. Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
. Fixation of proximal tibial metaphysis osteotomy.
. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
. Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extend to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

Device Description

The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixation devices intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomies.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Arthrex DynaNite Nitinol Staples." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the performance of an AI/ML powered device.

Therefore, the information required to answer your questions about acceptance criteria, study design for AI/ML performance, sample sizes, expert ground truth establishment, MRMC studies, and standalone algorithm performance is not present in the provided text. The document outlines performance testing related to the physical and material properties of the staples (e.g., pull-out strength, bend fatigue, biocompatibility, MRI compatibility), not the performance of a diagnostic AI.

Here's why each of your requested points cannot be addressed with the provided text:

A table of acceptance criteria and the reported device performance: The document states that testing was "conducted to demonstrate that the Arthrex DynaNite Nitinol Staples perform statistically equivalent to the devices cleared under K142292, K993714 and K172052." Specific numerical acceptance criteria and reported performance values beyond "statistically equivalent" are not provided. These are mechanical and material performance criteria, not related to AI.
Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing mechanical, chemical, and biocompatibility tests, not a dataset for an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is about correct diagnoses or classifications, which is not relevant to testing medical staples.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Pertains to expert consensus for AI ground truth.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a study design for evaluating the impact of AI on human reader performance, not relevant for a surgical staple.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. There is no algorithm mentioned.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device would be its physical properties meeting standards.
The sample size for the training set: Not applicable. There is no AI model mentioned.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) submission for a physical medical device (surgical staples), not an AI/ML software as a medical device. Therefore, the questions related to AI/ML device performance and study design are not addressed.

Summary

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December 16, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Arthrex Inc. Rebecca Homan Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K203180

Trade/Device Name: Arthrex DynaNite Nitinol Staples Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: October 26, 2020 Received: October 27, 2020

Dear Rebecca Homan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

Indications for Use

510(k) Number (if known)

K203180

Device Name Arthrex DynaNite Nitinol Staples

Indications for Use (Describe)

The Arthrex DynaNite Nitinol Staples are indicated for:

. Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
. Fixation of proximal tibial metaphysis osteotomy.
. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
. Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extend to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Date Prepared	October 20, 2020
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Rebecca R. HomanRegulatory Affairs Specialist1-239-643-5553, ext. 73429rebecca.homan@arthrex.com
Name of Device	Arthrex DynaNite Nitinol Staples
Common Name	Staple, Fixation, Bone
Product Code	JDR
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories
Regulatory Class	II
Predicate Device	K142292: BME, Inc. Speed, Speed Shift, Speed Titan, Speed Arc
Reference Device	K172052: Arthrex DynaNite Nitinol StapleK993714: BME, Inc. Memograph Staple System (OSStaple)
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain expandedindications for use for the Arthrex DynaNite Nitinol Staples.
Device Description	The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixationdevices intended to be permanently implanted. The implant is formed with twolegs connected by a bridge and is offered in multiple combinations of bridgewidths, leg lengths, and cross sections to accommodate various anatomies.
Indications for Use	The Arthrex DynaNite Nitinol Staples are indicated for:• Fracture and osteotomy fixation and joint arthrodesis of the hand andfoot.• Fixation of proximal tibial metaphysis osteotomy.• Hand and foot bone fragment and osteotomy fixation and jointarthrodesis.• Fixation of small bone fragments (i.e. small fragments of bone which arenot comminuted to the extend to preclude staple placement). Thesefragments may be located in long bones such as the femur, fibula andtibia in the lower extremities; the humerus, ulna or radius in the upperextremities; the clavicle and ribs; and in flat bone such as the pelvis,scapula and sternum.
Performance Data	Pull-out (ASTM F564), Static Four-Point Bend (ASTM F564), Four-Point BendFatigue (ASTM F564), Cyclic Potentiodynamic Polarization Corrosion (ASTMF2129) and Transformation Temperature (ASTM F2082/F2082M) testing wasconducted to demonstrate that the Arthrex DynaNite Nitinol Staples performstatistically equivalent to the devices cleared under K142292, K993714 andK172052.MRI force, torque, and image artifact testing were conducted in accordance withFDA guidance Testing and Labeling Medical Devices for Safety in the MagneticResonance (MR) Environment, ASTM F2052 Standard Test Method forMeasurement of Magnetically Induced Displacement Force on Medical Devices inthe Magnetic Resonance Environment, ASTM F2119 Standard Test Method forEvaluation of MR Image Artifacts from Passive Implants, ASTM F2182 StandardTest Method for Measurement of Measurement of Radio Frequency Induced
Heating Near Passive Implants During Magnetic Resonance Imaging and ASTMF2213 Standard Test Method for Measurement of Magnetically Induced Torqueon Medical Devices in the Magnetic Resonance Environment.
Bacterial Endotoxins Test (BET) was performed on the Arthrex DynaNite NitinolStaples utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMIST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. The testing conducteddemonstrates that the Arthrex DynaNite Nitinol Staples meet pyrogen limitspecifications.
Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity,Subchronic/Subacute Toxicity, Implantation and Material Characterization testingwas conducted on the Arthrex DynaNite Nitinol Staples in accordance with ISO10993-1:2018.
Assessment of physical product attributes including product, design, size, andmaterials as well as the conditions of manufacture and packaging has determinedthat the Arthrex DynaNite Nitinol Staples do not introduce additional risks orconcerns regarding sterilization and shelf-life.
ConclusionThe Arthrex DynaNite Nitinol Staples are substantially equivalent to the predicatedevices in which the basic design features and intended uses are the same. Anydifferences between the proposed device and the predicate devices areconsidered minor and do not raise different questions concerning safety oreffectiveness.
The submitted mechanical testing data demonstrates that the Pull-out, StaticFour-Point Bend, and Four-Point Bend Fatigue strength of the proposed device issubstantially equivalent to that of the predicate devices for the desiredindications.
Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate devices.

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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.