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Total hip components are indicated for uncemented use only in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJ) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyclitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; fernoral osteotomy, or Girdlestonc resection; fracture dislocation of the hip; and correction of deformity.

The Synergy Porous Size 8 Hip Stem is manufactured from titanium material (Ti-6AI-4V, ASTM F1472) and is designed for use with existing cobalt chrome or ceramic modular femoral heads with a 12/14 taper.

The provided text is a 510(k) summary for the Synergy Porous Size 8 Hip Stem. It describes the device, its intended use, and states that its technological and performance characteristics are "substantially equivalent" to legally marketed devices. However, the document does not contain any information about specific acceptance criteria, a study proving the device meets these criteria, or any of the detailed information requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).

The 510(k) submission process for this type of medical device at the time focused on demonstrating "substantial equivalence" to a predicate device, rather than requiring extensive de novo clinical trials with specific performance metrics and acceptance criteria as might be seen for novel technologies or higher-risk devices today.

Therefore, I cannot fulfill your request for the detailed table and study information because it is not present in the provided text. The document explicitly states:

"x croomance that the Synergy Porous Size 8 Hip Stem is substantially equivalent to legally marketed devices."

This indicates that the submission relied on demonstrating similarity to existing devices rather than a performance study with defined acceptance criteria and measurable outcomes.

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