The TriMed Clavicle Fixation Plates and Screws are intended for use in fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.

Device Description

The TriMed Clavicle Fixation Plates are designed to provide total immobilization of the clavicle. The plates utilize 2.7mm and 3.2mm locking cortical screw to secure the plates to the bone. All plates and screws are similar to predicate devices. The TriMed Clavicle Fixation Plates are available in a variety of shapes and sizes to provide superior and anterior fixation of the clavicle.

AI/ML Overview

The provided text describes a 510(k) submission for the TriMed Clavicle Fixation System. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies or standalone performance evaluations.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission. The primary "study" conducted for this device is an engineering analysis comparing its mechanical properties to those of existing devices.

Here's a breakdown of the information as it relates to the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance/Comparison
Mechanical Performance: Bending Strength (implied, not explicitly stated as a numerical criterion)	An engineering analysis was conducted to compare the bending strength of the TriMed Clavicle Fixation Plates to predicate devices. The submission implies that the TriMed devices demonstrate comparable or acceptable bending strength to justify safety and effectiveness relative to the predicates.
Indications for Use Equivalence:	"Substantial equivalence is based upon similarities in design features and overall indications for use" with K100944 (Clavicle Locking Plating System) and K012655 (Congruent Bone Plate System).
Design Features Equivalence:	The plates utilize 2.7mm and 3.2mm locking cortical screws, and all plates and screws are similar to predicate devices. The plates are available in various shapes and sizes for superior and anterior fixation.

Note: The 510(k) process for this type of device does not typically require the establishment of specific numerical performance acceptance criteria and a detailed study proving the device meets those in the way, for example, a diagnostic AI device would. Instead, the focus is on demonstrating that the device is as safe and effective as a legally marketed predicate device.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. No clinical or performance test set (in the sense of a data set for an algorithm) was described. The "test" involved an engineering analysis comparing the device's mechanical properties to predicates.
Data Provenance: Not applicable. The "data" comes from the engineering analysis, comparing the new device's specifications and performance to specifications of predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not applicable. Ground truth, in the context of an AI device, is not relevant here as this is a medical implant, not an AI diagnostic tool. The "ground truth" for proving substantial equivalence relies on established engineering principles and comparison to predicate device specifications.

4. Adjudication method for the test set

Adjudication method: Not applicable. There was no test set requiring expert adjudication.

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

MRMC Study: Not applicable. This is a medical implant (clavicle fixation system), not an AI diagnostic or assistive device. Therefore, a multi-reader multi-case comparative effectiveness study with or without AI assistance is not relevant.

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

Standalone Performance: Not applicable. This is a medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not applicable in the context of typical AI algorithm validation. For this 510(k) submission, the "truth" for substantial equivalence is derived from:
- Engineering analysis results: Comparing the bending strength of the new device to predicate devices.
- Predicate device information: Specifications, indications for use, and design features of the legally marketed predicate devices (K100944 and K012655).

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. There is no training set for this device.

Summary

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K112509

510(k) Summary of Safety and Effectiveness

TRIMED CLAVICLE FIXATION PLATES

Submitted/Distributed By:	TriMed, Inc.27533 Avenue HopkinsSanta Clarita, CA 91355(800)633-7221
Registration No.:	2031009
Prepared By/Contact Person:	Doug SteinbergerPhone: (661)255-7406Fax: (661)254-8485
Proprietary Name:	TriMed Clavicle Fixation System
Classification:	Class II: Screw, Fixation, BoneHWC - Section 888.3040Class II: Plate, Fixation, BoneHRS - Section 888.3030
Summary Preparation Date:	August 24, 2011

l. Indications for Use:

The TriMed Clavicle Fixation Plates and Screws are intended for use in fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.

II. Device Description

111. Substantial Equivalence Discussion

When compared to the predicate devices listed below, substantial equivalence is based upon similarities in design features and overall indications for use.

510(k) Number	Device Name or System	Manufacturer
K100944	Clavicle Locking PlatingSystem	NewClip
K012655	Congruent Bone Plate System	Acumed

An engineering analysis has been conducted to compare the bending strength of the TriMed Clavicle Fixation Plates to predicate devices to provide justification of the safety and effectiveness of the TriMed devices.

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Image /page/1/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

NOV - 4 2011

TriMed Inc. % Doug Steinberger 27533 Avenue Hopkins Santa Clarita CA 91355

Re: Ki12509

Trade/Device Name: TriMed Clavicle Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS, HWC Dated: August 24th, 2011 Received: August 30th, 2011

Dear Mr. Steinberger:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): unknown

Clavicle Fixation System Plates and Screws Device Name: Indications For Use:

The Clavicle Fixation System Plates and Screws are intended for use in fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.

ਮ Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Conqurrence of CDRH, Office of Device Evaluation (ODE)

Richard Oves to MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112501

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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.