The Omega™ Plus and 2 Systems are intended for use in the temporary stabilization of types of fractures of the proximal and distal femur. The subject devices are indicated for fixation of proximal and distal femoral fractures including but not limited to:

Intracapsular and basal neck fractures including transcervical and subcapital fractures .
Intertrochanteric fractures .
. Subtrochanteric fractures
Supracondylar fractures .
Intracondylar fractures .
Osteotomies for patients with diseases or deformities of the hip .
Hip arthrodesis ◆

Device Description

The Omega™ 2 System is a compression screw system designed to treat various types of fractures of the proximal and distal femur. The Omega™ 2 System is a modification to the existing Omega™ II, Omega™ Plus and Omega™ Systems. The subject Omega™ 2 System is a line extension to the predicate devices to modify and add new components to the system.

AI/ML Overview

The provided document is a 510(k) summary for the Omega™ 2 System, a compression screw system. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on design, function, materials, and mechanical properties.

Crucially, this document does not describe any clinical study or provide acceptance criteria and reported device performance in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics typically associated with medical imaging or diagnostic AI devices.

The information provided pertains to a mechanical orthopedic device (compression screw system) and focuses on engineering and regulatory aspects, not clinical performance metrics in the way your request anticipates.

Therefore, I cannot fulfill most of your request directly from the provided text, as the type of study and metrics you are asking for (e.g., sample size for test set, ground truth, expert opinions, MRMC studies, standalone performance of an algorithm) are simply not present for this type of device submission.

Here's a breakdown of what can be answered based on the provided text, and what cannot:

Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of clinical performance. The acceptance criteria for this type of device would likely involve mechanical testing standards (e.g., fatigue strength, torsional rigidity) and demonstrating equivalence to predicate devices in those engineering metrics, rather than clinical accuracy. The document states: "Mechanical testing demonstrated comparable mechanical properties to the predicate components." This implies the acceptance criteria would be "comparable mechanical properties," but specific numerical targets are not given.
- Reported Device Performance: "Mechanical testing demonstrated comparable mechanical properties to the predicate components." No specific numerical performance results are reported.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/not provided. This device is a mechanical implant, and the submission relies on engineering and design equivalence, not clinical data sets in the way an AI diagnostic device would.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth in this context would likely be defined by engineering standards tests (e.g., material properties, failure points), not expert human interpretation for diagnosis.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
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 not an AI or diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical devices, "ground truth" would relate to verifiable physical properties and performance under stress, often established through standardized laboratory testing and engineering specifications. The document implies this was done ("Mechanical testing demonstrated comparable mechanical properties"), but doesn't detail the specific type of ground truth or methods.
The sample size for the training set: Not applicable/not provided. There is no "training set" in the context of this mechanical device submission.
How the ground truth for the training set was established: Not applicable/not provided.

In summary, the provided document is a regulatory submission for a medical device that is a metal orthopedic implant, not a diagnostic or AI-driven system. Therefore, the questions related to clinical study design, performance metrics, and AI evaluation are not addressed by this type of document.

Summary

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JUL 0 1 2004

K041001
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510(k) Summary of Safety and Effectiveness for the Omega™ 2 System

Proprietary Name:	Omega™ 2 System
Common Name:	Compression Screw System
Classification Name and Reference	Single/multiple component metallic bone fixationappliances and accessories21 CFR §888.3030
Regulatory Class:	Class II
Device Product Code:	87 KTT
For Information contact:	Vivian Kelly, Regulatory Affairs Specialist
	Howmedica Osteonics Corp.
	325 Corporate Drive
	Mahwah, NJ 07430
	Phone: (201) 831-5581
	Fax: (201) 831-6038
Date Summary Prepared:	April 16, 2004

Description:

Intended Use:

The Omega™ Plus and 2 Systems are intended for use in the temporary stabilization of fractures of the proximal and distal femur.

Substantial Equivalence:

The design and function of the Omega™ 2 System is substantially equivalent to that of the predicate devices. Both the subject and predicate systems offer different types of plates in varying lengths and angles for use with the other accessories in the system. This system is equivalent to other systems on the market in regards to design, materials, indications and operational principals. Mechanical testing demonstrated comparable mechanical properties to the predicate components.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes on its wing, symbolizing service, science, and security. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

JUL 01 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K041001 Trade/Device Name: Omega™ 2 System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: April 16, 2004 Received: April 19, 2004

Dear Ms Kelly:

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. Iisting 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 - Vivian Kelly

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,

Muriam C. Provost

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): KO41001 Device Name: Omega™ 2 System

Indications for Use:

Intracapsular and basal neck fractures including transcervical and subcapital fractures .
Intertrochanteric fractures .
. Subtrochanteric fractures
Supracondylar fractures .
Intracondylar fractures .
Osteotomies for patients with diseases or deformities of the hip .
Hip arthrodesis ◆

Prescription Use Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

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510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.