MULTIDIRECTIONAL THREADED PEG by HAND INNOVATIONS, LLC.

The proposed Multidirectional Threaded Peg is manufactured from Cobalt Chromium (CoCr) and is available in 2.5 mm diameter and in a variety of lengths, ranging from 10 – 30 mm in 2 mm increments to accommodate varying patient anatomies and fracture morphologies.

AI/ML Overview

This submission describes a medical device, the Multidirectional Threaded Peg, which is a component of a bone fixation system. The FDA 510(k) summary provided indicates that this is a substantially equivalent device filing, meaning the device's performance is compared to an already legally marketed predicate device. Therefore, a comprehensive "study that proves the device meets the acceptance criteria" in the sense of a standalone clinical trial with acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy for an AI system) is generally not applicable for this type of submission.

Instead, the "acceptance criteria" and "study" for this type of device revolve around demonstrating substantial equivalence to the predicate device through pre-clinical testing, primarily mechanical testing, to ensure that the new device performs at least as well as the predicate for its intended use.

Here's the breakdown of the information requested, tailored to this device type and the provided documents:

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Material Biocompatibility	Meet requirements of ASTM F 1537-00 for Cobalt Chromium (CoCr) alloy.	The Multidirectional Threaded Peg is manufactured from CoCr alloy that meets the requirements of ASTM F 1537-00. This is considered an acceptable demonstration of biocompatibility, thus no further testing was deemed necessary.
Mechanical Performance	Demonstrate equivalent mechanical performance (e.g., strength, fatigue resistance, fixation stability) to the predicate device's threaded peg.	The equivalence was "confirmed through pre-clinical testing." Although specific numerical results or detailed test methods are not provided in this 510(k) summary, the FDA's clearance implies that these tests were conducted and the Multidirectional Threaded Peg's performance met the criteria for substantial equivalence to the predicate's threaded peg. (No specific quantitative performance metrics are given in the summary.)
Indications for Use	Maintain the same Indications for Use as the predicate device.	The Multidirectional Threaded Pegs have the same indications for use as the predicate device: "The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius."
Device Configuration	Available in 2.5 mm diameter and lengths ranging from 10–30 mm in 2 mm increments.	The device is available in 2.5 mm diameter and in a variety of lengths, ranging from 10–30 mm in 2 mm increments, matching the described specifications.

Regarding the other requested points (2-9), these are mostly relevant for diagnostic AI/software devices or clinical studies with human subjects, not for demonstrating substantial equivalence for a new mechanical implant component via pre-clinical testing as seen in this 510(k) summary.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for an implantable medical device undergoing pre-clinical mechanical testing for substantial equivalence. The "test set" would refer to physical prototypes or engineering samples.
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. Ground truth for mechanical testing is established by engineering standards, test methods, and quantitative measurements, not expert human assessment.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for pre-clinical mechanical testing.
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 or a diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant component, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the objective physical properties and performance measured against established ASTM standards and benchmarked against the predicate device's known performance.
The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical pre-clinical testing for substantial equivalence.
How the ground truth for the training set was established: Not applicable.

In summary, for this particular medical device (Multidirectional Threaded Peg), the "study" demonstrating its meeting of "acceptance criteria" is a series of pre-clinical mechanical tests (implicitly, as detailed test reports are not in the summary) comparing its performance to a legally marketed predicate device, ensuring substantial equivalence in material, design, and function for its stated indications for use. The acceptance criteria primarily centered on material compliance (ASTM F 1537-00) and comparable mechanical performance to the predicate device.

Summary

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K060864 Rge/1

510(k) Summary of Safety and Effectiveness
Name, Address andEstablishmentRegistration No.	The address and registration number of the manufacturer is as follows:Hand Innovations, LLC8905 SW 87 Avenue, Suite 220Miami, FL 33176-2227Establishment Registration No.: 9042874Tel.: (305) 270-6899Fax: (305) 412-8060
GeneralProvisions	The name of the device is:
	Proprietary Name	Common or Usual Name
	Multidirectional Threaded Peg	Plate Fixation Bone
Name ofPredicateDevices	The device is substantially equivalent to:Threaded Peg of the Distal Volar Radius Anatomical Plate System (510(k) # K050932 – April 26, 2005) – Hand Innovations, LLC.
Classification	Class II.
PerformanceStandards	Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
Indications forUse	The Multidirectional Threaded Pegs have the same indications for use as the predicate device:The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.
DeviceDescription	The proposed Multidirectional Threaded Peg is manufactured from Cobalt Chromium (CoCr) and is available in 2.5 mm diameter and in a variety of lengths, ranging from 10 – 30 mm in 2 mm increments to accommodate varying patient anatomies and fracture morphologies.
Biocompati-bility	The Proposed Multidirectional Threaded Peg do not require biocompatibility testing because the CoCr Alloy used in the fabrication meets the requirements of ASTM F 1537-00.
Summary ofSubstantialEquivalence	The proposed Multidirectional Threaded Peg is substantially equivalent to the predicate threaded peg of the Distal Volar Radius Anatomical Plate System. The equivalence was confirmed through pre-clinical testing.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2006

Hand Innovations c/o Ms. Natalie S. Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. 8905 SW 87th Avenue, Suite 220 Miami, Florida 33176

Re: K060864

Trade/Device Name: Multidirectional Threaded Peg Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: LXT Dated: April 24, 2006 Received: April 26, 2006

Dear Ms. Heck:

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 Codc 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 I'DA`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

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Page 2 - Ms. Natalie S. Heck

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 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Herbert Lemmer

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

Enclosure

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510(k) Number (if known): K060864

Device Name: Multidirectional Threaded Peg

Indications for Use Statement

The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V OR

Over-The-Counter Use

Helier Lescano

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

510(k) Number K060864

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.