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Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems:
· Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.

• · Failed previous surgery where pain, deformity, or dysfunction persists.
  · Revision of previously failed hip arthroplasty

The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:

• · Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases

• · Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, or total hip replacement (THR)

• · Acute traumatic fracture of the femoral head or neck

• · Avascular necrosis of the femoral head.

• · Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.

• · Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists.

• · Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

• · Acute traumatic fracture of the femoral head or neck.

• · Avascular necrosis of the femoral head.

The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis,
polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. · Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
· Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
· Patients with acute femoral neck fractures.

The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis,
polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.

• · Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.

• · Patients suffering from disability due to previous fusion.

• · Patients with previously failed endoprostheses and/or total hip components in the operative extremity.

• · Patients with acute neck fractures.

• This femoral stem is for total hip or hemi-hip arthroplasty and is indicated for the following conditions:

• Noninflammatory degenerative joint disease (NID), e. g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e. g., rheumatoid arthritis.

• · Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.

• · Optional use in revision: in some medical conditions (e. g., early revision when healthy and good bone stock exists) the surgeon may opt to use primary implants in a revision procedure.

• Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· Failed previous surgery where pain, deformity, or dysfunction persists.
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

· Revision of previously failed hip arthroplasty

Zimmer Hip Joint Replacement Prostheses are hip replacement system components. A femoral stem component is used in conjunction with a femoral head component for replacement of the proximal femur in total hip arthroplasty. Femoral stems are available in different designs, materials, sizes, neck lengths and taper sizes. A taper is incorporated in the design of the stem to interlock it with the femoral head. Femoral head components are available in a variety of sizes and neck lengths for reconstruction of the natural head center of the femur. The purpose of this submission is the addition of MR conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions of the components, compatibility, packaging, or sterilization.

The provided document is a 510(k) premarket notification for Zimmer Hip Joint Replacement devices. The submission focuses on adding MR conditional information to the labeling for existing predicate devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" pertain specifically to the MR Conditional safety of the implants and not to the efficacy of the hip replacements themselves.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with numerical values for MR Conditional testing results. Instead, it states that the devices have been determined to be MR Conditional based on specific testing. The acceptance criteria are implied by adherence to the standard ASTM F2503-13.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size of the devices tested for MR compatibility. It refers to "Zimmer Hip Joint Replacement implants" in general. The data provenance is not mentioned, but given the nature of the testing (evaluating physical interactions with magnetic fields), it would likely be laboratory-generated data rather than patient data. The country of origin of the data is not specified, but the applicant is Zimmer GmbH, Switzerland.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For MR compatibility testing, the "ground truth" is typically established by physical measurements and adherence to engineering standards, rather than expert consensus on diagnostic images. The expertise would lie in the engineers and physicists conducting the testing and interpreting the results according to ASTM F2503-13.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers evaluate medical images or data. This document describes a technical evaluation of device interaction with MRI fields. Therefore, an adjudication method in this sense is not applicable or described. The "adjudication" is essentially the determination of compliance with the ASTM F2503-13 standard.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is about the MR compatibility of hip implants, not about diagnostic AI or human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical medical implant, not an algorithm. The testing performed was related to the physical properties of the implant in an MRI environment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for MR Conditional testing is based on physical measurements and adherence to the technical requirements and thresholds defined in the ASTM F2503-13 standard. This includes measurements of RF-induced heating, static magnetic field interactions (e.g., deflection force, torque), and image artifact size.

8. The sample size for the training set

This question is not applicable. This is not an AI/algorithm-based device that requires a training set. The study is a technical evaluation of physical implants.

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set for this type of device and study.

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