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The Omega+ Compression Screw System consists of a series of lag screws, proximal hip sideplates, supracondylar side plates, and a compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area).

The Omega+ Compression Screw System consists of a series of lag screws, proximal hip sideplates, supracondylar side plates, and a compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area). These components were previously released under K850886, K872223, K922295, and K930156. These components are now made available in sterile packaging. It is Howmedica's intention to market these products both sterile and non-sterile.

This 510(k) summary for the Omega+ Compression Screw System is for a medical device, specifically an orthopedic implant, not a diagnostic AI device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment (which are typical for AI/diagnostic devices) is not applicable to this submission.

The summary clearly states that the submission is for sterile packaging of previously cleared components, implying that the safety and effectiveness of the device itself were established in prior 510(k) submissions (K850886, K872223, K922295, and K930156).

Here's why the AI-specific questions are not applicable:

• No AI component: The Omega+ Compression Screw System is a physical metallic bone fixation appliance. It does not involve any artificial intelligence, machine learning, or diagnostic algorithms.
• No diagnostic performance: Its purpose is mechanical stabilization of fractures, not to generate diagnostic outputs or interpretations. Therefore, terms like sensitivity, specificity, AUC, or the need for a "test set" and "ground truth" derived from expert review are irrelevant in this context.
• No human reader involvement: The device does not involve human readers interpreting AI output, so MRMC studies, reader improvement, or standalone performance are not relevant.
• No training data: As there's no AI model, there's no "training set" or "ground truth for training" to establish.

Instead, for a device like this, the "acceptance criteria" and "proof of meeting them" would typically involve:

• Substantial Equivalence: The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing aspects like:
  • Intended use
  • Design
  • Materials
  • Manufacturing process
  • Performance characteristics (e.g., mechanical strength, biocompatibility, sterilization validation)
• Sterilization Validation: Given this submission is specifically for sterile packaging, a major part of the "study that proves the device meets acceptance criteria" would be sterilization validation studies (e.g., to demonstrate the sterility assurance level (SAL) of $10^{-6}$ or better using methods like overkill, bioburden-based, or combined methods, often involving biological indicators and dose mapping for radiation sterilization).
• Biocompatibility: Confirmation that the materials used are biocompatible (often referenced from the predicate device or through specific testing if materials are new).
• Mechanical Testing: If there were any changes to the design or materials that could affect mechanical integrity, mechanical testing (e.g., fatigue, static strength) would be performed to demonstrate equivalence to the predicate.

In summary, for the provided text, none of the requested table or bullet points related to AI performance are meaningful or applicable. The 510(k) is focused on ensuring the continued safety and effectiveness of a physical implant now offered in a sterile presentation, primarily through sterilization validation and demonstration of substantial equivalence.

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