The TriMed X-Fix System is a unilateral external fixation device. It is intended to be used in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

Device Description

The X-Fix System is a unilateral external fixation device. It includes various size components to accommodate various anatomies and injuries. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use.

The X-Fix System is made of aluminum, black carbon composite and F-138 surgical grade stainless steel.

AI/ML Overview

This document describes the X-Fix System, a medical device, and its regulatory clearance. It does not contain information about acceptance criteria or a study proving its performance in the context of device performance metrics typically associated with AI/ML, clinical trials with statistical endpoints, or extensive testing against specific performance targets.

Instead, this document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "summary of safety and effectiveness" for this type of submission is primarily concerned with establishing that the new device is as safe and effective as a device already on the market, rather than proving performance against predefined quantitative metrics in a detailed study.

Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not Applicable / Not Provided. This document does not describe specific acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) for the X-Fix System itself, nor does it provide a report of such device performance. The "acceptance" here refers to regulatory acceptance by the FDA based on substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided. No "test set" in the context of performance evaluation (like in an AI/ML study or a clinical trial) is mentioned. The submission is based on a comparison to a predicate device, not on new performance data from a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable / Not Provided. No "ground truth" establishment by experts for a test set is discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided. No test set or adjudication method is described.

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 / Not Provided. This is a hardware medical device (external fixator). MRMC studies are typically relevant for diagnostic AI/ML devices where human readers interpret results. This type of study would not apply to the X-Fix System.

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

Not Applicable / Not Provided. The X-Fix System is not an algorithm.

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

Not Applicable / Not Provided. There is no mention of ground truth in the context of performance testing for this device.

8. The sample size for the training set

Not Applicable / Not Provided. No training set is mentioned as this is not an AI/ML device.

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

Not Applicable / Not Provided. No training set or ground truth establishment is mentioned.

Summary of what the document does provide regarding "acceptance" and "proof":

The document serves as a "Summary of Safety and Effectiveness" for a 510(k) submission to the FDA. The "proof" the device met "acceptance criteria" here is that the FDA determined it was substantially equivalent to a legally marketed predicate device.

Acceptance Criteria (Implicitly by FDA): The primary "acceptance criteria" for a 510(k) submission is demonstrating that the new device is as safe and effective as a predicate device already on the market, and does not raise new questions of safety or effectiveness. This is achieved by comparing indications for use, technological characteristics (design, materials), and performance (if applicable, through non-clinical or clinical data) to the predicate.
Study Proving Acceptance (Implicit): The "study" here is the comparison made by the submitter (TriMed, Inc.) and reviewed by the FDA.
- Device Compared To: Avanta Orthopaedics External Fixator (K974911/K981716).
- Basis of Equivalence: "The X-Fix is equivalent in dimensions, design and materials." (Section III. Substantial Equivalence).
- FDA Determination: The FDA reviewed the submission and found the device "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

In essence, the document serves as regulatory clearance, not a performance study report in the typical sense of testing against specific quantitative performance metrics.

Summary

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ummary of Safety and Effectiveness TRIMED X-FIX SYSTEM

SEP 1 5 2010

Submitted By:	TriMed, Inc.25864 Tournament Road, Ste. AValencia, CA 91355(800)633-7221
Registration #:	2031009
Prepared By/Contact Person:	Kelli AndersonPhone: (661)312-7150Fax: (661)254-8485
Proprietary Name:	X-Fix System
Classification:	Class II: Smooth or ThreadedMetallic Bone Fixation FastenerNDK - Section 888.3040

Summary Preparation Date:

September 13, 2010

I. Indications for Use:

II. Device Description:

The X-Fix System is made of aluminum, black carbon composite and F-138 surgical grade stainless steel.

III. Substantial Equivalence:

The TriMed X-Fix System has been compared to the Avanta Orthopaedics External Fixator (K974911/K981716). The X-Fix is equivalent in dimensions, design and materials.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized depiction of an eagle or bird, composed of three curved lines that suggest wings and a tail. The bird is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.

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

TriMed, Inc. % Ms. Kelli Anderson 25864 Tournament Road, Suite A Valencia, California 91355

SEP 1 5 2010

Re: K101375 Trade/Device Name: X-Fix System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: II Product Code: NDK Dated: August 11, 2010 Received: August 12, 2010

Dear Ms. Anderson

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 device-related adverse events) (21. CFR 803); good manufacturing practice requirements as set

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Page 2 – Ms. Kelli Anderson

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 enlitled, "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 vours.

Sincerely yours,

Mark A. Milliken

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 KIDI375

Device Name:___X-Fix

The TriMed X-Fix is a unilateral external fixation device. It is intended to be used in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

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)

Sonite
(Division Sign-Off) for nxn

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101375

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SEP 1 5 2010

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.