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 Supracondylar Plate is a compression screw system designed to treat various types of fractures of the distal femur.

AI/ML Overview

The provided text describes a medical device, the Omega™ 3 Supracondylar Plate, and its regulatory review for substantial equivalence. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the context of device performance metrics (like accuracy, sensitivity, specificity, etc.) for a diagnostic or AI-driven device.

This document is a 510(k) summary for a mechanical orthopedic implant, not a diagnostic device or one that employs AI. Therefore, the types of studies and acceptance criteria typically associated with AI/diagnostic performance (sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable or reported in this document.

Instead, the "study" referred to is mechanical testing demonstrating comparable mechanical properties to predicate devices, and the "acceptance criterion" is achieving substantial equivalence based on these mechanical properties and identical intended use.

Here's a breakdown of the available information based on your request, highlighting what is not present due to the nature of the device:

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

Acceptance Criteria (Implied)	Reported Device Performance
Comparable mechanical properties to predicate devices (Omega™ Plus System and Omega™ 2 System)	Mechanical testing demonstrated comparable mechanical properties to the predicate components.
Same intended use as predicate devices	The subject device shares the same intended use as the predicate devices.
Same basic design concepts as predicate devices	The subject device shares the same basic design concepts as the predicate devices.

2. 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 document refers to mechanical testing, not a clinical study involving a "test set" of patient data in the context of AI or diagnostic performance. Sample sizes for mechanical tests are typically specific to the type of test (e.g., number of plates tested for fatigue, bending, etc.), and this detail is not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable/Not provided. Ground truth, in the AI/diagnostic sense, is not established for this type of device. The mechanical properties are measured against established engineering standards or comparisons to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No adjudication method is mentioned as there's no diagnostic or interpretative element to this device's evaluation in the document.

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

No. This is a mechanical orthopedic implant, not an AI or diagnostic device. An MRMC study is not relevant to its evaluation.

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

Not applicable. This is a physical implant. The concept of "standalone performance" for an algorithm is not relevant.

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

Benchmarking against predicate devices' mechanical properties and established engineering standards. The "ground truth" for this device's evaluation is essentially the performance characteristics of previously cleared, substantially equivalent devices and adherence to relevant material/mechanical standards for orthopedic implants.

8. The sample size for the training set

Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. As above, no training set for AI is involved.

Summary

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K070454 182

APR 1 2 2007

Summary of Safety and Effectiveness Omega™ 3 Supracondylar Plate

Proprietary Name:

Common Name:

Classification Name and Reference

Device Product Code:

For Information Contact:

Omega™ 3 Supracondylar Plate

Compression Screw System

Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3030

87 KTT

Francisco Haro, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5493 Fax: (201) 831-6038

Date Summary Prepared:

February 9, 2007

Description:

The Omega™ 3 Supracondylar Plate is a compression screw system designed to treat various types of fractures of the 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:

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K070454 zg2

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

Substantial Equivalence:

The subject Omega™ 3 Supracondylar Plates 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized depiction of an eagle with its wings spread, positioned to the right. To the left of the eagle is a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 1 2 2007

Re: K070454

Trade/Device Name: Omega™ 3 Supracondylar Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: March 27, 2007 Received: March 28, 2007

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 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. Francisco Haro

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/dsma/dsmamain.html.

Sincerely yours.

Barbary Poucelin

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

Enclosure

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510(k) Number (if known):

Device Name: Omega™ 3 Supracondylar Plate

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(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 807 Subpart C)
-------------------------------------------------	---	--------	------------------------------------------------

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

Signature, Office of Device Evaluation (ODE)

(Division Sign-Off) MXM

Division of General, Restorative,

and Neurological Devices

510(k) Number K070454

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.