(112 days)
The Continuum and Trilogy IT Acetabular Systems are indicated for primary or revision surgery 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 devices are intended for use either with or without bone cement.
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, a polyethylene liner and optional screws. The shells with screw holes permit the use of Tivanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.
This document is a 510(k) premarket notification for the "Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems," which are components of a total hip prosthesis. The notification focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods is not directly available in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity) for a device like an AI algorithm are present in this document. This submission is for a medical device (hip prosthesis) and focuses on mechanical and biological performance, primarily through non-clinical testing and comparison to predicate devices, rather than a diagnostic or AI-driven system.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable - This document is a 510(k) for a medical device (hip prosthesis) focusing on substantial equivalence, not an AI/diagnostic device with numerical performance criteria. | Not applicable |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable. This submission doesn't describe a "test set" in the context of an AI or diagnostic algorithm's performance evaluation on patient data. The non-clinical testing would involve physical samples of the device.
- Data Provenance: Not applicable. The document discusses non-clinical testing of the physical device, not a dataset of patient information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined for AI/diagnostic studies (e.g., expert consensus on image interpretation, pathology reports) is not relevant to this type of device submission. The "ground truth" for a hip prosthesis would be its mechanical integrity and biocompatibility, assessed through laboratory tests and manufacturing controls.
4. Adjudication method for the test set:
Not applicable. There is no specific "adjudication method" mentioned for a test set of patient data, as this is not an AI/diagnostic device submission.
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 is not an AI-assisted diagnostic or interpretation device, so an MRMC study is not relevant.
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:
Not applicable in the context of AI/diagnostic algorithms. For this medical device, the "ground truth" would be established by validated engineering principles, material science standards, and biocompatibility testing.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. There is no "training set" involved.
Summary of the Study Discussed (Non-Clinical Performance):
The document states:
- "Non-Clinical Performance and Conclusions: Non-Clinical testing demonstrated that the Continuum and Trilogy IT Acetabular Systems met performance requirements and are as safe and effective as their predicates."
This indicates that the study performed was non-clinical (laboratory testing) and aimed to show that the new device's performance was equivalent to that of existing, legally marketed predicate devices. The "performance requirements" would refer to mechanical properties (e.g., strength, durability, fatigue resistance) and potentially other material-specific tests relevant to an orthopedic implant. The specific details of these "performance requirements" and the results are not elaborated upon in this summary document but would have been part of the full 510(k) 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.