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The Prime and DYNASTY® Additive Manufacturing Shells are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

MicroPort Orthopedics Inc. is introducing the Prime and DYNASTY® Additive Manufacturing (AM) Shells as a line extension of its existing Prime and DYNASTY® Acetabular Systems. The Prime and DYNASTY® AM Shells are made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process and are designed for cementless use on the bone interfacing surface. The device design is identical to its corresponding predicate devices. The design features of the Prime and DYNASTY® AM Shells are summarized below.

• Prime AM Shells: ●
  • Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
  • Available in the following configurations and their respective sizes: -
    • Solid (46mm-68mm outer diameter)
    • Quad (42mm- 68mm outer diameter) .
  • Sterilization: Gamma Sterilization -
• DYNASTY® AM Shells: ●
  • Material of Shell and Porous Coating: Titanium Alloy (Ti-6A1-4V) AM powder -
  • Available in the following configurations and their respective sizes:
    • o Standard (46mm- 76mm outer diameter)
    • Primary (46mm-68mm outer diameter) o
    • Revision (46mm-76mm outer diameter) o
  • Sterilization: Gamma Sterilization -

The subject implants are single-use only, are provided sterile, and are prescription only devices, intended to be implanted only by orthopedic specialists in an operating room setting.

The provided text does not contain information about an AI/ML-based medical device. Instead, it describes a traditional medical device, specifically Prime and DYNASTY® Additive Manufacturing Shells, which are hip implants.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI/ML device meets those criteria. The document details the substantial equivalence of the hip implants to legally marketed predicate devices based on non-clinical bench testing, material properties, and design similarity, not performance metrics for an AI algorithm.

Here's why the requested information cannot be provided from the given text:

• No AI/ML Component: The device described is a physical orthopedic implant. There is no mention of any AI or machine learning algorithm.
• No "Performance" in the AI/ML Sense: The "performance" discussed in the document relates to mechanical properties (tensile strength, fatigue, deformation, corrosion, shear strength, etc.) and biocompatibility of the implant, not the diagnostic or predictive performance of an algorithm.
• No Test Set/Training Set: These concepts are specific to AI/ML model development and evaluation. The document discusses "worst-case constructs" for physical testing and "predicate nonclinical test results," which are entirely different.
• No Experts for Ground Truth/Adjudication: Ground truth establishment and adjudication by experts are crucial for evaluating AI/ML models in medical imaging, but this is irrelevant for a physical implant.
• No MRMC Study: A Multi-Reader Multi-Case study is for evaluating human performance, often with or without AI assistance, in interpreting medical data. This device is not an interpretation tool.
• No Standalone Algorithm: This phrase applies to an AI algorithm operating without human intervention for diagnostic or predictive tasks.

In summary, the provided document does not describe an AI/ML device, and thus, the questions posed (which are relevant to AI/ML device evaluation) cannot be answered from this text.

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