The Mini Variable System, when used with the Mini MaxLock Extreme® Plating System, is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.

The Mini Variable System, when used with the MaxLock Extreme® Distal Radius Plates and Screws, is intended for fractures and osteotomies of the distal radius in adult patients.

Device Description

The submission is a modification to the Mini MaxLock Extreme® Plating System and MaxLock Extreme® Distal Radius Plates and Screws to add Mini Variable components. No modifications were made to the existing plates or screws - this addition will be compatible with all plates in the current systems. The OrthoHelix Mini Variable construct consists of a polymer ring which mates with the locking holes in a plate and allows for a specially designed locking screw to be inserted at angles up to 15° in any direction while maintaining angular stability.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Mini Variable System:

This device (OrthoHelix Mini Variable System) is a physical medical device (fixation plates and screws), not an AI/software-based medical device. Therefore, the typical "acceptance criteria" and "study" questions related to AI performance metrics, expert adjudication, or training/test sets are not directly applicable in the way they would be for an AI algorithm.

Instead, the "acceptance criteria" for a physical device like this revolve around mechanical performance, biocompatibility, and substantial equivalence to legally marketed predicate devices. The "study" typically involves mechanical testing and comparisons.

I will interpret your questions in the context of a physical medical device submission, focusing on the information available for mechanical testing and substantial equivalence.

Analysis of Acceptance Criteria and Study for OrthoHelix Mini Variable System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Bending Strength	Supports substantial equivalence to predicate devices.
Torsional Strength	Supports substantial equivalence to predicate devices.
Indications for Use	Substantially equivalent to predicate devices.
Design	Substantially equivalent to predicate devices.
Materials	Substantially equivalent to predicate devices.

Explanation: The 510(k) summary explicitly states that "Calculations and mechanical testing comparing the bending and torsional strength of the subject and predicate devices were performed and the results support substantial equivalence." This implies that the acceptance criteria for these mechanical properties were that the Mini Variable System performed comparably to or better than the predicate devices, thereby demonstrating substantial equivalence. The document doesn't provide specific numerical thresholds or results, but rather a summary of the outcome relative to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample size for the mechanical testing (e.g., number of constructs tested, number of cycles). This is common for 510(k) summaries where detailed testing protocols and results might be in the full submission but not summarized in public-facing documents. For mechanical testing, sample sizes are often determined by ISO standards (e.g., ISO 17140 for bone plates) or internal company protocols, typically involving a small number of samples (e.g., 5-10 per test condition).
Data Provenance: The mechanical testing was conducted by OrthoHelix Surgical Designs, Inc. It is in vitro testing, not human-derived data.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

Not Applicable. For a physical medical device undergoing mechanical testing, there is no "ground truth" to be established by human experts in the way an AI algorithm's output would be validated. The ground truth lies in the physical laws governing material science and mechanics, measured objectively by testing equipment.
The "experts" involved would be the engineers and scientists who designed and conducted the mechanical tests, interpreting the raw data against established engineering principles and predicate device performance. Their qualifications would typically include degrees in biomedical engineering, mechanical engineering, or related fields.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used to establish a consensus ground truth for complex, subjective interpretations (e.g., medical image diagnosis). Mechanical test results are objective measurements (e.g., force, displacement, cycles to failure) that do not require such adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not applicable as this is a physical medical device. These studies are used for evaluating diagnostic or interpretive AI systems where human readers are involved.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Not Applicable. This device is a physical implant, not an algorithm. Its performance is inherent in its design and material properties, tested in vitro.

7. Type of Ground Truth Used

Objective Mechanical Measurements and Predicate Device Performance. The "ground truth" for this device's performance is established by:
- Direct measurements of bending strength and torsional strength.
- Comparison to the known, established performance of legally marketed predicate devices. The substantial equivalence claim is the ultimate "ground truth" for regulatory approval in this context.

8. Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in this context. The design of the device is based on engineering principles and knowledge gained from previous designs (which could be considered analogous to a "training" process in a very loose sense, but not for an algorithm).

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for a physical device, this question is not relevant. The "ground truth" in design and manufacturing relies on engineering specifications, material properties, and manufacturing quality control.

Summary

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K III 041 (II)

JUN - 6 2011

510(k) SUMMARY

Submitter Information

Submitter's Name: Address:

Telephone Number: Fax Number: Prepared By: Contact Person: Date Prepared:

Device Information

Trade Name:

Common Name:

Classification Name:

Device Classification:

Material Composition:

Device Description:

Intended Use:

Substantial Equivalence:

OrthoHelix Surgical Designs, Inc. 1065 Medina Rd, Suite 500 Medina, Ohio 44256 330-869-9562 330-247-1598 Brian Hockett, Liz Altenau Derek Lewis 4/12/11

Mini Variable System

Fixation Plates and Screws

Plate, Fixation, Bone

Single/multiple component metallic bone fixation appliances (Class II per 21 CFR 888.3030) Panel: Orthopedic, Product Code: HRS Smooth or threaded metallic bone fixation fastener (Class II per 21 CFR 888.3040) Panel: Orthopedic, Product Code: HWC

Titanium Alloy, PEEK

The Mini Variable System, when used with the MaxLock Extreme® Distal Radius Plates and Screws, is intended for fractures and osteotomies of the distal radius in adult patients.

The Mini Variable System is substantially equivalent to the OrthoHelix Mini MaxLock Extreme® Plating System Screws (K101962), the OrthoHelix MaxLock Extreme® Distal Radius Screws (K102156), The OrthoHelix MaxLock Extreme® System with Variable Angle Technology (K100618), and the Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System. Calculations and mechanical testing comparing the bending and torsional strength of the subject and predicate devices were 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/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized emblem featuring three curved lines that resemble an abstract representation of a human figure or a bird.

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

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

JUN - 6 2011

Re: K111041 Trade/Device Name: Mini Variable System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: May 20, 2011 Received: May 23, 2011

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 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 (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 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.

Einc Keith

Jor 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):

Device Name: Mini Variable System

Indications for Use:

The Mini Variable System, when used with the MaxLock Extreme® Distal Radius Plates and Screws, is intended for fractures and osteotomies of the distal radius in adult patients.

Prescription Use × 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)

Eric N. Keith

Page 1 of _1

Surgical, Orthopedic, and Restorative Devices

510(k) Number K111041

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.