The Trauma Internal Fixation System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in adult and pediatric patients are as follows:

Adult indications:

Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head).
Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
Osteotomics for patients with discases or deformities of the hip.
Hip arthrodesis.
Supracondylar fractures and distal femoral fractures using a supracondylar plate.
Ipsilateral femoral shaft/neck fractures (IMHS only).

Pediatric indications:

Congenital coxa vara.
Congenital dislocation of the hip.
Subluxation or dislocation secondary to neurologic disorders such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities.
Coxa plana (Legg-Calve-Perthes disease) for containment of the head completely within the acetabulum.

Device Description

The Compression Hip Screw is composed of a plate, lag screw, compression screw,and bone screws. The Intramedullary Hip Screw is composed of a intramedullary nail, lag screw, compression hip screw, centering sleeve, set screw and bone screws. In addition, there are Compression Hip Screw Barrel Plates, Supracondylar Barrel Plates, Blade Plates, Condylar Blade Plates, Intramedullary Hip Screws, Lag Screws and Compression Hip Screws. There are various accessory items used with the Compression Hip Screw System, such as: Set Screws, Nail Caps, Centering Sleeves, Self-Tapping Bone Screw, Lag Screw Clips, Bone Bolts, and Bone Screws.

The above devices and accessories are made from cither Stainless Steel (ASTM F-138. ISO 5832/1) or Titanium (Ti-6A1-4V) alloy (ASTM F-1472, ISO 5832-3). Nail caps are made from ultra high density molecular weight polyethylene (ASTM F-648).

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria. Instead, it is a 510(k) premarket notification for a medical device (Trauma Internal Fixation System).

Here's what the document does include, and why it doesn't fit the requested criteria:

Substantial Equivalence: The primary purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and technological characteristics as the predicate, or if there are differences, those differences do not raise new questions of safety or effectiveness.
Predicate Devices: The document lists numerous predicate devices (14 in total) and states that the "safety and effectiveness of the Trauma Internal Fixation System is based on the long history of use of these devices in the market place."
Device Description: It details the components and materials of the Trauma Internal Fixation System.
Indications for Use: It outlines the specific adult and pediatric conditions for which the device is intended.

Therefore, I cannot provide the requested table or study details because the document explicitly states that the safety and effectiveness are based on the substantial equivalence to existing devices, not on a new study with acceptance criteria.

The document does not contain the following information:

A table of acceptance criteria and reported device performance.
Sample size used for a test set, data provenance, or study type (retrospective/prospective).
Number of experts, their qualifications, or adjudication methods for ground truth.
Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
Details of a standalone (algorithm only) performance study.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for a training set.
How ground truth for a training set was established.

This is a common approach for certain medical devices where a new device is very similar to existing ones, and extensive new clinical trials with specific performance metrics are not always required for market clearance via the 510(k) pathway.

Summary

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Summary of Safety and Effectiveness Smith & Nephew, Inc. Trauma Internal Fixation System

Substantial Equivalent Information

The Trauma Internal Fixation System is similar to the following trauma systems:

1. IMHS Hip Screw Systems Smith & Nephew
1. Titanium Classic Compression Hip Screw System Smith & Nephew
1. Osteotomy/ Blade Plates Smith & Nephew
1. Medoff Sliding Plate Wright Medical Technology
1. Biomet Compression Hip Screw System Biomet Medical Products
1. Vari-Angle Hip System Biomet
1. ACE Cannulated Hip Screw System ACE
1. Alta Modular Trauma System Howmedica
1. NoLok/Keyed Compression Hip Screw System DePuy
1. Frec-Lock Femoral Fixation System Zimmer
1. Dynamic Hip/Condylar Screw System Synthes
1. Synthes Femoral Nail System
1. Howmedica Gamma Locking Nail System
1. Angled/Condylar/Osteotomy Blade Plates Synthes

All of the devices listed above are indicated for the same use as compression hip screw systems, and arc similar in design to the Trauma Internal Fixation System. The safety and effectiveness of the Trauma Internal Fixation System is based on the long history of use of these devices in the market place.

Device Description

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Summary of Safety and Effectiveness Smith & Nephew, Inc. Trauma Internal Fixation System Page 2

Indications for Use

The Trauma Internal Fixation System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in adult and pediative patients are as follows:

Adult indications:

1. Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head).
1. Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
1. Osteotomics for patients with discases or deformities of the hip.
1. Hip arthrodesis.
1. Supracondylar fractures and distal femoral fractures using a supracondylar plate.
1. Ipsilateral femoral shaft/neck fractures (IMHS only).

Pediatric indications:

1. Congenital coxa vara.
1. Congenital dislocation of the hip.
1. Subluxation or dislocation secondary to neurologic disorders such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgusanteversion deformities.
1. Coxa plana (Legg-Calve-Perthes disease) for containment of the head completely within the acetabulum.

Technological Characteristics:

Trauma Internal Fixation System are similar to the predicate devices listed above in material, design, function, and use, and have similar technological characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three abstract, wavy lines that are stacked vertically. The lines are thicker at the top and taper towards the bottom, creating a sense of movement or flow.

Public Health Service

DEC 2 0 1999

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janet Johnson Green Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K993289

Trade Name: Trauma Internal Fixation System Regulatory Class: II Product Codes: KTT Dated: October 1, 1999 Received: October 1, 1999

Dear Ms. Green:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have undersections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Janet Johnson Green

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/edrh/dsma/dsmamain.html".

Sincerely yours,

Nat K. Kyler

James E. Dillard Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications Enclosure

510(k) Number (if known): 14993289

Page 1 of 1

Device Name: Trauma Internal Fixation System

Indications for Use:

The Trauma Internal Fixation System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in adult and pediatric patients are as follows:

Adult indications:

Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may 1 . be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head).
1. Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
1. Osteotomics for patients with discases or deformities of the hip.
1. Hip arthrodesis.
Supracondylar fractures and distal femoral fractures using a supracondylar plate. 5.
Ipsilateral femoral shaft/neck fractures (IMHS only). 6.

Pediatric indications:

1. Congenital coxa vara.
1. Congenital dislocation of the hip.
1. Subluxation or dislocation secondary to neurologic disorders such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities.
1. Coxa plana (Legg-Calve-Perthes disease) for containment of the head completely within the acetabulum.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDFID)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General Restorative Devices 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

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

CONFIDENTIAL

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.