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Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
The EMPHASYS Acetabular Shell with RapiTite HA is intended for single use only.
INDICATIONS
Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   EMPHASYS Acetabular Shells with RapiTite HA are indicated for cementless use only.

The EMPHASYS Acetabular Shell with RapiTite HA is a modular cementless porous-coated acetabular shell, with a hydroxyapatite (HA) coating applied conformally throughout the porous coating, offered in three configurations (No-Hole, 3-Hole, and Multi-Hole).

The provided text is a 510(k) summary for a medical device called "EMPHASYS Acetabular Shell with RapiTite HA". It details the device's purpose, indications, and comparison to predicate devices, and lists various tests conducted to demonstrate substantial equivalence.

However, the request asks for specific information regarding a study proving the device meets acceptance criteria and details about the data provenance, expert involvement, and ground truth establishment, often associated with a clinical or AI performance study.

The provided document does not contain information about a study that would require establishing ground truth with multiple experts, using a test set with specific data provenance, or performing MRMC comparative effectiveness studies. The "Animal & Performance Testing" section lists various mechanical, chemical, and biological tests that were performed (e.g., interfacial shear strength, fatigue testing, biocompatibility, bone ingrowth animal study), but these are primarily laboratory-based and do not involve human readers interpreting data or a "ground truth" derived from expert consensus in the way an AI/clinical performance study would.

Therefore, I cannot fulfill the request for information on the following points based on the provided text:

• A table of acceptance criteria and reported device performance related to a clinical/AI study. The document mentions acceptance criteria implicitly for the mechanical and biological tests (e.g., successfully passing ASTM standards), but not in the context of the requested AI/clinical performance study.
• Sample size for the test set and data provenance. The document mentions an "Animal Study" but no human test set.
• Number of experts and their qualifications for establishing ground truth. Not applicable to the studies described.
• Adjudication method for the test set. Not applicable.
• MRMC comparative effectiveness study and effect size. Not applicable.
• Standalone (algorithm only) performance. Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth used. Not applicable in the requested context.
• Sample size for the training set. Not applicable.
• How ground truth for the training set was established. Not applicable.

The document primarily focuses on demonstrating the substantial equivalence of a physical medical implant (an acetabular shell) through engineering, material, and biocompatibility testing, rather than a clinical performance study involving human interpretation or an AI algorithm.

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