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Total hip components are indicated for uncemented use 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 (NIDJD) 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 osteomyelitis 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; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Modular Hip components are for single use only.

The Smith & Nephew Modular Hip consists of primary and revision stems used with porous and HA coated modular sleeves. The stems feature a 12/14 taper and are used with existing Smith & Nephew femoral heads and acetabular components. Modular hip stems and sleeves are manufactured from Ti-6Al-4V conforming to ASTM F 1472 or ASTM F 136.

The provided text is related to the Smith & Nephew Modular Hip, a prosthetic hip joint. It contains information about its regulatory submission (510(k) K052426) and its substantial equivalence to predicate devices. However, the document does not provide information on acceptance criteria or a study that specifically describes device performance in the context of clinical outcomes, diagnostic accuracy, or a specific performance metric that would have associated acceptance criteria.

The document primarily focuses on:

• Device Description: What the hip implant is made of and its components.
• Device Classification: Its regulatory class (Class II).
• Indications for Use: The medical conditions for which the device is intended.
• Substantial Equivalence: How it compares to existing, legally marketed hip implants.
• Mechanical Testing: A general statement about mechanical test data indicating equivalence to clinically used devices and ability to withstand in vivo loading.
• Regulatory Clearance: The FDA's review and clearance of the 510(k) submission.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets those criteria because it is not present in the provided text.

The document states: "A review of the mechanical test data indicated that the Smith & Nephew Modular Hip is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure." This is the closest the document comes to mentioning performance, but it's a high-level summary and not a detailed study report with specific acceptance criteria or performance metrics that address clinical or diagnostic performance.

If this were a diagnostic or AI device, the requested information would be expected. However, for a mechanical orthopedic implant seeking 510(k) clearance, the "acceptance criteria" are generally met through demonstrating substantial equivalence to predicate devices via design, materials, and mechanical testing to established standards (like ASTM or ISO, as indicated by the reference to ISO 7206-4, ASTM F67, ASTM F1472, ASTM F136). The "study that proves the device meets the acceptance criteria" would be the mechanical testing summarized, rather than a clinical trial with patient outcomes or a diagnostic accuracy study.

Without specific performance metrics and acceptance criteria in the provided text, I cannot fill out the requested table or answer the specific questions about sample size, experts, ground truth, etc.

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