(69 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, internal fixation, arthrodesis, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
Partial hip replacement is indicated in the following conditions:
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
- 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 hip hemiarthroplasty.
The EMPHASYS Femoral Stems include HA-coated femoral stems in standard and high offsets and in collared and collarless configurations. The EMPHASYS Femoral Stems are designed to be used as one component of a system of prostheses in hip arthroplasty. The stems are compatible with a DePuy modular metal, dual mobility, or ceramic femoral head, and either a one-piece or a metal-backed two-piece acetabular component for use in total hip arthroplasty, and with a modular unipolar metallic femoral head or a modular bipolar head construct for hemi-hip arthroplasty.
The provided document is a 510(k) summary for a medical device (EMPHASYS Femoral Stems) and primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that no clinical tests were conducted to demonstrate substantial equivalence.
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or ground truth establishment for a study proving device performance against specified acceptance criteria.
The document discusses performance in terms of non-clinical tests for mechanical properties and biocompatibility. Here's a breakdown of what is present in the document related to "performance data" and "acceptance criteria" in a non-clinical context:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (against ISO standards) | Reported Device Performance (Conclusion) |
|---|---|
| Neck Fatigue (to ISO 7206-6: 2013) | Met (implied by "Testing... performed... to demonstrate substantial equivalence") |
| Distal Stem Fatigue (to ISO 7206-4: 2010) | Met (implied by "Testing... performed... to demonstrate substantial equivalence") |
| Range of Motion (to BS EN ISO 21535: 2009) | Met (implied by "Testing... performed... to demonstrate substantial equivalence") |
| Taper equivalence | Met (implied by "Testing... performed... to demonstrate substantial equivalence") |
| Biocompatibility evaluation (to ISO 10993-1:2018) | Met (implied by "Biocompatibility evaluation was carried out... and testing was carried out to include genotoxicity... cytotoxicity... sensitization... pyrogenicity... and chemical characterization") |
| Genotoxicity (to ISO 10993-3:2014) | Met (implied by "testing was carried out to include genotoxicity") |
| Cytotoxicity (to ISO 10993-5:2009) | Met (implied by "testing was carried out to include cytotoxicity") |
| Sensitization (to ISO 10993-10:2010) | Met (implied by "testing was carried out to include sensitization") |
| Pyrogenicity (to ISO 10993-11:2017) | Met (implied by "testing was carried out to include pyrogenicity") |
| Chemical Characterization (to ISO 10993-18:2020) | Met (implied by "testing was carried out to include chemical characterization") |
| Bacterial Endotoxin Testing (to ANSI/AAMI ST 72:2019) | Met ("The proposed devices also meet the requirement of bacterial endotoxin testing") |
| MRI Safety Evaluation (following ASTM F2503-13) | "No safety issues related to magnetic field interactions under specific conditions identified in the labelling." |
| Magnetic Induced Force (ASTM F2213-17) | Evaluated (worst-case components and constructs) |
| Image Artefact (ASTM 2119-07 (reapproved 2013)) | Evaluated (worst-case components and constructs) |
| RF Heating (ASTM F2182-19) | Evaluated (worst-case components and constructs) |
| Hydroxyapatite characterization data (FDA Guidance) | Provided |
Regarding the study that proves the device meets acceptance criteria (for clinical performance):
The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence."
Therefore, the following information cannot be provided from this document:
- 2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method for the test set: Not applicable.
- 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: Not applicable. This device is a hip implant, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not applicable for clinical performance. For non-clinical tests, the ground truth is established by the specified ISO/ASTM standards and internal compliance.
- 8. The sample size for the training set: Not applicable as no clinical study with training data was conducted.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission relies on non-clinical performance data and a comparison of technological characteristics to a legally marketed predicate device to establish substantial equivalence, rather than a clinical study demonstrating performance against specific clinical acceptance criteria.
§ 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.