HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2 by TRIAD MEDICAL, INC.

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Helical Compression Anchor System, Cannulated, Version 2." It primarily states that the device has been found substantially equivalent to a legally marketed predicate device for the stated indications for use.

The document does not include:

A table of acceptance criteria or reported device performance.
Details about sample sizes, data provenance, or types of studies conducted (e.g., test set, ground truth experts, adjudication methods, MRMC studies, standalone performance).
Information on the training set or how its ground truth was established.

The "Indications for Use Statement" only provides the general purpose of the device: "This device is used in the general management of fractures and reconstructive surgery." This is an intended use statement, not a list of performance acceptance criteria.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The overall design is simple and conveys the department's focus on health and human welfare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 200i

Triage Medical Inc. c/o Ms. Rita Giebel Regulatory Specialists, Inc. 3722 Avenue Sausalito Irvine, California 92606

Re: K013903

Trade/Device Name: Helical Compression Anchor System, Cannulated, Version 2 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 21, 2001 Received: November 26, 2001

Dear Ms. Giebel:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 20, 1978, ins cassordance with the provisions of the Federal Food, Drug, de noos mat hat o been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, increrere, mailes 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 rr your device to such additional controls. Existing major regulations affecting your device can may or babyer to back as a succeral 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 r toase of acrised alat i sermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 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.

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

Page 2 - Ms. Rita Giebel

This letter will allow you to begin marketing your device as described in your fection 510(k) This letter will anow you is cegain mailing of substantial equivalence of your device to a legally premarket notification: "The PDF intelling of easification 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 IT you desire specific advice for your avitro diagnostic devices), please contact the Office of additionally 21 CHC Fat 00710 Idditionally, for questions on the promotion and advertising of Compliance at (301) 591 1057. The may at (301) 594-4639. Also, please note the your do roo, produce combranding by reference to premarket notification" (21CFR Part 807.97). Tegulation entitled, "Misorananing of responsibilities under the Act may be obtained from the Other general information on your respectional 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,

f
Celia M. Witten, Ph.D., M.D.

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

{2}------------------------------------------------

Indications for Use Statement

Page 1 of 1

Labels	Values
510(k) Number (if known):	K013903

Device Name: Helical Compression Anchor System, Cannulated, Version 2

Indications for Use:

This device is used in the general management of fractures and reconstructive surgery.

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

510(k) Number K013903

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

REGULATORY SPECIALISTS

Pagc I l

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.