The Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
The Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
The Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
The Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

Device Description

The MaxLock Extreme® System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy or PEEK

AI/ML Overview

The provided text describes a 510(k) summary for the MaxLock Extreme® System, which is a bone fixation device (plates/screws). This type of medical device submission (510(k)) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information requested about acceptance criteria, test sets, ground truth establishment, expert adjudication, and MRMC studies, which are typical for AI/ML device evaluations, are not applicable to this submission.

The "study" conducted for this device to prove it meets acceptance criteria (i.e., substantial equivalence) largely relied on mechanical testing, finite element analysis, and mathematical analyses, comparing its performance to predicate devices.

Here's an breakdown based on the provided document:

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

The document doesn't provide a specific table of quantitative acceptance criteria and reported device performance in the same way an AI/ML study would (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" for a 510(k) in this context are primarily qualitative, focusing on whether the new device can be demonstrated to be "substantially equivalent" to predicate devices without raising new issues of safety and effectiveness.

The "performance" demonstration is stated as:

Performance: "Substantial equivalence was demonstrated with mechanical testing, finite element analysis and mathematical analyses."
Result: "No new issues of safety and effectiveness have been raised."

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

Sample Size: Not applicable in the context of clinical "test sets" for performance metrics like sensitivity/specificity. The "samples" used would be physical device prototypes for mechanical testing and computational models for finite element analysis. The document does not specify the number of prototypes tested.
Data Provenance: Not applicable for a non-clinical submission like this. The "data" comes from engineering tests and analyses, not patient data.

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. Ground truth as understood in AI/ML (e.g., disease presence confirmed by experts) is not relevant here. The "truth" is established by engineering principles and comparison to known performance of predicate devices.

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

Not applicable. There is no human reading or adjudication of a test set in this context.

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:

No. This is not an AI-assisted device. MRMC studies are not relevant to demonstrating substantial equivalence for a mechanical medical device like this.

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

Not applicable. This is not an algorithmic device. The "standalone" performance relates to the mechanical integrity and function of the physical plates and screws themselves, which was assessed via mechanical testing and FEA.

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

The "ground truth" for this device's performance is based on established engineering standards for bone fixation devices and the known performance and safety profiles of the predicate devices. It relies on the physical properties and mechanical behavior of the materials and designs, validated through testing, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable.

Summary of the "Proof" for this Device:

The "proof" that the MaxLock Extreme® System meets its "acceptance criteria" (which in this context means "is substantially equivalent and introduces no new safety/effectiveness issues") is entirely based on:

Mechanical Testing: Physical tests to assess strength, fatigue, and other biomechanical properties.
Finite Element Analysis (FEA): Computational simulations to predict mechanical behavior under various loads.
Mathematical Analyses: Calculations to support design choices and material properties.
Comparison to Predicate Devices: Demonstrating that the results of the above analyses and tests are comparable to or better than those of previously cleared, legally marketed predicate devices (MaxLock Extreme® System previous versions, Biomet Forerunner System, OrthoHelix Calcaneal Trauma System, Biomet/E.B.I. OptiLock Periarticular Plating System).

The 510(k) process for a Class II mechanical device like this does not typically involve clinical data or the detailed AI/ML study design questions you've posed.

Summary

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JAN 3 0 2012

ﺔ ﺍﻟﺘ t

K 11 30 48

510(k) SUMMARY

Submitter Information

Submitter's Name:	OrthoHelix Surgical Designs, Inc.
Address:	1065 Medina Rd, Suite 500Medina, Ohio 44256
Telephone Number:	330-869-9562
Fax Number:	330-247-1598
Prepared By:	Rebecca DiLiberto
Contact Person:	Derek Lewis
Date Prepared:	1/19/12
Device Information
Trade Name:	MaxLock Extreme® System
Common Name:	Plates/Screws
Classification Name:	Plate, Fixation, Bone and Screw, Fixation, Bone
Device Classification:	Single/multiple component metallic bone fixation appliances (Class IIper 21 CFR 888.3030 and 888.3040)Panel: Orthopedic, Product Code: HRS/HWC
Predicate Device:	The MaxLock, Extreme® System is equivalent to current legallymarketed devices.
Material Composition:	Titanium Alloy, PEEK
Device Description:	The MaxLock Extreme® System consists of various size plates andscrews used to stabilize and aid in the fusion or repair of fracturedbones and bone fragments. The plates are offered in different lengthsand sizes. The screws are offered in different diameters and lengths.All implantable components are manufactured from implant gradetitanium alloy or PEEK
Indications for Use:	The MaxLock Extreme® System is indicated for the following:The Universal Module is indicated for use in adult or pediatricpatients as indicated for pelvic, small and long bone fracturefixation and fixation of bones that have been surgically prepared(osteotomy) for correction of deformity or arthrodesis. Indicationsfor use include internal fixation of the tibia, fibula, femur,humerus, ulna, radius, and bones in the hand, wrist, foot andankle.The Clavicle Module is indicated for fractures, fusions andosteotomies of the clavicle and bones in the hand, wrist, foot andankle.The Foot Module is indicated for fractures, fusions andosteotomies of bones in the hand, wrist, foot and ankle inpediatric and adult patients.The Distal Radius Module is indicated for fractures andosteotomies of the distal radius in adult patients.

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Substantial Equivalence:

The MaxLock Extreme® System is substantially equivalent to previous versions of the MaxLock Extreme® System released under K-numbers: K07362, K090289, K093900, K100618, and K102156 as well as the Biomet Forerunner System (K092528), the OrthoHelix Calcaneal Trauma System (K061400) and the Biomet/E.B.I. OptiLock Periarticular Plating System (K061098). Substantial equivalence was demonstrated with mechanical testing, finite element analysis and mathematical analyses. No new issues of safety and effectiveness have been raised.

Page 2/2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

OrthoHelix Surgical Designs, Incorporated % Mr. Derek Lewis Vice President of Research and Development 1065 Medina Road, Suite 500 Medina. Ohio 44256

JAN 3 0 2012

Re: K113048

Trade/Device Name: Maxlock Extreme™ System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: January 3, 2012 Received: January 4, 2012

Dear Mr. Lewis:

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 - Mr. Derek Lewis

forth in 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 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 Peter DV
N. Meller Der CC

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

4113.049 510(k) Number (if known):

Device Name: MaxLock Extreme® System

Indications for Use:

The MaxLock Extreme System is indicated for the following:

The Universal Module is indicated for use in adult or pediatric patients as indicated for o pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
The Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and o bones in the hand, wrist, foot and ankle.
The Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, O wrist, foot and ankle in pediatric and adult patients.
The Distal Radius Module is indicated for fractures and osteotomies of the distal radius in o adult patients.

Prescription Use X

AND/OR

Over-The-Counter-Use_

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deale
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

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(113048 510(k) Number

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.