The Omega™ Plus, Omega™ 2, and Omega™ 3 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™ 3 System is a compression screw system designed to treat various types of fractures of the proximal and distal femur.

AI/ML Overview

The provided K062066 document is a 510(k) premarket notification for a medical device called the Omega™ 3 System, a compression screw system for treating femoral fractures. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data that would detail specific acceptance criteria and performance against those criteria in a typical clinical trial format.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert involvement, and ground truth establishment, which are common for AI/diagnostic device studies, are not applicable or not explicitly stated in this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices."

Acceptance Criteria (Implied)	Reported Device Performance
Comparable mechanical properties to predicate devices (Omega™ Plus System and Omega™ 2 System).	Demonstrated comparable mechanical properties to the predicate components.
Same intended use as predicate devices.	Shares the same intended use as predicate devices.
Basic design concepts are the same as predicate devices.	Shares the same basic design concepts as predicate devices.

Explanation: For a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use, is based on the same technological characteristics, and performs as safely and effectively as the predicate. In this case, "comparable mechanical properties" is the key performance metric. However, specific numerical thresholds or detailed results of these mechanical tests are not included in this summary.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The study mentioned is "mechanical testing," which typically involves material samples or device prototypes, not human subjects for a "test set" in the context of clinical performance.
Data Provenance: Not specified. Mechanical tests are usually conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. For mechanical testing of a surgical implant, "ground truth" is typically defined by engineering specifications and material science principles, not expert consensus interpretation.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. Adjudication (e.g., 2+1) is relevant for clinical or diagnostic studies involving human interpretation or subjective assessments. Mechanical testing relies on objective measurements.

5. 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:

MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, often in the context of AI assistance. The Omega™ 3 System is a surgical implant.
Effect size of human reader improvement with AI: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Not applicable. This device is a physical surgical implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: For the "comparable mechanical properties," the "ground truth" would be established engineering standards, material specifications, and the measured mechanical properties of the predicate devices. This is a technical, objective ground truth, not based on clinical pathology or outcomes data.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This concept is relevant for machine learning algorithms. The device is a physical product.

9. How the ground truth for the training set was established:

How Ground Truth for Training Set was Established: Not applicable.

In summary: The K062066 document provides information typical of a 510(k) submission for a predicate-based medical device. The "study" mentioned is "mechanical testing" to demonstrate comparable properties to existing devices, satisfying the requirements for substantial equivalence to a predicate. It does not involve patient data, expert reviews, or AI technologies, hence many of the requested details are not relevant to this specific device and its submission type.

Summary

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K062066 (pg 1 of 2)

Summary of Safety and Effectiveness Omega™ 3 System

Proprietary Name:	Omega™ 3 System
Common Name:	Compression Screw System
Classification Name and Reference	Single/multiple component metallic bonefixation appliances and accessories, 21 CFR§888.3030
Device Product Code:	87 KTT
For Information Contact:	Francisco Haro, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5493Fax: (201) 831-6038
Date Summary Prepared:	July 19, 2006

Description:

The Omega™ 3 System is a compression screw system designed to treat various types of fractures of the proximal and distal femur.

Intended Use:

The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are available sterile and non-sterile intended for use in the temporary stabilization of fractures of the proximal and distal femur. The indications for use for the Omega™ 3 System are provided below.

Indications for Use:

Intracapsular and basal neck fractures including transcervical and subcapital fractures .

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K062066 (pg 2 of 2)

Intertrochanteric fractures .
Subtrochanteric fractures .
. Supracondylar fractures
. Intracondylar fractures
Osteotomies for patients with diseases or deformities of the hip .
. Hip arthrodesis

Substantial Equivalence:

The subject Omega™ 3 System shares the same intended use, and basic design concepts as that of the currently available Omega™ Plus System and Omega™ 2 System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three human figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2006

Howmedica Osteonics Corporation % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K062066

Trade/Device Name: Omega™ 3 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: July 19, 2006 Received: July 21, 2006

Dear Mr. Haro:

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

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Page 2 - Mr. Francisco Haro

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 100-100. 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" (210) Part 807.97). You may ottain 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) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbave Onelino
to

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

Enclosure

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KOG2

510(k) Number (if known):

Device Name: Omega™ 3 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	X
(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 OF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE) for MACU

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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K Number	K162066
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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.