Bone fracture fixation,
Osteotomy,
Arthrodesis,
Correction of deformity,
Revision procedures where other treatments or devices have been unsuccessful, and;
Bone reconstruction procedures.

Device Description

The subject devices are also cobalt chromium alloy wires. They come either as 18" wires in an autoclavable tube (6 per tube), or as a 24" length, or as a 72" (6 Foot) coil. The subject devices are 0.0126", 0.0159", 0.020", 0.040" and 0.046" in diameter.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a line extension to an Orthopedic Wire. It explicitly states: "No testing was performed to demonstrate the equivalence of the subject devices."

Therefore, based on the provided text, the device did not undergo any specific study to prove it meets acceptance criteria. Instead, its clearance was based on demonstrating substantial equivalence to a legally marketed predicate device, without new performance testing.

Given this, most of the requested information cannot be extracted from the provided text.

Here's what can be inferred:

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

Acceptance Criteria: Not explicitly stated as specific performance metrics (e.g., tensile strength, flexibility limits) for the new wire sizes. The acceptance was based on substantial equivalence to the predicate device.
Reported Device Performance: Not performed or reported. The submission states, "No testing was performed to demonstrate the equivalence of the subject devices."

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

Sample Size: Not applicable as no new testing was performed.
Data Provenance: Not applicable.

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 no new testing or ground truth establishment was performed for performance evaluation.

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

Not applicable as no new testing or adjudication for performance was performed.

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. No MRMC study was mentioned.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable, as no new performance data was generated for the subject device. The clearance relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable as this is not a machine learning/AI device.

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

Not applicable as this is not a machine learning/AI device.

Summary of the document's approach:

The manufacturer pursued a "Special 510(k) Premarket Notification" for a line extension. This pathway is typically used when the modification to a legally marketed device does not raise new questions of safety and effectiveness. In this instance, the "line extension" involved new diameters of existing cobalt chromium alloy orthopedic wires. The core argument for substantial equivalence was likely based on:

The identical material (cobalt chromium alloy).
The identical intended use.
Presumably, the new wire sizes falling within a range that would not significantly alter the established mechanical properties or biological compatibility compared to the predicate devices, despite the lack of new testing. The FDA concurrence letter confirms that they found the device "substantially equivalent" for the stated indications.

Summary

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APR 2 8 2003

Line Extension to Orthopedic Wire

Image /page/0/Picture/2 description: The image shows the text "K031127 page 1 of 2" in a handwritten style. Below this text is the phrase "Special 510(k) Premarket Notification" in a smaller, more formal font. The text appears to be part of a document or report, possibly indicating a page number and a reference to a specific type of notification.

Special 510(k) Summary Line Extension to Orthopedic Wire

Proprietary Name:	Orthopedic Wire
Common Name:	Orthopedic Wire
Classification Name and Reference:	Bone Fixation Cerclage
	21 CFR §888.3010
Proposed Regulatory Class:	Class II
Device Product Code:	87 JDQ
Predicate Proprietary Name:	Orthopedic Wire
Predicate Regulatory Class:	Class II
Predicate Product Code:	assumed to be 87 JDQ (preamendment device)
For Information contact:	Debra Bing
	Howmedica Osteonics Corp.
	59 Route 17
	Allendale, New Jersey 07401-1677
	Phone: (201) 831-5413
	Fax: (201) 831-6038

Description/Technological Comparison

The predicate devices are cobalt chromium alloy wires. They come either as 18" wires in an autoclavable tube, or as a 120" wire coil with an autoclavable clip. The predicate devices are 0.032" and 0.040" in diameter.

{1}------------------------------------------------

Line Extension to Orthopedic Wire

03 1127
Page 2 of 2
Special 510(k) Premarket Notification

Intended Use

The subject orthopedic wires are single-use devices. Like the predicate devices, they are intended for:

Bone fracture fixation, 등
. Osteotomy,
바 Arthrodesis,
Correction of deformity, 포
Revision procedures where other treatments or devices have been unsuccessful, and; 미
Bone reconstruction procedures. l

Testing Summary

No testing was performed to demonstrate the equivalence of the subject devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2003

Ms. Debra Bing Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Re: K031127

Trade/Device Name: Line Extension - Orthopedic Wire Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDR Dated: April 4, 2003 Received: April 9, 2003

Dear Ms. Bing:

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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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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Mark n Milkers

elia 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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510(k) Number (if known): KQ3/lv

Device Name: Line Extension - Orthopedic Wire

The subject orthopedic wires are single-use devices. They are intended for:

Bone fracture fixation, 트
하 Osteotomy,
내 Arthrodesis,
해 Correction of deformity,
. Revision procedures where other treatments or devices have been unsuccessful, and;
해 Bone reconstruction procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Mark A Milliken

Division Sign-Off) Division of General, Restorative and Neurological D 510(k) Number

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.