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The Accin™ Unipolar Head is intended to be implanted for use in the reconstruction of the femoral portion of severely disabled and / or very painful hip joints resulting from: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Avascular Necrosis; The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip Stems.

The Accin™ Unipolar Head System consists of a cobalt chrome modular endo prosthesis femoral head.

This document is a 510(k) premarket notification for a medical device called the "Accin™ Unipolar Head System." It seeks to demonstrate substantial equivalence to a predicate device, rather than proving a new device's absolute safety and effectiveness through clinical trials with established acceptance criteria and detailed performance studies.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available within this document. This type of information is typically found in clinical study reports, scientific publications, or more extensive premarket approval (PMA) submissions where a novel device's performance needs to be rigorously proven.

Here's a breakdown of why this information is absent in this context:

• 510(k) Premarket Notification: This regulatory pathway is for devices that are "substantially equivalent" to legally marketed predicate devices. The primary goal is to show similarity in intended use, technological characteristics, and safety and effectiveness profiles, not necessarily to re-prove efficacy or establish new performance benchmarks.
• Focus on Substantial Equivalence: The document explicitly states: "Testing has shown that the proposed device is equivalent to the predicate device." This "testing" would likely refer to bench testing (e.g., mechanical, material properties) to ensure it performs identically to the predicate, rather than human clinical studies comparing outcomes or algorithm performance.
• Device Type: The Accin™ Unipolar Head is a physical implant (a component of a hip prosthesis). Its performance is assessed through its mechanical properties, biocompatibility, and manufacturing quality, not through an algorithm's diagnostic accuracy or a human-AI collaboration.

Therefore, I cannot provide the requested table and study details as they are not pertinent to or present within this 510(k) submission document. The document's purpose is to establish equivalence to an already approved device, not to present a new performance study with acceptance criteria.

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