The M-Fix™ Acromioclavicular Device is intended to provide fixation during the healing process following syndesmotic trauma such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

Device Description

The M-Fix™ Acromioclavicular Device (M-Fix™) is a suture band system designed to provide reduction and stabilization of the acromioclavicular joint following syndesmotic disruptions. The M-Fix is a polyethylene terephthalate (PET) band that may be tensioned and secured with the integrated, low-profile Connector/Button which is made of titanium or stainless steel.

The one-time use band with connector is provided sterile. Additional accessory instruments, including a Counter Traction Tool and a Punch Tool for securing the Connector/Button are single use devices provided sterile for use during the orthopedic procedure.

AI/ML Overview

This document describes a medical device called the M-Fix™ Acromioclavicular Device, which is a suture band system intended to provide fixation during the healing process following syndesmotic trauma such as acromioclavicular separations. The document is an FDA 510(k) premarket notification summary.

Based on the provided text, the device described is a physical medical device, not a software device or an AI/ML powered device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria based on metrics like sensitivity, specificity, F1-score, sample sizes for training/test sets, ground truth establishment methods, expert qualifications, and MRMC studies, are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering performance tests for a physical medical device to demonstrate substantial equivalence to predicate devices, rather than clinical performance or diagnostic accuracy.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criteria	Reported Device Performance
Ultimate Tensile Testing	The M-Fix™ device must demonstrate mechanical strength and integrity comparable to, or better than, the predicate devices (Arthrex TightRope™, Surgicraft Lockdown™, Dallen Medical Tensyn™ Band) for its intended use in fixing acromioclavicular separations. Specific quantitative values are not provided in this summary but are implied to be established through engineering comparisons.	"Ultimate Tensile and Cyclic Tests were performed." The outcome indicated "the M-Fix™ Acromioclavicular Device is substantially equivalent to the predicate devices." Specific numerical results are not detailed in this summary.
Cyclic Testing	The M-Fix™ device must maintain its structural integrity and functional performance over repeated loads, simulating the physiological stresses the device would experience post-implantation. This demonstrates durability and resistance to fatigue. Specific quantitative values are not provided, but comparison to predicate devices is key.	"Ultimate Tensile and Cyclic Tests were performed." The outcome indicated "the M-Fix™ Acromioclavicular Device is substantially equivalent to the predicate devices." Specific numerical results are not detailed in this summary.

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

Sample Size: Not specified in the provided text. The phrase "bench studies" typically refers to in-vitro testing where multiple samples of the device are tested.
Data Provenance: The studies are "bench studies," meaning they were conducted in a laboratory setting. This is not clinical data, so country of origin or retrospective/prospective is not applicable.

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):

This question is not applicable as the device is a physical medical device and the studies performed are mechanical bench tests, not involving expert interpretation or clinical ground truth.

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

This question is not applicable as the device is a physical medical device and the studies performed are mechanical bench tests, not involving human adjudication of clinical outcomes or images.

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:

This question is not applicable as the device is a physical medical device, not an AI/ML diagnostic or assistive tool.

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

This question is not applicable as the device is a physical medical device, not an algorithm.

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

The "ground truth" for these bench tests is the established mechanical properties of the predicate devices and general engineering standards for material strength and fatigue life. It is not clinical "ground truth" derived from patient data.

8. The sample size for the training set:

This question is not applicable as the device is a physical medical device and there is no "training set" in the context of an AI/ML algorithm.

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

This question is not applicable for the same reason as point 8.

Summary

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

February 2, 2016

Coracoid Solutions, Inc. % Michael Kolber Consultant, Regulatory Affairs Michael Kolber 337 Ester Ave Campbell, California 94025

Re: K153211 Trade/Device Name: M-Fix Acromioclavicular Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: November 4, 2015 Received: November 5, 2015

Dear Michael Kolber:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 -S

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

Enclosure

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Indications for Use

510(k) Number (if known): _K153211

Device Name: Coracoid Solutions, M-Fix™ Acromioclavicular Device

Indications for Use: The M-Fix™ Acromioclavicular Device is intended to provide fixation during the healing process following syndesmotic trauma such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/1 description: The image contains the logo for Coracoid Solutions. The logo consists of two intertwined letter C's, one in blue and one in green. To the right of the logo is the company name, "CORACOID" in blue, with "SOLUTIONS" underneath it, also in blue.

510(k) Summary (per 21CFR807.92)

General Company Information
Name:	Coracoid Solutions, LLC
Contact:	Michael KolberRegulatory Affairs
Address:	15 Normans WayPark City, UT 84060
Telephone:	408-505-6626
Fax:	408-608-0338
Date Prepared:	November 4, 2015
General Device Information
Product Name:	M-FixTM Acromioclavicular Device
Common Name:	Button/Suture
Classification Name:	Washer, Bolt Nut
Regulation Number:	21CFR888.3030, Single/multiple component metallic bonefixation appliances and accessories
Device Class:	Class II
Product Code:	HTN
Predicate Devices
Manufacturer	Device Name	510(k) Number
Arthrex, Inc.	TightRopeTM Acromioclavicular (AC) Device	K052776
Surgicraft, Ltd.	LockdownTM Acromioclavicular (AC) Device	K091207
Dallen Medical, Inc.	TensynTM Band	K131850
Description

Intended Use (Indications)

The M-Fix Acromioclavicular Device is intended to provide fixation during the healing process following syndesmotic trauma such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

Substantial Equivalence

This submission supports the position that the Coracoid Solutions M-Fix is substantially equivalent to the Arthrex TightRope™ Acromioclavicular (AC) Device (K052776), the

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Image /page/4/Picture/1 description: The image shows the logo for Coracoid Solutions. The logo consists of two intertwined letter C's, one in blue and one in green, with the green C appearing to be in front of the blue C. To the right of the intertwined C's is the text "CORACOID" in blue, with the text "SOLUTIONS" in blue below it. The logo is simple and modern, and the use of blue and green gives it a clean and professional look.

Surgicraft Lockdown™ Acromioclavicular (AC) Device (K091207), and the Dallen Medical Tensyn™ Band (K131850). The M-Fix™ has the following similarities to the previously cleared predicate devices: the same or similar intended use, same operating principle, similar technologies, and similar manufacturing process. Design verification activities were performed as a result of the risk analysis. The 510(k) notice contains summaries of bench studies, which were conducted to evaluate the performance characteristics of the M-Fix™ . Ultimate Tensile and Cyclic Tests were performed. The information presented demonstrates that the M-Fix™ Acromioclavicular Device is substantially equivalent to the predicate devices.

Conclusions

Coracoid Solutions, LLC believes that the information provided demonstrates that the proposed device is substantially equivalent to the predicate devices and does not raise any new issues of safety or efficacy. Based on the indications for use, technological characteristics, and comparison to predicate devices, the M-Fix has been shown to be substantially equivalent to predicate devices as described under the Federal Food, Drug and Cosmetic Act.

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.