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The Metagen All Poly Acetabular Cup consists of single use devices, intended for cemented replacement of the acetabular portion of the hip joint in primary and revision total hip arthroplasty.

The Metagen All Poly Acetabular Cup System is a family of acetabular components designed for use in total hip arthroplasty, that are manufactured using medical grade biocompatible materials. The basic design and materials are the same as those used in the predicate devices.

This document, K96403, is a 510(k) summary for the "Metagen All Poly Acetabular Cup System." It describes a medical device, its intended use, and argues for its substantial equivalence to previously marketed devices.

However, this document *does not contain any information regarding:

• Acceptance criteria for a study.
• A study that proves the device meets acceptance criteria.
• Device performance metrics (like sensitivity, specificity, AUC).
• Sample sizes for test or training sets.
• Data provenance (country, retrospective/prospective).
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance (as this is a physical medical device, not an AI algorithm).
• Type of ground truth used.
• How ground truth was established.

This K96403 document is a regulatory submission for a physical medical device (an acetabular cup for hip replacement), not an AI/ML-based diagnostic or imaging device. Therefore, the questions you've asked, which are typically relevant to the validation of AI/ML algorithms, are not applicable to the content provided in this specific K96403 summary.

The document primarily focuses on demonstrating substantial equivalence in terms of design, materials, and intended use to predicate devices, rather than presenting a performance study against specific acceptance criteria.

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