The intended use of the external fixator is unilateral external fixation, device which is intended for use in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

Device Description

The external fixator like the predicate device includes various size frames, bars, pin clamps, pins, accessories and instruments. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.

AI/ML Overview

This is a 510(k) premarket notification for an external fixator device, which is a hardware device. The provided text is a regulatory submission for a medical device and does not contain information about software algorithms, AI, or performance studies in the context of digital health or AI/ML-enabled devices. Therefore, I cannot extract the requested information.

Here's why:

Device Type: The document describes an "External Fixator," which is a physical, mechanical medical device used for orthopedic conditions. It is not a software device or an AI/ML system.
Approval Process: The 510(k) summary explicitly focuses on demonstrating substantial equivalence to a predicate device (another external fixator) based on similar design characteristics and intended use. This is a common pathway for traditional medical devices.
Missing Information: The document does not discuss:
- Acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
- Any study involving a "test set," "training set," "ground truth," "experts," "adjudication," or "human readers."
- "Multi reader multi case (MRMC) comparative effectiveness study" or "standalone performance."

In summary, the provided text is for a physical medical device and does not contain the kind of information requested about AI device performance studies.

Summary

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JUL 17 1998

510 (k) Summary

K981716

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

May 13, 1998 Prepared: Avanta Orthopaedics, Inc. Applicant: 9369 Carroll Park Drive, Suite A San Diego, CA 92121

Telephone: 619-452-8580 619-452-9945 Fax: Contact: Louise M. Focht

Device Name: Device Trade Name: Device Classification: Reviewing Panel: Regulation Number

External Fixator External Fixator Class II Orthopaedic 888.3040 Smooth or threaded metallic bone fixation fastener. JWD

Product Code: Accessories Predicate Device:

Avanta Orthopaedics (K974911) EBI/Orthofix K831576

Device Description:

Intended Use:

The intended use of the external fixation device is the same as that expressed in the predicate device 510k.

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Comparison to Predicate Device:

The table below summarizes similarities and differences between the EBI/Orthofix and the Avanta Orthopaedics external fixator.

Feature	EBI/Orthofix	Avanta Orthopaedics
Pins	Implantable	Implantable
Allows for application ofcompression or distraction	Yes	Yes
Pin Length	80-160 mm	50-90 mm

Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its body. The eagle is facing right, and the profiles are stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 17 1998

Ms. Louise M. Focht Avanta Orthopaedics, Inc. 9369A Carroll Park Drive San Diego, California 92121

K981716 Re: Trade Name: External Fixator Requlatory Class: II Product Code: JWD May 13, 1998 Dated: Received: May 15, 1998

Dear Ms. Focht:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 regulations.

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Page 2 - Ms. Louise M. Focht

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 advertisinq 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: K981716

Device Name: External Fixation

Intended Use:

The intended use of the external fixation device is the same as that expressed in the predicate device 510k.

boolefo
sion Sign-Off
of General Restorative Devices K981716
Number

Prescription Use
(Per 21 CFR 801.109)

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.