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The Converge RETi-Lock Multi-Hole Reinforcement Cup is intended for use in total hip arthroplasty for treatment of the following:

• Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• . Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
• . Revision of previously failed hip arthroplasty.

The Converge RETi-Lock Multi-Hole Reinforcement Cup is a hemispherical acetabular reinforcement shell made of titanium alloy. It is designed to expand the surgeon's options for treatment in cases when acetabular bone stock is deficient. This device also has a fixation plate designed to match the contour of the ilium of the acetabulum and a hook designed to attach to the obturator foramen. Numerous screw holes in the cup and along the plate help to ensure fixation in good bone stock.

The provided text describes a 510(k) summary for the "Converge RETi-Lock Multi-Hole Reinforcement Cup," a medical device for total hip arthroplasty. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications, or comparative effectiveness studies).

Instead, the document focuses on:

• Sponsor and Contact Information: Centerpulse Orthopedics, Inc.
• Trade and Common Name: Converge RETi-Lock Multi-Hole Reinforcement Cup, Non-porous, press-fit, acetabular shell system.
• Classification: Class II device (Product Codes LZO, KWA, JDI, LWJ).
• Predicate Devices: Ascendant Acetabular System (K022985) and Restoration GAP II Cup (K980774).
• Device Description: A hemispherical acetabular reinforcement shell made of titanium alloy, designed to expand treatment options for deficient acetabular bone stock, with a fixation plate and hook, and screw holes for fixation.
• Intended Use/Indications For Use: Treatment of noninflammatory degenerative joint disease (NIDJD), inflammatory joint disease (IJD), failed previous surgery where pain/deformity/dysfunction persists, and revision of previously failed hip arthroplasty.
• Basis of Substantial Equivalence: Stated as "Performance testing, design comparisons, and functional analyses conducted on the Converge RETi-Lock Multi-Hole Reinforcement Cup demonstrate that this device is substantially equivalent to the predicate devices."

Therefore, I cannot provide the requested table and study details because the necessary information is not present in the provided text. The document only states that performance testing was done to demonstrate substantial equivalence, but it does not elaborate on the specific criteria, results, or methodology of that testing.

To answer your request, I would need a different type of document that includes the actual study results, acceptance criteria, and methodological details of the performance testing.

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