Indications for Use: The FRS®-Screw is indicated for fixation of bone fractures, fusion of a joint, or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals, and carpals of the hand. Examples include: Hallux Valgus correction, Akin Osteotomies, MTP arthrodesis, Interphalangeal arthrodesis

Device Description

The DePuy FRS-Screw is a cannulated thread-head screw made of a Titanium alloy and is available in lengths of 10-34mm in 2mm increments.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device called the "FRS® Screw." This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity or specificity.

Therefore, many of the requested categories for a study proving device performance (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are not applicable to this type of regulatory submission.

The 510(k) summary primarily addresses:

Device Description: What the device is.
Intended Use and Indications: What the device is for.
Basis of Substantial Equivalence: How it is similar to already approved devices.

Here's how to address your request based on the provided text:

Acceptance Criteria and Device Performance Study Analysis

The provided document describes a 510(k) premarket notification for the FRS® Screw. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a previously legally marketed device (predicate device), not to prove performance against specific clinical acceptance criteria through a dedicated study with metrics like sensitivity, specificity, or reader improvement.

Therefore, the input document does not contain information on quantitative acceptance criteria for device performance (e.g., diagnostic accuracy metrics) nor a study designed to explicitly prove the device meets such criteria through a performance evaluation study. Instead, the "study" referred to in the context of a 510(k) is the demonstration of substantial equivalence based on similarities in intended use, indications for use, materials, and design, which relies on the predicate device's established safety and effectiveness.

Information from the Document:

Table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not specify quantitative performance acceptance criteria or report performance metrics like sensitivity, specificity, accuracy, etc. The "performance" demonstrated is that the device is substantially equivalent to predicate devices, implying similar safety and effectiveness.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No clinical "test set" or data directly evaluating the FRS® Screw's performance is described in this submission in the way you might find for a diagnostic or AI device. The demonstration of substantial equivalence is based on engineering principles, material properties, and comparison to existing devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of clinical performance evaluation often established by experts, is not relevant to this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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 is a bone fixation screw, not an AI-powered diagnostic device. An MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (bone screw), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable.
The sample size for the training set:
- Not Applicable. This device does not involve a "training set" in the context of AI or machine learning.
How the ground truth for the training set was established:
- Not Applicable.

Summary of Substantial Equivalence Basis:

The basis for the 510(k) clearance is substantial equivalence to predicate devices. This means the FRS® Screw is considered as safe and effective as the predicate devices because of the following similarities:

Intended Use: Fixation of bone fractures, fusion of a joint, or bone reconstructions.
Indications for Use: Specifically, for mid-foot bones, metatarsals, phalanges of the foot, phalanges, metacarpals, and carpals of the hand (e.g., Hallux Valgus correction, Akin Osteotomies, MTP arthrodesis, Interphalangeal arthrodesis).
Materials: Titanium alloy.
Design: Cannulated thread-head screw, available in specific lengths.

Predicate Devices Referenced:

DePuy SCARF THREAD-HEAD™ SCREW (K962236)
NewDeal SA BOLD® Screw (K011262)

The FDA reviewed this comparison and determined that the FRS® Screw is substantially equivalent to these devices, allowing it to be marketed.

Summary

{0}------------------------------------------------

Kα62352

510(k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93) OCT 1 9 2006

NAME OF SPONSOR:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46582Establishment Registration Number: 1818910
510(K) CONTACT:	Rebecca LennardRegulatory Affairs Associate IITelephone: (574) 372-5023Facsimile: (574) 371-4987Electronic Mail: RLennard@dpyus.jnj.com
DATE PREPARED:	May 24, 2006
PROPRIETARY NAME:	FRS® Screw
COMMON NAME:	Bone Fixation Screw
CLASSIFICATION:	Class II device per 21 CFR 888.3040: Smooth or threaded bone fixation fastener
DEVICE PRODUCT CODE:	87 HWC
SUBSTANTIALLY EQUIVALENTDEVICES:	DePuy SCARF THREAD-HEAD™ SCREW,K962236, cleared on September 20, 1996NewDeal SA BOLD® Screw,K011262, cleared on June 15, 2001
DEVICE DESCRIPTION:

DEVICE DESCRIPTION:

The DePuy FRS-Screw is a cannulated thread-head screw made of a Titanium alloy and is available in lengths of 10-34mm in 2mm increments.

INTENDED USE AND INDICATIONS:

Intended Use:

The DePuy FRS-Screw is intended to be implanted for the fixation of bone fractures, fusion of a joint or bone reconstructions.

Indications for Use:

The FRS®-Screw is indicated for fixation of bone fractures, fusion of a joint, or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals, and carpals of the hand. Examples include:

. Hallux Valgus correction
피 Akin Osteotomies

{1}------------------------------------------------

MTP arthrodesis
E Interphalangeal arthrodesis

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy FRS®-Screw devices described in this submission are substantially equivalent to the predicate devices based on similarities in intended use, indications for use, materials and design.

{2}------------------------------------------------

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 9 2006

DePuy Orthopaedics, Inc. % Ms. Rebecca Lennard 700 Orthopaedic Drive Warsaw. Indiana 46582

Re: K062352

Trade/Device Name: FRS® Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 10, 2006 Received: August 11, 2006

Dear Ms. Lennard:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ms. Rebecca Lennard

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/industry/support/index.html.

Sincerely vours.

$\mathbb{P}{k} \mathbb{P}{k}^{1/2}$

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

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510 (k) Number (if known):

FRS®-Screw Device Name:

Indications for Use:

Hallux Valgus correction 트
트 Akin Osteotomies
체 MTP arthrodesis
1 Interphalangeal arthrodesis

(Please do not write below this line - continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Over-The-Counter-Use:

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number LC(125)

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.