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Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

• Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head. 2.
• Acute traumatic fracture of the femoral head or 3. neck.
• Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• Certain cases of ankylosis. 5.
  The AML® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prostheses to the bone cement.

The AML hip stem is manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy and has a cobalt-chrome-molybdenum alloy bead sintered porous coating (Porocoat®) applied to the stem. The porous coating is applied to the entire stem with the exception of the tapered stem tip region.

It appears the provided text describes a 510(k) submission for a medical device called the "AML® Hip Prosthesis," a total hip joint replacement prosthesis. This submission focuses on establishing substantial equivalence to previously cleared devices rather than providing a performance study with detailed acceptance criteria and a study design to prove those criteria.

Therefore, the information required to populate the table and answer the study-related questions (points 1-9) about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided text.

The document details:

• Device Name: AML® Hip Prosthesis
• Sponsor: DePuy Orthopaedics, Inc.
• Classification: Class II
• Device Product Code: LPH (Hip Semi-constrained, Metal/Polymer, Porous Uncemented)
• Description: Manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy with a cobalt-chrome-molybdenum alloy bead sintered porous coating (Porocoat®) applied to the entire stem (except the tip).
• Intended Use: To provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients with sufficient sound bone to seat and support components.
• Indications for Use: Osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement), and certain cases of ankylosis. Indicated for cementless use (biological tissue ingrowth) and cemented use (porous coating augments fixation to bone cement).
• Substantially Equivalent Device(s): Porocoat® Prodigy™ Hip Prosthesis (K931641), Vision AML® Hip Prosthesis (K953694), AML Hip Prosthesis (K003800).
• Basis for Substantial Equivalence: Similarities of design, commonly used materials, identical sterilization processes, the same indications for use and intended use.
• FDA Clearance Date: October 19, 2001

The document explicitly states: "No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems." This further emphasizes that the 510(k) process for this device relies on demonstrating equivalence to predicate devices, not on meeting specific, pre-defined performance acceptance criteria through a new clinical or non-clinical study detailed in this submission.

Therefore, I cannot provide the requested table and study details as they are not included in the provided 510(k) summary.

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