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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques

Qualifier:

The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:

-The KYOCERA Medical Corporation ("KYOCERA") Initia Total Hip System 28mm CoCr and 28mm BIOCERAM AZUL femoral head and Initia femoral stems can be used with the KMTI 28mm ID Bipolar Head.

-The KYOCERA Initia Total Hip System femoral stem can be used with the KMTI 22mm CoCr femoral head and KMTI 22mm ID Bipolar Head.

The Bipolar Head is for uncemented use only.

Bipolar outer heads are not for use with acetabular shells and liners.

The Renovis Surgical Hip Replacement System (K112897) includes multiple subsystem offerings, including:

• K131354: Renovis Bipolar Hip System ●
  Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification is additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation. Japan Initia Total Hip System (now Kyocera Corporation, Japan; "KCJ") that may be used with the KMTI K131354 Kyocera Bipolar Hip System.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance results, or any study details that would allow me to answer your request.

The document is a 510(k) premarket notification from the FDA, which primarily focuses on establishing substantial equivalence to a predicate device. It discusses:

• Device name and classification.
• Intended use and indications for use.
• Comparison to a predicate device.
• Compliance with design controls and FDA guidance.

It does not contain any data from performance studies, clinical trials, or validation tests that would outline acceptance criteria and how a device achieved them. Specifically, there is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

Therefore, I cannot fulfill your request for this specific document.

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