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The EcoFit®, implaFit® and BethaLoc® hip stems are indicated for use in cases of:
· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

• · Rheumatoid arthritis;
  · Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
  · Revision of previously failed total hip arthroplasty.

The EcoFit®, implaFit® and BethaLoc® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended for the following indications:
· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis

• Rheumatoid arthritis
• · Correction of functional deformity
  · Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The EcoFit® hip stems, the implaFit® hip stems cementless and the BethaLoc® hip stems are intended for uncemented, press-fit fixation.

The implaFit® hip stems cemented are intended for cemented fixation.

The ic-Bipolar Head System is intended for uncemented use in hemiarthroplasty, where the femoral head requires replacement but the acetabulum does not, in conjunction with the BethaLoc® hip stems and EcoFit® Hip System for the following indications:
· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis

• Rheumatoid arthritis
• · Correction of functional deformity
  · Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the BethaLoc® hip stems. The BethaLoc® hip stems are femoral stems for total or hemi hip arthroplasty. The BethaLoc® hip stems are available in standard and lateralized offset configurations. The BethaLoc® hip stems are monoblock, tapered straight stems made from titanium alloy with a partial coating of hydroxyapatite (HA). They are fixed by press-fitting. The BethaLoc® hip stems are intended to be used with previously cleared EcoFit® Hip components.

This is a 510(k) summary for a medical device (hip stems), not an AI/ML device. Therefore, the requested information regarding AI/ML acceptance criteria, study details, human reader improvement with AI assistance, and training/ground truth datasets is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the "BethaLoc® stem cementless HA" device to legally marketed predicate devices. The performance testing section details the physical and biological tests performed on the device to ensure its safety and effectiveness, but these are engineering and biocompatibility tests, not studies related to AI/ML performance.

Therefore, I cannot provide a response that directly answers your prompt as it pertains to AI/ML device evaluation.

If you are looking for information on the acceptance criteria and performance studies for a hip stem (non-AI/ML), the document indicates the following:

1. Table of acceptance criteria and reported device performance:

The document states that "All performance testing conducted for the BethaLoc® hip systems met the predetermined acceptance criteria or were otherwise considered acceptable." Specific numerical acceptance criteria or performance metrics are not explicitly provided in a table format within this summary, but the types of tests performed are listed.

Regarding the AI/ML specific questions (2-9), the document does not contain this information as it describes a non-AI/ML medical device.

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