Search Results

EMPHASYS Femoral Stems are intended for use in total and partial hip arthroplasty. The stems are intended only for uncemented use.

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Partial hip arthroplasty (hip hemiarthroplasty) is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.

EMPHASYS Femoral Stems are intended for single use only.

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Partial hip replacement is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.

The EMPHASYS Femoral Stems are indicated for cementless use only.

The EMPHASYS Femoral Stems include HA-coated femoral stems in standard and high offsets and in collared and collarless configurations.

The stems are manufactured from titanium alloy forgings per ASTM F620-20 and coated with a layer of plasma-sprayed HA per ASTM F1185-14 and ISO 13779-6: 2015.

The provided FDA 510(k) summary (K233233) describes an application for an extension of the shelf life of the EMPHASYS Femoral Stems from 5 years to 10 years, not a new device or an AI/software-based device.

Therefore, the requested information regarding acceptance criteria for device performance, sample size for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training set details are not applicable to this submission. This document focuses on the equivalence of properties related to an extended shelf life.

However, I can extract and present the acceptance criteria and reported device performance related to the shelf-life extension from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission explicitly states:

• No clinical tests were conducted to demonstrate substantial equivalence for this shelf-life extension.
• The shelf life extension will not impact the fit, form, or function of these components as they are manufactured to the same specifications and utilize the same materials as the predicate devices.
• The nonclinical tests reviewed as part of K211657 and K203167 (previous clearances for the device and a predicate) remain current.

Given that this is a 510(k) for a shelf-life extension of an existing medical device, rather than the initial clearance of a device that relies on complex performance metrics or AI, the detailed performance study requirements (like those for AI/software devices) are not relevant here.

Ask a specific question about this device

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Partial hip replacement is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. 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)

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.

Ask a specific question about this device