The MaxTorque™ Cannulated Screw System is indicated for use in long and small bone fracture fixation, which includes but not limited to the following:

Fractures of the tarsals and metatarsals .
. Fractures of the olecranon, distal humerus
Fractures of the radius and ulna .
Patellar fractures .
Distal tibia and pilon fractures .
. Fractures of the fibula, medial malleolus, or calcis
Tarso-metatarsal and metatarsal-phalangeal Arthrodesis .
Metatarsal and Phalangeal osteotomies t
Osteochondritis dissecans .
Ligament fixation .
Other small fragment, cancellous bone fractures and osteotomies .

Device Description

This special 510(K) submission is a line extension to address modifications to the MaxTorque Cannulated Screw System. This line extension is to add smaller sizes to the system. The additional sizes are - ø 2.5mm, ø 3.0mm, ø 3.2mm diameter cannulated screws in various lengths. Washers for the ø 3.0mm screws, as well as guide wires and various orthopedic surgical instruments will also be added to the system.

The instruments classified as Class I devices under 21 CFR Parts 888.4300 and 888.4540 (Depth gage for clinical use and Orthopedic manual surgical instruments respectively) are exempt from premarket notification requirements.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the MaxTorque Cannulated Screw System line extension. This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than presenting a detailed study with acceptance criteria and device performance results as typically found in clinical trial reports or engineering verification and validation studies.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in the provided text.

Based on the available information, here's what can be extracted and what cannot:

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

Not Available: The document does not specify quantitative acceptance criteria or detailed performance results in the format of a table. The entire submission is built around demonstrating "substantial equivalence" to existing predicate devices (MaxTorque Cannulated Screw System K060428, Asnis Cannulated Screw System K000080, and K071092) based on design, intended use, performance, and operational principle. This implies that the performance is considered acceptable if it is comparable to these already approved devices, but specific numerical targets are not outlined.

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

Not Available: The document does not describe a "test set" in the context of a performance study with a defined sample size. The FDA's 510(k) process for this type of device relies heavily on comparison to predicate devices, and often involves mechanical testing to ensure new sizes meet certain strength/durability standards, but these details are not provided here.

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 Available: This type of information is relevant for studies involving diagnostic or prognostic devices where expert interpretation establishes ground truth. For a cannulated screw system, "ground truth" would typically relate to mechanical properties (e.g., strength, fatigue) or successful surgical outcomes, not expert consensus on image interpretation. The document does not describe any such expert panel for a "test set" ground truth.

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

Not Applicable/Not Available: Similar to point 3, adjudication methods like 2+1 are used in studies involving subjective assessments, often in diagnostic imaging. This is not relevant to the information provided about a bone fixation device.

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: An MRMC study is relevant to diagnostic interpretation by human readers. This device is a surgical implant for bone fixation and does not involve human "readers" or AI assistance in the way a diagnostic tool would.

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

Not Applicable: This question is pertinent to AI/algorithm-driven devices. The MaxTorque Cannulated Screw System is a physical surgical implant, not an algorithm.

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

Implied Mechanical/Biocompatibility/Clinical Equivalence: While not explicitly stated with details, for surgical implants new "ground truth" would typically involve:
- Mechanical Testing: Demonstrating the new, smaller screws retain appropriate strength, torque, and fatigue properties comparable to the predicate devices and industry standards.
- Material Equivalence: Confirmation that the materials (e.g., titanium alloy) are biocompatible and unchanged from the predicate.
- Clinical Performance Equivalence: The primary "ground truth" from a regulatory perspective for a 510(k) is that the device is "substantially equivalent" in safety and effectiveness to legally marketed predicate devices, meaning it performs similarly in clinical use. The document states this equivalence is based on "indications, intended use, and design."

8. The sample size for the training set

Not Applicable/Not Available: This question refers to training data for AI/machine learning models. This device is a physical implant. The concept of a "training set" is not relevant here.

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

Not Applicable/Not Available: As above, this is not relevant to the described device.

In summary, the provided document is a 510(k) summary for a medical device line extension. Its primary purpose is to demonstrate substantial equivalence to existing devices for regulatory clearance, rather than to detail a comprehensive performance study with specific acceptance criteria, statistical evidence, and ground truth methodologies as might be found in a clinical trial report for a novel medical technology or an AI-powered diagnostic tool.

Summary

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KURAST4 1/2

DEC 0 8 2008

510(K) Summary of Safety and Effectiveness MaxTorque Cannulated Screw System Line Extension

Class II

Cannulated Screws

Proprietary Name:

MaxTorque™ Mini Cannulated Screw System

Common Name:

Classification Name and Reference:

888.3040 - Smooth or threaded metallic bone fixation fastener

Regulatory Class:

Device Product Code:

HWC - Smooth or threaded metallic bone fixation fastener

Contact Information:

Derek Lewis Director of Engineering OrthoHelix Surgical Designs Inc. 1815 W Market Street, 205 Akron, OH 44313 Phone: 330 869-9562 Fax: 330 869-9583 E-Mail: DLewis@orthohelix.com

Summary Date:

December 5, 2008

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Device Description

Intended Use

The MaxTorque™ Cannulated Screw System is intended for fracture fixation of small and long bones.

Indications

The MaxTorque™ Cannulated Screw System is indicated for use in long and small bone fracture fixation, which includes but not limited to the following:

Fractures of the tarsals and metatarsals .
. Fractures of the olecranon, distal humerus
Fractures of the radius and ulna .
Patellar fractures .
Distal tibia and pilon fractures .
. Fractures of the fibula, medial malleolus, or calcis
Tarso-metatarsal and metatarsal-phalangeal Arthrodesis .
Metatarsal and Phalangeal osteotomies t
Osteochondritis dissecans .
Ligament fixation .
Other small fragment, cancellous bone fractures and osteotomies .

Substantial Equivalence

The MaxTorque Mini Cannulated Screw System is substantially equivalent to commercially marketed predicate devices with respect to design, intended use, performance and operational principle as internal fixation components. Predicate systems considered are the MaxTorque Cannulated Screw System (K060428) and Asnis Cannulated Screw System (K000080, and K071092).

The subject MaxTorque™ Mini Cannulated Screws are a modification to the MaxTorque Cannulated Screw System cleared in K060428. Substantial equivalence for the MaxTorque™ Mini Cannulated Screws is based on indications, intended use, and design to the previously cleared CSS Cannulated Screw System.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, with three overlapping lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OrthoHelix Surgical Designs. Inc. % Mr. Derek Lewis 1815 West Market Street, Suite 205 Akron, Ohio 44313

DEC 0 8 2008

Re: K082574

Trade/Device Name: MaxTorque Mini Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 4, 2008 Received: November 10, 2008

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,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 - Mr. Derek Lewis

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Mulkinson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(K) Number (if known): K082574

Device Name: MaxTorque™ Cannulated Screw System

Indications for Use: The MaxTorque™ Cannulated Screw System is indicated for use in long and small bone fracture fixation, which includes the following:

Fractures of the tarsals and metatarsals .
Fractures of the olecranon, distal humerus
Fractures of the radius and ulna
Patellar fractures
Distal tibia and pilon fractures
Fractures of the fibula, medial malleolus, or calcis
Tarso-metatarsal and metatarsal-phalangeal Arthrodesis
Metatarsal and Phalangeal osteotomies
Osteochondritis dissecans
Ligament fixation
Other small fragment, cancellous bone fractures and osteotomies

Prescription Use X OR Over-the-Counter Use (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restora. and Neurological Devices

K082517
510(k) Number

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.