(88 days)
Total hip components are indicated for 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 ioint 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; 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. The subject devices are intended for single use only.
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. 10/12 Taper Oxinium Femoral Heads. The subject devices are geometrically similar to the femoral head component in the Echelon Titanium Hip System cleared via submission K072817 and will include the addition of 32 mm and 36 mm diameter head sizes. This premarket notification seeks to add the 10/12 taper femoral head in oxidized zirconium material. Oxidized zirconium is the material of manufacture for 12/14 taper Femoral Heads cleared via submission K021673. The subject device will be offered in a size of 22 mm with offsets of -3, +0, and +3 mm; and is sizes ranging from 26 mm - 36mm, all with offsets of -5, +0, and +5 mm.
The provided document describes a 510(k) premarket notification for the "10/12 Taper Oxinium Femoral Heads" and its substantial equivalence to previously cleared predicate devices. It focuses on the physical and mechanical performance of the device rather than AI/software performance. Therefore, many of the requested fields related to AI model evaluation are not applicable or cannot be extracted from this document.
Here's the information that can be extracted from the provided text, along with an explanation for the inapplicable fields:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Aspects Tested) | Reported Device Performance |
|---|---|
| Pre-Fatigue and Post-Fatigue assembly and disassembly | Performs equal to or better than previously cleared devices (K021673, K072817) |
| Environmental Fatigue and Corrosion | Performs equal to or better than previously cleared devices (K021673, K072817) |
| Axial Fatigue | Performs equal to or better than previously cleared devices (K021673, K072817) |
| Range of Motion | Performs equal to or better than previously cleared devices (K021673, K072817) |
| Device Rigidity | Performs equal to or better than previously cleared devices (K021673, K072817) |
| Wear Performance | Performs equal to or better than previously cleared devices (K021673, K072817) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes physical and mechanical testing of a medical device (femoral head), not a software/AI device evaluated with a test set of data. Therefore, this information is not applicable. The "test set" here refers to physical components subjected to mechanical tests, not a data set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. Ground truth, in the context of expert review, typically relates to software predictions or image interpretations. For a physical device, performance is evaluated through engineering tests against established standards or predicate device performance, not expert consensus on data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in evaluating data, which is not relevant to the mechanical testing of a femoral head.
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
This information is not applicable. This study concerns the physical performance of a hip implant component, not an AI software or assistance system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. No algorithm or AI is described or evaluated in this document.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the performance data, the "ground truth" or reference for comparison is the performance of previously cleared predicate devices (Total Hip Femoral head - 12/14 Taper, K021673; and Echelon Titanium Hip System, K072817) in the specified mechanical and environmental tests. The underlying criteria for these tests would be derived from engineering standards and regulatory requirements for such devices.
8. The Sample Size for the Training Set
This information is not applicable. This document describes the testing of a physical medical device, not the training of an AI model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. There is no training set mentioned or implied as this is not an AI/software device.
§ 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.