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