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The Synergy Hip System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The Synergy Hip System is also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The Synergy Hip System is intended for single use only.

The Synergy Hip System includes Synergy Hip System Femoral Components with tantalum markers and acetabular component liners with tantalum markers. The addition of tantalum markers is the only change between the predicate devices and the devices included in this submission. The tantalum markers will allow the surgeon to perform radiostereometric analysis to measure implant migration or movement through radiographs.

This 510(k) summary describes a modification to the Synergy Hip System, specifically the addition of tantalum markers. The information provided heavily focuses on the regulatory aspects and equivalence to predicate devices, rather than a detailed study proving performance against acceptance criteria in the traditional sense of a clinical trial for a novel device.

The "acceptance criteria" and "device performance" in this context are interpreted as the regulatory requirement for substantial equivalence to legally marketed predicate devices, with the modification (tantalum markers) not raising new questions of safety or effectiveness. The study demonstrating this is primarily a comparison to predicate devices and an explanation of the function of the added markers.

Here's an attempt to extract and structure the requested information based on the provided text, while acknowledging that a traditional clinical study with explicit acceptance criteria and performance metrics for the entire hip system is not detailed here. Instead, the focus is on the incremental change (tantalum markers) and its impact on substantial equivalence.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

• Smith & Nephew Synergy Global Taper Hip System (K963509, K991485, K002996)
• Smith & Nephew Reflection Cross-Linked UHMWPE Acetabular Component (K002747)
• Biomet Tantalum Bead, Radiographic Marker (K010348)
• Encore Orthopedics Radiographic Marker (K011856) |
  | Functional Purpose of Tantalum Markers: The markers enable Radiostereometric Analysis (RSA) for measuring implant migration/movement via radiographs. | The tantalum markers will allow the surgeon to perform radiostereometric analysis to measure implant migration or movement through radiographs. This statement describes the intended and presumed function of the markers. |

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable or not specified for a traditional clinical "test set" in this submission. The "test" for substantial equivalence is primarily a comparison of design, materials, and intended use against predicate devices, rather than a performance study on a specific number of patients.
• Data Provenance: Not applicable in the context of a prospective or retrospective clinical study on the modified device itself. The data provenance implicitly relies on the regulatory approval and safety/effectiveness data of the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • Interpretation: For a 510(k) submission, the "ground truth" for substantial equivalence is established by the FDA's regulatory review process and comparison to existing, legally marketed devices. This process involves FDA reviewers (experts in medical device regulation and relevant scientific fields) evaluating the submitted documentation.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There is no mention of an adjudication process in the context of a clinical test set. The FDA's review process acts as the ultimate "adjudication" for substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No, this is not applicable. The device is a hip implant system, not an AI-assisted diagnostic or imaging device. The tantalum markers aid in a measurement technique (radiostereometric analysis) performed by a clinician, but the submission does not describe an MRMC study comparing human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: No, this is not applicable. This device is a physical implant, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: The "ground truth" here is the regulatory determination of substantial equivalence to previously cleared predicate devices. This relies on the established safety and effectiveness of those predicate devices, which would have been supported by their own ground truth data (e.g., historical clinical performance, mechanical testing, material compatibility, and potentially some outcomes data depending on their clearance pathway). For the tantalum markers specifically, their ability to enable RSA is a known radiographic technique, and the functional ground truth is that they are visible and aid in a measurement.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is not an AI/algorithm-based device requiring a training set.

9. How the Ground Truth for the Training Set was Established:

• How Ground Truth for Training Set was Established: Not applicable. There is no training set for this device.

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