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Intended Use: The Osteonics® Normalized AD-HA Acetabular Components are single-use devices. The shells are intended for cementless fixation within the prepared acetabulum. The Osteonics® Normalized AD-HA Acetabular Components are compatible with any appropriately selected Osteonics hip stem/femoral head combination.

Indications:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, theumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Each The Osteonics® Normalized AD-HA Acetabular Components are single-use devices. Osteonics® Normalized AD-HA Acetabular Component consists of two pieces: an Osteonics® Normalized AD-HA Acetabular Shell and an Osteonics® Omnifit® Scalloped Cup Insert. The metal shell is intended for cementless fixation within the prepared acetabulum.

The Osteonics" Normalized AD-HA Acetabular Shells are characterized by the following features:

• A basic spherical and tangent radii design.
• The predicate interior geometry which allows a mating polyethylene insert size to be used with more than one shell size.
• Peripheral screw holes.
• A dome hole which is compatible with the optional, currently marketed Osteonics" Acetabular Dome Hole Plugs.
• Circumferential normalizations.
• A wide range of sizes.
• One of two screw hole configurations:
  • 6 peripheral screw holes and no dome screw holes.
  • 6 peripheral screw holes, and 5-7 dome screw holes.
• Osteonics' AD-HA coating.

The Osteonics® Omnifit® Scalloped Cup Inserts differ from the predicate Osteonics® Omnifit® Cup Inserts in that they feature a scalloped rim. The scalloped rim allows for clearance between bone screws (which may be placed in the peripheral screw holes of the shell) and the insert's rim.

The provided text describes a medical device, the Osteonics® Normalized AD-HA Acetabular Component System, and its submission for 510(k) premarket notification. However, it does not contain information about acceptance criteria, device performance tables, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The "Performance Data" section specifically states: "A complete battery of tests, in accordance with the following FDA guidelines, was conducted to qualify and characterize the AD-HA coating of the subject devices: FDA's "Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants, November 11, 1992" and FDA's "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, April 28, 1994."

This indicates that pre-clinical engineering and material tests were performed to ensure the device's characteristics meet established standards for orthopedic implants, particularly regarding its AD-HA coating. It does not refer to clinical studies or performance evaluations on patient data that would typically involve acceptance criteria, test sets, experts, or ground truth as you've requested.

Therefore, I cannot provide the requested information based on the given input, as it is outside the scope of the provided document. The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, and design features, rather than presenting results from a performance study involving human interpretation or clinical outcomes.

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