(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. |
§ 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.