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The components are indicated for the following:

1. Non-inflammatory degenerative joint disease including osteonecrosis, avascular necrosis and post traumatic arthritis;
2. Rheumatoid arthritis;
3. Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
4. Revision procedures where other treatment or devices have failed; and
5. Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

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 or noninflammatory degenerative joint disease (NID/D) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The indications for use in total hip arthoplasty include rheumatoid arthritis; post-traumatic arthritis; avascular necrosis and femoral neck fractures.

1. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
2. Fracture or avascular necrosis of the femoral head
3. Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
4. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
5. Fracture or avascular necrosis of the femoral head
6. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
7. All forms of osteoarthritis
8. Patients with hips at risk of dislocation
9. Femoral neck fracture or proximal fracture to hip joint
   The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement> The POLARCUP Dual Mobility System is intended for single use only.
   The components are intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered.
   The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised.

The purpose of this Traditional 510(k) is to add "MR Conditional" labeling to the subject Smith & Nephew Hip Systems. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the devices' design, material, sterilization and the manufacturing processes of the previously cleared devices.

This document is a 510(k) Premarket Notification from Smith & Nephew, Inc. for various Hip Systems. The purpose of this submission is to add "MR Conditional" labeling to these hip systems.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes MR Conditional labeling, meaning the devices have been tested and found to be safe for use in specific MRI environments. The acceptance criteria are based on established standards for MRI compatibility.

Key takeaway: The document confirms that "Magnetic Resonance Imaging (MRI) compatibility testing was conducted as per the FDA's guidance and the Standards listed" to support the "MR Conditional" labeling. However, it does not provide specific data points (e.g., maximum temperature rise, angular deflection, or translational force metrics) for each test. Instead, it makes a general statement that the testing supports the MR Conditional claim.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in terms of patient data or clinical images, as the study is focused on the physical devices' compatibility with MRI environments, not clinical performance or diagnostic accuracy.

The studies were conducted on the devices themselves (hip systems and their components). The provenance is implied to be laboratory testing based on the referenced ASTM and ISO standards for MRI compatibility. The data is prospective in the sense that the tests were performed to demonstrate compliance for new labeling.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable to this type of submission. The "ground truth" here is established by the scientifically validated test methods and established standards (e.g., ASTM, ISO, IEC) for MRI compatibility, not by expert consensus on clinical cases. The tests themselves define the "ground truth" for the physical properties being measured (e.g., magnetic susceptibility, RF heating).

4. Adjudication Method for the Test Set:

This is not applicable as the studies are physical/engineering tests against objective standards, not interpretation of clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is used to assess the diagnostic performance of an AI algorithm in comparison to or in conjunction with human readers. This submission is for the "MR Conditional" labeling of hip systems, which is a safety and functional characteristic of the physical implant, not a diagnostic AI device.

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

No, a standalone algorithm performance study was not done. This submission is not for an algorithm or AI device.

7. The Type of Ground Truth Used:

The ground truth used for these "MR Conditional" studies is objective physical measurements conducted according to recognized international consensus standards (ASTM, ISO, IEC) and FDA guidance documents. These standards define the acceptable limits for parameters like magnetically induced displacement, torque, and RF-induced heating.

8. The Sample Size for the Training Set:

This information is not applicable as this is not an AI/machine learning device requiring a training set. The "training" for the hip systems refers to their design and manufacturing to meet performance specifications.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as this is not an AI/machine learning device. The "ground truth" for the design and manufacturing of the hip systems is established through engineering principles, material science, biomechanical testing, and adherence to quality systems and regulatory requirements, which are inherent to their previous clearances. The ground truth for the MR Conditional labeling is established by the referenced MRI compatibility test standards.

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