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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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   Hemi hip replacement is indicated in the following conditions:
6. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.
7. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
8. Avascular necrosis of the femoral head.
9. Non-union of femoral neck fractures.
10. Certain high subcapital and femoral neck fractures in the elderly.
11. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
12. 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.

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.

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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. Total hip replacement is indicated in the following conditions:

• Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head. 2.
• Acute traumatic fracture of the femoral head 3. or neck.
• Failed previous hip surgery including joint র্বা reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthro-plasty, or total hip replacement.
• Certain cases of ankylosis. র.

The Summit Duofix™ Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

The Summit DuoFix™ Porous Hip prosthesis is a collarless, titanium, tapered femoral stem. The hip stem is manufactured from titanium (Ti-6Al-4V) and has a sintered commercially pure bead porous coating (Porocoat®) titanium applied to the stem with a thin layer of hydroxyapatite (HA) coating applied. The hip stem consists of 10 body sizes ranging in diameter from 7mm (Size 1) to 18mm (Size 10) with each body size having two offset options.

The provided text is a 510(k) Summary for the DePuy Summit™ DuoFix™ Hip Prosthesis. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this 510(k) summary.

Explanation:

• 510(k) Premarket Notification: This regulatory pathway is for medical devices that are "substantially equivalent" to a legally marketed predicate device. The primary goal is to demonstrate that the new device is as safe and effective as the predicate, not necessarily to prove its performance against a predefined set of acceptance criteria in a new study.
• Focus on Substantial Equivalence: The document explicitly states: "The Summit™ DuoFix™ Hip Prosthesis has the same intended use, is made from similar materials and has the same basic design as the predicate devices and is therefore substantially equivalent." This is the core argument.
• "No performance standards have been established...": The document also notes under "Device Product Code" that "No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems." This further emphasizes that there aren't FDA-mandated performance metrics that a study would be designed to meet.

To provide the requested details, one would typically need information from a full clinical trial report or a performance study that measures specific outcomes against predefined acceptance criteria, which is not part of this 510(k) submission.

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