The Additive Orthopaedics Hammertoe Correction System is indicated for fixation of fractures, and fusion of small bones in the foot and hand; where such fragments are not under tension or load-bearing.

Device Description

The Additive Orthopaedics Hammertoe Correction System is a monoblock non-circular shaft implant that is cannulated and non-cannulated and incorporates barbs along its longitudinal axis. The system is provided with a drill designed for preparation of the implant site. The implant device, and the drill, are provided in a sterile procedure pack. The implant is intended for single use only and it is available in 0° and 10° configurations. The implant device is additively manufactured from medical grade titanium alloy (Ti-6A1-4V).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Additive Orthopaedics Hammertoe Correction System), not a study report or clinical trial. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria, especially for AI/ML-based devices.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing de novo performance criteria with specific acceptance thresholds for a novel device.

However, based on the provided text, I can infer and extract some relevant information:

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

The document does not specify quantitative acceptance criteria in a table format, nor does it report specific performance metrics with numerical values in relation to such criteria. Instead, it states that "Mechanical testing was performed as described in relevant recognized standards, including testing for pull-out force, static and dynamic flexion extension resistance." It then concludes, "From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device."

This implies that the acceptance criterion for substantial equivalence was that the device's mechanical performance, as measured by standard tests, was comparable to or better than predicate devices. The reported device performance is summarized as meeting this comparability standard, rather than providing specific numerical results.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not explicitly stated. The document refers to "mechanical testing," which typically involves a set number of physical samples, but the exact number isn't provided.
Data provenance: Not explicitly stated, but the testing would have been conducted on manufactured devices in a laboratory setting. This is not clinical data (retrospective or prospective from human patients) but rather engineering/mechanical test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable in this context. Mechanical testing of a bone fixation device does not involve human experts establishing ground truth in the same way an AI diagnostic tool would. The "ground truth" for mechanical testing is based on objective physical measurements according to established engineering standards.

4. Adjudication method for the test set:

Not applicable. There's no human interpretation or adjudication in the context of mechanical performance testing as 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 physical Hammertoe Correction System (implant), not an AI-assisted diagnostic or therapeutic tool for "human readers."

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For mechanical testing, the "ground truth" would be the objective physical measurements obtained during the tests (e.g., actual pull-out force values, flexion/extension resistance) against established engineering standards and comparative data from predicate devices. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

Not applicable. This is a physical device undergoing mechanical testing, not an AI/ML system requiring a training set.

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

Not applicable. This is a physical device, not an AI/ML system.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

June 1, 2016

Additive Orthopaedics, LLC Mr. Greg Kowalczyk President 83 Amelia Circle Little Silver, New Jersey 07739

Re: K160264

Trade/Device Name: Additive Orthopaedics Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: April 28, 2016 Received: May 2, 2016

Dear Mr. Kowalczyk:

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 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

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

510(k) Number (if known)

K160264

Device Name

Additive Orthopaedics Hammertoe Correction System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (Per 21 CFR 807.92)

General Company Information:	Additive Orthopaedics, LLC.Gregory KowalczykPresident83 Amelia CircleLittle Silver, NJ 07739Phone: (732) 882-6633greg@additiveortho.com
Date Prepared:	May 23, 2016
General Device Information
Proprietary Name:	Additive Orthopaedics Hammertoe Correction System
Classification:	Common Name: Smooth or threaded metallic bonefixation fastenerProduct code: HTY- Class IIClassification Name and Reference: 21 CFR 888.3040
Predicate Devices
Primary:
• Arthrex, Inc.	Arthrex Bio-Pin(Marketed as Arthrex Trim-It™ Spin Pin)[510(k) K050259]
Addional Predicates:
• MedShape, Inc.	Medshape FastForward(Marketed as MedShape Button)[510(k) K141420]
• Synchro Medical, Inc.	Synchro Medical(Marketed as ToeGrip)[510(k) K133477]

Description

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Intended Use (Indications)

(a) (6) Technological Characteristics Comparison

The Additive Orthopaedics Hammertoe Correction System and the legally marketed predicated devices have similar indications, dimensions, geometry and materials. The Additive Orthopaedics Hammertoe Correction System is technologically substantially equivalent to the predicate devices.

(b) (1) Substantial Equivalence- Non-Clinical Evidence

Mechanical testing was performed as described in relevant recognized standards, including testing for pull-out force, static and dynamic flexion extension resistance.

(b) (3) Substantial Equivalence

The Additive Orthopaedics Hammertoe Correction System possesses the same technologic characteristics of the predicate devices. These characteristics include the intended use, basic design, material, size and fundamental technology. The design characteristics of the subject system do not raise any new types of questions of safety and effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.