The system is used to stabilize and aid in the fusion of fractures and osteotomies of the distal radius.
The DRLock Distal Radius Volar System is indicated for the fixation of unstable distal radius fractures and osteotomies.

Device Description

The DRLock ™ Distal Radius Volar System (DRLock) is a series of metallic (stainless steel), implantable, bone fixation plates, pegs and screws. Its' intended use is to stabilize and aid in the fusion of fractures and osteotomies involving the distal radius.
The System includes four (4) fixation plates, twenty-five (25) screws and eleven (11) pegs. All screws and plates are made from type 316L Stainless Steel in conformance with ASTM F 138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Substantial equivalence to predicate devices	Finite Element Analysis in conjunction with mechanical testing confirms that the DRLock System is substantially equivalent to its' predicate devices.
Meets specified requirements for its intended use	Finite Element Analysis in conjunction with mechanical testing confirms that the DRLock System... meets specified requirements for its' intended use.
Stabilize and aid in the fusion of fractures and osteotomies of the distal radius	Implied performance based on the claim of substantial equivalence and meeting intended use requirements. The device's intended use is to stabilize and aid in the fusion of fractures and osteotomies involving the distal radius.
Material conformance to ASTM F 138	All screws and plates are made from type 316L Stainless Steel in conformance with ASTM F 138 Standard Speciation for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants.

2. Sample Sizes and Data Provenance

Test Set Sample Size: Not specified. The document refers to "mechanical testing" and "Finite Element Analysis" (FEA) but does not provide details on the number of physical samples tested or the specific parameters used in the FEA.
Data Provenance: Not specified. It's a premarket notification for a medical device submitted to the FDA in the USA, so the studies would presumably be conducted in the USA or under regulations compliant with FDA submissions. However, no specific geographic origin for the data is mentioned. The studies are described as "mechanical testing" and "Finite Element Analysis," which are typically laboratory-based and can be prospective in nature (new tests performed for the submission).

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Number of Experts: Not applicable. The "ground truth" for this type of device (metallic fixation appliances) is typically established through engineering standards, mechanical tests, and simulation rather than expert human interpretation of medical images or specimens.
Qualifications of Experts: Not applicable.

4. Adjudication Method (Test Set)

Adjudication Method: Not applicable. As the evaluation relies on objective mechanical and computational tests, there's no need for an adjudication method involving human experts.

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

MRMC Study Done?: No. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., radiologists reading images). This device is a surgical implant for fixation, and its performance is assessed mechanically and computationally.

6. Standalone Performance Study (Algorithm Only)

Standalone Study Done?: Yes, in a sense. The "Finite Element Analysis" is a computational simulation (algorithm only) that predicts the device's mechanical performance under specified loads without human intervention in the simulation process itself (though humans design the FEA). The "mechanical testing" is also a standalone evaluation of the device hardware.

7. Type of Ground Truth Used

Ground Truth Type:
- Engineering Standards: Conformance to ASTM F 138 for material.
- Mechanical Test Data: Results from physical tests (implied).
- Computational Modeling: Results from Finite Element Analysis (FEA).
- Predicate Device Performance: The "ground truth" for substantial equivalence is the established performance of the legally marketed predicate devices.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This document describes a medical device's mechanical and material performance, not an AI/ML algorithm that requires training data. Finite Element Analysis involves model creation and simulation, not "training" in the typical AI sense.

9. How Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable, as there is no training set in the AI/ML sense for this device. For the FEA, the "ground truth" for the model would be based on validated material properties, established engineering principles, and potentially prior empirical test data used to develop and validate the FEA models themselves.

Summary

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FEB 2 7 2006

510(k) Premarket Notification

DRLock™ Distal Radius Volar System

510(k) SUMMARY

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

OrthoHelix Surgical Designs, Inc. 1815 West Market Street Suite 205 Akron, Ohio 44313 Phone: (866) 904-3549 Fax: (352) 371-3932

Contact Person: Edward A. Kroll Representative Consultant for OrthoHelix Surgical Designs, Inc.

January 23, 2006 Date Prepared:

Name of Device

DRLock ™ Distal Radius Volar System

Common or Usual Name

Fixation Plates and Screws

Classification Name

Single/Multiple Component Metallic Fixation Appliances and Accessories

Predicate Devices

Hand Innovations Distal Volar Radius Fracture Repair System (K0022775) Synthes (USA) Stainless Steel Modular Hand System (K030310)

Intended Use

The system is used to stabilize and aid in the fusion of fractures and osteotomies of the distal radius.

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510(k) Premarket Notification

DRLock™ Distal Radius Volar System

Device Description

The System includes four (4) fixation plates, twenty-five (25) screws and eleven (11) pegs. All screws and plates are made from type 316L Stainless Steel in conformance with ASTM F 138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants.

Performance Data

Finite Element Analysis in conjunction with mechanical testing confirms that the DRLock System is substantially equivalent to its' predicate devices, and that it meets specified requirements for its' intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2006

Mr. Lee A. Strnad Senior Development Manager OrthoHelix Surgical Designs, Inc. 1815 West Market Street, Suite 205 Akron, Ohio 44313

K053182 Re:

K055162
Trade/Device Name: DRLock Distal Radius Volar System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS Dated: January 25, 2006 Received: January 26, 2006

Dear Mr. Strnad:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 9 rQxy press. In substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosure) to regions and ment date of the Medical Device Amendments, or to commerce provision way 20, 1976, the eccordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I bu may, incretore, market the device, books requirements for annual registration, listing of general controls provisions of the ling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 world). Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Couvencements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I DTT 3 issualled of a babbailer.
that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a deceminations administered by other Federal agencies. You must or any I catal suttates and regulations, including, but not limited to: registration and listing (21

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Page 2 - Mr. Lee A. Strnad

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set a CFR Part 807), labeling (21 CFR Part 800); good in and 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections over device as described in your Section 510(k) I his letter will anow you to ocgin manketing your arrivalence of your device to a legally premarket nothleation: "The PDF mailing of castination 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 IT you desire specific arrice ior J ow (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Compilance as (E++ Part 807.97). You may obtain Misolallang by relected to promantonionshibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Vicker Leen 40

for

Mark N. Melkerson, M.S. Acting 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

510(k) Number (if known): K053182

Device Name: DRLock™ Distal Radius Volar System

Indications for Use:

The DRLock Distal Radius Volar System is indicated for the fixation of unstable distal radius fractures and osteotomies.

Prescription Use 区 (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page | of |

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Image /page/4/Picture/14 description: The image shows a scatter plot with a concentration of points in the lower right corner. The density of points decreases as you move towards the upper left corner. The points appear to be randomly distributed, with no clear patterns or clusters visible other than the overall concentration in the lower right.

Regulation Number and Section

N/A