The Arrowhead is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.

Device Description

The Arrowhead Fixation Device implant features a three dimensional arrow shape. The implants are available in multiple lengths and in 2 different angles. The implant is manufactured from stainless steel and is designed for single use only.

AI/ML Overview

The provided text describes a medical device called the "Arrowhead Fixation Device" and its 510(k) summary for premarket notification. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing rather than a clinical study with human patients, AI algorithms, or expert consensus on images. Therefore, many of the requested categories related to such studies will not be applicable.

Here's an analysis based on the provided information:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria (What was measured/compared to)	Reported Device Performance
Technological Characteristics	Similar to predicate devices: newdeal K-wire, Arthrex K-wire, Nexfix Compression Pin, BioPro DCS, PRO-TOE VO Hammertoe, and PRO TOE Endosorb Small Hammer Toe Pin.	The Arrowhead Fixation Device has similar technological characteristics to the predicate devices.
Mechanical Strength (Rotational Forces)	At least equivalent to the newdeal K-wire.	Testing confirmed that the Arrowhead Fixation Device is at least equivalent to the newdeal K-wire in rotational forces.
Mechanical Strength (Pull-out Testing)	At least equivalent to the newdeal K-wire.	Testing confirmed that the Arrowhead Fixation Device is at least equivalent to the newdeal K-wire in pull-out strength.
Mechanical Strength (Four-Point Bend Testing)	At least equivalent to the newdeal K-wire.	Testing confirmed that the Arrowhead Fixation Device is at least equivalent to the newdeal K-wire in four-point bending.
Indications for Use	Similar to legally marketed predicate devices.	The Arrowhead Fixation Device has similar indications for use: fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures (not for use in the spine).
Single Use Only	Device design for single use only.	The implant is manufactured from stainless steel and is designed for single use only. (This is a design specification, not a performance metric in the same way as mechanical testing, but it's an important characteristic mentioned.)

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a mechanical testing study. This study was performed to demonstrate that the Arrowhead Fixation Device is at least equivalent to the identified predicate devices in key mechanical properties.

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size (number of devices tested) for the mechanical tests (Rotational Forces Testing, Pull-out Testing, Four-Point Bend Testing).
- The data provenance is not explicitly stated as "country of origin," but the submission is from a U.S. company (Arrowhead Products LLC, Hampton, GA). The testing would have been conducted as part of the premarket submission process. This is a prospective set of tests conducted specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a mechanical testing study, not a study requiring expert clinical or image-based ground truth. The "ground truth" for mechanical testing is the physical load/force applied and the resulting deformation/failure, which is objectively measured by testing equipment. Comparative performance was against a predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus ground truth. This was a mechanical testing study.
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 document describes a medical implant (bone fixation device) and its premarket mechanical testing. It does not involve AI, image analysis, or human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document does not describe an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study was the objective mechanical performance of the predicate device (newdeal K-wire) under specific test conditions (Rotational Forces, Pull-out, Four-Point Bend). The Arrowhead Fixation Device's performance was then compared to this established baseline.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical equivalence testing for an implantable device. Training sets are relevant for machine learning algorithms.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, there's no ground truth for it.

Summary

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OCT 2 9 2010

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

ARROWHEAD FIXATION DEVICE - K100926

Submitted by:	Arrowhead Products LLC2593 Lake Erma DriveHampton, GA 30228
Date:	September 18, 2010
Contact Person:	Scott R. Roman, DPMPhone: (404) 583-0248Fax: (954) 333-2520Email: romandpm@comcast.net
Proprietary Name:	Arrowhead Fixation Device
Common Name	Intramedullary Bone Fastener
DeviceClassificationRegulation	21 CFR 888.3040 - Class II
Device ProductCode and Panel	HTY: Pin, Fixation, Smooth87 Orthopedics
Device Description	The Arrowhead Fixation Device implant features a three dimensionalarrow shape. The implants are available in multiple lengths and in 2different angles. The implant is manufactured from stainless steel and isdesigned for single use only.
Intended Use	The Arrowhead is indicated for fixation of osteotomies, arthrodeses andreconstruction in the lesser toes following corrective procedures. It is notintended for use in the spine.
Predicate Devices	newdeal, S.A. K-wire (K022599)Arthrex, Inc. K-wire (K052736)Nexa Orthopedics, Inc. Nexfix Compression Pin (K072710)BioPro Inc., DCS (K963433)Wright Medical Technologies, Inc. PRO-TOE VO Hammertoe (K101165)Merete Medical GMBH PRO TOE Endosorb Small Hammer Toe Pin(K100414)
TechnologicalCharacteristics	The Arrowhead Fixation Device has similar technological characteristicswhen compared to the predicate devices. In addition, substantialequivalence was shown through Rotational Forces Testing, Pull-outTesting and Four-Point Bend Testing. The testing confirmed that theArrowhead Fixation Device is at least equivalent to the newdeal K-wire.
SubstantialEquivalenceInformation	The Arrowhead Fixation Device is similar to legally marketed devicesincluding the newdeal K-wire, Arthrex K-wire, Nexfix Compression Pin,BioPro DCS, PRO-TOE VO Hammertoe, and the PRO TOE EndosorbSmall Hammer Toe Pin. The Arrowhead Fixation Device has similarindications for use and technological characteristics as these predicatesystems. While the Arrowhead Fixation System includes an arrow designat the ends of the device, mechanical testing confirmed that the device issubstantially equivalent to the newdeal K-wire. Therefore, the ArrowheadDevice System is determined to be substantially equivalent to thepredicate devices.

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ARROWHEAD FIXATION DEVICE - K100926

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings, and three curved lines below representing its talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Arrow Products. Inc. c/o Dr. Scott Roman Podiatrist 2593 Lake Erma Drive Hampton, Georgia 30228

OCT 2 9 2010

Re: K100926 .

Trade/Device Name: Arrowhead Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: HTY Dated: October 26, 2010 Received: October 27, 2010

Dear Dr. Roman:

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 such 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 - Dr. Scott Roman

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.

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/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,

Mulh N Mllkuss

Mark N. Meikerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K100926

Device Name: Arrowhead Fixation Device

Indications for Use:

The Arrowhead is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.

Prescription Use
(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)

Sonata for mxm

(Di Sion Sign O Division of Surgical, Offhopedic, and Restorative Devices

510(k) Number K100926

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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.