TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE by TRI-MED, INC.

The TriMed Bearing Plate is intended for use as an aid the fracture healing. The implants are applied to a to fracture hound secured with bone screws and threaded or unthreaded locking fixation pegs.

The TriMed Bearing Plate is indicated for:

Fixation of fractures or non-unions of the distal radius
Osteotomies of the distal radius to correct malunion

Device Description

The TriMed Bearing Plate is a bone fixation plates are inc frined bound to fracture fixation. The plates are is ased as an an an either medical grade 316 stainless manalabourea (ASTM F139) or medical grade wrought Titanium-6Aluminum-4Vanadium alloy (ASTM F136). freamfamilian which workeristics of the devices are provided in enclosures 8 and 9.

AI/ML Overview

The provided text is a 510(k) summary for the TriMed Bearing Plate. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria through a study in the same way clinical trials for new drugs or software algorithms are conducted.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth is not present in this document.

This document specifically states: "report an 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."

Here's why the requested information is absent and what can be inferred from the document:

Acceptance Criteria & Reported Device Performance: This device, being a bone fixation plate, is evaluated based on its material properties (e.g., medical grade stainless steel or Titanium alloy) and its functional equivalence to existing plates. The document states, "The TriMed Bearing Plate has identical technical characteristics to existing bone plates in common use." There are no explicit performance metrics like sensitivity, specificity, or accuracy mentioned as there would be for a diagnostic or AI device.
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): A 510(k) for a physical medical device like this typically relies on bench testing for material and mechanical properties, and comparison to predicate devices, rather than clinical studies with human participants that would involve test sets, ground truth, or experts in the way your prompt describes for AI/diagnostic devices. The regulatory process for this type of device focuses on demonstrating that the new device is as safe and effective as a legally marketed device.
Ground Truth: For a bone fixation plate, "ground truth" would be related to mechanical integrity and biocompatibility, typically established through material testing standards and established clinical use of similar materials and designs. It's not about an "expert consensus" on an image or pathology.
Training Set (for AI/Algorithms): The concept of a "training set" is irrelevant for this type of physical medical device, as it does not involve any algorithms or machine learning.

What the document does provide:

Predicate Devices: The document lists several predicate devices (e.g., Zimmer Forte plate, Synthes bone fixation plates, Smith-Nephews bone fixation plates and screws). The "substantial equivalence" is established by comparing the TriMed Bearing Plate to these existing devices.
Material Specifications: The device is made of "medical grade 316 stainless steel (ASTM F139) or medical grade wrought Titanium-6Aluminum-4Vanadium alloy (ASTM F136)." These are standard materials used in similar devices, implying they meet established performance and safety requirements.
Intended Use/Indications for Use: Fixation of fractures or non-unions of the distal radius, and osteotomies of the distal radius to correct malunion. These are typical indications for bone fixation plates.

In summary, the provided text is a regulatory submission demonstrating substantial equivalence for a physical medical device, not a performance study for an AI-powered diagnostic tool. Therefore, the specific criteria and study details requested are not applicable or found within this document.

Summary

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

040112
page 1 of 2

Page 1 of 2 510(k) summary

510 (k) SUMMARY.

510 (k) nmbr: (ur.assigned)

TriMed, Inc. Submitted by: 25768 Parada Drive Valencia, California 91355 800-633-7221 Robert J. Medoff, MD Prepared by: Robert J. Medoff, MD Contact person: December 29, 2003 Date prepared: TriMed Bearing Plate Proprietary Name: TriMed Volar Bearing Plate Bone fixation plates Classification Name: Common/Usual Name: TriMed Bearing Plate TriMed Volar Bearing Plate (other names reserved for future sites of application)

Sample Predicate Devices:

Zimmer Forte plate

Synthes bone fixation plates

Smith-Nephews bone fixation plates and screws

Spinal Concepts Acufix Cervical Plate System, (regulation number 888.3060, issued by FDA 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9 / 9

Hand Innovations Distal Volar Radial Plate

TriMed plates

Sec. 888.3030 Bone fixation plate Class: II,

Classification Panel: These devices are reviewed by an orthopaedic panel (888)

HRS Product Code:

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

Koyolla

Page 2 of 2 510(k) summary

December 29, 2003

Description of the device:

Ipcion of the device.
The TriMed Bearing Plate is a bone fixation plates are inc frined bound to fracture fixation. The plates are is ased as an an an either medical grade 316 stainless manalabourea (ASTM F139) or medical grade wrought Titanium-6Aluminum-4Vanadium alloy (ASTM F136). freamfamilian which workeristics of the devices are provided in enclosures 8 and 9.

Intended use of the Device:

The TriMed Bearing Plate is intended for use as an aid the fracture healing. The implants are applied to a to fracture hound secured with bone screws and threaded or unthreaded locking fixation pegs.

Technological characteristics:

Orogredi Chararing Plate has identical technical ne frined boards to existing bone plates in common use. enardeceries implant sales literature is supplied sumple of the 510(k) application, and material specification sheets are supplied with enclosure 6 of the 510(k) application.

Indications for use:

The TriMed Bearing Plate is indicated for:

1. Fixation of fractures or non-unions of the distal radius
1. Osteotomies of the distal radius to correct malunion

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an emblem of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2004

Robert J. Medoff, MD TriMed. Inc. 25768 Parada Drive Valencia, California 91355

Re: K040112 Trade/Device Name: TriMed Bearing Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: December 29, 2003 Received: January 20, 2004

Dear Dr. Medoff:

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 he 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.

{3}------------------------------------------------

Page 2 - Robert J. Medoff, MD

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 vours.

Mark M. Milliken

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

{4}------------------------------------------------

510(k) nmbr: K040112 TriMed Bearing Plate Supplement A 12/29/2003

Supplement A to the 510(k) application for the TriMed Bearing Plate

Indication for Use Form

Page 1 of 1

510(k) Number (if known): K040112

Device Name: TriMed Bearing Plate

Indications for Use:

1. Fixation of fractures or non-unions of the distal radius
1. Osteotomies of the distal radius to correct malunion

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR Over-The-Counter Use
(Per 21 CFR 901.109)
(Divisior Sign-Off)
Division of General, Restorative,
and Neurological Devices

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.