The Arthrex PIP Dart is intended to fix small bony or apical chondral fragments in the foot, ankle, upper extremities, hand, and wrist, where such fragments are not under tension or load-bearing. These devices are used in cases of osteochondritis dissecans and osteochondral fragments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The devices can be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of digital deformities of the foot or hand. This device is also used in inherently stable long bone fractures such as the femur, fibula, tibia, radius and ulna, including the diaphyseal, epiphyseal, and metaphyseal areas.

Device Description

The Arthrex PIP Dart is an implant with a barbed design that is inserted between the proximal and middle- phalanges so the barbs fixate on the phalangeal canal of the toe. The PIP Darts are made of PEEK OPTIMA, offered in straight and 10 degree variations, and range from 2.5mm to 3.0mm in diameter and 25mm to 30mm in length.

AI/ML Overview

The document provided is a 510(k) summary for a medical device called the "Arthrex PIP Dart." This type of submission is for demonstrating "substantial equivalence" to a predicate device, not for proving a new level of clinical efficacy or diagnostic performance through extensive clinical studies. Therefore, much of the information typically found in acceptance criteria and study designs for AI/diagnostic devices will not be present.

Based on the provided text, here's what can be extracted:

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

The document focuses on demonstrating substantial equivalence to a predicate device (Arthrex Bio-Pin and others not explicitly named but implied by the comparison wording) rather than setting specific performance acceptance criteria against a defined clinical outcome. The primary "performance" evaluated here is mechanical strength to show it's equivalent to existing devices.

Acceptance Criteria (Implied)	Reported Device Performance
No significant difference in mechanical strength compared to predicate devices (for shear and pull-out properties).	"The shear testing and pull-out testing data submitted demonstrates that there is no significant difference in mechanical strength between the Arthrex PIP Dart and the predicate."

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

The document mentions "shear testing and pull-out testing data" but does not specify the sample size for these tests (e.g., number of darts tested) or the provenance of the data (e.g., in-house lab, external lab, country). These would typically be detailed in the full 510(k) submission, but are summarized here.

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

This is not applicable as the "ground truth" for this type of device comparison is based on mechanical testing results (quantitative measurements of shear and pull-out forces), not expert interpretation of clinical data or images.

4. Adjudication method for the test set

Not applicable for mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. This device is an implantable pin, and the evaluation focuses on its physical and mechanical properties, not its diagnostic or interpretative performance.

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

This is not applicable as the Arthrex PIP Dart is a physical medical device (an implantable pin), not an algorithm or a diagnostic tool that would have standalone performance.

7. The type of ground truth used

The "ground truth" in this context is the measured mechanical properties (shear strength and pull-out force) of the device and its predicate, obtained through validated laboratory testing methods.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical implant. The testing is for validation of the device's physical properties.

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

Not applicable. As above, there is no training set. The "ground truth" for the mechanical performance comparison was established through standardized mechanical tests conducted in a laboratory environment.

Summary

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JUL 1 8 2014

2.6 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Date Summary Prepared	June 11, 2014
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	David L RogersRegulatory Affairs AssociateArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71924Fax: 239/598.5508Email: david.rogers@Arthrex.com
Trade Name	Arthrex PIP Dart
Common Name	Pin
Product Code -Classification Name	HTY - Pin, Fixation, Smooth
CFR	21 CFR 888.3040: Smooth or threaded metallic bonefixation fastener
Predicate Device	K050259: Arthrex Bio-Pin
Purpose of Submission	This special 510(k) premarket notification is submitted toobtain FDA clearance for the Arthrex PIP Dart.
Device Description	The Arthrex PIP Dart is an implant with a barbed designthat is inserted between the proximal and middle-phalanges so the barbs fixate on the phalangeal canal ofthe toe.The PIP Darts are made of PEEK OPTIMA,offered in straight and 10 degree variations, and rangefrom 2.5mm to 3.0mm in diameter and 25mm to 30mmin length.
Intended Use	The Arthrex PIP Dart is intended to fix small bony orapical chondral fragments in the foot, ankle, upperextremities, hand, and wrist, where such fragments arenot under tension or load-bearing. These devices areused in cases of osteochondritis dissecans andosteochondral fragments, fixation of fractures, 1stmetatarsal (bunionectomy osteotomies), cuneiformbones, inherently stable osteotomies, and fusions of thephalanges, metatarsals, metacarpals, carpal bones, tarsalbones, ankle, and wrist. The devices can be used for
	inherently stable intramedullary stabilization of jointarthroplasty (resection) or fusion for the treatment ofdigital deformities of the foot or hand. This device is alsoused in inherently stable long bone fractures such as thefemur, fibula, tibia, radius and ulna, including thediaphyseal, epiphyseal, and metaphyseal areas.
Substantial Equivalence Summary	The Arthrex PIP Dart is substantially equivalent to thepredicate devices in which the basic design features andintended uses are the same. Any differences betweenthe Arthrex PIP Dart and the predicate are consideredminor and do not raise questions concerning safety andeffectiveness.
	The shear testing and pull-out testing data submitteddemonstrates that there is no significant difference inmechanical strength between the Arthrex PIP Dart andthe predicate.
	Based on the indications for use, technologicalcharacteristics, and the summary of data submitted,Arthrex, Inc. has determined that the Arthrex PIP Dart issubstantially equivalent to the predicates.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

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

July 18, 2014

Arthrex, Inc. Mr. David L. Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K141577

Trade/Device Name: Arthrex PIP Dart Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: June 27, 2014 Received: July 3, 2014

Dear Mr. Rogers:

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

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Page 2 - Mr. David L. Rogers

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" (21 CFR 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, Lori A. Wigqins

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K141577 page 1 of 1

INDICATIONS FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-01 Expiration Date: December 31, 201 See PRA Statement on last page

510(k) Number (if known) K141577

Device Name

Arthrex PIP Dart

Indications for Use (Describe)

The Arthrex PIP Dart is intended to fix small bony or apical chondral fragments in the foot, ankle, upper extremities, hand, and wrist, where such fragments are not under tension or lood-bearing. These devices are used in coses of osteochondritis dissecans and asteochondral frogments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The devices con be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of the foot or hand. This device is also used in inherently stable long bone froctures such as the femur, fibulo, tibia, radius ond ulno, including the diaphyseal, epiphyseal, and metaphyseal areas.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabethill@Frank -

Division of Orthopedic Devices

FORM FDA 3881 (9/13)

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.