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The Omega™ Plus and 2 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™ 2 System is a compression screw system designed to treat various types of fractures of the proximal and distal femur. The Omega™ 2 System is a modification to the existing Omega™ II, Omega™ Plus and Omega™ Systems. The subject Omega™ 2 System is a line extension to the predicate devices to modify and add new components to the system.

The provided document is a 510(k) summary for the Omega™ 2 System, a compression screw system. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on design, function, materials, and mechanical properties.

Crucially, this document does not describe any clinical study or provide acceptance criteria and reported device performance in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics typically associated with medical imaging or diagnostic AI devices.

The information provided pertains to a mechanical orthopedic device (compression screw system) and focuses on engineering and regulatory aspects, not clinical performance metrics in the way your request anticipates.

Therefore, I cannot fulfill most of your request directly from the provided text, as the type of study and metrics you are asking for (e.g., sample size for test set, ground truth, expert opinions, MRMC studies, standalone performance of an algorithm) are simply not present for this type of device submission.

Here's a breakdown of what can be answered based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in terms of clinical performance. The acceptance criteria for this type of device would likely involve mechanical testing standards (e.g., fatigue strength, torsional rigidity) and demonstrating equivalence to predicate devices in those engineering metrics, rather than clinical accuracy. The document states: "Mechanical testing demonstrated comparable mechanical properties to the predicate components." This implies the acceptance criteria would be "comparable mechanical properties," but specific numerical targets are not given.
   • Reported Device Performance: "Mechanical testing demonstrated comparable mechanical properties to the predicate components." No specific numerical performance results are reported.

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 device is a mechanical implant, and the submission relies on engineering and design equivalence, not clinical data sets in the way an AI diagnostic device would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth in this context would likely be defined by engineering standards tests (e.g., material properties, failure points), not expert human interpretation for diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.

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: Not applicable. This is not an AI or diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical devices, "ground truth" would relate to verifiable physical properties and performance under stress, often established through standardized laboratory testing and engineering specifications. The document implies this was done ("Mechanical testing demonstrated comparable mechanical properties"), but doesn't detail the specific type of ground truth or methods.

8. The sample size for the training set: Not applicable/not provided. There is no "training set" in the context of this mechanical device submission.

9. How the ground truth for the training set was established: Not applicable/not provided.

In summary, the provided document is a regulatory submission for a medical device that is a metal orthopedic implant, not a diagnostic or AI-driven system. Therefore, the questions related to clinical study design, performance metrics, and AI evaluation are not addressed by this type of document.

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