The Arthrex Low Profile Plate and Screw System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.

Device Description

The Arthrex Low Profile Plate and Screw System consists of plates and screws. The plate is an L-shaped plate with four holes for insertion of screws for fixation. The plate is available in opening and closing wedge design, in various lengths, in both left and right configurations. The Arthrex screw is a cortical, headed, self-tapping screw available in one diameter, in numerous length options.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This document is a 510(k) summary for a medical device (Arthrex Low Profile Plate and Screw System) seeking FDA clearance based on substantial equivalence to a predicate device.

Here's a breakdown of what is and is not in the document, in relation to your request:

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

Not present. The document does not define specific performance metrics or acceptance criteria for the device, nor does it report detailed performance results against such criteria. The clearance is based on substantial equivalence, implying similarity in fundamental features and intended use to an already cleared device, not necessarily on meeting new, explicit performance targets.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not present. There is no mention of a "test set" or any data used for performance evaluation in the context of a study. The 510(k) summary focuses on comparing the new device to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not present. This information would be relevant for clinical studies, which are not described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not present. Again, this pertains to clinical study design, which is not detailed here.

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 document is for a physical medical device (bone plates and screws), not an AI/software device. Therefore, MRMC studies or AI assistance metrics are irrelevant.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not present. No ground truth is mentioned as no performance study is detailed.

8. The sample size for the training set

Not present. This would be relevant for an AI/machine learning device, not a bone plate and screw system.

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

Not present. As above, not relevant for this type of device and no training set is mentioned.

Summary of Device and Approval Process:

The Arthrex Low Profile Plate and Screw System is a physical medical device intended for internal bone fixation in the ankle, foot, hand, and wrist. The approval granted in this 510(k) is based on the device being "substantially equivalent" to an already legally marketed predicate device (Arthrex Small Fragment Plates and Screws K040907). This means that the FDA determined that the new device has "basic features and intended uses [that] are the same" as the predicate, and any differences are "considered minor and do not raise questions concerning safety and effectiveness." The 510(k) process typically relies on comparisons to existing devices rather than extensive new clinical performance studies for demonstrating safety and effectiveness, especially for well-understood device types like bone fixation hardware.

Summary

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K052614

SEP 2 8 2005

VIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Arthrex Low Profile Plate and Screw System

NAME OF SPONSOR:	Arthrex, Inc.1370 Creekside BoulevardNaples, Florida 34108-1945
510(K) CONTACT:	Sally Foust, RACRegulatory Affairs Project ManagerTelephone: (239) 643-5553 extension 1251FAX: (239) 598-5539
TRADE NAME:	Arthrex Low Profile Plate and Screw System
COMMON NAME:	Plate, fixation, boneScrew, fixation, bone
CLASSIFICATION /PRODUCT CODE	21 CFR 888.3030 / HRSSingle/multiple component metallic bone fixationappliances and accessories21 CFR 888.3040 / HWCFastener, Fixation, Nondegradable, Soft TissueSmooth or threaded metallic bone fixationfastener
PREDICATE DEVICES:

PREDICATE D

Arthrex Small Fragment Plates and Screws K040907

DEVICE DESCRIPTION AND INTENDED USE:

SUBSTANTIAL EQUIVALENCE SUMMARY

The Arthrex Low Profile Plate and Screw System is substantially equivalent to the predicate device where basic features and intended uses are the same. Any differences between the Low Profile Plate and Screw System and the predicate device are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the Low Profile Plate and Screw System is substantially equivalent to the currently marketed predicate device.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

SEP 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sally Foust, RAC Regulatory Affairs Project Manager Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K052614 Trade/Device Name: Arthrex Low Profile Plate and Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: September 21, 2005 Received: September 23, 2005

Dear Ms. Foust:

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.

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 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.

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Page 2 - Ms. Sally Foust, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Millburn

Mark N. Melkerson Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE FORM III.

510(k) Number (if known):

Device Name: Arthrex Low Profile Plate and Screw System

Indications for Use:

Prescription Use __ × (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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ence of CDRH, Office of In Vitro Evaluation (

Mark A. Milliron

(Division Sign-Off) (Division Sign of General, Restorative, Divisiourological Devices

510(k) Number K052614

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.