Intramedullary Hip Screws are indicated for intracapsular fractures of the femoral neck; trochanteric or subtrochanteric fractures; osteotomies for patients with diseases or deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures using a supracondylar plate; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; femoral neck fractures; subcapital fractures; comminuted neck and shaft fractures; femur reconstruction following tumor resection; leg length discrepancies secondary to femoral inequality; and prophylactic nailing of impending pathologic fractures. Asian Intramedullary Hip Screws and accessories are for single use only.

Device Description

Intramedullary Hip Screws and accessories provide an intramedullary approach to the management of fractures of the proximal femur. Devices include intramedullary nails with various diameters, lengths and neck shaft angles. The long nails are available in a right or left hand configuration. Each nail includes a 4 " medio-lateral bend to allow for greater trochanteric insertion. Each nail is used with a choice of specially designed sliding lag screws or subtrochanteric lag screws in various lengths. Additional accessories are available such as a centering sleeve, a set screw, a compression screw and nail caps.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Asian Intramedullary Hip Screw), not a study analyzing AI/algorithm performance. Therefore, most of the requested information regarding acceptance criteria, study design for AI, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this document.

Medical device clearance through the 510(k) pathway primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than generating acceptance criteria and performing extensive clinical performance studies as would be required for novel AI-powered diagnostics.

However, I can extract the relevant information regarding the device itself.

1. Acceptance Criteria and Reported Device Performance:

The concept of "acceptance criteria" in the context of this 510(k) submission relates to demonstrating substantial equivalence, not to performance metrics like sensitivity, specificity, or AUC as seen in AI studies. The reported "performance" here is based on a comparison to predicate devices.

Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance (as stated in the document)
Intended Use: Match predicate devices	Identical to predicate devices (K040656, K993289, K040212, K952697). Indicatd for: intracapsular fractures of the femoral neck, trochanteric or subtrochanteric fractures; osteotomies; hip arthrodesis; supracondylar fractures and distal femoral fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; femoral neck fractures; subcapital fractures; comminuted neck and shaft fractures; femur reconstruction following tumor resection; leg length discrepancies; prophylactic nailing.
Technological Characteristics: Similar principle of operation, performance specifications, and method of operation to predicate devices.	"The principle of operation of the subject devices is identical to that of the predicates. There are no changes in intended use, performance specifications or method of operation."
Biomechanical/Mechanical Performance: Capable of withstanding expected in vivo loading without failure (implied equivalence to predicates).	"A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure." (Details of the "test data" are not provided in this summary.)
Material Composition: Similar to predicate devices.	"Substantial equivalence... is based on its similarities in indications for use, design features, operational principles, and material composition when compared to the predicate devices." (Specific materials are not detailed in this summary.)

The following points are Not Applicable (N/A) to this 510(k) submission, as it is for a physical medical device and not an AI or algorithmic diagnostic/decision support system:

Sample size used for the test set and the data provenance: N/A (No test set of data in the context of AI performance for this device)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth established by experts in the context of AI performance for this device)
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A
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: N/A
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A
The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A
The sample size for the training set: N/A
How the ground truth for the training set was established: N/A

Summary

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FEB 11 2005		510(k) Summary of Safety and EffectivenessAsian Intramedullary Hip Screw Nails	K 050226
Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date:	January 31, 2005
Contact Person:	David HenleySenior Regulatory Affairs Specialist
Proprietary Name:	Asian Intramedullary Hip Screw Nails
Common Name:	Intramedullary Hip Screw Nails and Accessories
Classification Name and Reference:	21 CFR 888.3030 - Single/multiple component metallicbone fixation appliances and accessories, Class II
Device Product Code and Panel Code:	KTT and HWC / Orthopaedics / 87

Device Description:

ray

Intended Use:

Smith & Nephew, Inc. Asian Intramedullary Hip Screws are indicated for intracapsular fractures of the femoral neck, trochanteric or subtrochanteric fractures; osteotomies for patients with directures on deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures using a supracondylar plate; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; femoral neck fractures; subcapital fractures; comminuted neck and shaft fractures; femur reconstruction following; tumor resection; leg length discrepancies secondary to femoral inequality; and prophylactic nailing of impending pathologic fractures. Asian Intramedullary Hip Screws and accessories are for single use only.

Technological Characteristics:

The principle of operation of the subject devices is identical to that of the predicates. There are no changes in intended use, performance specifications or method of operation. A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure.

Substantial Equivalence Information:

Substantial equivalence for the Asian Intramedullary Hip Screw is based on its similarities in indications for use, design features, operational principles, and material composition when compared to the predicate devices cleared under the following submissions: K040656, Smith & Nephew In the production K993289, Smith & Nephew Trauma Internal Fixation System; K040212, TriGen Internation System; and K952697, Ti Classic Compression Hip Screw.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The logo is black and white.

FEB 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Henley Senior Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K050226

Trade/Device Name: Asian Intramedullary Hip Screw Regulation Number: 21 CFR 888.3030,21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, KTT Dated: January 31, 2005 Received: February 1, 2005

Dear Mr. Henley:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimeres prior to 110) 2011 11:15 accordance with the provisions of the Federal Food, Drug, de Moos mat have t (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Per (110) market the device, subject to the general controls provisions of the Act. The r ou mayy aross 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to back additions, 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 r lease oe actived that I Dr unation that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 - Mr. David Henley

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 yours,

sincerely yours,

Mark A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Asian Intramedullary Hip Screw

Indications for Use:

Asian Intramedullary Hip Screws and accessories are for single use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ and/or (Per 21 CFR 801, 109)

Over-the-Counter Use (Optional Format 1-2-96)

(Please do not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

C. Mark N. Mulhausen

al. Restorative, and Neurological Devices

510(k) Number K05022

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.