The components of the EOS Small Bone Fixation System are indicated for use in osteosynthesis, osteotomy, and arthrodesis of the following areas of the bodv:

Large Cannulated Compression Screws – bones in the foot

Cannulated Compression Screws – small bones in the hand and foot

AND/OR

Snap-Off Screws - small bones in the foot

Bone Plates - first metatarso-phalangeal joint

Staples & Pins - small bones in the hand and foot

Device Description

The TriMed EOS Small Bone Fixation System components are designed to provide internal fixation of various bones. The Cannulated Compression Screws are available in 7.3mm, 3.0mm, and 2.5mm diameters while the Snap-Off Screws are available in a 2.0mm thick Bone Plates utilize 2.7mm Bone Screws to secure the plate to the bone, and both items are available in various lengths. All screws and plates are available in implant grade Ti6AL4V Titanium. Staples and Pins are available in diameters ranging from 1.0mm to 2.5mm and are available in implant grade Ti6AL4V Titanium. 316L Stainless Steel, or Nitinol (N(T),

AI/ML Overview

The provided document is a 510(k) summary for the TriMed EOS Small Bone Fixation System. It describes the device, its indications for use, and claims substantial equivalence to predicate devices. However, this document does not contain the type of information requested regarding acceptance criteria and a study proving a device meets those criteria.

Specifically, the document lacks details such as:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, or details about training sets.
The number and qualifications of experts for ground truth establishment.
Information on adjudication methods or multi-reader multi-case studies.
Results from standalone performance studies.
The type of ground truth used.

Instead, the document highlights:

Indications for Use: The system is indicated for osteosynthesis, osteotomy, and arthrodesis in specific small bones of the hand and foot.
Device Description: It comprises various screws, bone plates, staples, and pins made of Ti6AL4V Titanium, 316L Stainless Steel, or Nitinol.
Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through substantial equivalence to previously cleared predicate devices (Omnitech Large Compression Screws, Omnitech Compression Screws, SPIN Snap-Off Screws, Hallu Plates, EasyLock Osteosystem Plates, Uni-Clip Staple, Memory Staple, Varisation Staples).
Supporting Evidence for Substantial Equivalence: An engineering analysis, mechanical tests, functional implant and instrumentation tests, corrosion testing, and biocompatibility tests were performed to support this claim.

To answer your prompt, I would need a document that presents the results of a specific performance study (e.g., a clinical trial or a validation study) with defined acceptance criteria for a medical device's performance, along with the detailed methodology for that study. The current document is a regulatory submission focused on demonstrating substantial equivalence rather than reporting on a specific performance study with acceptance criteria.

Summary

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MAY 1 0 2012

. .

510(k) Summary of Safety and Effectiveness

TRIMED EOS SMALL BONE FIXATION SYSTEM

Submitted/Distributed By:

Registration No .:

Manufactured By:

Registration No .:

Prepared By/Contact Person:

Proprietary Name:

Classification:

TriMed, Inc. 27533 Avenue Hopkins Santa Clarita, CA 91355 (800)633-7221

2031009

Biotech International 305, Allée de Craponne 13300 Salon De Provence France

3005270144

Doug Steinberger Phone: (661)255-7406 Fax: (661)254-8485

TriMed EOS Small Bone Fixation System

Class II: Screw, Fixation, Bone HWC - Section 888.3040 Class II: Plate, Fixation, Bone HRS - Section 888.3030 Class II: Staple, Fixation, Bone JDR - Section 888.3030 Class II: Pin, Fixation, Smooth HTY - Section 888.3040

Summary Preparation Date:

September 9, 2011

I. Indications for Use:

The components of the TriMed EOS Small Bone Fixation System are indicated for use in osteosynthesis, osteotomy, and arthrodesis of the following areas of the body:

Large Cannulated Compression Screws - bones in the foot

Cannulated Compression Screws - small bones in the hand and foot

Snap-Off Screws - small bones in the foot

Bone Plates - first metatarso-phalangeal joint

Staples & Pins - small bones in the hand and foot

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K112794

II. Device Description

III. Substantial Equivalence Discussion

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

510(k) Number	Predicate Device(Manufacturer)	TriMed EOS Small BoneFixation Device
K093676	Omnitech Large CompressionScrews (TriMed)	Large CannulatedCompression Screws
K050681	Omnitech Compression Screws(TriMed)	Cannulated CompressionScrews
K991477	SPIN Snap-Off Screws(NewDeal)	Snap-Off Screws
K021626 &K050681	Hallu Plates (NewDeal)EasyLock Osteosystem Plates(TriMed)	Bone Plates
K011716,K070031, &K070033	Uni-Clip Staple (NewDeal),Memory Staple (MemoMetalTechnologies), &Varisation Staples(MemoMetal Technologies)	Staples & Pins

An engineering analysis has been conducted to compare the strength of the EOS Small Bone Fixation System components to the predicate devices to provide justification of the safety and effectiveness of the TriMed EOS Small Bone Fixation devices. In addition to the engineering analysis, mechanical tests, functional implant and instrumentation tests, corrosion testing, and biocompatibility tests have been performed to support the substantial equivalence of the EOS Small Bone Fixation System components to predicate devices.

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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 features the department's emblem, which is a stylized depiction of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.

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

MAY 1 0 2012

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

Re: K112794

Trade/Device Name: EOS Small Bone Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC, JDR, HTY Dated: April 26, 2012 Received: April 27, 2012

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.

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

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Page 2 - Mr. Doug Steinberger

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for
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

K 112794 510(k) Number (if known):

Device Name: EOS Small Bone Fixation System

Indications For Use:

The components of the EOS Small Bone Fixation System are indicated for use in osteosynthesis, osteotomy, and arthrodesis of the following areas of the bodv:

Large Cannulated Compression Screws – bones in the foot

Cannulated Compression Screws – small bones in the hand and foot

AND/OR

Snap-Off Screws - small bones in the foot

Bone Plates - first metatarso-phalangeal joint

Staples & Pins - small bones in the hand and foot

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ambsl

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

510(k) Number K112794

Page 1 of __1

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.