Address of the Manufacturer: Osteo AG Bohnackerweg 1 CH-2545 Selzach, Switzerland

Contact Person:

Date of Summary Preparation:

May 27, 1997

Allendale NJ 07401

Terry Sheridan

59 Route 17

Regulatory Affairs Specialist

Osteonics Corporation

Device Identification

Proprietary Name:	Osteo Kirschner Wires
Common Name:	Kirschner wires (K wires)
Classification Name and Reference:	Smooth or Threaded Metallic BoneFixation Fasteners21 CFR §888.3040

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Predicate Device Identification

The Osteo Kirschner Wires are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:

. Osteo Kirschner Wires (Osteo AG)
. Kirschner Wires (Smith + Nephew Richards)
. Kirschner Wires (Synthes)

Device Description

Intended Use

Indications and Contraindications

Indications

For use as guide wires in hip pinning procedures, .
For use in aligning and reducing long bone fractures, .
For use in securing non-long bone fractures such as olecranon fractures; patella . fractures; tibial plateau fractures; small hand and foot bone fractures; humeral, radial and ulnar fractures; etc.
. For use with cerclage wire/cable in treating greater trochanter fractures.

Statement of Technological Comparison:

The subject and predicate devices share the same intended uses. The subject and predicate devices are both manufactured from implantable stainless steel that complies with ASTM F-138-92. The subject Osteo Kirschner Wires come in threaded and smooth designs, as do the predicate devices cited. The subject devices come in diameters and lengths consistent with the range available for the predicate devices.

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Performance Data:

. . .

ﻣﻤﺎﺛﻠﺔ ﻣ

As the subject Osteo Kirschner Wires are stainless steel wires with diameters not smaller than those featured in the predicate device systems, testing is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner Wires.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Terry Sheridan Regulatory Affairs Specialist Osteonics Corporation ....... 59 Route 17 Allendale, New Jersey 07401-1677

AUG 11 1997

Re : K971962 Osteo Kirschner Wires Requlatory Class: II Product Code: HTY Dated: May 27, 1997 Received: May 28, 1997

Dear Ms. Sheridan:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Terry Sheridan

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K

Device Name: Osteo Kirschner Wires

Indications For Use:

Indications

For use as guide wires in hip pinning procedures, .
. For use in aligning and reducing long bone fractures,
For use in securing non-long bone fractures such as olecranon fractures; patella fractures; . tibial plateau fractures; small hand and foot bone fractures; humeral, radial and ulnar fractures; etc.
For use with cerclage wire/cable in treating greater trochanter fractures. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Uset Use ____________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Acotella

on Sion-Off Division of General Restorative Device 510(k) Number

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.