(207 days)
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
Hemi hip replacement is indicated in the following conditions: - Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.
- Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
- Avascular necrosis of the femoral head.
- Non-union of femoral neck fractures.
- Certain high subcapital and femoral neck fractures in the elderly.
- Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
- Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.
The submission covers a portfolio of hip implants including Hip Stems, Acetabular Shells and Liners, Femoral Heads, and Hip Components. Specific device descriptions are provided for various product families within these categories, detailing materials, designs, and available sizes.
The provided document is a 510(k) Premarket Notification from DePuy Ireland UC to the FDA, related to expanding the labeling for their hip implant portfolio to include updated MRI compatibility information. The submission asserts that there is no change to the indications, intended use, safety, fit, form, or technological characteristics of the devices. Therefore, the study presented focuses solely on demonstrating the MRI conditional safety of these devices, not on their primary clinical performance or effectiveness for total hip replacement.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the devices are established by adherence to specific ASTM (American Society for Testing and Materials) standards for evaluating medical devices in the MR environment. The study aims to demonstrate that the hip implants meet the "MR Conditional" labeling.
| Acceptance Criteria (ASTM Standards for MR Safety) | Reported Device Performance (as stated in the document) |
|---|---|
| Magnetically Induced Displacement Force (ASTM F2052-21) | Passed (Testing carried out and reported within the 510(k)) |
| Magnetically Induced Diplacement Torque (ASTM F2213-17) | Passed (Testing carried out and reported within the 510(k)) |
| Radio Frequency (RF) Heating (ASTM F2182-19) | Passed (Testing carried out and reported within the 510(k)) |
| Image Artifacts (ASTM F2119-07) | Passed (Testing carried out and reported within the 510(k)) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of clinical data for performance or effectiveness. The testing described is non-clinical for MRI compatibility. The data provenance is also non-clinical, deriving from tests conducted to ASTM standards for MRI safety of medical devices. There is no mention of country of origin for clinical data or whether data is retrospective or prospective, as the study is not a clinical one.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described study is a non-clinical, in-vitro evaluation of MRI compatibility. "Ground truth" in the context of expert consensus or clinical outcomes is not relevant for this type of engineering performance testing.
4. Adjudication Method for the Test Set
This information is not applicable as the described study is a non-clinical, in-vitro evaluation of MRI compatibility. Adjudication methods typically apply to clinical studies where human assessment of outcomes or data labeling is involved.
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
There is no MRMC comparative effectiveness study mentioned in the document. The submission is for modifying existing device labeling to reflect MRI compatibility, not for an AI-assisted diagnostic or treatment system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the document describes an MRI compatibility study of hip implants, which are physical medical devices, not a software algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical study is defined by the objective measurements and pass/fail criteria specified within the referenced ASTM standards for MRI conditional safety (e.g., maximum temperature rise, maximum magnetically induced displacement force, maximum change in object-induced torque and image artifact size).
8. The Sample Size for the Training Set
There is no training set for the device described in the document. The devices are physical implants, and the testing performed is non-clinical for MRI safety.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set mentioned or implied in the context of this 510(k) submission.
§ 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.