(121 days)
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.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Liner Push-Out Evaluation | Met performance requirements |
| Liner Lever-Out Evaluation | Met performance requirements |
| Liner Torque-Out Evaluation | Met performance requirements |
| Rim Deformation Testing | Met performance requirements |
| Liner Locking Mechanism Strength Analysis | Met performance requirements |
| Anatomic Fatigue Testing | Met performance requirements |
| Liner Wear Performance | Met performance requirements |
| Liner Durability and Backside Wear | Met performance requirements |
| Temperature Effects on Liner Assembly | Met performance requirements |
| Interaction of MRI with Implants | Met performance requirements |
| Range of Motion Evaluation | Met performance requirements |
| Shell Fatigue and Deformation Evaluation | Met performance requirements |
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.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.