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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:

1. 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 facture 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.
   Cemented Components:
   Femoral stem and acetabular cup total hip components labeled "For cemented use only" are indicated only for use with bone cement.
   This device is intended for single use.

The Summit™ Cemented Hip Prosthesis is a flanged, collared, tapered Cobalt-Chromium femoral stem with a smooth surface finish. There are 7 proportional body sizes with two offset options. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal.

The provided text describes a 510(k) premarket notification for the Summit™ Cemented Hip Prosthesis. This is a medical device approval document, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment relevant to the performance evaluation of an AI/ML powered device.

The document focuses on establishing substantial equivalence to previously marketed devices (predicate devices) based on intended use and basic design, rather than proving performance against specific acceptance criteria for a new AI/ML functionality.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI/ML device. Instead, it discusses indications for use and a comparison to predicate devices, which is a regulatory standard for traditional medical devices.
2. Sample size used for the test set and the data provenance: Not applicable. There's no test set in the context of an AI/ML performance study described here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to this device's approval pathway.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical hip prosthesis, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Conclusion:

This 510(k) summary is for a physical orthopedic implant (a hip prosthesis), not an AI/ML-powered medical device. Therefore, the information requested regarding acceptance criteria, study design, and performance metrics for an AI/ML device is not present in this document. The document's purpose is to demonstrate substantial equivalence to existing devices based on design and intended use, not to present data from a performance study against specific acceptance criteria like those used for AI/ML algorithms.

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