The WristJack System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction frame (fixator), application instrumentation and skeletal fixation pins. The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, stainless steel, titanium and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.

AI/ML Overview

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria, device performance studies, or clinical trial data.

The document is a 510(k) summary for a medical device called the "WristJack System (remanufactured)". This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting clinical study results to prove performance against specific acceptance criteria.

Here's why the requested information cannot be found in the provided text:

Acceptance Criteria and Device Performance: The document explicitly states "No performance standards exist for this device." and primarily discusses the device's technological characteristics and its similarity to a predicate device. It doesn't present any performance metrics or acceptance criteria for those metrics.
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): Because no performance study is described, all these related details are absent from the text. The 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, often through comparisons of materials, design, and intended use, rather than new clinical outcome studies.

In summary, the provided document is a regulatory filing focused on substantial equivalence, not a clinical study report. Therefore, it does not contain the information requested about acceptance criteria and device performance studies.

Summary

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JUN 1 0 2003

Image /page/0/Picture/1 description: The image shows the logo for the Hand Biomechanics Lab. On the left side of the logo is a black silhouette of a hand with a curved line above it. To the right of the hand is the text "Hand Biomechanics Lab", with each word on a separate line. The text is in a simple, sans-serif font.

510(k) Summary

030519
page 1 of 1

Hand Biomechanics Lab, Inc. 77 Scripps Drive, Suite 104 Sacramento, CA 95825-6209 Contact: Timothy R. Stallings (916) 923-5073 Phone: (916) 920-2215 Fax: Email: tstallings@handbiolab.com

Prepared February 18, 2003

Name of Device:

Regulatory Classification:	Class II
Classification Name:	Component, Traction, Invasive [888.3040]
Common Name:	External Fixator System
Trade Name/Proprietary Name:	WristJack System (remanufactured), sterile, Item No. CFD-147-RSWristJack System (remanufactured), non-sterile, Item No. CFD-147-RNS
Performance Standards:	No performance standards exist for this device.

Predicate Device:

Agee WristJack Fracture Reduction System (sterile), Item No. CFD-147, K984442

Description of Device:

The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, stainless steel, titanium and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.

Intended Use:

Fracture reduction and external fixation for treatment of distal radius fractures.

Technological Characteristics Compared to Predicate Device:

All device components and materials of the WristJack System (remanufactured) are identical to the device components and materials of the predicate device. The subject device is reprocessed and delivered to the customer in either sterile form. In the non-sterile model, the customer is responsible for sterilization before use. The predicate device is supplied sterile.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, with three parallel lines forming a wave-like shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2003

Mr. Timothy R. Stallings Manufacturing Manager Hand Biomechanics Lab, Inc. 77 Scripps Drive, Suite 104 Sacramento, California 95825

Re: K030519

Trade/Device Name: WristJack System (remanufactured) sterile and non-sterile Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JEC Dated: May 23, 2003 Received: May 29, 2003

Dear Mr. Stallings:

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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Page 2 - Mr. Timothy R. Stallings

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. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Miriam C. Provost

Celia 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): _KO30519 Device Name: WristJack System (remanufactured) _______________________________________________________________________________________________________________________________ Indications For Use:

Fracture reduction and external fixation for treatment of distal radius fractures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030579

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.