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The Renovis Surgical Hip Replacement System is indicated for patients suffering from:

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; and

5. Revision procedures where other treatment or devices have failed.

The Renovis A400 Hip System is intended for cementless used with the Renovis Cemented Hip Stem.

The subject of this application are Renovis 4.5mm femoral stems (and a 5.25 mm broach) which are an expansion of the FDA cleared Renovis A400 Surgical Hip Joint Replacement Prosthesis (K112897) which is now known as the Renovis Surgical Hip Replacement System. The 4.5mm and 5.25mm femoral stems are the same material, the same configuration and will be offered in the same standard and lateralized offsets, as are the FDA cleared Renovis A400 femoral stems.

In addition, this application includes an update of Letter-to-File expansions and changes to the Renovis Surgical Hip Replacement System.

Renovis implants and instruments comply with the following material standards:

• ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-. 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
• ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes
• ASTM F1537-11 Standard Specification for Wrought Cobalt-28Chromium-● 6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
• ASTM A276-13a Standard Specification for Stainless Steel Bars and Shapes
• ASTM A240-14 Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications

The document provided is a 510(k) premarket notification decision letter from the FDA to Renovis Surgical Technologies, Inc., regarding their "Renovis Surgical Hip Replacement System." This document primarily focuses on the regulatory clearance of a medical device and describes its intended use, design, and comparison to a predicate device.

It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm's performance. The document is for a traditional surgical implant (hip replacement system), not a software device or an AI/ML-driven diagnostic or therapeutic tool.

Therefore, I cannot extract the requested information based on the provided text. The questions posed in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) are relevant to the evaluation of AI/ML-based medical devices, which this document does not cover.

The "Non-clinical Testing" section (G) refers to bench testing of the femoral stems according to ISO 7206-4 and coating characterization, but this directly relates to the mechanical performance and material properties of the physical implant, not the diagnostic accuracy or performance of a software algorithm.

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