The MaxLock Extreme System is indicated for the following:
• The MaxLock Extreme 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 MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
• The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
• The MaxLock Extreme 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 allov or PEEK.

AI/ML Overview

The provided text describes the 510(k) summary for the MaxLock Extreme™ System, a medical device consisting of plates and screws for bone fixation. The submission focuses on establishing substantial equivalence to a previously cleared device (K123203).

Based on the provided information, no clinical study or performance data demonstrating specific acceptance criteria with reported device performance is available for an AI/ML powered device. The submission relies on non-clinical testing for substantial equivalence.

Here's an analysis of the provided text in relation to your questions, highlighting why most are not applicable in this context:

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

Not Applicable. The submission for the MaxLock Extreme™ System is for a physical medical device (plates and screws) and primarily relies on demonstrating substantial equivalence to a predicate device through non-clinical means. It does not involve an AI/ML component with associated acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc.
The text states: "Finite element analysis was performed on the subject device to determine the worst case Benchtop mechanical testing comparing the strength of the implant. subject and predicate devices was performed and the results support substantial equivalence." This refers to mechanical performance, not AI/ML performance.

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. As there are no AI/ML performance studies described, there is no "test set" of data in the context of an AI/ML model for this submission. The "test set" would refer to the mechanical testing described above, but the size and provenance of that data (e.g., number of implants tested, where the testing was performed) are not specified.

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. No ground truth establishment by human experts for an AI/ML model's performance is mentioned or relevant to this submission. Mechanical testing does not typically involve expert "ground truth" in this manner.

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

Not Applicable. There is no AI/ML performance study with a test set requiring 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

Not Applicable. This is a physical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.

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

Not Applicable. There is no algorithm or software component for standalone performance.

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

Not Applicable. For the mechanical testing mentioned, the "ground truth" would be the measured physical properties and performance against engineering standards or predicate device performance, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not Applicable. No AI/ML model is being trained.

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

Not Applicable. No AI/ML model is being trained.

Summary of what is described (non-AI/ML):

The submission for the MaxLock Extreme™ System is a 510(k) premarket notification for a physical medical device. The primary method for proving substantial equivalence to the predicate device (K123203) involves:

Finite element analysis: Used to determine the "worst case" strength of the implant.
Benchtop mechanical testing: Performed to compare the strength of the subject device to the predicate device.

The premise for substantial equivalence is based on "similarities in indications, design, and materials." This is a typical approach for non-AI/ML device submissions where physical and material properties are key.

Summary

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Submitter's Name: OrthoHelix Surgical Designs, Inc. 1065 Medina Rd, Suite 500 Address: Medina, Ohio 44256 Telephone Number: 330-869-0562 Fax Number: 330-247-1598 Andy Leither, Simon Sjovold Prepared By: Contact Person: Derek Lewis Date Prepared: 8/15/13 Device Information MaxLock Extreme™ System Trade Name: Common Name: Plates/Screws Classification Name: Plate, Fixation, Bone and Screw, Fixation, Bone Device Classification: Single/multiple component metallic bone fixation appliances (Class II per 21 CFR 888.3030 and 888.3040) Panel: Orthopedic, Product Code: HRS/HWC Predicate Device: The MaxLock Extreme™ System is equivalent to K123203. Material Composition: Titanium Alloy, PEEK The MaxLock Extreme™ System consists of various size plates and screws Device Description: 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 allov or PEEK.

The MaxLock Extreme™ System plates and screws are indicated for the following:

· The MaxLock Extreme™ 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 MaxLock Extreme™ Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
· The MaxLock Extreme™ Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
· The MaxLock Extreme™ Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

Submitter Information

Indications for Use:

510(k) SUMMARY

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Substantial Equivalence:

など

The new MaxLock Extreme™ System is substantially equivalent to the existing OrthoHelix MaxLock Extreme™ System (K123203). Finite element analysis was performed on the subject device to determine the worst case Benchtop mechanical testing comparing the strength of the implant. subject and predicate devices was performed and the results support substantial equivalence. Due to similarities in indications, design, and materials, no other testing was required. No new issues of safety and effectiveness have been raised.

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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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

Public Health Service

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

September 17, 2013

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

Re: K132591

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: August 8, 2013 Received: August 19, 2013

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

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Page 2 - Mr. Derek Lewis

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,

Laurence D. Coyne -S

for 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): K132591

Device Name: MaxLock Extreme™ System

Indications for Use:

The MaxLock Extreme System is indicated for the following:

· The MaxLock Extreme 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 MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle. • The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.

• The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

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)

Elizabeth L. Frank -S

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.