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The Dual Lock Hip Stem is indicated for use as the cemented femoral component in total hip arthroplasty for the treatment of:

1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis;
2. Avascular necrosis of the femoral head;
3. Acute traumatic fracture of the femoral head or neck;
4. Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement;
5. Certain cases of ankylosis.

The Dual Lock Hip Stem system consists of variously sized femoral hip stems made from Cobalt Chrome which will be available with standard and lateral offsets. The Dual Lock Hip Stems are designed with neck tapers intended to be used with DePuy femoral ball heads made from Cobalt Chrome or Zirconia Ceramic, and DePuy acetabular components with ultra high molecular weight polyethylene articulating surfaces.

I am sorry, but based on the provided text, there is no information about specific acceptance criteria or a study that proves the device meets such criteria. The document is a 510(k) summary for the Dual Lock® Hip Stem, which focuses on demonstrating substantial equivalence to previously cleared predicate devices.

The content mainly covers:

• Device identification: Trade name, common name, classification, product code.
• Device description and intended use: Materials, design features, and medical conditions for which it is indicated.
• Basis of substantial equivalence: Comparison of materials, design, sizing, and intended use with predicate devices (DePuy Porocoat Dual Lock Total Hip System, DePuy Prodigy Hip, and DePuy Cemented Hip Prosthesis). The statement "It is expected that the performance of the subject DePuy Dual Lock Hip Stem will be similar to these predicate devices" is made, but no specific performance metrics or studies are detailed to support this expectation.
• FDA clearance letter: A letter confirming the substantial equivalence determination but not detailing performance studies.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, ground truth details, or training set information. This type of detailed performance data is typically not included in a 510(k) summary, which primarily serves to establish equivalence to legally marketed devices.

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