The Distal Radius Locking Plating System consists of plates designed for various fracture modes of the radius. The system is used with locking screws, locking pegs, locking threaded pegs and cortical screws. Each device is manufactured from titanium alloy (Ti-6Al-V4 ELI - ASTM F 136-02a) and can be supplied color anodized or notanodized. The Distal Radius Locking Plating System will be provided non-sterile for steam sterilization by health care professionals prior to use.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, though it's important to note that this document is an FDA 510(k) clearance letter and not a detailed study report. Therefore, much of the requested information regarding study specifics and performance metrics for a device with an algorithm will not be present as this is a medical device (bone plating system), not an AI/software device.

Acceptance Criteria and Device Performance

This document is for a Distal Radius Locking Plating System, a physical medical device. It does not involve AI or algorithms for diagnosis or analysis. Therefore, traditional "acceptance criteria" related to algorithm performance (e.g., sensitivity, specificity, AUC) and a "device performance" table in that context are not applicable.

The "acceptance criteria" for this type of device typically revolve around demonstrating substantial equivalence to predicate devices in terms of intended use, materials, design, and performance through mechanical testing (e.g., fatigue, static strength, torsional strength). The FDA's acceptance is based on the submission demonstrating that the device is as safe and effective as the predicate devices.

Table of Acceptance Criteria and Reported Device Performance (as inferred for a mechanical device):

Acceptance Criteria Category (Inferred)	Reported Device Performance (Inferred from Substantial Equivalence Determination)
Intended Use Equivalence	Intended for fixation of intra/extra-articular fractures and distal radius osteotomy, similar to predicate devices.
Material Equivalence	Manufactured from titanium alloy (Ti-6Al-V4 ELI - ASTM F 136-02a), a widely accepted and used material in predicate devices.
Design Equivalence	Consists of plates, locking screws, locking pegs, locking threaded pegs, and cortical screws, similar to predicate device systems.
Biocompatibility	Implied to meet biocompatibility standards through material choice and comparison to predicate devices.
Sterilization	Provided non-sterile for steam sterilization by healthcare professionals, a common practice for similar predicate devices.
Mechanical Performance (e.g., Strength, Fatigue)	Implied to have undergone testing to demonstrate equivalent mechanical performance as predicate devices, but specific results are not provided in this summary.
Labeling	Complies with FDA labeling requirements for similar devices.

Study Details (Not applicable for this type of device and document)

Since this is a physical implantable device (a bone plating system) and not an AI/software diagnostic tool, the following questions are not directly applicable to the provided 510(k) summary. The FDA clearance is based on a demonstration of substantial equivalence to already cleared predicate devices, primarily through engineering testing and material characterization, not clinical studies with "test sets" or "ground truth" as described for AI.

Therefore, for questions 2 through 9, the answer is largely "Not applicable" or "Information not available in this 510(k) summary."

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

See table above. This is inferred from the nature of a 510(k) submission for a mechanical device. Specific numerical performance data (e.g., fatigue cycles, static load limits) are not included in this high-level summary but would have been part of the full 510(k) submission.

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

Not applicable. This summary does not describe a clinical study or a "test set" in the context of an algorithm or diagnostic performance. Mechanical testing would involve a sample size of devices, but 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. No ground truth establishment for a diagnostic test set is detailed.

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

Not applicable. No test set or adjudication method is described.

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 device is a mechanical implant; it does not involve human readers or AI assistance in diagnostic interpretation.

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

Not applicable. This device is not an algorithm.

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

Not applicable. Ground truth for diagnostic purposes is not relevant for this device. For mechanical devices, "ground truth" is established by engineering standards and accepted mechanical testing (e.g., ASTM standards for material properties and device performance).

8. The sample size for the training set

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

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

Not applicable. No training set or ground truth for it.

In summary: The provided document is for the FDA 510(k) clearance of a physical medical device (bone plating system) and therefore does not contain the kind of information typically associated with AI/software device performance studies, test sets, or ground truth establishment. The clearance is based on demonstrating substantial equivalence to predicate devices through design, materials, intended use, and mechanical performance (though specific mechanical results are not included in this summary).

Summary

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K061917 (pg. 1 of 2)

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SUMMARY OF SAFETY AND EFFECTIVENESS

A. Submitter's Name and adress

AUG 2 8 2006

NEWCLIP TECHNICS Z.A du Pâtis Rue de la fontaine grillée F-44 690 La Haye-Fouassiere France Telephone : (33) 2 28 21 37 12 Fax : (33) 2 40 63 68 37

Summary preparation date: February 15, 2011

B. Official Correspondent

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 Tele/Fax - 512-388-0199 Email - ortho.medix@sbcglobal.net

C. Establishment registration number : 3007143290

D. Device name

Distal Radius Locking Plating System

E. Device Classification Name

Plate, fixation, bone (21 CFR 888.3030) Screw, fixation, bone (21 CFR 888.3040)

F. Proposed regulatory Class

Class II

G. Device Product Code

HRS HWC

H. Panel Code

Orthopedic

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K061917 (pg. 2 of 2)

I. Device Description

The Distal Radius Locking Plating System will be provided non-sterile for steam sterilization by health care professionals prior to use.

J. Intended use:

The Distal Radius Locking Plating System is intended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy.

K. Predicate device:

Volar Radius Plate System of HAND INNOVATIONS (K030198) ●
Synthes Locking Distal Radius Plating System of SYNTHES (K012114) ●
Ace Humerus and Radius Plates of ACE MEDICAL COMPANY (K955472) ●

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR - 4 2011

NewClip Technics % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K061917

Trade/Device Name: Radius Locking Plating 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: June 29, 2006 Received: July 6, 2006

Dear Mr. Webb:

This letter corrects our substantially equivalent letter of August 28, 2006. 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 (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.

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Page 2 - Mr. J.D. Webb

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Atiz vs. nh
for

Mark N. Melkerson Director Division of Surgical, Restorative and Orthopedic Devices Center for Devices and Radiological Health

Enclosure

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Indications for Use

K061917

510(k) Number (if known):

Device Name: Radius Locking Plating System

Indications for Use:

The Distal Radius Locking Plating System is intended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy.

Prescription Use AND/OR Part 21 CFR 801 Subpart D) 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)

Page 1 of

for Mark Mellemson

(Divisio annedic.

Erie Insurance Group

510(k) Number K061917

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.