The Arthrex Compression Screws are a family of titanium, cannulated, compression screws that are offered in a diameter range of 5.0 to 7.0mm, length range of 20 to 140mm, in a fully threaded design.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrex Compression Screws, formatted as requested:

This document is a 510(k) premarket notification for Arthrex Compression Screws. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials with human readers or AI. Therefore, many of the requested fields related to AI performance, human reader studies, and large-scale ground truth establishment are not applicable.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Statistical equivalence to predicate device	Shear, push-out, torque, and compression testing demonstrated statistical equivalence to the predicate.
Meets pyrogen limit specifications	The device meets pyrogen limit specifications.
Substantial equivalence to predicate device	Determined to be substantially equivalent based on indications for use, technological characteristics, and data.

Study Details

Sample size used for the test set and the data provenance:
- The document mentions "Shear, push-out, torque, and compression testing" which are mechanical tests performed on the devices themselves, not tests involving human anatomical samples or patient data.
- The specific sample sizes for these mechanical tests are not provided in the summary.
- Data provenance is not applicable as it's not clinical data or images.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here refers to the performance of the predicate device for comparison in mechanical testing. Expert consensus related to diagnostic imaging or clinical outcomes is not involved.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as there's no clinical test set requiring adjudication.
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:
- No MRMC study was done. This is a medical device (bone fixation screw) and the submission is for its substantial equivalence, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for comparison was the performance characteristics of the legally marketed predicate device (K132217: Arthrex Compression FT Screws) as measured through mechanical testing. This is a benchmark against a predicate device's established mechanical properties.
The sample size for the training set:
- Not applicable. This is not a machine learning device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/2 description: The image shows a partial view of the Department of Health & Human Services (HHS) logo. The text "DEPARTMENT OF HEALTH & HUMAN" is visible, arranged in a circular fashion. To the right of the text, the HHS symbol, consisting of a stylized human figure, is also partially visible.

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

May 11, 2017

Arthrex Inc. Mr. David L. Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, FL 34108

Re: K170382

Trade/Device Name: Arthrex Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 11, 2017 Received: April 14, 2017

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

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related adverse events) (21 CFR 803); 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 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,

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) K170382

Device Name

Arthrex Compression Screws

Indications for Use (Describe)

The Arthrex Compression Screws are intended for fixation of fractures, osteotomies and arthrodesis in:

carpal, metacarpal and small hand bones .
. tarsal and metatarsals
. phalanges
. intra-articular fractures
. ankle
. proximal and distal humerus
. proximal and distal radius
. proximal and distal ulna
. osteochondral fixation and fractures
. osteochondritis dissecans
. fixation of fractures and osteotomies about the knee
. oblique fractures of the fibula
. reconstructive surgeries of the foot
malleolar fixation

where size of offered implant is patient appropriate.

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

Date Prepared	May 9, 2017
Submitter	Arthrex Inc.
	1370 Creekside Boulevard
	Naples, FL 34108-1945
Contact Person	David L Rogers
	Project Manager, Regulatory Affairs
	1-239-643-5553, ext. 71924
	david.rogers@arthrex.com
Name of Device	Arthrex Compression Screws
Common Name	Screw, fixation, bone
Product Code	HWC
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Regulatory Class	II
Primary Predicate Device	K132217: Arthrex Compression FT Screws
Reference Predicate Device	K123241: Arthrex Fracture Plates
Purpose of Submission	This Special 510(k) premarket notification is submitted to obtain clearance for aline extension to the Arthrex Compression Screw family cleared under K132217.
Device Description	The Arthrex Compression Screws are a family of titanium, cannulated,compression screws that are offered in a diameter range of 5.0 to 7.0mm, lengthrange of 20 to 140mm, in a fully threaded design.
Indications for Use	The Arthrex Compression Screws are intended for fixation of fractures,osteotomies and arthrodesis in:carpal, metacarpal and small hand bones tarsal and metatarsals phalanges intra-articular fractures ankle proximal and distal humerus proximal and distal radius proximal and distal ulna osteochondral fixation and fractures osteochondritis dissecans fixation of fractures and osteotomies about the knee oblique fractures of the fibula reconstructive surgeries of the foot malleolar fixation where size of offered implant is patient appropriate.
Performance Data	Shear, push-out, torque, and compression testing were conducted todemonstrate that the proposed compression screws perform statisticallyequivalent to the predicate.
	the device meets pyrogen limit specifications.
Conclusion	The Arthrex Compression Screws are substantially equivalent to the predicatedevice in which the basic design features and intended uses are the same. Anydifferences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness.
	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 device.

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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.