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The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NID) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The system is intended for use either with or without bone cement in total hip arthroplasty.

The Continuum and Trilogy IT Acetabular Systems are modular acetabular cup systems intended to replace a hip joint and designed to achieve fixation to bone either with or without bone cement. The systems consist of porous coated shells, optional dome and screw hole plugs, and highly cross-linked polyethylene (HXPE) liners. The shells with screw holes permit the use of previously cleared Tivanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient. The dome and screw hole plugs may be placed by the surgeon into any unused holes in the shell.

The provided document is a 510(k) premarket notification for a hip implant system (Continuum and Trilogy Integrated Taper (IT) Acetabular Systems). It specifically details a labeling modification to add Magnetic Resonance Imaging (MRI) compatibility information.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the criteria for demonstrating MRI compatibility, not the clinical effectiveness or safety of the hip implant itself as a medical device for its primary intended use.

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

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated in terms of a "sample size" for patients or devices tested in a clinical setting. The evaluation was for the device itself rather than human subjects.
• Data Provenance: The study was a non-clinical performance evaluation, so country of origin of data (in terms of patient origin) is not applicable. It was a prospective evaluation of the device's MRI compatibility.

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)

• Not applicable. The ground truth for MRI compatibility is established by engineering and physics principles and testing, not by expert medical consensus in this context.

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

• Not applicable. This was a non-clinical, technical evaluation.

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 MRMC or AI study was conducted. This submission is for MRI compatibility of a hip implant, not an AI-powered diagnostic device.

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

• Not applicable. This is not an algorithm or AI device.

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

• The ground truth for the MRI compatibility testing was based on results obtained from testing the physical device(s) against established standards and guidance documents for MRI compatibility. This would typically involve measurements of magnetic force, torque, heating, and artifact generation in an MRI environment.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. (See #8)

Summary of the Study:

The study referenced is a non-clinical performance evaluation that assessed the Continuum and Trilogy IT Acetabular Systems for compatibility in the Magnetic Resonance (MR) environment. This evaluation was conducted per the FDA's "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" Guidance for Industry and FDA Staff.

Based on the results of this evaluation, the conclusion was that the device met the criteria for "MR Conditional" labeling and that MR compatibility safety information should be included in the product's package insert. This indicates that the device has undergone specific testing to determine its behavior and safety within an MRI magnetic field, and conditions for safe scanning have been established. "MR Conditional" means that the device can be safely scanned under specified conditions (e.g., static magnetic field strength, gradient magnetic field, radiofrequency field).

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The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The system is intended for use either with or without bone cement in total hip arthroplasty.

The proposed Continuum and Trilogy IT Acetabular System Shells are a line extension to the predicate modular acetabular shells, with a smaller 40 mm outer diameter. The Longevity IT Elevated Liner in this submission is offered in a size to be used with the 40 mm Continuum and Trilogy IT Shells above and has a 22 mm articulation diameter. The Longevity IT Offset and Oblique Liners are modular acetabular cup liners intended to be used with the Continuum and Trilogy IT Acetabular Systems. Offset Liners have a head center that is offset 7 mm beyond the acetabular shell center of rotation and the Oblique Liners have a liner face and head center tilted by 10° relative to the acetabular shell rim.

The provided document describes the Zimmer Continuum® and Trilogy® IT Acetabular Systems & Longevity® IT Highly Crosslinked Polyethylene Elevated, Offset, and Oblique Liners. This is a medical device for total hip arthroplasty. The document details the non-clinical performance and conclusions, but explicitly states that clinical data and conclusions were not needed for this device. This means there was no study involving human subjects or expert readers to evaluate its performance against specific acceptance criteria in a clinical setting as would typically be done for AI/diagnostic devices.

Therefore, many of the requested elements for an AI/diagnostic device's acceptance criteria and study design are not applicable to this submission.

Here's an analysis based on the provided text, addressing the applicable points:

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

Since this is a non-clinical evaluation of a hip prosthesis, the "acceptance criteria" are related to mechanical and physical performance rather than diagnostic accuracy. The document lists the specific non-clinical tests conducted, implying that the device "met performance requirements." However, the specific quantitative acceptance criteria for each test (e.g., "liner push-out force must exceed X Newtons") and the actual numerical results are not explicitly detailed in this summary.

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

This information is not provided because the study was non-clinical (mechanical testing of physical devices), not a clinical study involving patients or data. The "test set" would refer to the number of physical liners and shells subjected to each mechanical test. This specific quantity is not disclosed in the summary document.

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)

Not applicable. Ground truth for mechanical testing is established by engineering specifications and measurements, not expert human interpretation.

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

Not applicable. Adjudication methods are relevant for subjective human assessments, not objective mechanical testing.

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 physical hip prosthesis, not an AI diagnostic tool that assists human readers.

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

Not applicable. This is not an algorithm.

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

For non-clinical performance, the "ground truth" implicitly refers to engineering specifications, material science standards, and biomechanical requirements for an implantable device to function safely and effectively within the human body. For example, a "liner push-out" test would have an engineering specification for the minimum force required to dislodge the liner, and the measured force would be compared against that.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. This is a physical device, not an AI model.

In summary: The provided document is a 510(k) premarket notification for a medical device (hip prosthesis) based entirely on non-clinical performance testing. It states that "Clinical data and conclusions were not needed for this device" because it is a line extension of previously cleared predicate devices and it met performance requirements through various mechanical and material tests. Therefore, questions related to clinical studies, expert readers, AI performance, and AI training/ground truth are not relevant to this specific submission.

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