The Universal Distal Radius System consists of a range of plates and screws for distal radius surgery. Each device is manufactured from titanium and can be color anodized. The Universal Distal Radius System will be provided non-sterile for steam sterilization by health care professional's prior use, or provided sterile by gamma sterilization.

AI/ML Overview

The provided 510(k) summary for the Universal Distal Radius System (K130774) describes a medical device, not an AI/ML powered device, therefore the information requested is not directly applicable.

However, I can extract information related to the device's performance based on the provided text, focusing on the non-clinical testing performed to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Equivalence to predicate devices in:	Met, through comparative compression and flexion testing. The device is "substantially equivalent to the predicate devices in terms of indications for use, design, material, and function."
- Compression strength	Demonstrated equivalence to predicate devices.
- Flexion strength	Demonstrated equivalence to predicate devices.

Explanation of "Implied" Acceptance Criteria:

For a 510(k) submission, especially for a Special 510(k) indicating minor changes from a predicate, the "acceptance criteria" are typically demonstrating substantial equivalence to the legally marketed predicate devices. This means showing that the new device performs at least as well as, and not worse than, the predicate devices in relevant performance metrics. Here, mechanical testing (compression and flexion) was used to demonstrate this.

Regarding the other requested information (focused on AI/ML studies):

Since the Universal Distal Radius System is a physical medical device (plates and screws for fracture fixation) and not an AI/ML powered device, the following points are not applicable and no information is provided in the document for them:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No clinical or data-driven test set mentioned.
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 human expert assessment for ground truth mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication process described.
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 not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth, in the context of AI/ML, is not relevant here.
The sample size for the training set: Not applicable. No training set for an AI/ML model is mentioned.
How the ground truth for the training set was established: Not applicable. No training set for an AI/ML model is mentioned.

Summary of the Study performed (Non-clinical):

The study performed was a non-clinical comparative mechanical testing study.

Test Performed: Comparative compression and flexion tests on plates.
Purpose: To demonstrate that the Universal Distal Radius System is substantially equivalent to predicate devices in terms of mechanical safety and performance.
Outcome: The tests supported the conclusion of substantial equivalence to predicate devices in terms of design, material, and function.
Clinical Studies: "No clinical studies were performed." (Section 8)

Summary

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K130774

JUN 1 9 2013

510 (k) Summary for Universal Distal Radius System 4.

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Universal Distal Radius System.

Summary preparation date: February 11, 2013

1. Submitter:

Contact Person:

NEWCLIP TECHNICS P.A. de la Lande Saint Martin 45 rue des Garottières F-44115 Haute-Goulaine - France Telephone: (33) 2 28 21 37 12

J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199

Trade name:

Class:

Product code:

Common Name:

Classification Name:

Universal Distal Radius System

HRS/HWC

Plates for distal radius Screws for distal radius

Plate, Fixation, Bone (21 CFR part. 888.3030) Screw, Fixation, Bone (21 CFR part. 888.3040)

Predicate or legally marketed devices which are substantially equivalent: 3.

The Distal Radius Locking Plating System of Newclip Technics (K061917). .
The Clavicle Locking Plating System of Newclip Technics (K100944). .
Synthes Locking Distal Radius Plating System (K102694). .
Acumed Congruent Bone Plate System (K102998). .
Medartis AGAPTUS® 2.0 Radial Head System (K090053).

Section 4 Page 1 of 3

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K130774

4. Description of the device:

Titanium alloy Ti-6A1-4V ELI (conform to ASTM F 136-02a and/or ISO 5832-3).

The implants of Universal Distal Radius System are indicated for fixation of intra and extra-articular fractures as well as distal radius osteotomy.

This Special 510(k) is submitted in order to gain clearance for plates that are substantially equivalent to the predicate and additional screws.

5. Substantial equivalence claimed to predicate devices:

The Universal Distal Radius System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.

6. Intended use:

The Universal Distal Radius System is intended for fixation of intra and extraarticular fractures as well as distal radius osteotomy

Section 4 Page 2 of 3

.
.

Materials:

Function:

Change from Predicate:

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K130774

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7. Non-clinical Test Summary:

The following tests were conducted:

Comparative compression and flexion test on plates. .

Non-clinical Test Summary:

No clinical studies were performed.

9. Conclusions Nonclinical and Clinical:

The Universal Distal Radius System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

Section 4 Page 3 of 3

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three overlapping wings, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 19, 2013

NEWCLIP TECHNICS

% The OrthoMedix Group, Incorporated Mr. J.D. Webb Official Correspondent 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K130774

Trade/Device Name: Universal Distal Radius 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: May 22, 2013 Received: May 24, 2013

Dear Mr. Webb:

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. J.D. Webb

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/Resourcesfor You/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/ReportalProblem/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.

For

Sincerely yours,

Erin DKeith

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 3.

510(k) Number (if known): K130774

Device Name: Universal Distal Radius System

Indications for Use:

The Universal Distal Radius System is intended for the fixation of intra and extraarticular fractures as well as distal radius osteotomy. -

Prescription Use _ X 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

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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.