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The indications for the Modular Protrusio Cup are as follows:

• 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis
• 3. Correction of functional deformity
• 3. Correction of nonunion, femoral neck fractures, and throchanteric fractures of Treatment of nomanon, remoring involvement, unmanageable using other techniques
• 5. Revision of failed joint construction or treatment

The Modular Protrusio Cup is a hemispherial metallic cup with a hook, flange, or blade extending from it. The ilium flange and hook are fabricated from commercially pure (CP) titanium. The cup and blade are made from titanium alloy. The malleable commercially pure (CP) titanium flange and hook can be shaped by the surgeon intraoperatively to fit the shape of the patient's anatomy. The surface of the hook and blade has a grit blasted (roughened) finish for potential enhanced fixation to the bone. The cup will have plasma spray porous coating to enhance potential fixation to any host bone available.

The purpose of the cup is to provide reinforcement for the acetabular socket and facilitate bone grafting in cases of severely deficient acetabulum. The pelvic bone grafts are protected form stress overload and potential collapses with the cup. This device can potentially resist acetabular migration by serving as a connection between host bone and to host bone.

There are several different options with the use of a hook and flanges. The flanges come in three different sizes, the blade in two and the hook in one. The use of 6.5-mm low profile screws is used to secure the flanges, hooks and cup in place.

Any polyethylene ring-loc liner may be used with this system. The liner may be placed anteverted to correct anatomic position within the cage if need be.

This document describes a medical device submission, specifically a 510(k) premarket notification for a "Modular Protrusio Cup." The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not to prove its safety and effectiveness through a clinical study with detailed acceptance criteria and performance metrics described here.

Therefore, the provided text does not contain information about:

• Acceptance criteria and reported device performance in a table.
• Sample sizes, data provenance, or details of a test set.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for training sets.
• How ground truth for training sets was established.

Instead, the document focuses on:

• Device Name: Modular Protrusio Cup
• Intended Use/Indications For Use:
  1. Noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis).
  2. Rheumatoid arthritis.
  3. Correction of functional deformity.
  4. Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
  5. Revision of failed joint construction or treatment.
• Device Description: A hemispherical metallic cup with a hook, flange, or blade made of CP titanium and titanium alloy. Designed to reinforce the acetabular socket, facilitate bone grafting, and resist acetabular migration. It can be used with a polyethylene ring-loc liner.
• Potential Risks: Standard risks associated with joint replacement devices, such as reaction to bone cement, fracture of the component, infection, loosening, etc.
• Substantial Equivalence: The primary method of demonstrating safety and effectiveness in a 510(k) is by showing substantial equivalence to legally marketed predicate devices. The document lists several predicate devices from Biomet, Osteonics, and Intermedics Orthopaedics.

Conclusion:

The provided document details a 510(k) premarket notification, which is a regulatory submission focused on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study with detailed acceptance criteria and performance metrics for a novel AI or diagnostic device. Therefore, the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not present in this text.

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