TRIMED RADIAL BULLET by TRI-MED, INC.

The TriMed Radial Bullet is intended for use as an aid to fracture healing. The implants are inserted across a fracture site and aid in stabilization of the bone fragments until bone healing occurs. The implant design includes a tip that is placed up against the subchondral bone of the tip of the radial styloid to prevent loss of radial length during fracture healing. The TriMed Radial Bullet may be used with bone screws, washers, locking bone screws and/or locking fixation pegs of the same material. The principal site of application is along the radial column in the context of distal radius fixation for treatment of fractures or osteotomies. Other sites of application may be reserved for future use.

The TriMed Radial Bullet is indicated for:

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

Device Description

AI/ML Overview

The provided text is a 510(k) summary for the TriMed Radial Bullet, a bone fixation implant. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study to prove the device meets specific acceptance criteria through performance metrics.

Therefore, many of the requested sections about study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not present in this type of regulatory document.

However, I can extract information related to the device's intended use, technological characteristics, and how its equivalence is established.

Here's an attempt to structure the available information, noting the absence of details requested that are typically found in a clinical or performance study report:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify "acceptance criteria" in terms of performance metrics (e.g., accuracy, sensitivity, specificity) as one would find for a diagnostic or AI device. Instead, the "acceptance criteria" for a 510(k) submission for a bone fixation plate generally revolve around demonstrating substantial equivalence to legally marketed predicate devices. This typically involves showing:

Similar intended use: The device is intended for the same uses as the predicate.
Similar technological characteristics: The device operates and is constructed similarly to the predicate.
Safety and efficacy: The differences (if any) do not raise new questions of safety or effectiveness.

Therefore, the "reported device performance" in this context is the assertion that it meets these substantial equivalence criteria due to its identical technical characteristics and intended use compared to existing devices.

Acceptance Criterion (for 510(k) submission)	Reported Device Performance (Statement of Equivalence)
Intended Use: Aid to fracture fixation, stabilization of bone fragments, prevent loss of radial length for distal radius fractures/osteotomies.	The TriMed Radial Bullet is intended for use as an aid to fracture healing, inserted across a fracture site to aid in stabilization of bone fragments until bone healing occurs. Its design prevents loss of radial length. It is indicated for fixation of fractures or non-unions of the distal radius and osteotomies of the distal radius to correct malunion, which are similar to predicate devices.
Technological Characteristics: Materials, design, function.	"The TriMed Radial Bullet has identical technical characteristics to existing bone fixation plates that are in common use." (e.g., medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy, plate-and-screw/peg fixation system)
Safety and Efficacy: No new questions of safety or effectiveness.	Implied by the "identical technical characteristics" and "substantial equivalence" determination by the FDA based on comparison to already cleared predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a 510(k) submission for a medical device (bone fixation plate), not a study involving a "test set" of data or patient images for an AI algorithm. The evaluation is based on comparison to existing predicate devices and material specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No "test set" or "ground truth" establishment in this context. The "expert" involved in the submission is Robert J. Medoff, MD, who prepared the 510(k) and is likely the device inventor/developer or a clinical consultant. His qualifications aren't explicitly detailed beyond being a Medical Doctor, but his role suggests expertise in orthopedics, given the device's application.

4. Adjudication Method for the Test Set

Not applicable. No "test set" to adjudicate.

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 a bone fixation plate, not an AI-assisted diagnostic tool.

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

Not applicable. This is a bone fixation plate, not an algorithm.

7. The Type of Ground Truth Used

Not applicable for a typical "ground truth" definition for an AI or diagnostic study. For a medical device 510(k), the "ground truth" in a broader sense is the established safety and effectiveness of the legally marketed predicate devices, against which the new device is compared. This "ground truth" is established through years of clinical use, regulatory history, and potentially prior clinical studies for the predicate devices.

8. The Sample Size for the Training Set

Not applicable. No "training set" for an algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. No "training set" for an algorithm.

Summary

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FEB - 5 2004

Page 1 of 2 510(k) summary

December 29, 2003

510(k) SUMMARY, revised.

K030877 510(k) number:

TriMed, Inc. Submitted by: 25768 Parada Drive Valencia, California 91355 800-633-7221

Prepared by:	Robert J. Medoff, MD
Contact person:	Robert J. Medoff, MD (rmedoff@hawaii.rr.com)
Date prepared:	December 29, 2003
Proprietary Name:	TriMed Radial Bullet
Classification Name:	Bone fixation plate
Common/Usual Name:	TriMed Radial Bullet
	(other names reserved for future sites of application)

Sample Predicate Devices:

TriMed small fragment clamp and buttress pin (510(k) K951303) Distal radius plate (Hand Innovations) Forte distal radius fixation plate (Zimmer) TriMed Radial Pin Plate (TriMed) Dorsal Nail Plate (Hand Innovations) Flexible Intramedullary Nail System for metacarpal fractures (Hand Innovations)

(PLATE, FIXATION, BONE) Class: II, Sec. 888.3030

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

Product Code: HRS

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Page 2 of 2 510(k) summary

December 29, 2003

Description of the device:

The TriMed Radial Bullet is a bone fixation implant that is used as an aid to fracture fixation. All components of the implant are manufactured either from medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy. Dimensional characteristics of the devices have been provided in enclosure 1 of the 510(k) submission as well as attachment A of the first 510(k) supplement.

Intended use of the Device:

Technological characteristics:

The TriMed Radial Bullet has identical technical characteristics to existing bone fixation plates that are in common use. Sample existing implant literature is supplied with enclosure 5 of the 510(k) application, and material specification sheets are supplied with enclosure 6 of the initial 510(k) application as well as attachment C of the first 510(k) supplement.

Indications for use:

The TriMed Radial Bullet is indicated for:

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

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Image /page/2/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 of three horizontal lines that resemble a person.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2004

TriMed, Inc. C/o Robert J. Medoff, M.D. 159 Ku'ukama Street Kailua, Hawaii 96734

Rc: K030877

Trade/Device Name: TriMed Radial Bullet 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 7, 2004

Dear Dr. Medoff:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 107 use stated in the enatiment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de rices mat have been require approval of a premarket approval application (PMA). and cosmetre rearly for, 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 Codc 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 - Robert J. Medoff, M.D.

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 Milliman

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: K030877 Supplement 2 - Attachment 2A

Indications for Use

The TriMed Radial Bullet is indicated for:

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

f Mark A. Mulkinson

Restorative
Devices

Page 1 of

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.