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. Smith & Nephew, Inc. Intramedullary Hip Screws are for single use only.

Device Description

Intramedullary Hip Screw

AI/ML Overview

The provided text does not describe a study to prove acceptance criteria for a device using an AI algorithm.

Instead, it is a 510(k) premarket notification summary for a medical device called an "Intramedullary Hip Screw" manufactured by Smith & Nephew, Inc. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of design features, indications for use, and material composition.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) because the information is not present in the provided text.

Here's a breakdown of what the document does provide:

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

The document states:

Acceptance Criteria (Implied): Mechanical test data showed the device is "capable of withstanding expected in vivo loading without failure."
Reported Device Performance: "A review of the mechanical test data indicated that the Intramedullary Hip Screw is equivalent to predicate devices currently used clinically and is capable of withstanding expected in vivo loading without failure."

Acceptance Criteria (Implied)	Reported Device Performance
Withstand expected in vivo loading without failure.	Indicated as equivalent to predicate devices; capable of withstanding expected in vivo loading without failure based on mechanical test data review.
Equivalent to predicate devices in mechanical performance.	Stated to be equivalent to predicate devices currently used clinically based on mechanical test data.
Similar in indications for use, design, principles, & materials.	Substantial equivalence is based on similarities in indications for use, design features, operational principles, and material composition to listed predicate devices.

Missing Information (as per your request, because it's an AI-related prompt and this document is not AI-related):

Sample sizes used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance.
If a standalone (algorithm only) performance study was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

Summary

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MAY 25 2004

K04 0656

Page 1 of 1

Smith & Nephew, Inc. Summary of Safety and Effectiveness Intramedullary Hip Screw

Date of Summary: March 11, 2004

Contact Person and Address Janet Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-5153

Name of Device: Intramedullary Hip Screw Common Name: Intramedullary Hip Screw Nails and Accessories

Device Classification Name

21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories - Class II

Indications for Use

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 turnor resection; leg length discrepancies secondary to femoral inequality; and prophylactic nailing of impending pathologic fractures. Smith & Nephew, Inc. Intramedullary Hip Screws are for single use only.

Mechanical and Clinical Data

A review of the mechanical test data indicated that the Intramedullary Hip Screw is equivalent to predicate devices currently used clinically and is capable of withstanding expected in vivo loading without failure.

Substantial Equivalence Information

The substantial equivalence of the Intramedullary Hip Screw is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices - Smith & Nephew's Intramedullary Hip Screw (K954712), Titanium Nail System (K981529), Trauma Internal Fixation System (K993289), Intramedullary Nail System (K983942) and TriGen InterTAN (K040212).

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which represent the department's mission to promote the health and well-being of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2004

Ms. Janet Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116

Re: K040656

Trade/Device Name: Intramedullary Hip Screw Regulation Number: 21 CFR 888.3030 and 21 CFR 888.3040 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories, and Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: KTT and HWC Dated: March 11, 2004 Received: March 12, 2004

Dear Ms. Akil:

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 rcquirements 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. Janet Akil

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 (301) 594-4659. 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. Wilkerson

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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Indications for Use

510(k) Number (if known): K040656

Device Name: Intramedullary Hip Screw

Intramedullary Hip Screws are indicated for intracapsular Indications For Use: 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. Smith & Nephew, Inc. Intramedullary Hip Screws are for single use only.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark H. Millhess

(Division Digand Neurological Devices

Page 1 of 1

510(k) Number K040656

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.