(107 days)
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 Platform Hip Stem components are for single use only.
The Smith & Nephew Platform Hip Stem features a 12/14 taper and is used with existing Smith & Nephew femoral heads and acetabular components. The Platform Stem is manufactured from Ti-6Al-4V conforming to ASTM F 136.
The provided text is a 510(k) summary for the Smith & Nephew Platform Hip Stem. It is a premarket notification for a medical device and therefore describes the device, its classification, and its indications for use, but typically does not contain detailed clinical study data with acceptance criteria in the same way a PMA (Premarket Approval) application would.
Based on the provided text, the device is found to be substantially equivalent to predicate devices rather than proving its safety and effectiveness through a new clinical study with predefined acceptance criteria. This means the device is considered as safe and effective as a legally marketed device (predicate device) and does not require new clinical data demonstrating its performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement are not applicable or not present in this type of submission.
Here's a breakdown of the information that can be extracted or deduced from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as this is a 510(k) submission for substantial equivalence. The "acceptance criteria" here implicitly refer to demonstrating equivalence to predicate devices in design, materials, indications for use, and operational principles.
- Reported Device Performance:
- "A review of the test report data indicated that the Smith & Nephew Platform Hip Stem is capable of withstanding expected in vivo loading without failure." This is a general statement about mechanical testing, not a specific performance metric against a numerical acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable/Not provided. The submission relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study with a specific test set.
- Data Provenance: Not applicable/Not provided. The evidence for equivalence is primarily based on comparison to existing legally marketed devices, mechanical testing data (mentioned broadly), and design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable/Not provided. No new clinical 'test set' requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/Not provided. No clinical 'test set' requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No. This is a hip stem (implant) and not typically subject to MRMC studies like imaging AI algorithms. The submission is for a medical device's safety and effectiveness, established via substantial equivalence.
6. Standalone (Algorithm Only) Performance:
- Standalone Performance: Not applicable. This is a physical orthopedic implant, not an algorithm or AI.
7. Type of Ground Truth Used:
- Ground Truth: Not applicable. For a 510(k) submission of a physical implant, the "ground truth" for demonstrating safety and effectiveness is largely based on:
- Comparison to predicate devices (historical data of predicate device performance).
- Mechanical testing (materials science properties, fatigue testing, etc.).
- Clinical experience with the predicate devices.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable. This is not an AI/ML device.
Summary based on the document:
The regulatory pathway chosen for the Smith & Nephew Platform Hip Stem is a 510(k) premarket notification, which establishes substantial equivalence to already legally marketed predicate devices. This pathway does not typically involve the detailed clinical studies with specific acceptance criteria, test sets, ground truth, or expert adjudications that would be present in a Premarket Approval (PMA) application or in submissions for novel AI/ML devices. The "study" mentioned is a "review of the test report data," which primarily focuses on mechanical performance "withstanding expected in vivo loading without failure," implicitly comparing it to the performance of predicate devices.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.