(89 days)
The Omega® II System is intended for use in the temporary stabilization of fractures of the proximal femur.
The Omega® II System is indicated for temporary stabilization of fractures of the proximal femur which may include the following:
- Intracapsular fractures of the femoral neck .
- Intertrochanteric fractures .
The Omega® II System is a compression hip screw system designed to treat various indications in the proximal femur. The Omega® II System consists of a range of Hip Plates, Lag Screws and a Compression Screw as well as the corresponding instruments. The Omega® II System is a modification to the existing Omega + Plus System. The subject Omega® II Low Profile Hip Plate is shorter and has a thinner profile than the predicate Omega + Plus Side Plate. The profile of the Omega® III Low Profile Hip Plate is similar to the design of the Synthes DHS Side Plate. The Omega® II Low Profile Hip Plates use the same Lag Screws as the predicate Omega® + Plus System.
This 510(k) premarket notification for the Omega® II System is for a medical device (a compression hip screw system), not an AI/ML powered device. As such, the information requested in the prompt, which pertains to AI/ML device studies and acceptance criteria (e.g., sample size for test sets, ground truth establishment, MRMC studies, standalone performance, training sets), is not applicable and is not found within the provided documents.
The submission focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing performance metric-based acceptance criteria for an AI/ML algorithm.
Therefore, for this particular document, the answer to all questions related to acceptance criteria and study details for an AI/ML device is "Not Applicable" or "Information not provided in the document as it is not an AI/ML device."
Here’s a breakdown as per your requested format, indicating the irrelevance for this device type:
| Criteria/Study Aspect | Response (Not Applicable / Information Not Provided) |
|---|---|
| Acceptance Criteria and Reported Device Performance | Not Applicable. The document does not describe acceptance criteria in terms of performance metrics typical for AI/ML devices (e.g., sensitivity, specificity, AUC). The submission focuses on demonstrating substantial equivalence to a predicate device based on design, function, and intended use. |
| 1. Table of Acceptance Criteria and Reported Device Performance | Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criterion is "Substantial Equivalence" to the predicate device. Reported Device Performance: Not applicable for an AI/ML device. The document states the Omega® II System is a modification to the existing Omega + Plus System, with a shorter and thinner hip plate, and uses the same Lag Screws as the predicate. The performance is implied to be equivalent to the predicate through design. |
| 2. Sample size used for the test set and data provenance | Not Applicable. This is not an AI/ML device, so there is no "test set" in the context of evaluating an algorithm's performance on a dataset. |
| 3. Number of experts used to establish ground truth & qualifications | Not Applicable. No ground truth establishment by experts is described as this is not an AI/ML device. |
| 4. Adjudication method for the test set | Not Applicable. No test set or adjudication method described. |
| 5. MRMC comparative effectiveness study? Effect size? | Not Applicable. This is not an AI/ML device, so no MRMC study to compare human readers with/without AI assistance. |
| 6. Standalone (algorithm only) performance done? | Not Applicable. This is a physical medical device, not an algorithm. |
| 7. Type of ground truth used | Not Applicable. No ground truth is established in the context of an AI/ML algorithm. |
| 8. Sample size for the training set | Not Applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set. |
| 9. How the ground truth for the training set was established | Not Applicable. No training set or ground truth establishment for a training set. |
{0}------------------------------------------------
JUN 0 5 2002
510(k) PremarketNotification
510(k) Summary for the Omega® II System
Proprietary Name: Common Name: Classification Name and Reference
Regulatory Class: Device Product Code: For Information contact: Omega® II System Compression Hip Screw System Single/multiple component metallic bone fixation appliances and accessories 21 CFR 8888.3030 Class II 87 KTT Karen Ariemma, Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 Phone: (201) 760-8187 Fax: (201) 760-8435 March 6, 2002
Date Summary Prepared:
Description:
The Omega® II System is a compression hip screw system designed to treat various indications in the proximal femur. The Omega® II System consists of a range of Hip Plates, Lag Screws and a Compression Screw as well as the corresponding instruments. The Omega® II System is a modification to the existing Omega + Plus System. The subject Omega® II Low Profile Hip Plate is shorter and has a thinner profile than the predicate Omega + Plus Side Plate. The profile of the Omega® III Low Profile Hip Plate is similar to the design of the Synthes DHS Side Plate. The Omega® II Low Profile Hip Plates use the same Lag Screws as the predicate Omega® + Plus System.
Intended Use:
The Omega® II System is intended for use in the temporary stabilization of fractures of the proximal femur.
Substantial Equivalence:
The design and function of the Omega® II System is substantially equivalent to that of the predicate devices. Both the subject and predicate systems offer Hip Plates in varying lengths and angles, and offer a combination of Lag Screws, Compression Screws and Locking Screws.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 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" around the perimeter. Inside the circle is a stylized design of three human profiles facing to the right, arranged in a way that suggests forward movement or progress.
JUN 0 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Staub Vice President. Ouality Assurance/Regulatory Affairs/Clinical Research Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Re: K020772 Trade Name: Omega® II System Regulatory Number: 21 CFR 888.3030 Regulatory Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: March 6, 2002 Received: March 8, 2002
Dear Ms. Staub:
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.
{2}------------------------------------------------
Page 2 -- Ms. Elizabeth Staub
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Sincerely yours,
Marle N Milburn
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number (if known): K OD 0772
Device Name: Omega® II System
Indications for Use
The Omega® II System is indicated for temporary stabilization of fractures of the proximal femur which may include the following:
- Intracapsular fractures of the femoral neck .
- Intertrochanteric fractures .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Mark n Wilkerson
ivision of General, Restorative and Neurological Devices
510(k) Number _
§ 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.