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The Groupe Lepine B2C Espace, revision acetabular cup system is intended to be used as the pelvic component of a total hip arthoplasty. The acetabular component geometry has been designed to fill large acetabular defects in the floor and superior aspects of the acetabular cavity. It can be implanted either as a press fit cup with bone screw fixation or cemented into the cavity.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (B2C "Espace" Revision Cup System) and does not contain the specific details required to answer your request about acceptance criteria and a study proving a device meets those criteria.

The document states that the device is "substantially equivalent" to previously marketed devices, which is the basis for its clearance, but it does not include information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or data provenance.
• Number of experts for ground truth or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training was established.

This document is a regulatory approval, not a technical study report.

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