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The DePuy aSphere M-Spec Head is indicated for use in the treatment of:

1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia;
2. Avascular necrosis of the femoral head;
3. Acute traumatic fracture of the femoral head or neck;
4. Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
5. Certain cases of ankylosis.
   The subject aSphere M-Spec Head is intended for use as part of the femoral component in a total hip arthroplasty.

The aSphere M-Spec Head is part of a modular prosthesis system for use in total hip replacement. It mates with DePuy femoral stems and articulates with DePuy acetabular inserts and cups.

The provided text details a 510(k) premarket notification for the "DePuy aSphere M-Spec Head," a modular femoral head for total hip replacement. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document outlines:

• Device Description: The aSphere M-Spec Head is part of a modular prosthesis system for total hip replacement, mating with DePuy femoral stems and articulating with DePuy acetabular inserts and cups.
• Indications for Use: Treatment of severely painful/disabled joints due to various arthritic conditions, avascular necrosis, acute femoral head/neck fractures, failed previous surgeries, and certain cases of ankylosis.
• Intended Use: As part of the femoral component in total hip arthroplasty.
• Basis of Substantial Equivalence: Similarities in intended use, indications for use, materials, design, method of manufacture, sterilization, and packaging methods to previously cleared DePuy M-Spec Heads (K980513, internal documentation to K851422, and K060031).

The FDA's letter (K082585) confirms the device's substantial equivalence to predicate devices, allowing it to be marketed. This 510(k) pathway for medical device approval primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with explicitly defined acceptance criteria for the new device's performance.

Therefore, I cannot provide the requested information in the table or answer the specific questions about acceptance criteria and a study proving their fulfillment, as this information is not present in the provided text. The document focuses on regulatory clearance based on equivalence, not on a detailed performance study with acceptance criteria.

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